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



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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 Regulations

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 of 1980 require the Department 
semiannually to publish an agenda summarizing all current and projected 
rulemaking and indicating those regulatory actions that are being 
analyzed for their effect on small businesses. The Department published 
its last such agenda on November 28, 1995. The document reflects the 
Department's efforts to reinvent its rulemaking practices in accordance 
with the President's strategy and invites comments to assist the 
Department in reviewing its regulatory processes and products.

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 Executive order and the Administration's effort to implement it 
have brought about substantial improvement in the Department's 
regulatory practices.

    Building on this success, the President announced in March of 
1995 an initiative involving more comprehensive reform. The 
President directed each agency to undertake an exhaustive review of 
all existing regulations with a view to eliminating or modifying 
those that are obsolete, impose undue burden on the public, or are 
otherwise in need of reform. He directed each agency to change the 
way regulatory outcomes are measured--focusing on results, not 
process. The President asked senior executives to regularly convene 
grassroots-partnership meetings to allow greater collaboration and 
participation in reinventing the regulatory process on the part of 
those affected by it. He also directed that agencies expand their 
efforts to use newly emerging consensus-building techniques during 
the rulemaking process.

    This agenda that follows constitutes the Department's most 
recent inventory of the regulatory actions to be taken in pursuit 
of the President's new approach to rulemaking. As we continue with 
this effort, we invite comments on the agenda entries and look 
forward to receiving suggestions for furthering the President's 
regulatory-reinvention strategy.

    Comments should be sent to the addresses listed below, 
depending on the specific regulations under discussion. Comments 
may be sent to the Office of the Secretary if that is preferable or 
if a responsible division of the Department is not clear or when 
the comment covers subjects crossing agency lines.

    Office of the Secretary: Jacquelyn Y. White, Deputy Executive 
Secretary, Office of the Executive Secretariat, Room 603H, Hubert 
H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 
20201.

    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 V. Dutra, Jr., Director, 
Regulatory Policy and Management Staff, 5600 Fishers Lane, 
Rockville, Maryland 20857; phone 301-443-3480.

    Administration on Children and Families: Madeline Mocko, 
Director, Office of Legislative Affairs and Budget, 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, 
6000 Executive Drive, Suite 603, Rockville, Maryland 20852; phone 
301-594-1457.

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

    Health Resource Services Administration: Alice Wallis, 5600 
Fishers Lane, Room 14-A-12, Rockville, Maryland 20857; phone 301-
443-1960.

    Indian Health Service: Betty Penn, 5600 Fishers Lane, Twinbrook 
Building, Suite 450, Rockville, Maryland 20857; phone 301-443-1116.

    National Institutes of Health: Jerry Moore, 9000 Rockville 
Pike, Building 31, Room 3B-11, Bethesda, Maryland 20205; phone 301-
496-4606.

    Substance Abuse and Mental Health Services Administration: Joe 
Faha, 5600 Fishers Lane, Room 12-A-17, Rockville, Maryland 20857; 
phone 301-443-4640.

Dated: April 4, 1996.

Claudia Cooley,

Executive Secretary to the Department.

                                  Office of the Secretary--Proposed Rule Stage                                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
936         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 
937         Civil Money Penalties for False Information on Drug Manufacturer Price Surveys and                  
            Rebate Agreements.....................................................................    0991-AA80 
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                                    Office of the Secretary--Final Rule Stage                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
938         Clarification of the Initial OIG Safe Harbor Provisions and Establishment of                        
            Additional Safe Harbor Provisions Under the Anti-Kickback Statute.....................    0991-AA66 
----------------------------------------------------------------------------------------------------------------


                                   Office of the Secretary--Long-Term Actions                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
939         Civil Money Penalties (CMPs) for Certain Hospital Physician Incentive Plans...........    0991-AA45 
940         Civil Money Penalties (CMPs) for Certain Practices Relating to Medicare Supplemental                
            Policies..............................................................................    0991-AA53 
941         Civil Money Penalties for Physician Ownership of and Referral to Certain Health Care                
            Entities..............................................................................    0991-AA65 
942         Senior Biomedical Research Services...................................................    0991-AA82 
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                                   Office of the Secretary--Completed Actions                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
943         Uniform Administrative Requirements for Grants and Cooperative Agreements.............    0991-AA56 
944         Safe Harbors for Protecting Health Plans..............................................    0991-AA69 
945         Revisions to the PRO Sanctions Process................................................    0991-AA73 
946         Revisions to the Civil Money Penalty Provisions Relating to the Misuse of Certain                   
            Symbols and Emblems...................................................................    0991-AA81 
----------------------------------------------------------------------------------------------------------------


                   Substance Abuse and Mental Health Services Administration--Final Rule Stage                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
947         Protection and Advocacy for Individuals With Mental Illness...........................    0930-AA02 
----------------------------------------------------------------------------------------------------------------


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


                  Substance Abuse and Mental Health Services Administration--Completed Actions                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
949         Block Grants for Prevention and Treatment of Substance Abuse (Tobacco Provisions).....    0930-AA03 
----------------------------------------------------------------------------------------------------------------


                                    Departmental Management--Final Rule Stage                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
950         Implementation of the Equal Access to Justice Act in Agency Proceedings...............    0990-AA02 
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[[Page 22958]]



                                   Food and Drug Administration--Prerule Stage                                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
951         Medical Foods.........................................................................    0910-AA20 
952         Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding               
            of Drugs; Proposed Amendment of Certain Requirements for Finished Pharmaceuticals.....    0910-AA45 
953         Reinventing FDA Food Regulations......................................................    0910-AA58 
954         Food Standards of Identity, Quality, and Fill of Container; Common or Usual Name                    
            Regulations: Request for Comments on Existing Regulations.............................    0910-AA67 
955         Reinvention of Regulations............................................................    0910-AA69 
956         Investigational New Drug Applications; Request for Information and Comments...........    0910-AA83 
----------------------------------------------------------------------------------------------------------------


                                Food and Drug Administration--Proposed Rule Stage                               
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
957         Over-the-Counter (OTC) Drug Review....................................................    0910-AA01 
958         Infant Formula: Good Manufacturing Practice, Quality Control Procedures, Quality                    
            Factors, Notification Requirements, and Records and Reports...........................    0910-AA04 
959         Implementation of the Safe Medical Devices Act of 1990................................    0910-AA09 
960         Reporting of Errors and Accidents.....................................................    0910-AA12 
961         Mammography Quality Standards Act of 1992.............................................    0910-AA24 
962         Latex Condoms: Expiration Date Labeling...............................................    0910-AA32 
963         Latex Warning.........................................................................    0910-AA34 
964         Hearing Aids; Professional and Patient Labeling; Conditions for Sale..................    0910-AA39 
965         Human Tissue Intended for Transplantation.............................................    0910-AA40 
966         Animal Medicinal Drug Use Clarification Act of 1994; Extra-Label Use; Implementation..    0910-AA47 
967         Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution....    0910-AA49 
968         Bioavailability and Bioequivalence Requirements.......................................    0910-AA51 
969         Consolidation of Regulations..........................................................    0910-AA53 
970         Name of Selling Agent or Distributor..................................................    0910-AA56 
971         Changes to an Approved Application....................................................    0910-AA57 
972         Dietary Supplement Regulations in Response to DSHEA...................................    0910-AA59 
973         Export Requirements for Drugs for Investigational Use in Other Countries..............    0910-AA61 
974         Human Tissue Intended for Transplantation and Human Reproductive Tissue Intended for                
            Fertilization, Implantation or Insemination...........................................    0910-AA70 
975         Adverse Experience Reporting for Human Drug and Licensed Biological Products;                       
            Increased Frequency Reports...........................................................    0910-AA72 
976         Investigational New Drug Applications; Clinical Holds.................................    0910-AA73 
977         Parenteral Drug Products Containing Aluminum as an Ingredient or Contaminant; Labeling              
            Requirements; Warning Statement.......................................................    0910-AA74 
978         Long-Term Contraceptive Drug Products and Medical Devices; Informed Consent                         
            Requirements..........................................................................    0910-AA75 
979         Debarment Certification Regulations for Drug Applications.............................    0910-AA76 
980         Certification of Drugs Composed Wholly or Partly of Insulin...........................    0910-AA77 
981         Over-the-Counter Human Drugs; Labeling Requirements...................................    0910-AA79 
982         National Environmental Policy Act; Policies and Procedures............................    0910-AA80 
983         Investigational New Drug Applications; Clinical Holds for Drugs for Life-Threatening                
            Illnesses.............................................................................    0910-AA84 
984         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.............................................................................    0910-AA86 
985         Sterility Requirements for Inhalation Solution Products...............................    0910-AA88 
986         Informed Consent for Human Drugs and Biologics; Determination That Informed Consent Is              
            Not Feasible..........................................................................    0910-AA89 
987         Direct-to-Consumer Promotion Regulations..............................................    0910-AA90 
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Final Rule Stage                                 
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
988         New Animal Drug Approval Process; Implementation of Title I of the Generic Animal Drug              
            and Patent Term Restoration Act (GADPTRA).............................................    0910-AA02 

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989         Current Good Manufacturing Practice for Blood and Blood Components; Notification of                 
            Consignees Receiving Blood and Blood Components at Increased Risk for Transmitting HIV              
            Infection.............................................................................    0910-AA05 
990         Prescription Drug Marketing Act of 1987; Policy Information, Guidance, and                          
            Clarifications........................................................................    0910-AA08 
991         Food Labeling Review..................................................................    0910-AA19 
992         Disqualification of Clinical Investigators............................................    0910-AA21 
993         Investigational Device Exemption; Intraocular Lenses..................................    0910-AA22 
994         Specific Requirements on Content and Format of Labeling for Human Prescription Drugs;               
            Addition of ``Geriatric Use'' Subsection in the Labeling..............................    0910-AA25 
995         Tamper-Evident Packaging Requirements for Over-the-Counter Human Drug Products........    0910-AA26 
996         Adverse Experience Expedited Reporting Requirements for Human Drug and Licensed                     
            Biological Products...................................................................    0910-AA28 
997         Electronic Signatures; Electronic Records.............................................    0910-AA29 
998         Financial Disclosure by Clinical Investigators........................................    0910-AA30 
999         Effective Date of Requirement for Submission of Premarket Approval Applications.......    0910-AA31 
1000        Prescription Drug Product Labeling; Medication Guide..................................    0910-AA37 
1001        Iron Containing Drugs and Supplements.................................................    0910-AA42 
1002        Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco               
            Products To Protect Children and Adolescents..........................................    0910-AA48 
1003        Revocation of Certain Regulations.....................................................    0910-AA54 
1004        Protection of Human Subjects; Informed Consent........................................    0910-AA60 
1005        Export Requirements for Medical Devices...............................................    0910-AA62 
1006        Well-Characterized Biotechnology Products; Elimination of Establishment License                     
            Application...........................................................................    0910-AA71 
1007        New Drug Applications; Drug Master File...............................................    0910-AA78 
1008        Current Good Manufacturing Practice for Finished Pharmaceutical; Positron Emission                  
            Tomography............................................................................    0910-AA81 
1009        Investigational New Drug Applications and New Drug Applications.......................    0910-AA82 
1010        New Drugs for Human Use; Clarification of Requirements for Application Supplements....    0910-AA87 
----------------------------------------------------------------------------------------------------------------



                                 Food and Drug Administration--Long-Term Actions                                
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1011        Policies Concerning Uses of Sulfiting Agents..........................................    0910-AA03 
1012        Lead in Foods.........................................................................    0910-AA06 
1013        Fees for Certification Services; Insulin and Color Additive Certification Programs....    0910-AA07 
1014        Bottled Water.........................................................................    0910-AA11 
1015        Review of Warnings, Use Instructions, and Precautionary Information Under Section 314               
            of the National Childhood Vaccine Injury Act of 1986..................................    0910-AA14 
1016        Dietary Supplement Label Review.......................................................    0910-AA23 
1017        Amalgam Ingredient Labeling...........................................................    0910-AA33 
1018        Classification of Computer Software Programs That Are Medical Devices.................    0910-AA41 
1019        Development of Hazard Analysis Critical Control Points for the Food Industry; Request               
            for Comments..........................................................................    0910-AA43 
1020        Habit Forming Drugs...................................................................    0910-AA50 
1021        Drugs Used for Treatment of Narcotic Addicts..........................................    0910-AA52 
1022        Substances Approved for Use in the Preparation of Meat and Poultry Products...........    0910-AA66 
1023        Postmarketing Periodic Adverse Experience Reporting Requirements for Human Drug and                 
            Licensed Biological Products..........................................................    0910-AA85 
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Completed Actions                                
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1024        Final Regulation To Establish Procedures for the Safe and Sanitary Processing and                   
            Importing of Fish and Fishery Products................................................    0910-AA10 
1025        General Biological Product Standards; Alternative Procedures and Exceptions...........    0910-AA16 
1026        Medical Devices; Protective Restraints; Revocation of Exemptions From 510(k) Premarket              
            Notification Procedures and Current Good Manufacturing Practices Regulations..........    0910-AA17 

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1027        Certification of Drugs Composed Wholly or Partly of Insulin; Fees for Certification of              
            Drugs Composed Wholly or Partly of Insulin............................................    0910-AA27 
1028        Premarket Approval of Medical Devices; Supplemental Applications......................    0910-AA35 
1029        Public Information; Communications With State and Foreign Government Officials........    0910-AA46 
1030        OTC Drug Labeling Review..............................................................    0910-AA63 
1031        Medical Device Exemptions From Premarket Notification.................................    0910-AA65 
----------------------------------------------------------------------------------------------------------------



                         Health Resources and Services Administration--Final Rule Stage                         
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1032        Organ Procurement and Transplantation Network Rules...................................    0906-AA32 
1033        National Vaccine Injury Compensation Program: Revisions and Additions to the Vaccine                
            Injury Table--II......................................................................    0906-AA36 
1034        Removal of Obsolete Regulations of the Title VII Grant for the Construction of                      
            Teaching Facilities for Health Professions Personnel..................................    0906-AA39 
----------------------------------------------------------------------------------------------------------------


                         Health Resources and Services Administration--Long-Term Actions                        
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1035        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   
----------------------------------------------------------------------------------------------------------------
1036        Technical Amendments to the Health Professions, Nursing, and Allied Health Training                 
            Grant Programs Under 42 CFR Parts 57 and 58...........................................    0906-AA38 
----------------------------------------------------------------------------------------------------------------


                                   Indian Health Service--Proposed Rule Stage                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1037        Acquisition Under the Buy Indian Act..................................................    0917-AA00 
1038        Indian Child Protection and Family Violence Prevention Act Minimum Standards of                     
            Character and Suitability for Employment..............................................    0917-AA02 
----------------------------------------------------------------------------------------------------------------


                                     Indian Health Service--Final Rule Stage                                    
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1039        Revision of Indian Self-Determination Regulations.....................................    0917-AA01 
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[[Page 22961]]



                          Agency for Health Care Policy and Research--Final Rule Stage                          
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1040        Health Services Research, Evaluation, Demonstration, and Dissemination Projects; Peer               
            Review of Grants and Contracts........................................................    0919-AA00 
----------------------------------------------------------------------------------------------------------------


                               National Institutes of Health--Proposed Rule Stage                               
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1041        National Institutes of Health AIDS Research Loan Repayment Program....................    0925-AA02 
1042        National Institutes of Health Clinical Research Loan Repayment Program for Individuals              
            From Disadvantaged Backgrounds........................................................    0925-AA09 
1043        Undergraduate Scholarship Program Regarding Professions Needed by the NIH.............    0925-AA10 
1044        Traineeships (Termination Policies)...................................................    0925-AA11 
1045        Additional DHHS Protection for Pregnant Women and Human Fetuses Involved as Subjects                
            for Research, and Pertaining to Human In Vitro Fertilization..........................    0925-AA14 
1046        National Research Service Awards......................................................    0925-AA16 
----------------------------------------------------------------------------------------------------------------


                                 National Institutes of Health--Final Rule Stage                                
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1047        Grants for Research Projects..........................................................    0925-AA01 
1048        Hazardous Substances Basic Research and Training Grants...............................    0925-AA03 
1049        National Institutes of Health Construction Grants.....................................    0925-AA04 
1050        Training Grants.......................................................................    0925-AA05 
1051        National Institutes of Health Center Grants...........................................    0925-AA06 
1052        Grants for National Alcohol Research Centers..........................................    0925-AA08 
1053        Removal of Obsolete Patent Regulations................................................    0925-AA15 
1054        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   
----------------------------------------------------------------------------------------------------------------
1055        Standards of Compliance for Abortion-Related Services in Family Planning Service                    
            Projects..............................................................................    0937-AA00 
----------------------------------------------------------------------------------------------------------------


                            Health Care Financing Administration--Proposed Rule Stage                           
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1056        Medicare Coverage of Outpatient Occupational Therapy Services (BPD-425-P).............    0938-AD32 
1057        Revisions to the Confidentiality and Disclosure Regulation (OPA-001-P)................    0938-AD60 
1058        ''Without Fault'' and Beneficiary Waiver of Recovery As It Applies to Medicare                      
            Overpayment Liability (BPD-719-P).....................................................    0938-AD95 
1059        Protection of Income and Resources for Community Spouses of Institutionalized                       
            Individuals (MB-023-P)................................................................    0938-AE12 
1060        Provider Reimbursement Determinations and Appeals Revisions (BPD-727-P)...............    0938-AF28 
1061        Alternative Sanctions for Psychiatric Hospitals (HSQ-191-P)...........................    0938-AF32 
1062        Assessing Interest Against Medicare Secondary Payer (MSP) Debts (BPO-108-P)...........    0938-AF87 
1063        Revisions to Rules on Health Care Prepayment Plans (OMC-016-P)........................    0938-AF97 
1064        Conditions of Participation for Rural Health Clinics (BPD-764-P)......................    0938-AG05 
1065        Appointment of Representatives for Medicare Appeals (BPO-120-P).......................    0938-AG30 
1066        Enforcement Requirements for Renal Dialysis Facilities (HSQ-204-P)....................    0938-AG31 
1067        General Criteria and Standards for Evaluating Performance of Contract Obligations (HSQ-             
            207-NC)...............................................................................    0938-AG32 

[[Page 22962]]

                                                                                                                
1068        Disclosure of Confidential PRO Information for Research Purposes (HSQ-208-P)..........    0938-AG33 
1069        Effect of Change of Ownership on Provider and Supplier Penalties, Sanctions, and                    
            Overpayments (HSQ-215-P)..............................................................    0938-AG59 
1070        New Payment Methodology for Routine Extended Care Services Provider in a Swing Bed                  
            Hospital (BPD-805-P)..................................................................    0938-AG68 
1071        Salary Equivalency Guidelines for Physical Therapy, Respiratory Therapy, Speech                     
            Pathology, and Occupational Therapy (BPD-808-PN)......................................    0938-AG70 
1072        Medicaid: Optional Coverage of TB-Related Services for Individuals Infected with                    
            Tuberculosis (MB-082-P)...............................................................    0938-AG72 
1073        Revision of Medicare Hospital Conditions of Participation (BPD-745-P).................    0938-AG79 
1074        Physicians' Referrals to Health Care Entities With Which They Have Financial                        
            Relationships--Expanded to Designated Health Services (BPD-809-P).....................    0938-AG80 
1075        Home Health Agency (HHA) Conditions of Participation (BPD-819-P)......................    0938-AG81 
1076        End-Stage Renal Disease (ESRD) Conditions for Coverage (BPD-818-P)....................    0938-AG82 
1077        Wage Index Used To Adjust Payment Rates for Hospice Services Under the Medicare                     
            Program (BPD-820-P)...................................................................    0938-AG93 
1078        Liability for Third Parties To Pay for Care and Services (MB-080-P)...................    0938-AH01 
1079        Definition of Skilled Nursing Facility (SNF) and Home Health Agency (HHA) for Coverage              
            of Durable Medical Equipment (DME) (BPD-834-P)........................................    0938-AH16 
1080        Schedule of Limits for Skilled Nursing Facility Inpatient Routine Service Costs (BPD-               
            837-NC)...............................................................................    0938-AH18 
1081        Additional Supplier Standards (BPD-864-P).............................................    0938-AH19 
1082        State Plan Amendment (SPA) Reconsideration Process (MB-096-P).........................    0938-AH24 
1083        Changes in Coverage and Payment Policies for Physician Assistant Services (BPD-829-P).    0938-AH26 
1084        Hospice Care--Conditions of Participation (BPD-844-P).................................    0938-AH27 
1085        Limitations on Payment for Home Oxygen Therapy Based on Inherent Reasonableness                     
            Criteria (BPD-845-PN).................................................................    0938-AH28 
1086        Medicaid Eligibility Quality Control, Staffing and Training, and Utilization Control:               
            Removal of Obsolete and Restrictive Requirements (MB-099-P)...........................    0938-AH31 
1087        Changes to the Hospital Inpatient Prospective Payment System and Fiscal Year 1997                   
            Rates (BPD-847-P).....................................................................    0938-AH34 
1088        Medicare Coverage of Services of Speech-Language Pathologists and Audiologists (BPD-                
            843-P)................................................................................    0938-AH37 
1089        Medicare Program: Five-Year Review of Work Relative Value Units Under the Physician                 
            Fee Schedule (BPD-846-PN).............................................................    0938-AH38 
1090        Medicare Program: Revisions to Payment Policies Under the Physician Fee Schedule for                
            Calendar Year 1997 (BPD-852-P)........................................................    0938-AH40 
1091        Privacy and Security Enforcement for the Medicare Transaction System (BPO-142-P)......    0938-AH47 
1092        Medicare: Amount of Payments If Customary Charges for Services Furnished Are Less Than              
            Reasonable Costs (BPD-860-P)..........................................................    0938-AH49 
1093        Limitations on Liability (BPD-859-P)..................................................    0938-AH51 
----------------------------------------------------------------------------------------------------------------



                             Health Care Financing Administration--Final Rule Stage                             
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1094        Deduction of Incurred Medical Expenses (Spenddown) (MB-020-F).........................    0938-AB07 
1095        Effective Dates for Provider Agreements and Supplier Approvals (HSQ-139-F)............    0938-AC88 
1096        Changes Concerning Suspension of Medicare Payments and Determinations of Allowable                  
            Interest Expense (BPO-118-FC).........................................................    0938-AC99 
1097        Criteria and Procedures for Making Medical Services Coverage Decisions That Relate to               
            Health Care Technology (BPD-432-FC)...................................................    0938-AD07 
1098        Prohibition on Unbundling of Hospital Outpatient Services (BPD-426-F).................    0938-AD33 
1099        Changes to Peer Review Organization Regulations (HSQ-135-F)...........................    0938-AD38 
1100        Omnibus Nursing Home Reform Requirements (BPD-488-F)..................................    0938-AD81 
1101        HMO Organizational Structure and Services (OMC-007-F).................................    0938-AE25 
1102        Hospital Standard for HIV Infectious Blood and Blood Products (BPD-633-F).............    0938-AE40 
1103        Medicare, Medicaid, and CLIA Programs: Regulations Implementing the Clinical                        
            Laboratory Improvement Amendments of 1988 (CLIA '88) (HSQ-226-F)......................    0938-AE47 
1104        Conditions of Coverage for Organ Procurement Organizations (BPD-646-FC)...............    0938-AE48 
1105        Resident Assessment in Long-Term Care Facilities (HSQ-180-F)..........................    0938-AE61 
1106        Post-Contract Beneficiary Protections and Other Provisions (OMC-003-F)................    0938-AE63 
1107        Employer Contributions to HMOs (OMC-004-F)............................................    0938-AE64 
1108        Payment for Nursing and Allied Health Science Education (BPD-685-F)...................    0938-AE79 
1109        Coverage of Screening Pap Smears (BPD-705-F)..........................................    0938-AE98 

[[Page 22963]]

                                                                                                                
1110        Medicare Coverage of Clinical Psychologist, Other Psychologist, and Clinical Social                 
            Worker Services--Medicare (BPD-706-F).................................................    0938-AE99 
1111        OBRA '90 and Miscellaneous Managed Care Technical Amendments (OMC-018-FC).............    0938-AF15 
1112        Medicaid Payment for Covered Outpatient Drugs Under Rebate Agreements (MB-046-F)......    0938-AF42 
1113        Referral to Child Support Enforcement Agencies of Medicaid Families (MB-051-F)........    0938-AF68 
1114        Medicaid: Outstationed Intake Locations for Certain Low-Income Pregnant Women, Infants              
            and Children Under Age 19 (MB-052-F)..................................................    0938-AF69 
1115        Medicare and Medicaid Programs: Requirements for Physician Incentive Plans in Prepaid               
            Health Care Organizations (OMC-010-FC)................................................    0938-AF74 
1116        Part B Advance Payments to Physicians/Suppliers or Other Entities Furnishing Items or               
            Services Under Medicare Part B (BPO-105-F)............................................    0938-AF85 
1117        Retroactive Enrollment and Disenrollment in Risk Health Maintenance Organizations and               
            Competitive Medical Plans (OMC-015-F).................................................    0938-AF98 
1118        Payment for Preadmission Services (BPD-731-F).........................................    0938-AG00 
1119        Change in Provider Agreement Regulations Related to Federal Employee Health Benefits                
            (BPD-748-F)...........................................................................    0938-AG03 
1120        Revised Medicaid Management Information Systems (MB-38-FN)............................    0938-AG10 
1121        Medicare Program: Limitations on Medicare Coverage of Intermittent Positive Pressure                
            Breathing Machine Therapy (BPD-781-FN)................................................    0938-AG44 
1122        Telephone and Electronic Requests for Review of Part B Initial Claim Determinations                 
            (BPO-121-F)...........................................................................    0938-AG48 
1123        Medicare Program: Limitations on Medicare Coverage of Cataract Surgery (BPD-797-FN)...    0938-AG65 
1124        CLIA Program: Categorization of Waived Tests (HSQ-225-F)..............................    0938-AG99 
1125        Reporting of Interest From Zero Coupon Bonds (BPD-647-F)..............................    0938-AH11 
1126        Medicare Program: Uniform Electronic Cost Reporting for Skilled Nursing Facilities and              
            Home Health Agencies (BPD-788-F)......................................................    0938-AH12 
1127        Update of the Reasonable Compensation Equivalent Limits for Services Furnished by                   
            Physicians (BPD-816-N)................................................................    0938-AH14 
1128        Criteria and Procedures for Extending Coverage to Certain Devices and Related Services              
            (BPD-841-FC)..........................................................................    0938-AH21 
1129        Delegation of Civil Money Penalties (BPO-135-FC)......................................    0938-AH22 
1130        Medicaid: Limitations on Aggregate Payments to Disproportionate Share Hospitals;                    
            Federal Fiscal Year 1996 (Preliminary) (MB-098-N).....................................    0938-AH30 
1131        Medicare Program; Special Enrollment Periods and Waiting Periods (BPD-752-FC).........    0938-AH33 
1132        Medicare Program: Physician Fee Schedule Update for Calendar Year 1996 and Physician                
            Volume Performance Standard Rates of Increase for Federal Fiscal Year 1996 (BPD-853-                
            FN)...................................................................................    0938-AH41 
1133        Medicare Program: Monthly Actuarial Rates and Monthly Supplementary Medical Insurance               
            Premium Rates Beginning January 1, 1997 (OACT-052-N)..................................    0938-AH42 
1134        Medicaid: Limitations on Aggregate Payments to Disproportionate Share Hospitals;                    
            Federal Fiscal Year 1996 (Final) (MB-100-N)...........................................    0938-AH44 
1135        Part A Premium for 1997 for the Uninsured Aged for Certain Disabled Individuals Who                 
            Have Exhausted Other Entitlement (OACT-053-N).........................................    0938-AH45 
1136        Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance                   
            Amounts for 1997 (OACT-054-N).........................................................    0938-AH46 
1137        Requirements for Enrollment of Medicaid Recipients Under Cost Effective Employer-Based              
            Group Health Plans (MB-047-F).........................................................    0938-AH48 
----------------------------------------------------------------------------------------------------------------



                             Health Care Financing Administration--Long-Term Actions                            
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1138        Payment for Clinical Diagnostic Laboratory Tests (BPD-309-F)..........................    0938-AB50 
1139        Participation in CHAMPUS and CHAMPVA, Hospital Admissions for Veterans, Discharge                   
            Rights Notice, and Hospital Responsibility for Emergency Care (BPD-393-F).............    0938-AC58 
1140        Medicare Secondary Payer for Disabled Individuals (BPD-482-F).........................    0938-AD73 
1141        New Minimum Standards for Medicare Supplemental (Medigap) Policies (BPD-491-P)........    0938-AD82 
1142        Survey Requirements and Alternative Sanctions for Home Health Agencies (HSQ-169-F)....    0938-AE39 
1143        Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Services (MB-28-F)....    0938-AE72 
1144        Fire Safety Standards for Hospitals, Long-Term Care Facilities, Ambulatory Surgical                 
            Centers, Hospices, and Intermediate Care Facilities for the Mentally Retarded (BPD-650-             
            FC)...................................................................................    0938-AE97 
1145        Changes to the Long-Term Care Facility Survey Process (HSQ-175-FC)....................    0938-AF02 

[[Page 22964]]

                                                                                                                
1146        Case Management (MB-27-F).............................................................    0938-AF07 
1147        Presumptive Limits on Payments to HMOs, CMPs, and HCPPs (OMC-006-F)...................    0938-AF16 
1148        Partial Hospitalization Services in Community Mental Health Centers (BPD-736-F).......    0938-AF53 
1149        Intermediary and Carrier Functions (BPO-111-F)........................................    0938-AG06 
1150        End-Stage Renal Disease (ESRD) Payment Exception Requests and Organ Procurement Costs               
            (BPD-763-F)...........................................................................    0938-AG20 
1151        Noncoverage of Electrostimulation of Salivary Glands for the Treatment of Xerostomia                
            (Dry Mouth) (BPD-782-FN)..............................................................    0938-AG45 
1152        Distinct Part Requirements for Nursing Homes and Prohibition of Financial Screening of              
            Applicants for Nursing Home Admission (BPD-815-P).....................................    0938-AG84 
1153        Clinical Laboratory Improvement Amendment (CLIA) Fee Schedules (HSQ-219-FC)...........    0938-AG87 
1154        Categorization and Certification Requirements for a New Subcategory of Moderate                     
            Complexity Testing (HSQ-222-F)........................................................    0938-AG98 
1155        Medicaid Coverage of Personal Care Services (MB-071-F)................................    0938-AH00 
1156        Ambulance Services (BPD-813-P)........................................................    0938-AH13 
1157        Adjustment in Payment Amounts for New Technology Intraocular Lenses (BPD-831-P).......    0938-AH15 
1158        Medicare Coverage of Liver Transplantation (BPD-835-PN)...............................    0938-AH17 
1159        CLIA Program: Cytology Proficiency Testing (HSQ-233-P)................................    0938-AH35 
1160        Limits on Actual Charges of Nonparticipating Physicians (BPD-862-P)...................    0938-AH50 
1161        Medicare Secondary Payer Clarifications and Amendments (BPD-865-P)....................    0938-AH52 
1162        Payment for Hospital Outpatient Radiology Services and Other Diagnostic Procedures                  
            (BPD-861-FC)..........................................................................    0938-AH53 
----------------------------------------------------------------------------------------------------------------



                             Health Care Financing Administration--Completed Actions                            
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1163        Fee Schedule for Payment of Clinical Psychologist Services (BPD-495-P)................    0938-AD84 
1164        Coverage of Nurse Practitioner and Clinical Nurse Specialist Services (BPD-708-P).....    0938-AF00 
1165        Payment for Federally Qualified Health Center (FQHC) Services (BPD-728-F).............    0938-AF14 
1166        Federally Qualified Health Center Services (Medicaid) (MB-043-P)......................    0938-AF90 
1167        Medicare Appeals of Individual Claims (BPD-453-P).....................................    0938-AG18 
1168        Withdrawal of Coverage of Diagnostic Nocturnal Penile Tumescence Testing (Impotence                 
            Testing) (BPD-780-FN).................................................................    0938-AG43 
1169        Schedule of Limits on Home Health Agency Costs Per Visit (BPD-793-N)..................    0938-AG54 
1170        Medicaid Program: Nurse-Midwife Services (MB-085-F)...................................    0938-AG73 
1171        Medicaid Program: Fees for Vaccine Administration Under Pediatric Immunization Program              
            (MB-084-FN)...........................................................................    0938-AG77 
1172        Medicaid: Nominal Copayments for Institutional Services for Medicaid Recipients (MB-                
            090-FC)...............................................................................    0938-AG90 
1173        Mandatory Medigap Crossover Claims Transmittal Requirements (BPD-811-P)...............    0938-AG94 
1174        Medicare Program: Changes to the Inpatient Hospital Prospective Payment Systems and                 
            Fiscal Year 1996 Rates (BPD-825-FC)...................................................    0938-AG95 
1175        Medicare Program: Revisions to Payment Policies and Adjustments to the Relative Value               
            Units (RVUs) Under the Physician Fee Schedule for Calendar Year 1996 (BPD-827-FC).....    0938-AG96 
1176        Medicare Program: Coverage of Certified Nurse-Midwife Services (BPD-496-P)............    0938-AH02 
1177        Medicare Program: Physician Fee Schedule Update for Calendar Year 1996 & Physician                  
            Volume Performance Standard Rates of Increase for Federal Fiscal Year 1996 (BPD-828-                
            FN)...................................................................................    0938-AH03 
1178        Part A Premium for 1996 for the Uninsured Aged and for Certain Disabled Individuals                 
            Who Have Exhausted Other Entitlement (OACT-051-N).....................................    0938-AH06 
1179        Medicare Program: Monthly Actuarial Rates and Monthly Supplementary Medical Insurance               
            Premium Rates Beginning January 1, 1996 (OACT-050-N)..................................    0938-AH07 
1180        Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance                   
            Amounts for 1996 (OACT-049-N).........................................................    0938-AH08 
1181        Limitations on Aggregate Payments to Disproportionate Share Hospitals: Federal Fiscal               
            Year 1995 (Medicaid Program) (MB-094-N)...............................................    0938-AH09 
1182        Provisions That Allow Rural Primary Care Hospitals (RPCHs) To Enter Into Swing-Bed                  
            Agreements (BPD-839-P)................................................................    0938-AH20 
1183        Transfer of Assets for Less Than Fair Market Value: Medicaid Program (MB-095-P).......    0938-AH23 
1184        Evidence of Lawful Permanent Residence (MB-097-P).....................................    0938-AH25 
1185        CLIA Program; Granting and Withdrawal of Authority to Private Nonprofit Accreditation               
            Organizations and of CLIA Exemption Under State Laboratory Programs; Technical                      
            Corrections (HSQ-205-FC)..............................................................    0938-AH32 
----------------------------------------------------------------------------------------------------------------


[[Page 22965]]



                          Administration for Children and Families--Proposed Rule Stage                         
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1186        Foster Care, Adoption Assistance, and Child Welfare Services..........................    0970-AA97 
1187        Block Grant Programs (Low Income Home Energy Assistance Program --LIHEAP)--FY 1995 and              
            FY 1996 Provisions....................................................................    0970-AB47 
1188        Administrative Flexibility Rule.......................................................    0970-AB49 
1189        Designation of Alternative Agency To Serve Indian Tribal Children.....................    0970-AB52 
1190        Construction of Head Start Facilities.................................................    0970-AB54 
1191        Quality Standards for Early Head Start and Head Start Programs........................    0970-AB55 
1192        Head Start Fellowship Program.........................................................    0970-AB56 
1193        On-Site Foster Care Eligibility Reviews...............................................    0970-AB60 
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Final Rule Stage                           
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1194        Amendments to Developmental Disabilities Rules........................................    0970-AB11 
1195        Child Abuse and Neglect State Grant Program...........................................    0970-AB23 
1196        Standards for Safe Transportation.....................................................    0970-AB24 
1197        Standards for Purchase of Facilities..................................................    0970-AB31 
1198        National Voter Registration Act of 1993 Provisions Affecting Public Assistance                      
            Agencies..............................................................................    0970-AB32 
1199        Child Care--Revised Regulations.......................................................    0970-AB33 
1200        Family Preservation and Support.......................................................    0970-AB34 
1201        Administration for Native Americans (ANA) 45 CFR Part 1336............................    0970-AB37 
1202        Reduction of Reporting Requirements for the State Systems Advance Planning Document                 
            (APD) Process.........................................................................    0970-AB46 
1203        Income Eligibility Criteria for Indian Tribes.........................................    0970-AB53 
1204        Making Information Available to Consumer Reporting Agencies: Extension of Deadline for              
            Certified Statewide Systems; and Revisions for the President's Reform Initiative......    0970-AB57 
1205        Income and Resource Disregards Related to Interests of Individual Indians in Trust or               
            Restricted Lands......................................................................    0970-AB59 
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Completed Actions                          
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1206        Family Violence Prevention and Services...............................................    0970-AB18 
----------------------------------------------------------------------------------------------------------------


                                   Administration on Aging--Long-Term Actions                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1207        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 
----------------------------------------------------------------------------------------------------------------

_______________________________________________________________________

[[Page 22966]]




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


Office of the Secretary (OS)



_______________________________________________________________________




936. 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                            10/00/96

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, OMP, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-3270

RIN: 0991-AA79
_______________________________________________________________________




937. 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                            10/00/96

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, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-3270

RIN: 0991-AA80
_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




938. 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                    10/00/96

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, OMP, Department of Health and Human Services, Office 
of the Secretary, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-3270

RIN: 0991-AA66
_______________________________________________________________________

[[Page 22967]]




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


Office of the Secretary (OS)



_______________________________________________________________________




939. 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


Next Action Undetermined

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, OMP, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-3270

RIN: 0991-AA45
_______________________________________________________________________




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

RIN: 0991-AA53
_______________________________________________________________________




941. 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, OMP, Department of Health and Human Services, Office 
of the Secretary, 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089

RIN: 0991-AA65
_______________________________________________________________________




942.  SENIOR BIOMEDICAL RESEARCH SERVICES

Priority:  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 eligiblity 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

[[Page 22968]]

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)



_______________________________________________________________________




943. UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND COOPERATIVE 
AGREEMENTS

Priority:  Substantive, Nonsignificant

CFR Citation:  45 CFR 74

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/22/96                    61 FR 11743

Small Entities Affected: None

Government Levels Affected: State, Local

Agency Contact: Charles Gale
Phone: 202 690-6377

RIN: 0991-AA56
_______________________________________________________________________




944. SAFE HARBORS FOR PROTECTING HEALTH PLANS

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 1001

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/25/96                     61 FR 2122

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Joel Jay Schaer
Phone: 202 619-3270

RIN: 0991-AA69
_______________________________________________________________________




945. REVISIONS TO THE PRO SANCTIONS PROCESS

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 1004

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/12/95                    60 FR 63634

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Joel Jay Schaer
Phone: 202 619-3270

RIN: 0991-AA73
_______________________________________________________________________




946. REVISIONS TO THE CIVIL MONEY PENALTY PROVISIONS RELATING TO THE 
MISUSE OF CERTAIN SYMBOLS AND EMBLEMS

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 1003

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/27/95                    60 FR 58239

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Joel Jay Schaer
Phone: 202 619-3270

RIN: 0991-AA81
_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




947. 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 P.L. 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                    07/00/96

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
_______________________________________________________________________

[[Page 22969]]




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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




948. 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: Sue Martone, DLEA, SAMHSA, PHS, 5600 Fishers Lane, 
Room 12C-15, Rockville, MD 20852; 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-AA01
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




949. BLOCK GRANTS FOR PREVENTION AND TREATMENT OF SUBSTANCE ABUSE 
(TOBACCO PROVISIONS)

Priority:  Other Significant

CFR Citation:  45 CFR 96

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/19/96                     61 FR 1492

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Tribal

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

RIN: 0930-AA03
_______________________________________________________________________


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


Departmental Management (HHSDM)



_______________________________________________________________________




950. 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 generally requires agencies 
to pay attorney fees to parties prevailing against the Government in 
certain types of administrative proceedings. It requires each agency to 
issue rules implementing the Act as it applies to these proceedings. As 
originally enacted, the Act had a sunset clause. A statutory amendment 
eliminated the sunset provision and made other changes in the Act. The 
instant regulation would amend 45 CFR part 13 (HHS's regulation 
implementing the Act) to eliminate the corresponding sunset provision 
and to make other changes conforming with the statutory changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/19/87                    52 FR 23311
NPRM Comment Period End         08/17/87
Final Action                    10/00/96
Final Action Effective          11/00/96

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
_______________________________________________________________________

[[Page 22970]]




DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)             Prerule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________




951. 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                           10/00/96

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: 202 205-5372

RIN: 0910-AA20
_______________________________________________________________________




952. 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 proposing 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 
proposal would create or clarify requirements for process and methods 
validation, appropriate laboratory testing procedures, and protection 
against contamination. The proposal 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

________________________________________________________________________

ANPRM                           05/00/96

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), 7500 
Standish Place, Rockville, MD 20855
Phone: 301 594-1046
Fax: 301 827-0901

RIN: 0910-AA45
_______________________________________________________________________




953. 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 will be initiating rulemaking to retain, revise, or 
revoke certain of its regulations for food. FDA will be proposing: (1) 
to establish a notification procedure for companies to use for 
independent GRAS determinations; (2) to request information on the need 
to retain, revise, or revoke its food standards of identity regulations 
and its common or usual name regulations; (3) to coordinate the food 
additive, GRAS, and color additive approval process with USDA when meat 
and poultry product uses are petitioned for; and (4) to increase the 
number of categorical exclusions from the requirements for 
environmental review.

Timetable:

Additional categorical exclusions for environmental impact  NPRM 04/03/
96 (61 FR 14922)

Food Additive and Other Regulations  Final Action 05/00/96

Food Labeling and Other Regulations  NPRM 05/00/96

Food Regulations; Plan for Revisions  ANPRM 05/00/96

Notification Procedures for Independent GRAS Determinations  NPRM 05/
00/96

Revocation of Lower Fat Milk  NPRM 11/09/95 (60 FR 56541)  Comment 
Period End 01/23/96  Final Action 00/00/00

Revocation of Obsolete Regulations  NPRM 10/13/95 (60 FR 
53480)  Comment Period End 01/11/96  Final Action 05/00/96

Small Entities Affected: Businesses

Government Levels Affected: State

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
_______________________________________________________________________




954. FOOD STANDARDS OF IDENTITY, QUALITY, AND FILL OF CONTAINER; COMMON 
OR USUAL NAME REGULATIONS: REQUEST FOR COMMENTS ON EXISTING REGULATIONS

Priority:  Other Significant

Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will revise text in

[[Page 22971]]

the CFR to reduce burden or duplication, or streamline requirements.

Legal Authority:  21 USC 321; 21 USC 336; 21 USC 341; 21 USC 343; 21 
USC 348; 21 USC 349; 21 USC 371; 21 USC 376

CFR Citation:  21 CFR 102 to 103; 21 CFR 130 to 131; 21 CFR 133; 21 CFR 
135 to 137; 21 CFR 139; 21 CFR 145 to 146; 21 CFR 150; 21 CFR 152; 21 
CFR 155 to 156; 21 CFR 158; 21 CFR 160 to 161; 21 CFR 163 to 166; 21 
CFR 168 to 169

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is considering 
amending, revising, or revoking its food standards of identity, 
quality, and fill of container and its common or usual name regulations 
for nonstandardized foods to make them less burdensome on industry and 
more responsive to the needs of consumers. A notice of proposed 
rulemaking that published October 13, 1995, identified, among other 
obsolete or otherwise unnecessary regulations, 17 specific CFR sections 
on food standards for possible revocation. In addition, FDA published 
an advance notice of proposed rulemaking (ANPRM) in the Federal 
Register on December 29, 1995, requesting comments on other such 
standards from all interested parties, including consumers, consumer 
groups, academia, the regulated food industry, food distributors, 
importers, and exporters on these regulations. The agency is seeking 
comments on the benefits or lack of benefits of such regulations in 
facilitating domestic, as well as international, commerce and on their 
value to consumers, less costly alternative means of accomplishing the 
statutory objective of food standards, that is, to promote honesty and 
fair dealing in the interest of consumers, in the manufacture and sale 
of food products covered by these regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           12/29/95                    60 FR 67492
ANPRM Comment Period End        04/29/96
NPRM                            00/00/00
Final Action                    00/00/00

Small Entities Affected: Businesses, Organizations

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 St. SW., Washington, DC 20204
Phone: 202 205-4561

RIN: 0910-AA67
_______________________________________________________________________




955.  REINVENTION OF 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 402; 15 USC 409; 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; 21 CFR 70 to 71; 21 CFR 80; 21 CFR 101; 21 
CFR 170; 21 CFR 172 to 175; 21 CFR 177 to 178; 21 CFR 184; 21 CFR 730 
to 740; ...

Legal Deadline: None

Abstract: FDA is considering ways to further streamline certain 
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                           06/00/96

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
_______________________________________________________________________




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

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 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                           05/00/96
ANPRM Comment Period End        08/00/96

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Procurement: This is a procurement-related action for which there is no 
statutory requirement. The agency has not yet determined whether there 
is a paperwork burden associated with this action.

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
_______________________________________________________________________

[[Page 22972]]




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


Food and Drug Administration (FDA)



_______________________________________________________________________




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

Priority:  Routine and Frequent

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

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

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

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. NOTE: NPRM for 
``Antidotes, Toxic Ingestion Products'' was combined with NPRM for 
``Emetic Products'' and reproposed as ``Poison Treatment Products.'' 
NPRM for ``Astringent (Wet Dressings) Products'' was included in the 
NPRM for ``Skin Protectant Products.'' NPRM for ``Diaper Rash 
Products'' was included in NPRMs for ``Antifungal,'' ``Antimicrobial,'' 
``External Analgesic'' and ``Skin Protectant Products.'' NPRM for 
``Fever Blister/Cold Sore Products (External)'' was included in NPRMs 
for ``External Analgesic'' and ``Skin Protectant Products.'' NPRM for 
``Insect Bites and Stings (Relief) Products'' was included in NPRMs for 
``External Analgesic'' and ``Skin Protectant Products.'' ``Poison Ivy/
Oak/Sumac Prevention'' was included in NPRMs for ``External Analgesic'' 
and ``Skin Protectant Products.'' NPRM for ``Mercurial (Topical) 
Products'' was included in revised NPRM for ``Antimicrobial Products.'' 
NPRM for ``Alcohol (Topical) Products'' was included in revised NPRM 
for ``Antimicrobial Products.'' The NPRM for ``Antimicrobial Products'' 
was updated and split into two sections: First Aid Products and Health 
Care 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) 05/00/96

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)

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)

Antidiarrheal Products  ANPRM 03/21/75 (40 FR 12924)  NPRM 04/30/86 (51 
FR 16138)  Final Action 08/00/96

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)

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 00/00/00

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)

[[Page 22973]]

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

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

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

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

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)

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) 05/00/96

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 09/00/96

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) 09/00/96

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 07/00/96

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)  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) 06/00/96  Final Action (Cardio/
Cerebrvasclar) 09/00/96  NPRM (Amendment)(Alcohol Warning) 09/00/
96  NPRM (Labeling-revised indications) 09/00/96

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 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 
(Calcium/Magnesium/Potassium) 04/22/96 (61 FR 17807)  NPRM (Format/
Examples) 08/00/96

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) 09/00/96  NPRM (Amendment)(Phosphates Label.) 09/
00/96  Final Action 09/00/96

[[Page 22974]]

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

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

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

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)

NDA Labeling Exclusivity  NPRM 11/09/93 (58 FR 59622)

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) 07/00/96

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) 
07/00/96  Final Action 09/00/96

Quinine for Malaria  NPRM 04/19/95 (60 FR 19650)  Final Action 09/00/96

Reporting of Adverse Reactions  NPRM 07/00/96

Skin Bleaching Products  ANPRM 11/03/78 (43 FR 51546)  NPRM 09/03/82 
(47 FR 39108)  NPRM (Reproposed) 09/00/96

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) 08/00/96  Final Action 08/00/96

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)

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)

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)

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) 06/00/
96

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. Commissioner for OTC Drug 
Monographs, Office of Drug Evaluation, 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
_______________________________________________________________________




958. 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 on December 24, 1991, a final rule 
implementing certain aspects of the Infant Formula Act of 1986. The 
rule

[[Page 22975]]

establishes infant formula record and record retention requirements. 
The agency is preparing a proposed rule that will establish current 
good manufacturing practice regulations, quality control procedures, 
quality factors, notification requirements, and reports for the 
production of infant formulas.

Timetable:

Current Good Mfg. Practices; Qual Control Proc  NPRM 07/00/96  NPRM 
(Comment Period End) 10/00/96

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: 202 205-5372

RIN: 0910-AA04
_______________________________________________________________________




959. 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 marketed devices are safe and 
effective, FDA learns quickly of device problems, and 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 device in 
class III, or reclassify it in class I or II. Good Manufacturing 
Practices for Medical Devices--FDA proposed to add preproduction design 
validation in existing CGMP regulations. Exemption of Humanitarian 
Devices--The proposed rule gives 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 data summaries on 
which substantial equivalence determinations are made. 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 made revisions in regulations necessary because of procedural 
changes made 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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    00/00/00
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 06/
00/96

Distributor Reporting  NPRM 06/00/96

Exemption of Humanitarian Devices  NPRM 12/21/92 (57 FR 60491)  Final 
Action 06/00/96

Medical Device Recall Authority  NPRM 06/14/94 (59 FR 30656)  NPRM 
(Correction) 06/23/94 (59 FR 32489)  Final Action 06/00/96

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)

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 06/00/96

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 06/00/96

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

[[Page 22976]]

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-84), 2098 Gaither Road, Rockville, 
MD 20850
Phone: 301 594-4765

RIN: 0910-AA09
_______________________________________________________________________




960. REPORTING OF ERRORS AND ACCIDENTS

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: All licensed manufacturers are required to notify FDA 
promptly of errors or accidents in the manufacture of products that may 
affect the safety, purity, or potency of any distributed biological 
product (21 CFR 600.14). The reporting of certain errors or accidents 
occurring in the manufacture of blood and blood components is necessary 
so that FDA can respond where the public health may be endangered and 
provide added assurance as to the continued safety, identity, quality, 
purported quality, and purity of blood and blood components. FDA has 
determined that errors and accidents that are detected and corrected 
before a finished unit is removed from the unprocessed inventory and 
made available for release and distribution do not affect the safety of 
the blood supply and need not be reported to the Agency. 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                            11/00/96
NPRM Comment Period End         02/00/97

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-650), 1401 Rockville Pike, Suite 
200N, Rockville, MD 20852-1448
Phone: 301 594-1077

RIN: 0910-AA12
_______________________________________________________________________




961. MAMMOGRAPHY QUALITY STANDARDS ACT OF 1992

Priority:  Economically Significant

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 has 
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.

Timetable:

Alternative Approaches  NPRM 04/03/96 (61 FR 14856)

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)

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

Personnel Requirements  NPRM 04/03/96 (61 FR 14898)

Quality Standards for Mammography Equipment and QA  NPRM 04/03/96 (61 
FR 14908)

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)

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, 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
_______________________________________________________________________

[[Page 22977]]





962. LATEX CONDOMS: EXPIRATION DATE LABELING

Priority:  Substantive, Nonsignificant

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 proposed 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                            06/00/96

Small Entities Affected: Undetermined

Government Levels Affected: None

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-84), 2098 Gaither Road, Rockville, 
MD 20850
Phone: 301 594-4765

RIN: 0910-AA32
_______________________________________________________________________




963. 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 propose to 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                            06/00/96

Small Entities Affected: Undetermined

Government Levels Affected: None

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-84), 2098 Gaither Road, Rockville, 
MD 20850
Phone: 301 594-4765

RIN: 0910-AA34
_______________________________________________________________________




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

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 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 
reconsidering which types of health professionals are competent to 
perform hearing 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                            07/00/96

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-84), 2098 Gaither Road, Rockville, 
MD 20850
Phone: 301 594-4765

RIN: 0910-AA39
_______________________________________________________________________




965. 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: FDA is issuing a final rule requiring certain infectious 
disease testing, donor screening, and recordkeeping to help prevent the 
transmission of AIDS and hepatitis through human tissue used in 
transplantation. FDA is also clarifying and modifying those 
requirements previously promulgated by the interim rule. In addition, 
FDA is amending the regulations to require the registration of those 
establishments engaged in procurement, processing, storage, or 
distribution of human tissue intended for transplantation. Also, FDA 
will be proposing regulations to govern the recovery, processing, 
storage, or distribution of human reproductive tissue.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Rule; Opport. for 
Comment                         12/14/93                    58 FR 65514
Interim Rule; Comment Period End03/14/94
NPRM                            10/00/96
NPRM Comment Period End         01/00/97
Final Action                    02/00/97

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Additional Information: Previously reported under RIN 0905-AE49.

Agency Contact: Tracey Forfa, Regulatory Counsel, 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
_______________________________________________________________________

[[Page 22978]]





966. ANIMAL MEDICINAL DRUG USE CLARIFICATION ACT OF 1994; EXTRA-LABEL 
USE; IMPLEMENTATION

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 103-396

CFR Citation:  None

Legal Deadline:  Final, Statutory, October 22, 1996.
Two years after bill was signed into law (10/22/94).

Abstract: Upon promulgation of regulations, the Animal Drug Amendments 
of 1994 will allow licensed veterinarians to prescribe off-label use of 
approved animal and human drugs for animals under certain circumstances 
within limits set by FDA. If the Secretary finds there is a reasonable 
probability that a use may present a risk to the public, the Secretary 
may establish a safe level for residues of such use by order and 
require the development of analytical methods for detection of 
resultant residues. If the Secretary finds, after affording an 
opportunity for public comment, that a use presents a risk to public 
health or if no analytical method is developed, when called for, the 
Secretary may prohibit such use. The Secretary may also, by regulation, 
provide access to veterinarian records to ascertain any use or intended 
extra-label use that may present a risk to public health. The proposed 
rule will implement the statute by providing policies, procedures, and 
limitations on extra-label use and by setting the circumstances and 
conditions for Agency examination of veterinarian records.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/96
Final Action                    10/00/96

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE66.

Agency Contact: Richard L. Arkin, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Veterinary Medicine (HFV-238), 7500 Standish Place, Rockville, MD 20855
Phone: 301 594-1737

RIN: 0910-AA47
_______________________________________________________________________




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

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 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                            09/00/96
NPRM Comment Period End         12/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Howard Muller, Regulatory Counsel, 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
Fax: 301 827-0901

RIN: 0910-AA49
_______________________________________________________________________




968. BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

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 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                            07/00/96
NPRM Comment Period End         10/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Christine Rogers, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 7500 
Standish Place Rockville, MD 20855
Phone: 301 594-1046
Fax: 301 827-0901

RIN: 0910-AA51
_______________________________________________________________________




969. CONSOLIDATION OF REGULATIONS

Priority:  Other

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

Legal Authority:  21 USC 371

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

Legal Deadline: None

Abstract: FDA is proposing to consolidate into one section a list of 
drugs previously determined to be new drugs. This document would also 
remove the section now providing for these drugs. This action, which 
will make the regulations more concise and efficient, is being taken in 
response to the President's regulatory reinvention initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/96
NPRM Comment Period End         06/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Mary E. Catchings, 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: 301 594-2041

[[Page 22979]]

Fax: 301 827-0901

RIN: 0910-AA53
_______________________________________________________________________




970. NAME OF SELLING AGENT OR DISTRIBUTOR

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 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 610

Legal Deadline: None

Abstract: This proposed rule proposes to allow distributors' and 
selling agents' names to be prominently displayed on biological product 
containers, package labels, and labeling, while retaining current 
product manufacturer labeling information. The proposed rule modifies 
the current requirement giving precedence to the name of the 
manufacturer by deleting the requirement for prominence of the name of 
the manufacturer. The proposed rule is intended to remove an impediment 
to flexible manufacturing, packaging, and distribution arrangements and 
to harmonize with the drug regulations (21 CFR 201).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/96
NPRM Comment Period End         09/00/96

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Gloria Hicks, 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-AA56
_______________________________________________________________________




971. 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 351 to 353; 
21 USC 355; 21 USC 360; 21 USC 360c to 360f; 21 USC 360u to 360j; 21 
USC 371; 21 USC 374; 21 USC 379e; 21 USC 381; 42 USC 216; 42 USC 241; 
42 USC 262 to 263

CFR Citation:  21 CFR 601

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is proposing to revise 
21 CFR 601.12, which deals with proposed changes in the production of 
licensed biological products--for example, product labeling, production 
process, equipment, facilities, and responsible personnel. Currently, 
licenseholders must obtain FDA preapproval of all such changes through 
supplements to approved applications. In the proposed revision, 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. Proposed procedures 
for reporting changes in production include three categories:
No supplements to approved applications will be required. Firms would 
notify FDA of changes and dates of implementation in an annual report.
License holders would notify FDA not less than 30 days prior to 
implementing a change.
Changes would require FDA approval prior to implementation.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/29/96                     61 FR 2739
NPRM Comment Period End         04/29/96
Final Action                    08/00/96

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Tracey Forfa, Regulatory Counsel, 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
_______________________________________________________________________




972. DIETARY SUPPLEMENT REGULATIONS IN RESPONSE TO DSHEA

Priority:  Routine and Frequent

Legal Authority:  15 USC 1453; 15 USC 1454; 15 USC 1455; 21 USC 321; 21 
USC 331; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 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, 1995, modifying the provisions for 
labeling of dietary supplements. FDA is initiating rulemaking to modify 
its regulations for dietary supplements accordingly. One proposal would 
modify the nutrition labeling and ingredient declaration requirements. 
A second proposal would modify the provisions for nutrient content 
claims and health claims 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.

Timetable:

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

Nutrition Content and Health Claims; Dietary Supplements  NPRM 12/28/95 
(60 FR 67176)  Comment Period End 06/10/96  Final Action 00/00/00

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

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Agency Contact: F. Edward Scarbrough, Director, Office of Food 
Labeling, Department of Health and

[[Page 22980]]

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
_______________________________________________________________________




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

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 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 in other countries. The proposal would 
permit an unapproved new drug product to be exported without prior FDA 
approval if the product is to be exported for use in a clinical 
investigation in any country. Persons exporting such products would be 
required to report to FDA the country receiving the unapproved new drug 
product, the consignee in the foreign country, the name of the drug 
product, and the quantity being exported. Thus, the proposal would 
eliminate the need to submit a written request to FDA and to obtain FDA 
approval before exporting an unapproved new drug product for use in a 
clinical investigation in a foreign country. The proposal carries out 
the President's and Vice-President's ``National Performance Review'' 
for drugs and is consistent with recent Congressional initiatives.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/96

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-AA61
_______________________________________________________________________




974.  HUMAN TISSUE INTENDED FOR TRANSPLANTATION AND HUMAN 
REPRODUCTIVE TISSUE INTENDED FOR FERTILIZATION, IMPLANTATION OR 
INSEMINATION

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: The proposed rule will propose the registration of all 
establishments engaged in the recovery, processing, storage, or 
distribution of human tissue intended for transplantation or human 
reproductive tissue intended for fertilization, implantation, or 
insemination (and extend the existing rule requirements testing, 
screening and recordkeeping to such tissue).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/96

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, 1401 Rockville Pike, Rockville, MD 20852
Phone: 301 594-3074
Fax: 301 443-3874
Email: [email protected]

RIN: 0910-AA70
_______________________________________________________________________




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

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 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 proposed rule would revoke the requirement for increased 
frequency reports to FDA for postmarketing adverse experience 
reporting.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/96

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: Audrey Thomas, Consumer Safety Officer, 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
Fax: 301 827-0901

RIN: 0910-AA72
_______________________________________________________________________




976.  INVESTIGATIONAL NEW DRUG APPLICATIONS; CLINICAL HOLDS

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

CFR Citation:  21 CFR 312

Legal Deadline: None

Abstract: The proposed rule will 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

[[Page 22981]]

notifies the sponsor that it has reinstated the clinical hold.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/96
NPRM Comment Period End         08/00/96

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
_______________________________________________________________________




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

Priority:  Other Significant

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 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                            09/00/96
NPRM Comment Period End         12/00/96

Small Entities Affected: Businesses, Organizations

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: Erica L. Keys, 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
Fax: 301 827-0901

RIN: 0910-AA74
_______________________________________________________________________




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

Priority:  Other Significant

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                            09/00/96
NPRM Comment Period End         12/00/96

Small Entities Affected: Businesses, Organizations

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: Erica L. Keys, Regulatory Counsel, 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
Fax: 301 827-0901

RIN: 0910-AA75
_______________________________________________________________________




979.  DEBARMENT CERTIFICATION REGULATIONS FOR DRUG APPLICATIONS

Priority:  Substantive, Nonsignificant

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                            05/00/96
NPRM Comment Period End         07/00/96

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Procurement: This is a procurement-related action for which there is a 
statutory requirement. There is a paperwork burden associated with this 
action.

Agency Contact: Wayne Mitchell, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, (HFD-7), 7500 Standish Place, Rockville, MD 20855
Phone: 301 594-1049
Fax: 301 827-0901

RIN: 0910-AA76
_______________________________________________________________________

[[Page 22982]]





980.  CERTIFICATION OF DRUGS COMPOSED WHOLLY OR PARTLY OF 
INSULIN

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 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                            09/00/96
NPRM Comment Period End         12/00/96

Small Entities Affected: Businesses

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: Wayne Mitchell, Regulatory Counsel, 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
Fax: 301 827-0901

RIN: 0910-AA77
_______________________________________________________________________




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

Priority:  Other Significant

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                            09/00/96
NPRM Comment Period End         12/00/96

Small Entities Affected: Businesses

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: Melvin Lessing, Division of OTC Drug Evaluation, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Drug Evaluation and Research (HFD-560), 9200 Corporate Blvd. 
Rockville, MD 20850
Phone: 301 827-2222

RIN: 0910-AA79
_______________________________________________________________________




982.  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 4332

CFR Citation:  21 CFR 25

Legal Deadline: None

Abstract: The proposed rule would amend the regulations governing 
compliance with the National Environmental Policy Act (NEPA) as 
implemented by the regulations of the Council on Environmental Quality. 
The proposed rule would 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 proposed rule would 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         07/00/96

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
_______________________________________________________________________




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

Priority:  Other Significant

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 of 
childbearing potential from Phase 1 and early Phase 2 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 other methods 
available for preventing such exposure.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/96
NPRM Comment Period End         08/00/96

Small Entities Affected: Businesses, Organizations

[[Page 22983]]

Government Levels Affected: Undetermined

Procurement: This is a procurement-related action for which there is no 
statutory requirement. The agency has not yet determined whether there 
is a paperwork burden associated with this action.

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), 7500 Standish Place, Rockville, 
MD 20855
Phone: 301 594-1049
Fax: 301 827-0901

RIN: 0910-AA84
_______________________________________________________________________




984.  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

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                            09/00/96
NPRM Comment Period End         12/00/96

Small Entities Affected: Businesses

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: Howard P. Muller, Regulatory Counsel, 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
Fax: 301 827-0901

RIN: 0910-AA86
_______________________________________________________________________




985.  STERILITY REQUIREMENTS FOR INHALATION SOLUTION PRODUCTS

Priority:  Other Significant

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                            05/00/96
NPRM Comment Period End         08/00/96

Small Entities Affected: Businesses

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: Tamar Nordernberg, 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: 301 594-2041
Fax: 301 827-0901

RIN: 0910-AA88
_______________________________________________________________________




986.  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 proposes an amendment to 
informed consent regulations. The proposal would replace the interim 
final rule regulation promulgated December 21, 1990. The proposal 
establishes requirements to allow agency approval for waiver of 
informed consent in use of investigational drugs or biologics in 
certain military combat circumstances. Findings required that obtaining 
consent is not feasible and withholding treatment would be contrary to 
the best interests of military personnel. Individual waivers are 
required for each product and circumstance, with one year maximum 
extendable duration. Each waiver request from the Department of Defense 
must justify need for waiver, reasons use is the best preventive or 
therapeutic treatment, and verify that such use was approved by a 
properly constituted institutional review board.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/96

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
_______________________________________________________________________

[[Page 22984]]





987.  DIRECT-TO-CONSUMER PROMOTION REGULATIONS

Priority:  Substantive, Nonsignificant

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                            12/00/96

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
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




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

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 360b; 21 USC 371

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 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:

New Animal Drug Approval Process  NPRM 12/17/91 (56 FR 65544)  NPRM 10/
00/96

Reporting Requirements for Marketed Animal Drugs  NPRM 12/17/91 (56 FR 
65581)  Final Action 06/00/96

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: Andrew J. Beaulieu, Deputy Director, Office of New 
Animal Drug Evaluation, Department of Health and Human Services, Food 
and Drug Administration, Center for Veterinary Medicine (HFV-101), 7500 
Standish Place, Rockville, MD 20855
Phone: 301 594-1620

RIN: 0910-AA02
_______________________________________________________________________




989. CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS; 
NOTIFICATION OF CONSIGNEES RECEIVING BLOOD AND BLOOD COMPONENTS AT 
INCREASED RISK FOR TRANSMITTING HIV INFECTION

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 351 to 360k; 21 USC 374; 42 USC 262 to 264

CFR Citation:  21 CFR 606; 21 CFR 610

Legal Deadline: None

Abstract: The agency currently requires that all blood and blood 
components intended for transfusion or for the manufacture of any 
product be tested for antibody to human immunodeficiency virus (HIV). 
In instances when the blood of a donor is found to contain antibodies 
to HIV, some blood centers have initiated a program of voluntary 
``look-back'' to determine the suitability of previous donations and to 
notify consignees of blood and blood components obtained from the 
donor's prior donations. Consignees may withdraw or destroy such blood 
and blood products, and may trace and notify recipients. A well-
conducted look-back program can provide an effective mechanism for 
quarantine of products and for identifying, testing, and counseling 
recipients of transfusions determined to be at increased risk of HIV 
infection--those who receive blood from a donor later found to be 
infected with HIV. The agency is publishing a final rule

[[Page 22985]]

to establish a mandatory look-back program. The final rule will require 
blood collection facilities to develop a procedure to identify and 
quarantine products from prior collections and to notify consignees 
promptly whenever a blood donor who has previously donated blood or 
source plasma is found to be positive for the antibody to HIV; and to 
keep appropriate records when such notification has been made. In 
addition, the final rule will require hospital transfusion services to 
notify recipients of blood products at increased risk for transmitting 
HIV and to keep appropriate records of the notification process. The 
purpose of the rulemaking is to ensure the notification of consignees 
and blood transfusion recipients and that prompt and appropriate action 
is taken.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/30/93                    58 FR 34962
Final Action                    06/00/96

Small Entities Affected: Businesses, Organizations

Government Levels Affected: Undetermined

Additional Information: Previously reported under RIN 0905-AC90.

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 
200N, Rockville, MD 20852-1448
Phone: 301 594-3074

RIN: 0910-AA05
_______________________________________________________________________




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

Priority:  Other Significant

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

CFR Citation:  21 CFR 203

Legal Deadline: None

Abstract: The Prescription Drug Marketing Act of 1987 (PDMA) amended 
the Federal Food, Drug, and Cosmetic Act to: (1) require State 
licensing of wholesale distributors of prescription human drugs under 
Federal guidelines including minimum standards for storage, handling, 
and recordkeeping; (2) ban the reimportation of prescription human 
drugs produced in the United States, except when reimported by the 
manufacturer or for emergency use; 3) ban the sale, trade, or purchase 
of drug samples; (4) ban trafficking in or counterfeiting of drug 
coupons; (5) mandate storage, handling, and recordkeeping requirements 
for drug samples; (6) require licensed practitioners to request drug 
samples in writing; (7) prohibit, with certain exceptions, the resale 
of prescription human drugs purchased by hospitals or health care 
facilities; and (8) set forth criminal and civil penalties for 
violations of these provisions. In the Federal Register of September 
14, 1990 (55 FR 38012), FDA issued a final rule setting forth Federal 
guidelines for State licensing of wholesale drug distributors. 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                    09/00/96

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), 7500 
Standish Place, Rockville, MD 20855
Phone: 301 594-1049
Fax: 301 827-0901

RIN: 0910-AA08
_______________________________________________________________________




991. FOOD LABELING REVIEW

Priority:  Routine and Frequent

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

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

Legal Deadline: None

Abstract: The Nutrition Labeling and Education Act of 1990 (NLEA) 
requires that most foods bear nutrition labeling. The agency issued 
final rules implementing most of the provisions contained in the NLEA 
on January 6, 1993. Subsequently, however, the agency has identified 
additional areas that should be the subject of rulemaking. FDA issued a 
proposal on January 6, 1993, to establish requirements for the 
identification of certain ingredients on food labels. FDA proposed on 
June 15, 1993, to amend its January 6, 1993, final rules on nutrient 
content and health claims to remove the provisions that exempted 
restaurant menus from the requirements for how nutrient content claims 
and health claims are to be made. 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.

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)

[[Page 22986]]

Nutrient Content Claims and Health Claims; Restaurant Foods  NPRM 06/
15/93 (58 FR 33055)  Final Action 00/00/00

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 07/00/96

Voluntary Guidelines for Nutrition Labeling Produce  NPRM 07/18/94 (59 
FR 36379)  Final Action 08/00/96

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Additional Information: Previously reported under RIN 0905-AD89.

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
_______________________________________________________________________




992. DISQUALIFICATION OF CLINICAL INVESTIGATORS

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 360j(g)

CFR Citation:  21 CFR 812

Legal Deadline: None

Abstract: The rule would amend the investigational device exemption 
(IDE) regulations to provide for a procedure for disqualification of 
clinical investigators in cases of fraud or other serious violations of 
the regulations. Persons whose disqualification is proposed would be 
entitled to an opportunity for hearing.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/06/93                    58 FR 52144
Final Action                    06/00/96

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD94.

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-84), 2098 Gaither Road, Rockville, 
MD 20850
Phone: 301 594-4765

RIN: 0910-AA21
_______________________________________________________________________




993. INVESTIGATIONAL DEVICE EXEMPTION; INTRAOCULAR LENSES

Priority:  Other

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

Legal Authority:  21 USC 360j(g)

CFR Citation:  21 CFR 813; 21 CFR 812

Legal Deadline: None

Abstract: The rule would revoke the separate investigational device 
exemption regulation for intraocular lenses (IOLs). IOLs would then be 
subject to the same IDE regulation (21 CFR part 812) as all other 
devices. The IOL-IDE regulation was originally created as an interim 
measure.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/06/93                    58 FR 52142
Final Action                    06/00/96

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD95.

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-84), 2098 Gaither Road, Rockville, 
MD 20850
Phone: 301 594-4765

RIN: 0910-AA22
_______________________________________________________________________




994. 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 proposal 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 
necessary for the safe and effective use of prescription drugs in older 
populations. The final rule would finalize 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                    09/00/96

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), 7500 
Standish Place, Rockville, MD 20855
Phone: 301 594-1046
Fax: 301 827-0901

RIN: 0910-AA25
_______________________________________________________________________




995. 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 371

CFR Citation:  21 CFR 211

Legal Deadline: None

[[Page 22987]]

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                    05/00/96

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE27.

Agency Contact: Tamar S. Nordenberg, 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
Fax: 301 827-0901

RIN: 0910-AA26
_______________________________________________________________________




996. 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 would amend the adverse experience expedited 
reporting regulations for human drug and licensed biological products 
to make the requirements consistent with a new unified agency 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 expedited 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                    07/00/96

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.
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), 7500 Standish Place, Rockville, 
MD 20855
Phone: 301 594-1049
Fax: 301 827-0901

RIN: 0910-AA28
_______________________________________________________________________




997. 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.

Legal Authority:  21 USC 301 et seq; 21 USC 201 et seq

CFR Citation:  21 CFR 11

Legal Deadline: None

Abstract: FDA is preparing regulations to set forth criteria for agency 
acceptance of electronic records and electronic signatures in lieu of 
paper records and handwritten signatures. The new rules would apply to 
any records requirements in chapter I of title 21 (all program areas 
and industries), unless specifically exempted by future regulations. 
For documents required to be maintained, but not submitted to FDA, 
persons could use electronic records and signatures upon the effective 
date of a final rule. For documents submitted to FDA, persons could use 
electronic records and signatures if FDA has stated, in a public docket 
to be maintained for that purpose, that the intended receiving 
organization is prepared to accept the submission in electronic form. 
(The proposed rule does not require use of electronic records and 
signatures, but permits their use under certain circumstances.) This 
action was taken as a follow-up to the Agency's 7/21/92 advance notice 
of proposed rulemaking. The intended effect is to permit and foster use 
of new technologies in a manner that is consistent with FDA's overall 
mission and that preserves the integrity of the Agency's enforcement 
activities.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           07/21/92                    57 FR 32185
ANPRM Comment Period End        10/19/92
NPRM                            08/31/94                    59 FR 45160
NPRM Comment Period End         11/29/94
Final Action                    05/00/96

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: Federal

Additional Information: Previously reported under RIN 0905-AE31.

Agency Contact: Paul J. Motise, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research (HFD-323), 7500 Standish Place, Rockville, 
MD 20855
Phone: 301 594-1089
Fax: 301 594-2202
Email: [email protected]

RIN: 0910-AA29
_______________________________________________________________________

[[Page 22988]]





998. 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 
the clinical investigator is not a party to any problematic financial 
interests and arrangements or a statement disclosing problematic 
interests and arrangements to which the investigator is a party. This 
information would enable FDA to subject the relevant clinical research 
data to an appropriate level of scrutiny to test 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                    12/00/96

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.
Additional Information: Previously reported under RIN 0905-AE32.

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
_______________________________________________________________________




999. EFFECTIVE DATE OF REQUIREMENT FOR SUBMISSION OF PREMARKET APPROVAL 
APPLICATIONS

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 360e

CFR Citation:  21 CFR 868; 21 CFR 870; 21 CFR 872; 21 CFR 878; 21 CFR 
882; 21 CFR 888

Legal Deadline:  Final, Statutory, December 1, 1995.

Abstract: Class III devices which were on the market before 1976 are 
exempt from premarket approval until FDA issues a rule requiring the 
submission of premarket approval applications. The Safe Medical Devices 
Act of 1990 directed FDA to review the classification of pre-1976 class 
III devices for which premarket approval is not yet required, and 
either reclassify them into class I or class II or require premarket 
approval for those devices remaining in class III. There are 
approximately 125 pre-1976 class III devices not yet addressed. The 
devices covered by this final rule are devices which FDA believes may 
no longer be commercially viable.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          05/06/94                    59 FR 23731
NPRM                            09/07/95                    60 FR 46718
NPRM Comment Period End         01/05/96
Final Action                    09/00/96

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE34.

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-84), 2098 Gaither Road, Rockville, 
MD 20857
Phone: 301 594-4765

RIN: 0910-AA31
_______________________________________________________________________




1000. 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: Inadequate access to appropriate patient information is a 
major cause of inappropriate use of prescription medications, resulting 
in serious personal injury and related costs to the health care system. 
The Food and Drug Administration (FDA) believes that it is essential 
that patients receive information accompanying dispensed prescription 
drugs. This information needs to be widely distributed and be of 
sufficient quality to promote the proper use of prescription drugs. 
Therefore, FDA is proposing performance standards that would define 
acceptable levels of information distribution and quality, and to 
assess supplied information according to these standards. In accordance 
with the Administration's philosophy of fairly assessing a voluntary 
approach before imposing requirements through regulations, FDA is 
proposing that this information be disseminated through voluntary 
private-sector initiatives. Preliminary evidence suggests recent 
increases in the distribution of privately produced patient medication 
information with dispensed prescriptions; however, estimated 
distribution rates indicate that significant numbers of patients still

[[Page 22989]]

do not receive information with their medications. FDA analyses also 
indicate that there is a high variability in the quality of this 
information. FDA believes that, with greater encouragement and clear 
objectives, the private sector will substantially improve the quality 
and distribution of patient information. Therefore, in concert with 
Healthy People 2000, FDA is proposing that private-sector initiatives 
meet the goal of distributing useful patient information to 75 percent 
of individuals receiving new prescriptions by the year 2000 and 95 
percent of individuals receiving new prescriptions by the year 2006. 
FDA is proposing two alternative approaches to help ensure that these 
goals (performance standards) are achieved. FDA would periodically 
evaluate and report on achievement of these goals. If the goals are not 
met in the specified timeframes, FDA would either (a) implement a 
mandatory comprehensive Medication Guide program, or (b) seek public 
comment on whether the comprehensive program should be implemented or 
whether, and what, other steps should be taken to meet patient 
information goals.
Regardless of the approach chosen, a mandatory Medication Guide program 
would initially be limited to instances where a product poses a serious 
and significant public health concern requiring immediate distribution 
of FDA-approved patient information. FDA believes that substantial 
health care cost savings can be realized by ensuring that consumers 
obtain the inherent benefits of proper use of prescription drugs, and 
by reducing the potential for harm caused by inappropriate drug use by 
the patient.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/24/95                    60 FR 44182
Final Action                    06/00/96

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
_______________________________________________________________________




1001. IRON CONTAINING DRUGS AND SUPPLEMENTS

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 342; 21 USC 343; 21 USC 351; 21 USC 352

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

Legal Deadline: None

Abstract: On October 6, 1994, FDA published a proposal responding to 
three citizen petitions that were submitted in response to an increase 
in deaths and poisonings in small children due to accidental ingestion 
of iron-containing drugs and dietary supplements. The petitions 
requested that FDA require label warning statements for these products 
and special packaging to ensure the safe use of these products. Because 
of recent changes in the laws regulating dietary supplements brought 
about by the Dietary Supplement Health and Education Act (Pub. L. 103-
417), FDA published a supplemental proposal on February 16, 1995, that 
set forth its revised legal authority a supplemental proposal that sets 
forth its revised legal authority.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/06/94                    59 FR 51030
NPRM Correction                 11/14/94                    59 FR 56573
NPRM Comment Period End         12/20/94
Supplemental NPRM               02/16/95                     60 FR 8989
Supplemental NPRM Comment Period 
End                             04/17/95
Final Action                    08/00/96

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE59.

Agency Contact: Linda Kahl, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Food Safety and Applied Nutrition (HFS-206), 200 C Street SW., 
Washington, DC 20204
Phone: 202 418-3101

RIN: 0910-AA42
_______________________________________________________________________




1002. REGULATIONS RESTRICTING THE SALE AND DISTRIBUTION OF CIGARETTES 
AND SMOKELESS TOBACCO PRODUCTS TO PROTECT CHILDREN AND ADOLESCENTS

Priority:  Economically Significant

Legal Authority:  21 USC 351; 21 USC 360; 21 USC 360j; 21 USC 371; 21 
USC 374

CFR Citation:  21 CFR 801; 21 CFR 803; 21 CFR 804; 21 CFR 897

Legal Deadline: None

Abstract: The Food and Drug Administration is proposing new regulations 
governing the sale and distribution of nicotine-containing cigarettes 
and smokeless tobacco products to children and adolescents, in order to 
address the serious public health problems caused by the use of and 
addiction to these products. The proposed rule would reduce children's 
and adolescents' easy access to cigarettes and smokeless tobacco and 
would significantly decrease the amount of positive imagery that makes 
these products so appealing to them. The proposed rule would not 
restrict the use of tobacco products by adults.
The objective of the proposed rule is to meet the goal of the report 
``Healthy People 2000'' by reducing roughly by half children's and 
adolescents' use of tobacco products. If this objective is not met 
within 7 years of the date of publication of the final rule, the agency 
would take additional measures to help achieve the reduction in the use 
of tobacco products by young people. In the proposed rule, the agency 
is requesting comment regarding the type of additional measures that 
would be most effective.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/11/95                    60 FR 41314
NPRM Comment Period Extended to 
01/02/96                        10/16/95                    60 FR 53560
NPRM Comment Period End         11/09/95
NPRM Comment Period Reopened for 
Specific Documents to 04/19/96  03/20/96                    61 FR 11349
Final Action                    00/00/96

[[Page 22990]]

Jurisdictional Analysis  Notice 08/11/95 (60 FR 41453)  Notice Com. 
Per. Ext. to 01/02/96 10/16/95 (60 FR 53620)  Reopened for Spec. Docs. 
to 4/19/96 03/20/96 (61 FR 11419)

Small Entities Affected: Businesses

Government Levels Affected: State

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

RIN: 0910-AA48
_______________________________________________________________________




1003. 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                    06/00/96
Revocation of Certain Regulations; General  NPRM 01/25/96 (61 FR 
2192)  Final Rule 00/00/00

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
_______________________________________________________________________




1004. PROTECTION OF HUMAN SUBJECTS; INFORMED CONSENT

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 346; 21 USC 346a; 21 USC 348; 21 
USC 352; 21 USC 353; 21 USC 355 to 357; 21 USC 360; 21 USC 360c to 
360f; 21 USC 360h to 360j; 21 USC 371; 21 USC 379e; 42 USC 216; 42 USC 
241; 42 USC 381

CFR Citation:  21 CFR 50; 21 CFR 56; 21 CFR 312; 21 CFR 314; 21 CFR 
601; 21 CFR 812; 21 CFR 814

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is proposing to amend 
its current informed consent regulations to permit harmonization of FDA 
and National Institutes of Health (NIH) policies on emergency research, 
and to reduce confusion as to when such research can proceed without 
obtaining informed consent. The regulation provides a narrow exception 
to the requirement for obtaining and documenting informed consent from 
each human subject prior to initiation of an experimental treatment. 
The exception would apply to a limited class of research activities 
involving human subjects who, because of their life-threatening medical 
condition and the unavailability of legally authorized persons to 
represent them, are in need of emergency medical intervention and 
cannot provide legally effective informed consent.
The proposed rule would permit an Institutional Review Board (IRB) to 
approve an emergency research protocol if the IRB finds and documents 
that (a) the human subjects will be in a life-threatening situation, 
available treatments are unproven or unsatisfactory, and the collection 
of valid scientific evidence is necessary to determine what particular 
treatment is most beneficial; (b) obtaining informed consent is not 
feasible; (c) the opportunity for the subjects to participate in the 
research is in the interest of the subjects because treatment is 
required, and the risk is ``reasonable'' given what is known about the 
risks and benefits of experimental treatment, the current therapy, and 
the medical condition; (d) the research could not practically be 
carried out without the waiver; (e) additional protection of the rights 
and welfare of the subjects will be provided; and, (f) the IRB has 
reviewed and approved an informed consent document for use with 
subjects for whom consent is possible.
The proposed rule provided that, when possible and at the earliest 
possible opportunity, each subject will be informed about the details 
of the study and permitted to discontinue participation at any time 
without penalty. The rule also incorporates additional patient 
protections,

[[Page 22991]]

including: FDA review of the protocol; consultation with 
representatives of the communities from which the subjects will be 
drawn; public disclosure prior to the study sufficient to describe the 
study and its risks and benefits; the establishment of an independent 
data and safety monitoring board; and public disclosure following 
completion of the study sufficient to apprise the community and 
researchers of the study and its results.
FDA, in coordination with NIH, developed this proposal because of 
concerns expressed by the research community and patient advocacy 
groups that emergency research is at a virtual halt pending a revision 
of both FDA's informed consent regulations and a waiver of HHS 
regulations for the protection of research subjects. HHS intends to 
bring both policies into harmony on this matter at the time this rule 
is made final.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/21/95                    60 FR 49086
NPRM Comment Period End         11/06/95
Final Action                    04/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Glen D. Drew, Department of Health and Human Services, 
Food and Drug Administration, Office of Health Affairs (HFY-20) 5600 
Fishers Lane Rockville, MD 20857
Phone: 301 443-1382

RIN: 0910-AA60
_______________________________________________________________________




1005. 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 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 
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: The Food and Drug Administration (FDA) is proposing 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 is 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.'' 
It is also consistent with recent Congressional initiatives.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/27/95                    60 FR 58308
Final Action                    08/00/96

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
_______________________________________________________________________




1006.  WELL-CHARACTERIZED BIOTECHNOLOGY PRODUCTS; ELIMINATION OF 
ESTABLISHMENT LICENSE 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 351 to 353; 
21 USC 355; 21 USC 360; 21 USC 360c to 360f; 21 USC 360j to 360u; 21 
USC 371; 21 USC 374; 21 USC 379e; 21 USC 381; 42 USC 216; 42 USC 241; 
42 USC 262 to 263

CFR Citation:  21 CFR 601.2

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is amending the 
biologics regulations to eliminate the establishment license 
application (ELA) requirement for well-characterized biotechnology 
products licensed under the Public Health Service Act (PHS Act). The 
final rule will exempt well-characterized biotechnology products 
licensed under the PHS Act from certain biologics' regulations and 
harmonize the requirements applicable to these products with those 
applicable to similar drug products which are approved under the 
Federal Food, Drug, and Cosmetic Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/29/96                     61 FR 2733
Final Action                    05/00/96

Small Entities Affected: Businesses, Organizations

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 
200N, Rockville, MD 20852-1448
Phone: 301 594-3074
Fax: 301 443-3874

RIN: 0910-AA71
_______________________________________________________________________




1007.  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

Abstract: The final rule would eliminate Type I Drug Master Files,

[[Page 22992]]

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                    07/00/96

Small Entities Affected: None

Government Levels Affected: None

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

Agency Contact: Thomas Kuchenburg, Regulatory Counsel, 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
Fax: 301 827-0901

RIN: 0910-AA78
_______________________________________________________________________




1008.  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 would 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                    07/00/96

Small Entities Affected: Businesses

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: Thomas Kuchenberg, Regulatory Counsel, 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
Fax: 301 827-0901

RIN: 0910-AA81
_______________________________________________________________________




1009.  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 would 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 would 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                    08/00/96

Small Entities Affected: Businesses, Organizations

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: Audrey Thomas, Consumer Safety Officer, 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
Fax: 301 827-0901

RIN: 0910-AA82
_______________________________________________________________________




1010.  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 would 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/04/86                    51 FR 20310
Final Action                    07/00/96

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Erica L. Keys, Regulatory Counsel, 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
Fax: 301 827-0901

RIN: 0910-AA87
_______________________________________________________________________

[[Page 22993]]




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


Food and Drug Administration (FDA)



_______________________________________________________________________




1011. POLICIES CONCERNING USES OF SULFITING AGENTS

Priority:  Other Significant

Legal Authority:  21 USC 321; 21 USC 336; 21 USC 341; 21 USC 342; 21 
USC 343; 21 USC 348; 21 USC 371

CFR Citation:  21 CFR 182.3616; 21 CFR 182.3637; 21 CFR 182.3739; 21 
CFR 182.3766; 21 CFR 182.3798; 21 CFR 182.3862; 21 CFR 100.100; 21 CFR 
130.9

Legal Deadline: None

Abstract: Acceptable evidence and information exist to show that a 
subgroup of asthmatics is at moderate to severe risk for a severe 
reaction upon exposure to sulfites. The agency's primary tool for 
handling a situation where population subgroups may be at increased 
risk from a food ingredient that is safe for most people is to use 
labeling to inform those persons who need or want to avoid the 
ingredient. The agency issued a final rule, effective January 9, 1987, 
that requires that when a sulfiting agent is present in a finished food 
at 10 parts per million or greater, the sulfiting agent must be 
declared on the label. In addition, FDA issued a final rule, effective 
August 8, 1986, prohibiting the use of sulfiting agents on raw fruits 
and vegetables intended to be served or sold raw to consumers (e.g., in 
salad bars). On December 10, 1987, FDA announced its tentative 
conclusion that there is no longer a basis to find that the use of 
sulfiting agents on ``fresh'' potatoes served or sold unpackaged to 
consumers is GRAS. On December 19, 1988, FDA proposed to affirm, with 
specific limitations, that certain other uses of sulfiting agents are 
GRAS and to establish labeling requirements for sulfiting agents in 
standardized foods.
On March 15, 1990 (55 FR 9826), FDA issued a final rule prohibiting the 
use of sulfiting agents on ``fresh'' potatoes (55 FR 9826) and 
requested data and information concerning the use of sulfiting agents 
on frozen potatoes (55 FR 9834).
On August 3, 1990, the United States District Court for the Middle 
District of Pennsylvania declared the final rule concerning ``fresh'' 
potatoes to be null and void on procedural grounds. The Government 
appealed the district court's decision. On May 22, 1991, the U.S. Court 
of Appeals for the Third Circuit en banc split equally. Therefore, the 
decision of the district court invalidating on procedural grounds FDA's 
final rule revoking the GRAS status of the use of sulfiting agents on 
fresh potatoes was left in place. On December 22, 1994 (59 FR 65938), 
FDA withdrew the invalidated rule.
FDA's reproposed rule will address the regulatory status of sulfiting 
agents on both minimally processed (``fresh'') and frozen potatoes. FDA 
also plans to issue a tentative final rule regarding the use of 
sulfiting agents in shrimp.

Timetable:

Food Labeling; Declaration of Sulfiting Agents  NPRM 04/03/85 (50 FR 
13306)  Final Action 07/09/86 (51 FR 25012)  Final Action Effective 01/
09/87

GRAS Status of the Use of Sulfiting Agents on Fresh Potatoes  NPRM-To 
be Merged w/Frozen Potatoes 12/10/87 (52 FR 46968)  Final Action 03/15/
90 (55 FR 9826)

GRAS Status of Certain Other Food Uses of Sulfiting Agents, Etc.  NPRM 
12/19/88 (53 FR 51065)  Final Action 00/00/00

Revoking Use of Sulfiting Agents on Fruits & Vegetables, Etc.  NPRM 08/
14/85 (50 FR 32836)  Final Action 07/09/86 (51 FR 25021)  Final Action 
Effective 08/09/86

Use of Sulfiting Agents on Minimally Processed & Frozen Potatoes  NPRM 
00/00/00

Use of Sulfiting Agents on Shrimp  NPRM 12/19/88 (53 FR 
51065)  Tentative Final Rule 00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: Previously reported under RIN 0905-AB52.

Agency Contact: JoAnn Ziyad, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Food Safety and Applied Nutrition (HFS-207), 200 C Street SW., 
Washington, DC 20204
Phone: 202 418-3116

RIN: 0910-AA03
_______________________________________________________________________




1012. LEAD IN FOODS

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 321; 21 USC 336; 21 USC 342(a); 21 USC 346; 21 
USC 346a; 21 USC 348; 21 USC 371

CFR Citation:  21 CFR 109; 21 CFR 182; 21 CFR 189

Legal Deadline: None

Abstract: In light of the public health concerns raised by continuing 
findings concerning the effects of low levels of exposure to lead, 
particularly exposure by pregnant women, infants, and children, the 
agency is undertaking a comprehensive effort to further reduce lead 
levels in food where controllable or avoidable sources of lead addition 
to food can be identified. The goal of FDA is to reduce consumers' 
exposure to lead in the diet to the lowest level that can be 
practicably obtained.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    02/08/96
Final Action Effective          02/08/96
Lead From Ceramic Pitchers  NPRM 06/01/89 (54 FR 23485)  NPRM Comment 
Period End 07/31/89  Withdrawal of NPRM 00/00/00

Prohibit Use of Lead-Soldered Food Cans  NPRM 06/21/93 (58 FR 
33860)  Final Action 06/27/95 (60 FR 33106)

Prohibit Use of Tin-Coated Lead Foil Capsules on Wine Bottles  NPRM 11/
25/92 (57 FR 55485)  Final Rule 02/08/96 (61 FR 4816)

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AC91.

Agency Contact: Michael E. Kashtock, Supervisory Consumer Safety 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Food Safety and Applied Nutrition (HFS-306), 
200 C Street SW., Washington, DC 20204
Phone: 202 205-4681

RIN: 0910-AA06
_______________________________________________________________________




1013. 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,

[[Page 22994]]

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.
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 Association of Color Manufacturers (IACM) on an 
interim rule FDA published in the Federal Register of November 29, 1994 
(59 FR 60808). 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.

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)


Next Action Undetermined

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 Management (HFA-120), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 443-1766
Fax: 301 443-6242

RIN: 0910-AA07
_______________________________________________________________________




1014. BOTTLED WATER

Priority:  Routine and Frequent

Legal Authority:  21 USC 341; 21 USC 343(g); 21 USC 343(h); 21 USC 349; 
21 USC 371(a)

CFR Citation:  21 CFR 103; 21 CFR 165

Legal Deadline:  Other, Statutory.
Other deadline is for publication of NPRM or Notice within 180 days of 
EPA final action.

Abstract: In fulfillment of its mandate under the Safe Drinking Water 
Act, EPA is currently in the midst of reviewing and establishing 
standards for contaminants in public drinking water such as pathogenic 
bacteria, pesticides, and organic chemicals. When EPA establishes such 
standards for public drinking water, FDA is required to take 
appropriate action to amend its regulations for bottled drinking water 
or to state its reasons for not doing so. FDA also establishes identity 
standards for a food when it has determined that the standard will 
promote honesty and fair dealing in the interest of consumers.

Timetable:

Beverages; Bottled Water  NPRM 01/05/93 (58 FR 393)  Final Action 11/
13/95 (60 FR 57132)

Microbiological Quality Standard  NPRM 10/06/93 (58 FR 25042)  Final 
Action 00/00/00

Quality Standard for Lead and Copper  NPRM 01/05/93 (58 FR 389)  Final 
Action 05/25/94 (59 FR 26933)

Quality Standards for 24 Contaminants  NPRM 08/04/93 (58 FR 
41612)  Final Action 03/26/96 (61 FR 13258)

Quality Standards for 35 Contaminants  NPRM 01/05/93 (58 FR 382)  Final 
Action 12/01/94 (59 FR 61529)

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD65.

Agency Contact: Michael E. Kashtock, Supervisory Consumer Safety 
Officer, Department of Health and Human Services, Food and Drug 
Administration, Center for Food Safety and Applied Nutrition (HFS-306), 
200 C Street SW., Washington, DC 20204
Phone: 202 205-4681

RIN: 0910-AA11
_______________________________________________________________________




1015. 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                            00/00/00

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: Tracey Forfa, Regulatory Counsel, 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
_______________________________________________________________________




1016. DIETARY SUPPLEMENT LABEL REVIEW

Priority:  Routine and Frequent

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

[[Page 22995]]

USC 342; 21 USC 343; 21 USC 348; 21 USC 371

CFR Citation:  21 CFR 101

Legal Deadline:  NPRM, Statutory, June 15, 1993. Final, Statutory, 
December 31, 1993.
If final regulations on labeling of Dietary Supplements are not 
published by 12/31/93, the proposed regulations shall be considered the 
final regulations.

Abstract: With the publication of various final rules on January 6, 
1993, the Agency completed action on its food labeling initiative under 
the Nutrition Labeling and Education Act of 1990. Rulemaking on 
nutrition labeling of dietary supplements was delayed due to 
requirements of the Dietary Supplement Act of 1992 (DSA), which amended 
the law to provide that the Agency would issue proposed regulations for 
dietary supplements by June 15, 1993, and final regulations by December 
31, 1993. Three proposed regulations were developed and published on 
June 18, 1993: Health Claims for Dietary Supplements, Nutrient Content 
Claims for Dietary Supplements, and Mandatory Nutrition Labeling for 
Dietary Supplements. On October 14, 1993, FDA published a proposal to 
not authorize health claims on the labels of dietary supplements of 
five nutrient/disease relationships: (1) Dietary fiber and cancer, (2) 
Dietary fiber and CVD, (3) Antioxidants and cancer, (4) Omega-3 fatty 
acids and CHD, and (5) Zinc and immune function in the elderly. In 
addition, FDA also published a proposed rule to authorize the use of 
health claims about the relationship of folates and neural tube 
defects. On January 4, 1994, FDA published notices stating that the 
proposed health claim regulations be final by operation of law. 
However, the notices also stated that FDA considers the October 14, 
1993, rulemakings to be ongoing. The Agency intends to continue 
rulemaking with respect to folates and to issue a final rule as quickly 
as possible. FDA is also considering new scientific information that 
may support health claims for some of the nutrient-disease 
relationships given above. If this information is sufficient to support 
claims, the Agency will repropose to allow those claims.

Timetable:

Health Claims; Diet. Fiber/Cancer, CHD; Antioxidant/CVD; Omega-3  NPRM 
10/14/93 (58 FR 53296)  Final Action 00/00/00

Health Claims; Dietary Supplements  NPRM 06/18/93 (58 FR 33700)  Final 
Action 01/04/94 (59 FR 395)

Health Claims; Folate and Neural Tube Defects  Final Action 01/04/94 
(59 FR 433)  Final Action Effective 07/01/95

Nutrient Content Claims; Dietary Supplements  NPRM 06/18/93 (58 FR 
33731)  Final Action 01/04/94 (59 FR 378)

Nutrition Labeling; Dietary Supplements  NPRM 06/18/93 (58 FR 
33715)  Final Action 01/04/94 (59 FR 354)

Regulation of Diet. Supp.  ANPRM 06/18/93 (58 FR 33690)  Withdrawal of 
ANPRM 12/06/94 (59 FR 62644)

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Additional Information: Previously reported under RIN 0905-AD96.

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

RIN: 0910-AA23
_______________________________________________________________________




1017. AMALGAM INGREDIENT LABELING

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 352

CFR Citation:  21 CFR 801

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 amalgam for the 
patient.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

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-84), 2098 Gaither Road, Rockville, 
MD 20850
Phone: 301 594-4765

RIN: 0910-AA33
_______________________________________________________________________




1018. CLASSIFICATION OF COMPUTER SOFTWARE PROGRAMS THAT ARE MEDICAL 
DEVICES

Priority:  Other Significant

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 announcing its intention to classify stand-alone 
computer software products that fit the definition of a medical device 
under the Federal Food, Drug, and Cosmetic Act. The Agency anticipates 
classifying these devices by using a risk-based approach as required 
under the Medical Device Amendments to the act. 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
_______________________________________________________________________

[[Page 22996]]





1019. DEVELOPMENT OF HAZARD ANALYSIS CRITICAL CONTROL POINTS FOR THE 
FOOD INDUSTRY; REQUEST FOR COMMENTS

Priority:  Other Significant

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

CFR Citation:  None

Legal Deadline: None

Abstract: FDA announced on April 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 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.

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: Undetermined

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: 202 205-4010

RIN: 0910-AA43
_______________________________________________________________________




1020. HABIT FORMING DRUGS

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

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), 7500 
Standish Place, Rockville, MD 20855
Phone: 301 594-1049
Fax: 301 827-0901

RIN: 0910-AA50
_______________________________________________________________________




1021. DRUGS USED FOR TREATMENT OF NARCOTIC ADDICTS

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 355; 21 USC 371; 42 USC 241; 42 USC 257; 42 
USC 290; 42 USC 300

CFR Citation:  21 CFR 291

Legal Deadline: None

Abstract: The proposed rule would revise the regulations under part 291 
to reduce burden, to streamline requirements, to consolidate various 
sections.

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), 7500 
Standish Place Rockville, MD 20855
Phone: 301 594-1049
Fax: 301 827-0901

RIN: 0910-AA52
_______________________________________________________________________




1022. SUBSTANCES APPROVED FOR USE IN THE PREPARATION OF MEAT AND POULTRY 
PRODUCTS

Priority:  Other Significant

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

Legal Authority:  21 USC 321; 21 USC 342; 21 USC 348; 21 USC 371; 21 
USC 379e; 21 USC 381; 42 USC 216; 42 USC 262

CFR Citation:  21 CFR 71; 21 CFR 170; 21 CFR 171

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is proposing to amend 
its regulations governing the review of petitions for the approval of 
food and color additives and substances generally recognized as safe 
(GRAS) to provide for simultaneous review of such petitions by the Food 
Safety and Inspection Service (FSIS), U.S. Department of Agriculture 
(USDA), when meat or poultry product uses are proposed. By agreement 
between USDA and FDA, such listings would eliminate the need for a 
separate FSIS rulemaking to allow the use in meat and poultry products 
of FDA-approved substances.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/29/95                    60 FR 67490
NPRM Comment Period End         03/14/96


Next Action Undetermined

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: Federal

[[Page 22997]]

Agency Contact: George Pauli, Supervisory Consumer Safety Officer, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Food Safety and Applied Nutrition (HFS-200) 200 C Street 
SW., Washington, DC 20204
Phone: 202 418-3090

RIN: 0910-AA66
_______________________________________________________________________




1023.  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 would 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                            00/00/00

Small Entities Affected: Businesses, Organizations

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: Audrey Thomas, Consumer Safety Officer, 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
Fax: 301 827-0901

RIN: 0910-AA85
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Food and Drug Administration (FDA)



_______________________________________________________________________




1024. FINAL REGULATION TO ESTABLISH PROCEDURES FOR THE SAFE AND SANITARY 
PROCESSING AND IMPORTING OF FISH AND FISHERY PRODUCTS

Priority:  Economically Significant

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

CFR Citation:  21 CFR 123; 21 CFR 1240

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/18/95                    60 FR 65096
Final Action Effective          12/18/97

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Philip Spiller
Phone: 202 418-3133

RIN: 0910-AA10
_______________________________________________________________________




1025. GENERAL BIOLOGICAL PRODUCT STANDARDS; ALTERNATIVE PROCEDURES AND 
EXCEPTIONS

Priority:  Substantive, Nonsignificant

CFR Citation:  21 CFR 610; 21 CFR 640; 21 CFR 630

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       02/12/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Stephen Ripley
Phone: 301 594-3074

RIN: 0910-AA16
_______________________________________________________________________




1026. MEDICAL DEVICES; PROTECTIVE RESTRAINTS; REVOCATION OF EXEMPTIONS 
FROM 510(K) PREMARKET NOTIFICATION PROCEDURES AND CURRENT GOOD 
MANUFACTURING PRACTICES REGULATIONS

Priority:  Substantive, Nonsignificant

CFR Citation:  21 CFR 880.6760; 21 CFR 890.3910

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/04/96                     61 FR 8432

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

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

RIN: 0910-AA17
_______________________________________________________________________




1027. CERTIFICATION OF DRUGS COMPOSED WHOLLY OR PARTLY OF INSULIN; FEES 
FOR CERTIFICATION OF DRUGS COMPOSED WHOLLY OR PARTLY OF INSULIN

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Duplicate of RIN 
0910-AA07                       02/13/96

RIN: 0910-AA27
_______________________________________________________________________




1028. PREMARKET APPROVAL OF MEDICAL DEVICES; SUPPLEMENTAL APPLICATIONS

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:  21 CFR 814.39

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - The agency has 
determined this regulation is 
unnecessary.                    02/12/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Joseph M. Sheehan

[[Page 22998]]

Phone: 301 594-4765

RIN: 0910-AA35
_______________________________________________________________________




1029. PUBLIC INFORMATION; COMMUNICATIONS WITH STATE AND FOREIGN 
GOVERNMENT OFFICIALS

Priority:  Other

CFR Citation:  21 CFR 20

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/08/95                    60 FR 63372
Final Action Effective          01/08/96

Small Entities Affected: None

Government Levels Affected: State, Local, Federal

Agency Contact: Linda Horton
Phone: 301 827-3344
Fax: 301 443-6906
Email: [email protected]

RIN: 0910-AA46
_______________________________________________________________________




1030. OTC DRUG LABELING REVIEW

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Duplicate of RIN 
0910-AA79                       03/20/96

RIN: 0910-AA63
_______________________________________________________________________




1031. MEDICAL DEVICE EXEMPTIONS FROM PREMARKET NOTIFICATION

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 862; 21 CFR 866; 21 CFR 868; 21 CFR 870; 21 CFR 
872; 21 CFR 874; 21 CFR 876; 21 CFR 878; 21 CFR 880; 21 CFR 882; 21 CFR 
884; 21 CFR 886; 21 CFR 888; 21 CFR 890; 21 CFR 892

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/16/96                     61 FR 1117
Final Action Effective          02/15/96

Small Entities Affected: Businesses

Government Levels Affected: Federal

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

RIN: 0910-AA65
_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1032. 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

CFR Citation:  42 CFR 121

Legal Deadline: None

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 or provide any benefit other 
than that which now exists.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/08/94                    59 FR 46482
NPRM Comment Period End         12/07/94
Final Action                    06/00/96

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 7-18 
Parklawn Bldg., 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 443-7577

RIN: 0906-AA32
_______________________________________________________________________




1033. NATIONAL VACCINE INJURY COMPENSATION PROGRAM: REVISIONS AND 
ADDITIONS TO THE VACCINE INJURY TABLE--II

Priority:  Other Significant

Legal Authority:  42 USC 216; 42 USC 300aa-14; 42 USC 300aa-1 note.

CFR Citation:  42 CFR 100

Legal Deadline: None

Abstract: The Secretary has made findings as to the illnesses and 
conditions that can reasonably be determined in some circumstances to 
be caused or significantly aggravated by certain vaccines. Based on 
these findings, the Secretary amends the Vaccine Injury Table by 
regulation pursuant to section 313 of the National Childhood Vaccine 
Injury Act of 1986 and section 2114(c) of the Public Health Service 
Act. This final rule would have effect only for petitions for 
compensation under the National Vaccine Injury Compensation Program 
(VICP) filed after the final regulations become effective.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/08/95                    60 FR 56289
Final Action                    02/00/97

Small Entities Affected: None

Government Levels Affected: None

[[Page 22999]]

Additional Information: Previously reported under RIN 0905-AE52.

Agency Contact: Thomas E. Balbier, Jr., Director, Division of Vaccine 
Injury Compensation Program, BHPr, Department of Health and Human 
Services, Health Resources and Services Administration, Room 8A-35, 
Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 443-6593

RIN: 0906-AA36
_______________________________________________________________________




1034. 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.

Legal Authority:  42 USC 292 et seq

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

Legal Deadline: None

Abstract: The purpose of this action is to remove regulations rendered 
obsolete by P.L. 102-408, which rescinded the authority for a health 
professions training facilities construction grant program that the now 
obsolete regulations governed.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Charlotte Pascoe, Chief, Division of Facilities 
Compliance and Recovery, Department of Health and Human Services, 
Health Resources and Services Administration, Room 7-31 Parklawn Bldg., 
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 443-6512

RIN: 0906-AA39
_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1035. 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
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1036. TECHNICAL AMENDMENTS TO THE HEALTH PROFESSIONS, NURSING, AND 
ALLIED HEALTH TRAINING GRANT PROGRAMS UNDER 42 CFR PARTS 57 AND 58

Priority:  Other

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

CFR Citation:  42 CFR 57; 42 CFR 58

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    02/16/96                     61 FR 6118
Final Action Effective          02/16/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jennifer Burks
Phone: 301 443-1590

RIN: 0906-AA38
_______________________________________________________________________

[[Page 23000]]




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


Indian Health Service (IHS)



_______________________________________________________________________




1037. 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

________________________________________________________________________

NPRM                            05/00/96
NPRM Comment Period End         07/00/96

Small Entities Affected: None

Government Levels Affected: Tribal

Procurement: This is a procurement-related action for which there is a 
statutory requirement. The agency has not yet determined whether there 
is a paperwork burden associated with this action.
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
_______________________________________________________________________




1038.  INDIAN CHILD PROTECTION AND FAMILY VIOLENCE PREVENTION 
ACT MINIMUM STANDARDS OF CHARACTER AND SUITABILITY FOR EMPLOYMENT

Priority:  Other

Legal Authority:  5 USC 301; 25 USC 3201 et seq; 42 USC 13041

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 
prescribes minimum standards of character and suitability of employment 
for individuals whose duties and responsibilities involve regular 
contact with, or control over, Indian children. These regulations also 
incorporate suitability of employment criteria required by section 231 
of the Crime Control Act of 1990, P.L. 101-647, 42 U.S.C. 13041, which 
applies to each agency of the federal government and contractors with 
the federal government which hires individuals to provide child care 
services.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/96
NPRM Comment Period End         07/00/96

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)



_______________________________________________________________________




1039. REVISION OF INDIAN SELF-DETERMINATION REGULATIONS

Priority:  Other Significant

Legal Authority:  PL 93-638; PL 100-202; PL 100-446; PL 100-472; PL 
100-581; PL 101-301; PL 103-413; 25 USC 450

CFR Citation:  42 CFR 36; 48 CFR 380.4; 48 CFR 352.280-4

Legal Deadline:  Final, Statutory, June 1996.

Abstract: Public Law 93-638, passed in 1975, requires the Indian Health 
Service (IHS) to turn over administrative responsibility for service 
delivery programs to tribes so requesting, using the mechanism of 
contracting. Public Law 93-638 also authorizes the IHS to make grants 
to tribes for the planning, development, and/or operations of health 
programs. Public Law 100-472, enacted October 5, 1988, made significant 
changes to the statute and required that regulations implementing the 
amendments be promulgated in final within 10 months of enactment. The 
NPRM was published on January 20, 1994. The 120-day comment period was 
extended until August 20, 1994. On October 26, 1994, Public Law 103-413 
was enacted. These amendments superseded the published NPRM and 
authorized the Secretaries of Interior and Health and Human Services to 
publish joint regulations only in specified areas. These regulations 
would be developed using the negotiated rulemaking procedure and are to 
be published within 18 months of enactment of the authorizing 
legislation.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/24/96                     61 FR 2037
NPRM Comment Period End         03/25/96
Final Action                    06/00/96

Small Entities Affected: None

Government Levels Affected: Tribal

Additional Information: Previously reported under RIN 0905-AE68. Future 
action undetermined because statutory deadline and end of comment 
period differ by 30 days. Legislation to change statutory deadline to 
June 25, 1996, has been introduced in both houses of Congress.

Agency Contact: Betty J. Penn, Chief, Regulations Branch, DLR, 
Department of Health and Human Services, Indian Health Service, 12300 
Twinbrook Parkway, Suite 450, Rockville, MD 20852
Phone: 301 443-1116

RIN: 0917-AA01
_______________________________________________________________________

[[Page 23001]]




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


Agency for Health Care Policy and Research (AHCPR)



_______________________________________________________________________




1040. HEALTH SERVICES RESEARCH, EVALUATION, DEMONSTRATION, AND 
DISSEMINATION PROJECTS; PEER REVIEW OF GRANTS AND CONTRACTS

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 299c-1(e)

CFR Citation:  42 CFR 67

Legal Deadline: None

Abstract: This final rule revises the regulations under 42 CFR part 67 
to establish updated regulations for the administration of grants and 
peer review of grants and contracts for health services research 
projects supported by the Agency for Health Care Policy and Research. 
These grants and contracts are under authority of Title IX of the PHS 
Act and section 1142 of the Social Security Act, as amended by P.L. 
101-239 and P.L. 102-410. Public Comment was solicited on an NPRM on 
November 16, 1993. The final rule will also remove an existing subpart, 
which is obsolete.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/16/93                    58 FR 60510
NPRM Comment Period End         01/18/94
Final Action                    08/00/96

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD30.

Agency Contact: Phyllis Zucker, Dir., Off. of Planning and Evaluation, 
Department of Health and Human Services, Agency for Health Care Policy 
and Research, Suite 603, 2101 East Jefferson Street, Rockville, MD 
20852
Phone: 301 594-2453

RIN: 0919-AA00
_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




1041. 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 634 of PL 100-607 creates a new program through which 
health professionals can obtain federally funded repayment of 
educational loans by conducting AIDS research as NIH employees. The new 
regulations will cover this program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/96

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
_______________________________________________________________________




1042. 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 would 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                            05/00/96

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
_______________________________________________________________________




1043. UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING PROFESSIONS NEEDED BY 
THE NIH

Priority:  Other

Legal Authority:  42 USC 288-4; 42 USC 216

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                            06/00/96

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE57.

[[Page 23002]]

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
_______________________________________________________________________




1044. TRAINEESHIPS (TERMINATION POLICIES)

Priority:  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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/96

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
_______________________________________________________________________




1045. ADDITIONAL DHHS PROTECTION FOR PREGNANT WOMEN AND HUMAN FETUSES 
INVOLVED AS SUBJECTS FOR RESEARCH, AND PERTAINING TO HUMAN IN VITRO 
FERTILIZATION

Priority:  Other

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 in 
research.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/96

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: F. William Dommel, Jr., J.D., Senior Policy Advisor, 
Department of Health and Human Services, National Institutes of Health, 
Office for Protection from Research Risks, 6100 Executive Blvd., Ste. 
3801, MSC 7507, Rockville, MD 20892-7507
Phone: 301 496-7005
Fax: 301 402-2071
Email: [email protected]

RIN: 0925-AA14
_______________________________________________________________________




1046.  NATIONAL RESEARCH SERVICE AWARDS

Priority:  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                            04/00/96

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
_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




1047. GRANTS FOR RESEARCH PROJECTS

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 216

CFR Citation:  42 CFR 52

Legal Deadline: None

Abstract: Regulations covering grants for research projects will be 
amended to show changes necessitated by enactment of Public Laws 99-
158, 99-660, 100-607, 101-549, 101-613, 102-222, 102-321, and 102-588, 
and to show their applicability to various programs administered by the 
Centers for Disease Control and Prevention and the Food and Drug 
Administration previously omitted from the regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/02/94                    59 FR 39312
NPRM Comment Period End         10/03/94
Final Action                    04/00/96

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AC02.

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

[[Page 23003]]

Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA01
_______________________________________________________________________




1048. HAZARDOUS SUBSTANCES BASIC RESEARCH AND TRAINING GRANTS

Priority:  Other

Legal Authority:  42 USC 9660; 42 USC 216

CFR Citation:  42 CFR 65a

Legal Deadline: None

Abstract: Regulations will be promulgated concerning grants for 
research and training made for the purpose of understanding, assessing, 
and reducing the adverse effect on human health of exposure to 
hazardous substances. The grants are authorized by section 311(a) of 
the Comprehensive Environmental Response, Compensation, and Liability 
Act (CERCLA) of 1980, as added by section 209 of the Superfund 
Amendments and Reauthorization Act (SARA) of 1986, P.L. 99-499.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/07/95                    60 FR 12525
NPRM Comment Period End         05/08/95
Final Action                    04/00/96

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD46.

Agency Contact: Dr. William A. Suk, Program Administrator, Division of 
Extramural Research and Training, Department of Health and Human 
Services, National Institutes of Health, NIEHS, P.O. Box 12233, 
Research Triangle Park, NC 27709
Phone: 919 541-0797

RIN: 0925-AA03
_______________________________________________________________________




1049. NATIONAL INSTITUTES OF HEALTH CONSTRUCTION GRANTS

Priority:  Other

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 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 more clearly show their general applicability to all NIH 
extramural programs with construction grant authority. Additionally, 
the regulations will be amended to show new administrative and 
technical requirements, add new procedures for the recovery of grant 
funds for facilities no longer used for biomedical research, show new 
PHS Act section numbers, and update the listing of other HHS 
regulations relevant to construction grants.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/06/95                    60 FR 35266
NPRM Comment Period End         09/05/95
Final Action                    04/00/96

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
_______________________________________________________________________




1050. TRAINING GRANTS

Priority:  Other

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 242l(b)(3); 42 USC 284(b)(1)(C); 
42 USC 287c(b); 42 USC 300cc-15(a)(1); 42 USC 300cc-41(a)(3)(C); 42 USC 
7403(h)(2)

CFR Citation:  42 CFR 63a

Legal Deadline: None

Abstract: New regulations concerning non-NRSA training grants 
authorized by various PHS Act sections and training activities 
authorized by section 103(h)(2) of the Clean Air Act, as amended by 
section 901 of the Clean Air Act Amendments of 1990, P.L. 101-549. The 
regulations are intended to serve as a standing set of regulations that 
could be adapted for future training grant programs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/24/95                     60 FR 4742
NPRM Comment Period End         03/27/95
Final Action                    04/00/96

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD56.

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-AA05
_______________________________________________________________________




1051. NATIONAL INSTITUTES OF HEALTH CENTER GRANTS

Priority:  Other

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-3; 42 USC 285b-4; 42 USC 
285c-5; 42 USC 285d-6; 42 USC 285e-2; 42 USC 285e-3; 42 USC 285f-1; 42 
USC 285g-5; 42 USC 285g-7; 42 USC 285m-3; 42 USC 285o-2; 42 USC 300cc-
16; 42 USC 285a-6(c)(1)(E); 42 USC 285c-8

CFR Citation:  42 CFR 52a

Legal Deadline: None

Abstract: NIH Center Grants regulations will be amended to show their 
applicability to the Drug Abuse Research Centers Program authorized by 
PHS Act, section 464N, as added by section 123 of the ADAMHA 
Reorganization Act, P.L. 102-321, and several new centers authorized 
under the NIH Revitalization Act of 1993. Additionally, in accordance 
with the

[[Page 23004]]

President's Reinventing Government effort, NIH is merging the 
regulations governing Grants for National Alcohol Research Centers 
codified at 42 CFR Part 54a with the Center Grants regulations and 
removing 42 CFR Part 54a from the CFR.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/17/95                     60 FR 9560
NPRM Comment Period End         04/18/95
Final Action                    04/00/96

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE00. NIH 
plans to modify the National Alcohol Research Centers regulations to 
set forth changes necessitated by enactment of the ADAMHA 
Reorganization Act, Public Law 102-321, and other changes to update the 
regulations previously reported under RIN 0905-AE08. Additional Legal 
Authorities: 42 USC 286a-7(c)(1)(G)

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, Behtesda, MD 20892-2975
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA06
_______________________________________________________________________




1052. GRANTS FOR NATIONAL ALCOHOL RESEARCH CENTERS

Priority:  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; 42 USC 285n-2

CFR Citation:  42 CFR 54a

Legal Deadline: None

Abstract: In accordance with the President's Reinventing Government 
effort, regulations governing grants for alcohol abuse and alcoholism 
prevention, treatment, and rehabilitation services, and National 
Alcohol Research Centers are being merged with the regulations 
governing NIH center grants codified at 42 CFR Part 52. Part 54a is 
being removed from the CFR.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/19/94                    59 FR 42793
NPRM Comment Period End         10/18/94
Final Action                    04/00/96

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE08. 
Merging of the National Alcohol Research Center grants regulations with 
the NIH center grant regulations is also reported under RIN 0925-AA06.

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-AA08
_______________________________________________________________________




1053.  REMOVAL OF OBSOLETE PATENT REGULATIONS

Priority:  Other

Legal Authority:  42 USC 216

CFR Citation:  45 CFR 6; 45 CFR 8

Legal Deadline: None

Abstract: Currently HHS regulations relating to inventions and patents 
generally, and inventions resulting from research grants and contracts 
and fellowships awards are being rescinded because those regulations 
are obsolete. The current regulations were superseded by the Bayh-Dole 
Act and implementing regulations issued by the Department of Commerce 
at 37 CFR Part 401 that provide for the transfer of Government-funded 
technology to the private sector through the elimination of Government 
control over inventions made under Federal grants and contracts.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    04/00/96

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-AA15
_______________________________________________________________________




1054.  REMOVAL OF NATIONAL CANCER INSTITUTE CLINICAL CANCER 
EDUCATION PROGRAM

Priority:  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

________________________________________________________________________

Interim Final Rule              04/00/96

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 23005]]




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


Office of Assistant Secretary for Health (OASH)



_______________________________________________________________________




1055. 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, l988, 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: Felicia Stewart, M.D., 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., 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 594-4000

RIN: 0937-AA00
_______________________________________________________________________


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


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1056. 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

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                            12/00/96

Small Entities Affected: None

Government Levels Affected: None

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
_______________________________________________________________________




1057. REVISIONS TO THE CONFIDENTIALITY AND DISCLOSURE REGULATION (OPA-
001-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:  5 USC 552; 5 USC 552a; PL 99-570, Sec 1801; PL 99-
570, Sec 1802; PL 99-570, Sec 1803; PL 99-570, Sec 1804; 42 USC 1306; 
EO 12600

CFR Citation:  42 CFR 401.101 to 401.102; 42 CFR 401.110; 42 CFR 
401.120 to 401.123; 42 CFR 401.124 to 401.125; 42 CFR 401.105 to 
401.108; 42 CFR 401.115 to 401.116

Legal Deadline: None

Abstract: This proposed rule would supplement the existing Department 
of Health and Human Services (HHS) Freedom of Information Act (FOIA) 
and Privacy Act regulations by establishing rules specific to HCFA. The 
rule would also revise existing HCFA regulations to delete language 
that reiterates or conflicts with HHS-FOIA or Privacy Act regulations 
or that pertains to the Social Security Act. This proposed rule is part 
of the Department's regulatory reinvention initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Melody Hardy, Freedom of Information & Privacy Office, 
Department of Health and Human Services, Health Care Financing 
Administration, C2-01-11, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5358

RIN: 0938-AD60
_______________________________________________________________________




1058. ``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

[[Page 23006]]

circumstances involving Medicare overpayments. This rule is part of 
HCFA's regulatory reform initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/96

Small Entities Affected: None

Government Levels Affected: None

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
_______________________________________________________________________




1059. 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: These regulations would interpret section 303(a) of MCCA '88, 
as amended by section 608(d)(16) of the FSA (PL 100-485), section 
6411(e)(3) of OBRA '89, section 4714 of OBRA '90 and 513611(d) and 
513643(c) of OBRA '93 (Pl 103-66). Section 303(a) allocates income and 
resources between a spouse who is institutionalized and the spouse 
remaining in the community. It also provides special post-eligibility 
rules for institutionalized individuals who have spouses in the 
community. The revision would allow the community spouse to retain more 
income to meet living expenses.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/96

Small Entities Affected: Undetermined

Government Levels Affected: State, Local

Agency Contact: Jennifer Ryan, Medicaid Bureau, Department of Health 
and Human Services, Health Care Financing Administration, C4-23-07, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4459

RIN: 0938-AE12
_______________________________________________________________________




1060. PROVIDER REIMBURSEMENT DETERMINATIONS AND APPEALS REVISIONS (BPD-
727-P)

Priority:  Other

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 1395f(b); 42 USC 1395g(a); 42 USC 
1395l; 42 USC 1395x(u); 42 USC 1395hh; 42 USC 1395jj; 42 USC 1395oo; 42 
USC 1395ww

CFR Citation:  42 CFR 405.1801; 42 CFR 405.1889

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. This rule is part of HCFA's 
regulatory reform initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/96

Small Entities Affected: None

Government Levels Affected: None

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
_______________________________________________________________________




1061. 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. The alternative sanctions could be imposed 
instead of, or in addition to, terminating a psychiatric hospital's 
participation in the Medicare and Medicaid programs where deficiencies 
do not present 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 becomes 
necessary.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/96

Small Entities Affected: Undetermined

Government Levels Affected: State, Federal

Agency Contact: Frank Sololik, Center for Hospital and Community Care, 
Health Standards and Quality Bureau, Department of Health and Human 
Services, Health Care Financing Administration, S2-13-23, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-7089

RIN: 0938-AF32
_______________________________________________________________________




1062. ASSESSING INTEREST AGAINST MEDICARE SECONDARY PAYER (MSP) DEBTS 
(BPO-108-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  31 USC 3711; 31 USC 3717; 42 USC 1395y(b)(2)(B)

CFR Citation:  42 CFR 411.40; 42 CFR 405.376

Legal Deadline: None

Abstract: This proposal would establish in HCFA rules 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

[[Page 23007]]

all parties would have a clear understanding of the period subject to 
payment of interest charges.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: 
TIMETABLE: Pending revisions resulting from PL 103-432.

Agency Contact: John Albert, Health Insurance Specialist, Bureau of 
Program Operations, Department of Health and Human Services, Health 
Care Financing Administration, S3-02-26, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-7457

RIN: 0938-AF87
_______________________________________________________________________




1063. 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 417

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                            09/00/96

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Tim Love, Office of Managed Care, Department of Health 
and Human Services, Health Care Financing Administration, S3-02-01, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1094

RIN: 0938-AF97
_______________________________________________________________________




1064. 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 1395l(d); 42 USC 1395x(aa); 
42 USC 1395ww(a)(4); 42 USC 1396a(a)(13)(E); 42 USC 263a

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. (This rule is part of HCFA's regulatory reform 
initiative.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/96

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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
_______________________________________________________________________




1065. APPOINTMENT OF REPRESENTATIVES FOR MEDICARE APPEALS (BPO-120-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395ff; 42 USC 1302; 42 USC 1320(c); 42 USC 
1395hh; 42 USC 1395ii; 42 USC 1395pp; 42 USC 1395u

CFR Citation:  42 CFR 405.870; 42 CFR 405.701(c); 42 CFR 405.801(c); 42 
CFR 405.871; 42 CFR 405.872

Legal Deadline: None

Abstract: This rule would clarify current regulations concerning: who 
can be appointed as representatives at Medicare appeal proceedings; the 
appointment procedure for representatives; whether a representative may 
be paid for his or her services; and the representative's specific 
responsibilities. These changes would improve the administration of the 
claims appeal process.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Betsy Horn, Bureau of Program Operations, Department of 
Health and Human Services, Health Care Financing Administration, S1-05-
15, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0973

RIN: 0938-AG30
_______________________________________________________________________




1066. ENFORCEMENT REQUIREMENTS FOR RENAL DIALYSIS FACILITIES (HSQ-204-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395rr(g)

CFR Citation:  42 CFR 405; 42 CFR 405.2181; 42 CFR 405.2182; 42 CFR 
405.2184

Legal Deadline: None

Abstract: This rule would implement section 12 of PL 100-93, which 
amended section 1881 of the Social Security Act by adding a new 
paragraph (h). Paragraph (h) (redesignated as (g) by section 
4036(d)(5)(D) of OBRA '87) broadens the Secretary's authority to impose 
alternative sanctions on suppliers of end-stage renal disease services 
when the noncompliance of the supplier with the conditions of coverage 
does not immediately jeopardize patient health and safety. Alternative 
sanctions provide HCFA with a more flexible response to facility 
deficiencies short of termination. This rule is part of HCFA's 
regulatory reform initiative.

[[Page 23008]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/96

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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
_______________________________________________________________________




1067. GENERAL CRITERIA AND STANDARDS FOR EVALUATING PERFORMANCE OF 
CONTRACT OBLIGATIONS (HSQ-207-NC)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302; 42 USC 1320c; 42 USC 132c-2

CFR Citation:  42 CFR 462

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice With Comment Period      08/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Heidi Gelzer, Health Standards & Quality Bureau, 
Department of Health and Human Services, Health Care Financing 
Administration, S1-08-24, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-9352

RIN: 0938-AG32
_______________________________________________________________________




1068. 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 will make confidential PRO information accessible 
to researchers while still protecting the identities of beneficiaries 
and practitioners from unwarranted disclosure. PRO flexibility to share 
information with researchers is comparable with the revised 
requirements in the PRO's Fourth Scope of Work contract.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/97

Small Entities Affected: None

Government Levels Affected: State, Federal

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
_______________________________________________________________________




1069. 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 1395x(j)and (l); 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 suppliers; i.e., we 
would require the new owner of a supplier to be liable for any Medicare 
overpayments, penalties, and sanctions incurred by or imposed on the 
previous owner.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/96

Small Entities Affected: None

Government Levels Affected: Undetermined

Additional Information: Legal Authority (Continued) 42 USC 1395f(b) 42 
USC 1395l 42 USC 1395x(v) 42 USC 1395cc 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: 410 786-6768

RIN: 0938-AG59
_______________________________________________________________________




1070. NEW PAYMENT METHODOLOGY FOR ROUTINE EXTENDED CARE SERVICES 
PROVIDER IN A SWING BED HOSPITAL (BPD-805-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395tt

CFR Citation:  42 CFR 413.53; 42 CFR 413.114

Legal Deadline: None

Abstract: This proposed rule would revise the regulations governing the 
methodology for payment of routine extended care services provided in a 
swing bed hospital. Medicare payment for such services would be 
determined prospectively based on the average rate

[[Page 23009]]

per patient day paid by Medicare for routine care services provided in 
a free standing skilled nursing facility in the region where the 
hospital is located. This rule would also provide that payment for 
these services will be the higher of the payment cost rate in effect 
for the current calendar year or for the payment rate received by the 
swing-bed hospital for the prior calendar year. In addition, this rule 
would revise the regulations concerning the method used to allocate 
hospital general routine inpatient service costs for purposes of 
determining payment to swing-bed hospitals.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/96

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Katie Walker, Office of Hospital Policy, Department of 
Health and Human Services, Health Care Financing Administration, C5-03-
03, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7278

RIN: 0938-AG68
_______________________________________________________________________




1071. SALARY EQUIVALENCY GUIDELINES FOR PHYSICAL THERAPY, RESPIRATORY 
THERAPY, SPEECH PATHOLOGY, AND OCCUPATIONAL THERAPY (BPD-808-PN)

Priority:  Other Significant

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

CFR Citation:  42 CFR 413.106

Legal Deadline: None

Abstract: This notice proposes revisions to 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. The notice also proposes 
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

________________________________________________________________________

Proposed Notice                 10/00/96

Small Entities Affected: Undetermined

Government Levels Affected: None

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
_______________________________________________________________________




1072. 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 amend the existing Medicaid regulations to 
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                            07/00/96

Small Entities Affected: None

Government Levels Affected: State, Local

Agency Contact: Jennifer Ryan, Medicaid Bureau, Department of Health 
and Human Services, Health Care Financing Administration, C4-20-14, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4459

RIN: 0938-AG72
_______________________________________________________________________




1073. 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

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. This regulation is part of the 
Administration's reinventing government and regulatory reform 
initiatives.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/96
Final Action                    06/00/96

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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
_______________________________________________________________________

[[Page 23010]]





1074. 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

CFR Citation:  42 CFR 411

Legal Deadline: None

Abstract: This proposed rule would provide that a physician who has (or 
has a family member who 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. This proposed rule would also 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 the OBRA '93, as 
amended by SSA '94.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/96

Small Entities Affected: Businesses

Government Levels Affected: State

Agency Contact: Betty Burrier, 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 
Boulevard, Baltimore, MD 21244
Phone: 410 786-0191

RIN: 0938-AG80
_______________________________________________________________________




1075. 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 patient-centered, 
outcome-oriented survey process that focuses on the organization and 
delivery of quality care services. This proposed rule is part of HCFA's 
regulatory reform initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/96

Small Entities Affected: Businesses, Organizations

Government Levels Affected: Undetermined

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
_______________________________________________________________________




1076. 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

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. This rule is part of HCFA's regulatory 
reform initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/96

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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
_______________________________________________________________________




1077. WAGE INDEX USED TO ADJUST PAYMENT RATES FOR HOSPICE SERVICES UNDER 
THE MEDICARE PROGRAM (BPD-820-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 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 proposed rule would update the wage index used to adjust payment 
rates to reflect local differences in area wage levels. The proposed is 
the successful result of a ``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                            06/00/96

Small Entities Affected: Businesses

Government Levels Affected: None

[[Page 23011]]

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
_______________________________________________________________________




1078. 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 the 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                            03/00/97

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

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
_______________________________________________________________________




1079. DEFINITION OF SKILLED NURSING FACILITY (SNF) AND HOME HEALTH 
AGENCY (HHA) FOR COVERAGE OF DURABLE MEDICAL EQUIPMENT (DME) (BPD-834-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 1495x(n)

CFR Citation:  42 CFR 409; 42 CFR 410

Legal Deadline: None

Abstract: This proposed rule would define skilled nursing facilities 
(SNFs) for purposes of Medicare coverage of durable medical equipment 
(DME) and home health services. A Medicare SNF (as defined under 
section 1819 of the Act) can not be considered a home under Medicare 
Part B for DME and home health coverage. This proposed rule would 
presume that all Medicaid nursing facilities are section 1819(a) 
facilities and thus would not be considered a home for DME and home 
health coverage. This rule would identify non-Medicare nursing homes as 
skilled facilities based upon the receipt of skilled care by a 
proportion of its resident population that is at least comparable to 
the proportion typically found in participating Medicare SNFs. This 
proposed rule is part of the Department's regulatory reinvention 
initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/96

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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 Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4605

RIN: 0938-AH16
_______________________________________________________________________




1080. SCHEDULE OF LIMITS FOR SKILLED NURSING FACILITY INPATIENT ROUTINE 
SERVICE COSTS (BPD-837-NC)

Priority:  Other Significant

Legal Authority:  42 USC 1395f(b); 42 USC 1395x(v)(1); 42 USC 1395yy; 
42 USC 1302; 42 USC 1395cc(a); 42 USC 1395hh

CFR Citation:  42 CFR 413

Legal Deadline:  Final, Statutory, October 1, 1995.

Abstract: This final notice with comment period will set forth an 
updated schedule of limits on skilled nursing facility (SNF) routine 
service costs for which payment may be made under the Medicare program. 
Section 1888(a) of the Social Security Act requires that for cost 
reporting periods, beginning on or after October 1, 1995 and every 2 
years thereafter, the Secretary will update the per diem cost limits 
for SNF routine service costs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice With Comment Period      10/00/96

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Robert Kuhl, Technical Advisor, Bureau of Policy 
Development, Department of Health and Human Services, Health Care 
Financing Administration, C4-11-06, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4597

RIN: 0938-AH18
_______________________________________________________________________




1081. 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 1395(cc); 42 USC 1395m; 42 USC 1395pp(h); 42 
USC 1395u(b) and (p); 42 USC 1395cc(d); 42 USC 1302; 42 USC 1395x; 42 
USC 1395hh; 42 USC 1395ii

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 medical equipment and supplies. This rule is part of HCFA's 
regulatory reform initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/96

Small Entities Affected: Businesses

Government Levels Affected: None

[[Page 23012]]

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
_______________________________________________________________________




1082. STATE PLAN AMENDMENT (SPA) RECONSIDERATION PROCESS (MB-096-P)

Priority:  Other

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 and by permitting the State to take the 
issue directly to court. The reconsidered decision would then be made 
without a hearing. This rule is part of the Department's regulatory 
reinvention initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/96

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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
_______________________________________________________________________




1083. 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                            06/00/96

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Pat Moore, Bureau of Policy Development, Department of 
Health and Human Services, Health Care Financing Administration, C4-02-
26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-8098

RIN: 0938-AH26
_______________________________________________________________________




1084. 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)

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. This rule is part of the Department's regulatory 
reinvention initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/30/96

Small Entities Affected: Businesses

Government Levels Affected: State, Local

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

RIN: 0938-AH27
_______________________________________________________________________




1085. LIMITATIONS ON PAYMENT FOR HOME OXYGEN THERAPY BASED ON INHERENT 
REASONABLENESS CRITERIA (BPD-845-PN)

Priority:  Economically 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 sets 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 charge or 
methodology for determining home oxygen payment amounts.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Notice                 08/00/96

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: William J. Long, Health Insurance Specialist, Bureau of 
Policy Development, Department of Health and Human Services, Health 
Care Financing Administration, C4-04-05, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-5655

RIN: 0938-AH28
_______________________________________________________________________

[[Page 23013]]





1086. MEDICAID ELIGIBILITY QUALITY CONTROL, STAFFING AND TRAINING, AND 
UTILIZATION CONTROL: REMOVAL OF OBSOLETE AND RESTRICTIVE REQUIREMENTS 
(MB-099-P)

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 1396a(a)(4); 42 USC 1396a(a)(26); 
42 USC 1396b(g) and (i); 42 USC 1396b(u); 42 USC 1396d(a)(16); 42 USC 
1396d(h); 42 USC 1396a(a)(31)

CFR Citation:  42 CFR 431.861; 42 CFR 431.862; 42 CFR 431.863; 42 CFR 
431.864; 42 CFR 432.10; 42 CFR 456

Legal Deadline: None

Abstract: This rule would remove several obsolete sections of the 
Medicaid regulations that specify rules and procedures for disallowing 
Federal financial participation for erroneous medical assistance 
payments due to eligibility and beneficiary liability errors as 
detected through the Medicaid eligibility quality control (MEQC) 
program for assessment periods from 1980 through June 1990. The rule 
also would eliminate certain regulations that specify Federal standards 
for personnel administration and training programs to allow States more 
flexibility and reduce burden. In addition, the rule would remove most 
of the regulations that prescribe requirements concerning control of 
the utilization of all Medicaid services, including specific 
requirements for control of utilization in institutions. The statutory 
requirements for utilization control remain in effect. This effort is 
part of our initiative to reinvent health care regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/96

Small Entities Affected: Businesses, Organizations

Government Levels Affected: State, Local

Agency Contact: Robert Weaver, Medicaid Bureau, Department of Health 
and Human Services, Health Care Financing Administration, C4-25-02, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5914

RIN: 0938-AH31
_______________________________________________________________________




1087. CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEM AND 
FISCAL YEAR 1997 RATES (BPD-847-P)

Priority:  Other Significant

Legal Authority:  42 USC 1395ww

CFR Citation:  42 CFR 412; 42 CFR 413

Legal Deadline:  NPRM, Statutory, May 1, 1996. Final, Statutory, 
September 1, 1996.

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 will announce the 
prospective payment rates for operating and capital-related costs for 
FY 1997. We will 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 system. In addition, we will set forth rate-of-
increase limits as well as policy changes for hospitals and hospital 
units excluded from the prospective payment systems. These changes are 
applicable to discharges occurring on or after October 1, 1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/96
Interim Final Rule              09/00/96

Small Entities Affected: Businesses, Organizations

Government Levels Affected: State, Federal

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-AH34
_______________________________________________________________________




1088.  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 to provide 
coverage for speech-language provision pathology services furnished by 
a qualified pathologist.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/96

Small Entities Affected: None

Government Levels Affected: None

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
_______________________________________________________________________




1089.  MEDICARE PROGRAM: FIVE-YEAR REVIEW OF WORK RELATIVE VALUE 
UNITS UNDER THE PHYSICIAN FEE SCHEDULE (BPD-846-PN)

Priority:  Other Significant

Legal Authority:  42 USC 1395w-4(c)(2)(B)(i)

CFR Citation:  None

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

Abstract: This proposed notice discusses changes to work relative value 
units (RVUs) affecting payment for physician services. Section 
1848(c)(2)(B)(i) of the Social Security Act requires that we review all 
work RVUs no less often than every 5 years. Since we implemented the 
physician fee schedule effective for services furnished beginning 
January 1, 1992, we have initiated the 5-year review of work RVUs that 
will be effective for services furnished beginning January 1, 1997.

[[Page 23014]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Terrance Kay, Office of Physician & Ambulatory Care 
Policy, Bureau of Policy Development, Department of Health and Human 
Services, Health Care Financing Administration, C4-10-26, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4497

RIN: 0938-AH38
_______________________________________________________________________




1090.  MEDICARE PROGRAM: REVISIONS TO PAYMENT POLICIES UNDER THE 
PHYSICIAN FEE SCHEDULE FOR CALENDAR YEAR 1997 (BPD-852-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 1395w-4

CFR Citation:  42 CFR 414

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

Abstract: This proposed rule involves several policy changes affecting 
payment for physician services under the Medicare Physician Fee 
Schedule for calendar year 1997. The proposed rule will discuss changes 
concerning Medicare payment for drugs and comprehensive locality 
changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/96

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Shana Olshan, Bureau of Policy Development, Department 
of Health and Human Services, Health Care Financing Administration, C4-
10-07, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5246

RIN: 0938-AH40
_______________________________________________________________________




1091.  PRIVACY AND SECURITY ENFORCEMENT FOR THE MEDICARE 
TRANSACTION SYSTEM (BPO-142-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 1320a-3; 42 USC 1320a-5; 42 USC 
1395l(e); 42 USC 1395cc; 42 USC 1395hh; 42 USC 1320a-3a

CFR Citation:  42 CFR 401; 42 CFR 420

Legal Deadline: None

Abstract: The Medicare transaction system will rely heavily on highly 
sophisticated electronic technology, thus requiring changes in privacy 
and security enforcement provisions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/96

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Gerald Waters, Bureau of Program Operations, Department 
of Health and Human Services, Health Care Financing Administration, S2-
25-13, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1009

RIN: 0938-AH47
_______________________________________________________________________




1092.  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 in the CFR of any reference to the carryover provision. Since 
payment for DME is no longer based on the lesser of the reasonable cost 
or reasonable charges but based on 80% for the lesser of the actual 
charge or the DME fee schedule amount and 80% of the fee schedule 
amount for nominal charge; HHAs the lesser of costs or charges (LCC) 
provision no longer applies and should be deleted from the CFR. This 
rulemaking is part of the reinventing Government effort. It will 
eliminate existing text in the CFR.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/96

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Ward Pleinas, 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
_______________________________________________________________________




1093.  LIMITATIONS ON LIABILITY (BPD-859-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 1302 and 1395hh; 42 USC 1395pp

CFR Citation:  42 CFR 411.404

Legal Deadline: None

Abstract: This proposed rule would implement section 1879 of the Social 
Security Act, which limits beneficiary liability for certain durable 
medical equipment. This rulemaking is part of the Reinventing 
Government effort. It will revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

[[Page 23015]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/96

Small Entities Affected: Undetermined

Government Levels Affected: None

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
_______________________________________________________________________


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


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1094. DEDUCTION OF INCURRED MEDICAL EXPENSES (SPENDDOWN) (MB-020-F)

Priority:  Substantive, Nonsignificant

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. Only States that cover the medically 
needy, and States that use more restrictive criteria to determine 
eligibility of the aged, blind, and disabled than the criteria used to 
determine eligibility for Supplemental Security Income (SSI) benefits, 
have a spenddown.

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                    08/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Roy Trudel, 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: 410 786-3417

RIN: 0938-AB07
_______________________________________________________________________




1095. 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/08/92                    57 FR 46362
NPRM Comment Period End         12/07/92
Final Action                    11/00/96

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Agency Contact: Irene Gibson, Depty Dir., Office of Survey & 
Certification, Health Standards and Quality Bureau, Department of 
Health and Human Services, Health Care Financing Administration, S2-14-
17, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-6768

RIN: 0938-AC88
_______________________________________________________________________




1096. CHANGES CONCERNING SUSPENSION OF MEDICARE PAYMENTS AND 
DETERMINATIONS OF ALLOWABLE INTEREST EXPENSE (BPO-118-FC)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1320b-4; 42 USC 1395g; 42 USC 1395x(v)(1)(A); 
42 USC 1395l; 42 USC 1395gg

CFR Citation:  42 CFR 405.370 to 405.378; 42 CFR 413.5; 42 CFR 413.90; 
42 CFR 413.153

Legal Deadline: None

Abstract: This rule will change the Medicare regulations to provide for 
the following: (1) elimination of the requirement that in case of 
overpayments to health care providers, the contractor make a 
determination that a suspension of payment is needed to protect the 
program against financial loss before the payment can be suspended; (2) 
clarification of procedures and roles of contractors, HCFA, and the 
DHHS Office of Inspector General relating to suspension of payment; (3) 
elimination of the requirement that investment income of providers from 
gifts, grants, and endowments be offset against allowable interest 
expenses if that investment income is commingled with other funds; and 
(4) extension of the list of exceptions to the interest expense 
investment income offset provision to include investment income from 
deferred compensation plans and self-insurance funds.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/22/88                    53 FR 31888
NPRM Comment Period End         10/21/88
Final Rule With Comment Period  06/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Lisa Vriezen, Overpayment & Medicare Secondary Payer 
Collection Unit,Bureau of Program Operations, Department of Health and 
Human Services, Health Care Financing Administration, S3-05-07, 7500 
Security Blvd., Baltimore, MD 21244
Phone: 410 786-1492

RIN: 0938-AC99
_______________________________________________________________________

[[Page 23016]]





1097. CRITERIA AND PROCEDURES FOR MAKING MEDICAL SERVICES COVERAGE 
DECISIONS THAT RELATE TO HEALTH CARE TECHNOLOGY (BPD-432-FC)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395y

CFR Citation:  42 CFR 400.200; 42 CFR 405.201; 42 CFR 405.203; 42 CFR 
405.205; 42 CFR 405.207; 42 CFR 405.209

Legal Deadline: None

Abstract: The final rule with comment period will establish generally 
applicable criteria and procedures for determining whether a service is 
``reasonable and necessary'' under the Medicare program; set forth the 
coverage decisionmaking process; and summarize and provide an analysis 
of the public comments that we received in response to the January 30, 
1989 proposed rule. The objective of the criteria and procedures set 
forth in this rule is to ensure that Federal funds are expended only 
for medical services that are appropriate to meet an individual's 
medical needs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/30/89                     54 FR 4302
NPRM Comment Period End         03/31/89
Final Rule With Comment Period  10/00/96

Small Entities Affected: None

Government Levels Affected: None

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
_______________________________________________________________________




1098. PROHIBITION ON UNBUNDLING OF HOSPITAL OUTPATIENT SERVICES (BPD-
426-F)

Priority:  Substantive, Nonsignificant

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 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                    08/00/96

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Carolyn Mullen, 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: 410 786-4589

RIN: 0938-AD33
_______________________________________________________________________




1099. 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 
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                    01/00/97

Small Entities Affected: None

Government Levels Affected: Undetermined

Agency Contact: Harvey Brook, Office of Quality Improvement Programs, 
Health Standards and Quality Bureau, Department of Health and Human 
Services, Health Care Financing Administration, S1-13-07, 7500 Security 
Blvd., Baltimore, MD 21244
Phone: 410 786-6853

RIN: 0938-AD38
_______________________________________________________________________




1100. OMNIBUS NURSING HOME REFORM REQUIREMENTS (BPD-488-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 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

[[Page 23017]]

'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. 
This rule is part of the Department's regulatory reinvention 
initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/05/92                     57 FR 4516
NPRM Comment Period End         04/06/92
Final Action                    10/00/96

Small Entities Affected: Businesses

Government Levels Affected: None

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
_______________________________________________________________________




1101. HMO ORGANIZATIONAL STRUCTURE AND SERVICES (OMC-007-F)

Priority:  Other Significant

Legal Authority:  42 USC 300e

CFR Citation:  42 CFR 417.100; 42 CFR 417.101; 42 CFR 417.103; 42 CFR 
417.104; 42 CFR 417.107; 42 CFR 417.120; 42 CFR 417.122; 42 CFR 
417.123; 42 CFR 417.124; 42 CFR 417.126; 42 CFR 417.143; 42 CFR 417.152

Legal Deadline: None

Abstract: This final rule will provide organizations operating health 
maintenance organizations (HMOs) that are federally qualified under 
title XIII of the Public Health Service Act with greater flexibility in 
operating other health benefit plans. It will also authorize, with 
certain limitations, federally qualified HMOs to offer out-of-plan 
physician services and require a reasonable deductible for those 
services. Further, this final rule will permit the HMO to use assets of 
the parent organization to meet fiscal soundness and insolvency 
protection requirements.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/15/93                    58 FR 38170
Correction Notice               09/03/93                    58 FR 46925
NPRM Comment Period End         09/13/93                    58 FR 38170
Final Action                    09/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Maureen Miller, Office of Managed Care, Department of 
Health and Human Services, Health Care Financing Administration, S3-02-
01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1097

RIN: 0938-AE25
_______________________________________________________________________




1102. HOSPITAL STANDARD FOR HIV INFECTIOUS BLOOD AND BLOOD PRODUCTS 
(BPD-633-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395x(e)(9)

CFR Citation:  42 CFR 482

Legal Deadline: None

Abstract: This final rule will require hospitals to notify the 
patient's attending physician whenever potentially HIV infectious blood 
has been administered, and to ask the physician to inform the patient 
of the need for HIV testing and counseling. If the physician is 
unavailable or declines to inform the patient, the hospital must notify 
the patient. This rule implements a recommendation of the President's 
Commission on AIDS.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/30/93                    58 FR 34977
NPRM Comment Period End         08/30/93
Final Action                    04/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Janet Samen, Office of Chronic Care & Insurance Policy, 
Bureau of Policy Development, Department of Health and Human Services, 
Health Care Financing Administration, C5-13-07, 7500 Security Blvd., 
Baltimore, MD 21244
Phone: 410 786-9161

RIN: 0938-AE40
_______________________________________________________________________




1103. MEDICARE, MEDICAID, AND CLIA PROGRAMS: REGULATIONS IMPLEMENTING 
THE CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 (CLIA '88) (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: Historically the Department regulated by ``location,'' rather 
than by the types of tests they performed. CLIA changes this approach. 
CLIA requires that the Department ``regulate by test,'' using what is 
commonly referred to as the ``complexity model.'' A final rule with 
comment period was published February 28, 1992, that set forth 
standards for all laboratories, based on complexity, and responded to 
public comments on the proposed standards. The regulation was revised 
by rules with comment period published on January 19, 1993, December 6, 
1994, and April 24, 1995. A final rule, which will respond to these 
public comments, will be issued.

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
Effective Date                  01/19/93                     58 FR 5215
Final Rule With Comment Period  01/19/93                     58 FR 5215
Comment Period End              03/22/93
Final Action                    11/00/96

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Agency Contact: Anthony J. Tirone, Director, Office of Survey & 
Certification, Health Standardss and Quality Bureau, Department of 
Health and Human Services, Health Care Financing Administration, S2-19-
26, 7500 Security Boulevard, Baltimore, MD 21244

[[Page 23018]]

Phone: 410 786-6763

RIN: 0938-AE47
_______________________________________________________________________




1104. CONDITIONS OF COVERAGE FOR ORGAN PROCUREMENT ORGANIZATIONS (BPD-
646-FC)

Priority:  Other Significant

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

Legal Authority:  42 USC 1320b-8

CFR Citation:  42 CFR 485; 42 CFR 405; 42 CFR 482

Legal Deadline:  Final, Statutory, November 16, 1991.

Abstract: This final rule with comment period will respond to comments 
on the final rule with comment period which set forth changes to the 
conditions of coverage for organ procurement organizations (OPOs). It 
deals with the definition of an OPO service area; qualifications of the 
board of directors; establishment of qualification and performance 
criteria for OPOs; clarification of operational policy for 
certification and recertification of OPOs, competition for open areas, 
and, appeals of the Secretary's decisions. This rule contains 
provisions that are part of the Department's regulatory reinvention 
initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/21/91                    56 FR 28513
NPRM Comment Period End         08/21/91
Interim Final Rule With Comment 
Period                          09/08/94                    59 FR 46500
Effective Date                  10/11/94
Comment Period End              11/07/94
Final Action                    04/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Claude Mone, Health Insurance Specialist, Department of 
Health and Human Services, Health Care Financing Administration, C5-05-
27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5666

RIN: 0938-AE48
_______________________________________________________________________




1105. RESIDENT ASSESSMENT IN LONG-TERM CARE FACILITIES (HSQ-180-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395i-3; 42 USC 1396r; 42 USC 1302

CFR Citation:  42 CFR 483; 42 CFR 456.1; 42 CFR 456.600; 42 CFR 
456.601; 42 CFR 456.602; 42 CFR 456.603; 42 CFR 456.608; 42 CFR 
456.609; 42 CFR 456.610; 42 CFR 456.612; 42 CFR 456.651; 42 CFR 
456.654; 42 CFR 483.20; 42 CFR 483.315

Legal Deadline:  Final, Statutory, January 1, 1989.

Abstract: Sections 1819(b)(3) and 1919(b)(3) of the Social Security 
Act, as amended by PL 100-203, require skilled nursing facilities in 
the Medicare program (and before October 1, 1990, nursing facilities in 
the Medicaid program) to conduct a comprehensive, standardized 
assessment of each resident's capability to perform daily life 
functions. The assessment must also describe significant impairments in 
the resident's functional capacity and be based on a uniform minimum 
data set specified by the Secretary. Sections 1819(f)(6)(A) and 1919 
(f)(6)(A) of the Act require the Secretary to specify a minimum data 
set of core elements and common definitions for use by nursing 
facilities in conducting the assessments. This rule will specify this 
minimum data set and establish guidelines for using it.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/28/92                    57 FR 61614
NPRM Comment Period End         02/26/93
Final Action                    10/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Sue Nonemaker, Health Standards Quality Bureau, 
Department of Health and Human Services, Health Care Financing 
Administration, S2-19-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6825

RIN: 0938-AE61
_______________________________________________________________________




1106. 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 (HMO) 
or competitive medical plans (CMP) that cease to contract with HCFA 
under section 1876 to provide Medicare beneficiaries with certain 
coverage for pre-existing conditions under supplemental insurance; 
provide a 30-day open enrollment period for 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 submit adjusted 
community rate proposals; require all HMOs and CMPs to furnish a copy 
of an executed enrollment application form to Medicare applicants; and, 
require HCPPs 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                    08/00/96

Small Entities Affected: Businesses

Government Levels Affected: None

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
_______________________________________________________________________




1107. EMPLOYER CONTRIBUTIONS TO HMOS (OMC-004-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 300e(c); 42 USC 300e-1(l); 42 USC 300e-9

CFR Citation:  42 CFR 417

Legal Deadline: None

Abstract: This rule would conform existing regulations to sections 5(b) 
and 7 of the Health Maintenance Organization (HMO) Amendments of

[[Page 23019]]

1988 (PL 100-517). It would prohibit employers from financially 
discriminating against HMO enrollees in setting the contributions the 
employers make to employees' health plans.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/05/91                    56 FR 30723
Comment Period End              09/03/91
Final Action                    04/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Marty Abeln, Office of Managed Care, Department of 
Health and Human Services, Health Care Financing Administration, S3-02-
01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1096

RIN: 0938-AE64
_______________________________________________________________________




1108. 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:  NPRM, Statutory, July 1, 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                    12/00/96

Small Entities Affected: None

Government Levels Affected: None

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: 410 786-1850

RIN: 0938-AE79
_______________________________________________________________________




1109. COVERAGE OF SCREENING PAP SMEARS (BPD-705-F)

Priority:  Substantive, Nonsignificant

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 410.15; 42 CFR 410.56

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                    09/00/96

Small Entities Affected: None

Government Levels Affected: None

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
Phone: 410 786-4619

RIN: 0938-AE98
_______________________________________________________________________




1110. MEDICARE COVERAGE OF CLINICAL PSYCHOLOGIST, OTHER PSYCHOLOGIST, 
AND CLINICAL SOCIAL WORKER SERVICES--MEDICARE (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 will require 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                    09/00/96

Small Entities Affected: None

Government Levels Affected: None

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
_______________________________________________________________________

[[Page 23020]]





1111. OBRA '90 AND MISCELLANEOUS MANAGED CARE TECHNICAL AMENDMENTS (OMC-
018-FC)

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                    08/00/96

Small Entities Affected: None

Government Levels Affected: None

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
_______________________________________________________________________




1112. 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. The 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                    08/00/96

Small Entities Affected: Businesses

Government Levels Affected: State

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
_______________________________________________________________________




1113. 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                    10/00/96

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Randy Graydon, Director, Division of Benenficiary 
Services, 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-AF68
_______________________________________________________________________




1114. 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

Legal Deadline: None

Abstract: This rule implements a statutory requirement that State 
Medicaid agencies must 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 Aid to Families with Dependent 
Children (AFDC) applications. The statutory requirement also provides 
that the application form for these individuals must not be the AFDC 
application form.
The rule is based on section 1902(a)(55) of the Social Security Act as 
added by section 4602 of OBRA '90, PL 101-508.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              09/23/94                    59 FR 48805
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                    10/00/96

Small Entities Affected: None

Government Levels Affected: None

[[Page 23021]]

Agency Contact: Robert Tomlinson, Health Insurance Specialist, Medicaid 
Bureau, Department of Health and Human Services, Health Care Financing 
Administration, C4-07-22, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4531

RIN: 0938-AF69
_______________________________________________________________________




1115. MEDICARE AND MEDICAID PROGRAMS: REQUIREMENTS FOR PHYSICIAN 
INCENTIVE PLANS IN PREPAID HEALTH CARE ORGANIZATIONS (OMC-010-FC)

Priority:  Other Significant

Legal Authority:  42 USC 1395mm(i); 42 USC 1396b

CFR Citation:  42 CFR 417.01; 42 CFR 417.409; 42 CFR 417.495; 42 CFR 
434.67; 42 CFR 1003.100 to 1003.103

Legal Deadline: None

Abstract: This rule will amend the regulations governing federally 
qualified health maintenance organizations (HMOs) and competitive 
medical plans (CMPs) contracting with the Medicare program, and certain 
HMOs and health insuring organizations (HIOs) contracting with States 
under the Medicaid program, by implementing changes made by sections 
4204(a) and 4731(a) of OBRA '90 concerning physician incentive plans. 
The changes are intended to allow HMOs, CMPs, and HIOs the flexibility 
to provide reasonable financial incentives to their physicians and 
physician groups in order to eliminate unnecessary care while still 
protecting enrollees from reduced quality of care or reduced access to 
care.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/14/92                    57 FR 59024
Comment Period End              04/13/93                     58 FR 8568
Final Rule                      03/27/96                    61 FR 13430
Final Rule Effective Date       04/26/96
Final Rule Comment Period End   05/28/96
Final Action                    00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Tony Hausner, Office of Managed Care, Department of 
Health and Human Services, Health Care Financing Administration, S-3-
23-24, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1093

RIN: 0938-AF74
_______________________________________________________________________




1116. PART B ADVANCE PAYMENTS TO PHYSICIANS/SUPPLIERS OR OTHER ENTITIES 
FURNISHING ITEMS OR SERVICES UNDER MEDICARE PART B (BPO-105-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395u

CFR Citation:  42 CFR 421.214

Legal Deadline: None

Abstract: This rule will amend Medicare regulations to provide advance 
payment to physicians, suppliers, or entities that furnish items or 
services under Medicare Part B. These payments will be made only when 
claims processing is so delayed that interest payments alone are 
insufficient to adequately compensate the provider, in light of cash 
flow needs. This change will result in more efficient and economical 
administration of the Medicare program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/18/94                    59 FR 36415
NPRM Comment Period End         09/16/94
Final Action                    04/00/96

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Bob Shaw, Bureau of Program Operations, Department of 
Health and Human Services, Health Care Financing Administration, S2-01-
23, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3312

RIN: 0938-AF85
_______________________________________________________________________




1117. RETROACTIVE ENROLLMENT AND DISENROLLMENT IN RISK HEALTH 
MAINTENANCE ORGANIZATIONS AND COMPETITIVE MEDICAL PLANS (OMC-015-F)

Priority:  Other Significant

Legal Authority:  42 USC 1395mm

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

Legal Deadline: None

Abstract: This rule implements section 4204(e) of OBRA '90. It permits 
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 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                    10/00/96

Small Entities Affected: None

Government Levels Affected: None

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
_______________________________________________________________________




1118. 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 confirms the 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 ``inpatient operating cost'' 
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                    10/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Nancy Edwards, Director, Division of Prospective 
Payment System, Department of Health

[[Page 23022]]

and Human Services, Health Care Financing Administration, C5-06-27, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4531

RIN: 0938-AG00
_______________________________________________________________________




1119. 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                    09/00/96

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

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
_______________________________________________________________________




1120. 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                    09/00/96

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Richard Friedman, Director, Div. of Systems Data and 
Analysis, Medicaid Bureau, Department of Health and Human Services, 
Health Care Financing Administration, C4-17-07, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-3292

RIN: 0938-AG10
_______________________________________________________________________




1121. 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                    07/00/96

Small Entities Affected: None

Government Levels Affected: None

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
_______________________________________________________________________




1122. 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 1395hh; 42 USC 1395ff

CFR Citation:  42 CFR 405.807

Legal Deadline: None

Abstract: Current Medicare regulations allow a Medicare beneficiary to 
appeal, in writing, decisions to deny payment for a claim under 
supplementary medical insurance. This rule will allow a beneficiary to 
appeal an initial payment determination either in writing or by 
telephone. This rule will allow beneficiaries to more easily pursue 
appeals.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/10/95                    60 FR 35544

[[Page 23023]]

NPRM Comment Period End         09/08/95
Final Action                    07/00/96

Small Entities Affected: None

Government Levels Affected: None

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
_______________________________________________________________________




1123. MEDICARE PROGRAM: LIMITATIONS ON MEDICARE COVERAGE OF CATARACT 
SURGERY (BPD-797-FN)

Priority:  Other Significant

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

CFR Citation:  None

Legal Deadline: None

Abstract: This notice announces the Medicare program's definition of 
medical necessity with respect to Medicare coverage of preoperative 
testing for cataracts, cataract surgery, and Nd:YAG capsulotomy.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Notice                 10/06/95                    60 FR 52396
NPRM Comment Period End         12/05/95                    60 FR 52396
Final Action                    11/00/96

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: Karen McVearry, Technology & Special Analysis Staff, 
Bureau of Policy Development, Department of Health and Human Services, 
Health Care Financing Administration, C4-10-07, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4643

RIN: 0938-AG65
_______________________________________________________________________




1124. 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: This rule would revise our current process of evaluating 
tests against generic criteria. A waiver would be granted to any test 
that meets the statutory criteria, provided that scientifically valid 
data were submitted verifying that the criteria were met.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/13/95                    60 FR 47534
NPRM Comment Period End         11/13/95
Final Action                    07/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Anthony Tirone, 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: 410 786-6810

RIN: 0938-AG99
_______________________________________________________________________




1125. REPORTING OF INTEREST FROM ZERO COUPON BONDS (BPD-647-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395x(v)

CFR Citation:  42 CFR 413.153

Legal Deadline: None

Abstract: This final rule requires Medicare providers to report all 
interest expense and income from zero coupon bonds in the cost 
reporting period in which the interest was accrued.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/13/93                    58 FR 65150
Final Action                    05/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Ann Pash, Health Insurance Specialist, Bureau of Policy 
Development, Department of Health and Human Services, Health Care 
Financing Administration, C5-03-17, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4615

RIN: 0938-AH11
_______________________________________________________________________




1126. MEDICARE PROGRAM: UNIFORM ELECTRONIC COST REPORTING FOR SKILLED 
NURSING FACILITIES AND HOME HEALTH AGENCIES (BPD-788-F)

Priority:  Other Significant

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

CFR Citation:  42 CFR 413.24

Legal Deadline: None

Abstract: This rule will add the requirement that, for cost reporting 
periods beginning on or after October 1, 1995 all skilled nursing 
facilities and home health agencies must submit cost reports currently 
required under Medicare regulations in a uniform electronic format. 
This rule will also allow a delay or waiver of this requirement where 
implementation would result in financial hardship for a provider.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/05/95                    60 FR 62237
NPRM Comment Period End         02/05/96
Final Action                    10/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Thomas Talbott, Auditor, Bureau of Policy Development, 
Department of Health and Human Services, Health Care Financing 
Administration, C5-01-01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4592

RIN: 0938-AH12
_______________________________________________________________________




1127. 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)

[[Page 23024]]

Legal Deadline: None

Abstract: This notice sets forth updated payment limits on the amount 
of allowable compensation for services furnished by physicians to 
providers 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                    08/00/96

Small Entities Affected: Businesses

Government Levels Affected: None

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
_______________________________________________________________________




1128. CRITERIA AND PROCEDURES FOR EXTENDING COVERAGE TO CERTAIN DEVICES 
AND RELATED SERVICES (BPD-841-FC)

Priority:  Other Significant

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

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

CFR Citation:  42 CFR 405; 42 CFR 411

Legal Deadline: None

Abstract: This final rule will provide that certain medical devices 
with an investigational device exemption (IDE) approved by the Food and 
Drug Administration (FDA) may be covered under Medicare. Specifically, 
it will set forth the process by which the FDA will 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                    09/00/96

Small Entities Affected: None

Government Levels Affected: None

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
_______________________________________________________________________




1129. DELEGATION OF CIVIL MONEY PENALTIES (BPO-135-FC)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 405(a); 42 USC 1302; 42 USC 1320; 42 USC 
1395cc; 42 USC 1395u(j)(2); 42 USC 1395hh; 42 USC 1395ii

CFR Citation:  None

Legal Deadline: None

Abstract: This rule will contain the processes and procedures to be 
undertaken in the imposition of civil money penalties and in the 
appeals process.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Joel Cohen, Bureau of Program Operations, Department of 
Health and Human Services, Health Care Financing Administration, S3-14-
17, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3349

RIN: 0938-AH22
_______________________________________________________________________




1130. MEDICAID: LIMITATIONS ON AGGREGATE PAYMENTS TO DISPROPORTIONATE 
SHARE HOSPITALS; FEDERAL FISCAL YEAR 1996 (PRELIMINARY) (MB-098-N)

Priority:  Other Significant

Legal Authority:  42 USC 1396r-4

CFR Citation:  42 CFR 447.297; 42 CFR 447.298; 42 CFR 447.299

Legal Deadline:  Final, Statutory, October 1995.

Abstract: This notice announces the preliminary Federal fiscal year 
1996 national target and individual State allotments for Medicaid 
payments made to hospitals that serve a disproportionate number of 
Medicaid recipients and low-income patients with special needs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          05/00/96

Small Entities Affected: None

Government Levels Affected: State

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

RIN: 0938-AH30
_______________________________________________________________________




1131. MEDICARE PROGRAM; SPECIAL ENROLLMENT PERIODS AND WAITING PERIODS 
(BPD-752-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

CFR Citation:  42 CFR 406; 42 CFR 407; 42 CFR 408; 42 CFR 416

Legal Deadline: None

Abstract: This rule reflects statutory changes made by OBRA's 1987, 
1989, 1990, 1993 and the Social Security Act Amendments of 1994. These 
changes will provide an additional way for certain disabled individuals 
to qualify for special enrollment periods (SEPs); extend through 1998 
the period during which certain disabled individuals under age 65 may 
take advantage of SEPs if they are covered under large group health 
plans; and provide that a second 24-month waiting period is not 
required for disability-based reentitlement if the current impairment 
is the same as or directly related to the impairment on which the 
previous period of entitlement was based. The

[[Page 23025]]

rule ensures clear understanding of these rights for applicants and 
recipients. This rule also reflects several technical and clarifying 
changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule With Comment Period  05/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Margaret Jefferson, Health Insurance Specialist, Bureau 
of Policy Development, Department of Health and Human Services, Health 
Care Financing Administration, C4-07-22, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-4482

RIN: 0938-AH33
_______________________________________________________________________




1132.  MEDICARE PROGRAM: PHYSICIAN FEE SCHEDULE UPDATE FOR 
CALENDAR YEAR 1996 AND PHYSICIAN VOLUME PERFORMANCE STANDARD RATES OF 
INCREASE FOR FEDERAL FISCAL YEAR 1996 (BPD-853-FN)

Priority:  Other Significant

Legal Authority:  42 USC 1395w-4

CFR Citation:  None

Legal Deadline:  Final, Statutory, October 31, 1996.

Abstract: This notice announces the calendar year 1997 updates to the 
Medicare physician fee schedule and the Federal fiscal year 1997 
performance standard rates of increase for expenditures and volume of 
physicians' services under the Medicare Supplementary Medical Insurance 
(Part B) program as required by sections 1848(d) and (f) of the Social 
Security Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Notice                    10/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Terrence Kay, Office of Physician & Ambulatory Care 
Policy, Bureau of Policy Development, Department of Health and Human 
Services, Health Care Financing Administration, C4-10-26, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4497

RIN: 0938-AH41
_______________________________________________________________________




1133.  MEDICARE PROGRAM: MONTHLY ACTUARIAL RATES AND MONTHLY 
SUPPLEMENTARY MEDICAL INSURANCE PREMIUM RATES BEGINNING JANUARY 1, 1997 
(OACT-052-N)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395r

CFR Citation:  None

Legal Deadline:  Final, Statutory, September 30, 1996.

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, 1997. It also announces the monthly SMI premium rate to be 
paid by all enrollees during the 12 months beginning January 1, 1997.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Notice                    09/30/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Carter Warfield, Director, Division of Supplementary 
Medical Insurance, Office of the Actuary, Department of Health and 
Human Services, Health Care Financing Administration, N3-26-00, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6396

RIN: 0938-AH42
_______________________________________________________________________




1134.  MEDICAID: LIMITATIONS ON AGGREGATE PAYMENTS TO 
DISPROPORTIONATE SHARE HOSPITALS; FEDERAL FISCAL YEAR 1996 (FINAL) (MB-
100-N)

Priority:  Other Significant

Legal Authority:  42 USC 1396r-4

CFR Citation:  42 CFR 447.297; 42 CFR 447.298; 42 CFR 447.299

Legal Deadline:  Final, Statutory, April 1, 1996.

Abstract: This notice announces the final Federal fiscal year 1996 
national target and individual State allotments for Medicaid payments 
made to hospitals that serve a disproportionate number of Medicaid 
recipients and low-income patients with special needs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          06/00/96

Small Entities Affected: None

Government Levels Affected: State

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

RIN: 0938-AH44
_______________________________________________________________________




1135.  PART A PREMIUM FOR 1997 FOR THE UNINSURED AGED FOR 
CERTAIN DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER ENTITLEMENT (OACT-
053-N)

Priority:  Other Significant

Legal Authority:  42 USC 1395i-2; 42 USC 1395i-20

CFR Citation:  None

Legal Deadline:  Final, Statutory, September 30, 1995.

Abstract: This notice announces the hospital insurance premium for 
calendar year 1997 under the 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

________________________________________________________________________

Final Notice                    09/00/96

Small Entities Affected: None

Government Levels Affected: Undetermined

Agency Contact: John Wandishin, Office of the Actuary, Department of 
Health and Human Services, Health

[[Page 23026]]

Care Financing Administration, N3-36-24, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-6389

RIN: 0938-AH45
_______________________________________________________________________




1136.  INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED 
CARE SERVICES COINSURANCE AMOUNTS FOR 1997 (OACT-054-N)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395e

CFR Citation:  None

Legal Deadline:  Final, Statutory, September 15, 1996.

Abstract: This notice announces the inpatient hospital deductible and 
the hospital and extended care services coinsurance amounts for 
services furnished in calendar year 1997 under Medicare's hospital 
insurance program (Medicare Part A). The Medicare statute specifies the 
formulas to be used to determine these amounts.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Notice                    09/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: John Wandishin, Office of the Actuary, Department of 
Health and Human Services, Health Care Financing Administration, N3-26-
24, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6389

RIN: 0938-AH46
_______________________________________________________________________




1137.  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 amend our regulations to 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                            06/04/94                    59 FR 31569
NPRM Comment Period End         08/19/94
Final Action                    10/00/96

Small Entities Affected: None

Government Levels Affected: None

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
_______________________________________________________________________


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


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1138. 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 would set forth the methods by 
which the fee schedules would be updated and would 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                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

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
_______________________________________________________________________




1139. 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

[[Page 23027]]

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 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

Agency Contact: Tzvi Hefter, Director, Division of Hospital Service, 
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
_______________________________________________________________________




1140. 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 implement the Medicare secondary payer (MSP) 
provision 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                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

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
_______________________________________________________________________




1141. NEW MINIMUM STANDARDS FOR MEDICARE SUPPLEMENTAL (MEDIGAP) POLICIES 
(BPD-491-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 1395ss

CFR Citation:  42 CFR 403.200; 42 CFR 403.205; 42 CFR 403.206; 42 CFR 
403.210; 42 CFR 403.215; 42 CFR 403.216; 42 CFR 403.220; 42 CFR 
403.222; 42 CFR 403.232; 42 CFR 403.239; 42 CFR 403.250 to 403.258

Legal Deadline: None

Abstract: This rule would organize and codify in regulations the 
statutory changes to Medigap provisions made in 1987, 1988, 1989, 1990 
and 1994. It will contain specific procedures for review of State 
regulatory plans (and individual policies) as required in OBRA '90. The 
new standards were enacted by OBRA '87, and '90, the Medicare 
Catastrophic Coverage Act of 1988, the Medicare Catastrophic Coverage 
Repeal Act of 1989, and the Social Security Act Amendments of 1994. 
This rule is part of HCFA's regulatory reform initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Julie Walton, Office of Chronic Care & Insurance 
Policy, Bureau of Policy Development, Department of Health and Human 
Services, Health Care Financing Administration, C4-08-18, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4622

RIN: 0938-AD82
_______________________________________________________________________




1142. 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 a number of 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

Agency Contact: Frank Sokolik, Center for Hospital and Community Care,

[[Page 23028]]

Health Standards and Quality Bureau, Department of Health and Human 
Services, Health Care Financing Administration, S2-13-23, 7500 Security 
Blvd., Baltimore, MD 21244
Phone: 410 786-7089

RIN: 0938-AE39
_______________________________________________________________________




1143. 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

Agency Contact: Robert Wardwell, Director, Office of Medical & Remedial 
Care Services, Medicaid Bureau, Department of Health and Human 
Services, Health Care Financing Administration, C4-14-17, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-3254

RIN: 0938-AE72
_______________________________________________________________________




1144. FIRE SAFETY STANDARDS FOR HOSPITALS, LONG-TERM CARE FACILITIES, 
AMBULATORY SURGICAL CENTERS, HOSPICES, 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 1395x; 42 USC 1396d

CFR Citation:  42 CFR 482.41(b)(1); 42 CFR 483.70(a); 42 CFR 
483.470(j)(2)(i)(C); 42 CFR 416.44(b); 42 CFR 418.100(d); 42 CFR 
483.470(j)(1)

Legal Deadline: None

Abstract: This final rule with comment period will revise the fire 
safety standards for hospitals, long term care facilities participating 
in Medicare and Medicaid, intermediate care facilities for the mentally 
retarded, ambulatory surgical centers and hospices. It deletes 
references to the 1967 and 1973, 1981, and 1985 editions of the Life 
Safety Code (LSC) of the National Fire Protection Association and 
requires compliance with only the 1994 edition of the LSC. This is a 
part of the Department's regulatory reinvention initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/01/90                    55 FR 31196
NPRM Comment Period End         10/01/90
Final Action                    00/00/00

Small Entities Affected: Businesses

Government Levels Affected: None

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
_______________________________________________________________________




1145. 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.

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: 
TIMETABLE: This regulation may be published only with the concurrence 
of the U.S. District Court in the Smith v. Shalala suit.

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
_______________________________________________________________________

[[Page 23029]]





1146. 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 place into our regulations provisions of COBRA 
'85, OBRA '86, TEFRA '86, OBRA '87 and TMRA '88 dealing with case 
management services. These regulations 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

Agency Contact: Robert Wardwell, Office of Medical and Remedial Care 
Services, Medicaid Bureau, Department of Health and Human Services, 
Health Care Financing Administration, C4-25-07, 7500 Security Blvd., 
Baltimore, MD 21244
Phone: 410 786-5659

RIN: 0938-AF07
_______________________________________________________________________




1147. 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 will establish 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 will also revise the criteria that HCFA 
uses to determine reasonable costs for HCPPs that do not furnish 
inpatient hospital care. This rule is part of HCFA's regulatory reform 
initiative.

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

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
_______________________________________________________________________




1148. PARTIAL HOSPITALIZATION SERVICES IN COMMUNITY MENTAL HEALTH 
CENTERS (BPD-736-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395k(a)(2)(J); 42 USC 1395x(ff); 42 USC 
1395cc(e)(2)

CFR Citation:  42 CFR 400; 42 CFR 410; 42 CFR 413; 42 CFR 489; 42 CFR 
498

Legal Deadline: None

Abstract: In accordance with section 4162 of OBRA '90, this rule sets 
forth the coverage criteria and payment methodology for partial 
hospitalization services furnished in community mental health centers. 
Also in accordance with the law, the rule will specify the requirements 
a community mental health center must meet in order to enter into a 
Medicare provider agreement to furnish partial hospitalization 
services. This final rule will respond to public comments to the 
interim rule published on February 2, 1994.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              02/11/94                     59 FR 6570
Effective Date                  03/13/94
Comment Period End              04/12/94
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

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-AF53
_______________________________________________________________________




1149. INTERMEDIARY AND CARRIER FUNCTIONS (BPO-111-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 1395h; 42 USC 1395u

CFR Citation:  42 CFR 421.100; 42 CFR 421.200

Legal Deadline: None

Abstract: Current regulations list functions that intermediaries and 
carriers must perform. All intermediaries and all carriers must perform 
all the enumerated functions. This rule changes the regulations to 
bring them into greater conformance with the Medicare statute, which 
gives the Health Care Financing Administration flexibility to move some 
functions from one contractor to another to reduce inefficiency, lower 
cost or achieve better program administration. This rule is part of 
HCFA's regulatory reform initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/22/94                     59 FR 8446
NPRM Comment Period End         04/25/94
Notice to Reopen Comment Period 07/17/94                    59 FR 35664
Comment Period End              10/11/94
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Alan Bromberg, Bureau of Program Operations, Department 
of Health and Human Services, Health Care Financing Administration, S2-
01-23, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7441

RIN: 0938-AG06
_______________________________________________________________________

[[Page 23030]]





1150. 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                    00/00/00

Small Entities Affected: Businesses

Government Levels Affected: State

Additional Information: CFR CITATIONS (CONTINUED) 42 CFR 412.113 42 CFR 
413.202 42 CFR 413.203

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
_______________________________________________________________________




1151. 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

Agency Contact: Francina 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
_______________________________________________________________________




1152. DISTINCT PART REQUIREMENTS FOR NURSING HOMES AND PROHIBITION OF 
FINANCIAL SCREENING OF APPLICANTS FOR NURSING HOME ADMISSION (BPD-815-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 1395i-3; 42 USC 1396r

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: None

Government Levels Affected: None

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
_______________________________________________________________________




1153. CLINICAL LABORATORY IMPROVEMENT AMENDMENT (CLIA) FEE SCHEDULES 
(HSQ-219-FC)

Priority:  Other Significant

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

Legal Authority:  42 USC 263a(m)

CFR Citation:  42 CFR 493.638; 42 CFR 493.649

Legal Deadline: None

[[Page 23031]]

Abstract: The preamble to this final rule with comment period announces 
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. In addition, technical 
conforming changes are made to the regulations to ensure consistent and 
complete references. This rule is part of HCFA's regulatory reform 
initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

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
_______________________________________________________________________




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: This rule would develop criteria for simple and easy-to-use 
test systems that have demonstrated accuracy and precision through 
scientific studies. It would 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. A small number of 
surveys would 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

Agency Contact: Anthony Tirone, Health Standarads and Quality Bureau, 
Department of Health and Human Services, Health Care Financing 
Administration, S2-19-26, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-6810

RIN: 0938-AG98
_______________________________________________________________________




1155. 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 would revise the Medicaid regulations to 
incorporate the provisions of OBRA '93 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                    00/00/00

Small Entities Affected: None

Government Levels Affected: State

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
_______________________________________________________________________




1156. AMBULANCE SERVICES (BPD-813-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1861(s)(7)

CFR Citation:  42 CFR 410.40

Legal Deadline: None

Abstract: This proposed rule would revise HCFA's policy on Medicare 
coverage of ambulance services. It focuses on the medical necessity for 
ambulance service, redefines an ambulance as an ``emergency vehicle'' 
and revises the policy on coverage of non-emergency ambulance 
transportation for beneficiaries with end-stage renal disease. These 
changes would prevent use of non-emergency vehicles and the use of 
ambulance transportation in non-emergency situations where the medical 
need has not clearly been determined. These changes require the use of 
emergency vehicles as ambulances and would focus on the medical 
treatment rather than transportation as the primary concern for 
furnishing ambulance services, as required by Title XVIII, Section 
1861(s)(7) of the Social Security Act. This rule is part of HCFA's 
regulatory reform initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: None

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 Boulevard, Baltimore, MD 21244
Phone: 410 786-4642

RIN: 0938-AH13
_______________________________________________________________________




1157. 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.

[[Page 23032]]

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 
ASCs. This rule is part of HCFA's regulatory reform initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: None

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
_______________________________________________________________________




1158. MEDICARE COVERAGE OF LIVER 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 liver transplantations. Currently, 
Medicare coverage for liver transplantation in adults is limited to 
seven diagnoses. This notice proposes to expand the diagnoses for which 
Medicare would cover a liver transplant to include all end stage liver 
disease except malignancies, hepatitis B, and hemochromatosis. We are 
also proposing a change in the criteria for approval of a facility to 
perform liver transplants.

Timetable: Next Action Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

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
_______________________________________________________________________




1159.  CLIA PROGRAM: CYTOLOGY PROFICIENCY TESTING (HSQ-233-P)

Priority:  Other Significant

Legal Authority:  42 USC 263a(f)(4)(B)(IV)

CFR Citation:  42 CFR 493.855

Legal Deadline: None

Abstract: In this proposal, HHS is complying with a court order 
requiring publication of a proposed rule to require that cytology 
proficiency testing be conducted to the extent practicable, under 
normal working conditions. We propose 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 solicit 
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                    60 FR 61509
Final Action                    00/00/00

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

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
_______________________________________________________________________




1160.  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 1395hh; 42 USC 1395rr(b)(1)

CFR Citation:  42 CFR 414.48

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

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
_______________________________________________________________________




1161.  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 regulation is necessary to clarify and amend various 
Medicare secondary payer regulations. For instance, we wish to 
incorporate in regulations, policies with respect to liability 
insurance issues, such as structured liability settlements, future 
medical expenses, provider malpractice, wrongful death, and Federal 
tort claims policy. Also, we wish to clarify the rules dealing with 
group health plan bankruptcies, religious orders, and foreign group 
health plans, and make numerous other changes.

[[Page 23033]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Dave Holstein, Health Insurance Specialist, Department 
of Health and Human Services, Health Care Financing Administration, C4-
08-27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4476

RIN: 0938-AH52
_______________________________________________________________________




1162.  PAYMENT FOR HOSPITAL OUTPATIENT RADIOLOGY SERVICES AND 
OTHER DIAGNOSTIC PROCEDURES (BPD-861-FC)

Priority:  Other

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 413.122

Legal Deadline: None

Abstract: The rule revises section 413.133 to remove references to 
payment blend effective prior to January 1, 1991. This rulemaking is 
part of the Reinventing Government effort. It will eliminate text in 
the CFR to reduce burden or duplication, or streamline requirements.

Timetable: Next Action Undetermined

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Janet Wellham, Health Policy Specialist, Department of 
Health and Human Services, Health Care Financing Administration, C4-13-
26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4510

RIN: 0938-AH53
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1163. FEE SCHEDULE FOR PAYMENT OF CLINICAL PSYCHOLOGIST SERVICES (BPD-
495-P)

Priority:  Other Significant

CFR Citation:  42 CFR 414

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Publication Not 
Expected During This Semiannual 
Period                          04/01/96

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Elisa Tunanidas
Phone: 410 786-4505

RIN: 0938-AD84
_______________________________________________________________________




1164. COVERAGE OF NURSE PRACTITIONER AND CLINICAL NURSE SPECIALIST 
SERVICES (BPD-708-P)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 410; 42 CFR 413; 42 CFR 414; 42 CFR 491

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Publication Not 
Expected During this Semiannual 
Period.                         03/25/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Roberta Epps
Phone: 410 786-4503

RIN: 0938-AF00
_______________________________________________________________________




1165. PAYMENT FOR FEDERALLY QUALIFIED HEALTH CENTER (FQHC) SERVICES 
(BPD-728-F)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 405.2401; 42 CFR 405.2430; 42 CFR 405.2446; 42 
CFR 405.2448; 42 CFR 405.2450; 42 CFR 405.2463; 42 CFR 405.2466; 42 CFR 
405.2468; 42 CFR 491.5; 42 CFR 491.8

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    04/03/96                    61 FR 14640
Final Action Effective          05/03/96

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Bernadette Schumaker
Phone: 410 786-4568

RIN: 0938-AF14
_______________________________________________________________________




1166. FEDERALLY QUALIFIED HEALTH CENTER SERVICES (MEDICAID) (MB-043-P)

Priority:  Other Significant

CFR Citation:  42 CFR 440; 42 CFR 447

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Publication Not 
Expected During This Semiannual 
Period                          04/01/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: David Worgo
Phone: 410 786-5919

RIN: 0938-AF90
_______________________________________________________________________




1167. MEDICARE APPEALS OF INDIVIDUAL CLAIMS (BPD-453-P)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 405.732; 42 CFR 405.801; 42 CFR 405.837; 42 CFR 
405.838; 42 CFR 405.839; 42 CFR 405.840

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Publication Not 
Expected During This Semiannual 
Period                          04/01/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Paul Olenick
Phone: 410 786-4472

RIN: 0938-AG18
_______________________________________________________________________

[[Page 23034]]





1168. WITHDRAWAL OF COVERAGE OF DIAGNOSTIC NOCTURNAL PENILE TUMESCENCE 
TESTING (IMPOTENCE TESTING) (BPD-780-FN)

Priority:  Substantive, Nonsignificant

CFR Citation:  None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       02/07/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Bob Ulikowski
Phone: 410 786-5721

RIN: 0938-AG43
_______________________________________________________________________




1169. SCHEDULE OF LIMITS ON HOME HEALTH AGENCY COSTS PER VISIT (BPD-793-
N)

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:  None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    02/14/95                     60 FR 8389

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Michael Bussacca
Phone: 410 786-4602

RIN: 0938-AG54
_______________________________________________________________________




1170. MEDICAID PROGRAM: NURSE-MIDWIFE SERVICES (MB-085-F)

Priority:  Other Significant

CFR Citation:  42 CFR 440

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/30/95                    60 FR 61483

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Linda Sizelove
Phone: 410 786-3255

RIN: 0938-AG73
_______________________________________________________________________




1171. MEDICAID PROGRAM: FEES FOR VACCINE ADMINISTRATION UNDER PEDIATRIC 
IMMUNIZATION PROGRAM (MB-084-FN)

Priority:  Other Significant

CFR Citation:  None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Publication Not 
Expected During This Semiannual 
Period                          04/01/96

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State

Agency Contact: Marge Sciulli
Phone: 410 786-0691

RIN: 0938-AG77
_______________________________________________________________________




1172. MEDICAID: NOMINAL COPAYMENTS FOR INSTITUTIONAL SERVICES FOR 
MEDICAID RECIPIENTS (MB-090-FC)

Priority:  Other Significant

CFR Citation:  42 CFR 447.54; 42 CFR 447.55

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Publication Not 
Expected During This Semiannual 
Period                          04/01/96

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Ingrid Osburne
Phone: 410 786-4461

RIN: 0938-AG90
_______________________________________________________________________




1173. MANDATORY MEDIGAP CROSSOVER CLAIMS TRANSMITTAL REQUIREMENTS (BPD-
811-P)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 403.206; 42 CFR 403.212; 42 CFR 403.222; 42 CFR 
403.232; 42 CFR 403.204; 42 CFR 424.68

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Publication Not 
Expected During this Semi-annual 
Period.                         03/25/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Thomas Hoyer, Director
Phone: 410 786-5661

RIN: 0938-AG94
_______________________________________________________________________




1174. MEDICARE PROGRAM: CHANGES TO THE INPATIENT HOSPITAL PROSPECTIVE 
PAYMENT SYSTEMS AND FISCAL YEAR 1996 RATES (BPD-825-FC)

Priority:  Other Significant

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

CFR Citation:  42 CFR 412; 42 CFR 413

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/01/95                    60 FR 45778

Small Entities Affected: Businesses, Organizations

Government Levels Affected: State, Federal

Agency Contact: Nancy Edwards
Phone: 410 786-4531

RIN: 0938-AG95
_______________________________________________________________________




1175. MEDICARE PROGRAM: REVISIONS TO PAYMENT POLICIES AND ADJUSTMENTS TO 
THE RELATIVE VALUE UNITS (RVUS) UNDER THE PHYSICIAN FEE SCHEDULE FOR 
CALENDAR YEAR 1996 (BPD-827-FC)

Priority:  Other Significant

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

CFR Citation:  42 CFR 400; 42 CFR 405; 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                    12/08/95                    60 FR 63124

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Terrence Kay

[[Page 23035]]

Phone: 410 786-4497

RIN: 0938-AG96
_______________________________________________________________________




1176. MEDICARE PROGRAM: COVERAGE OF CERTIFIED NURSE-MIDWIFE SERVICES 
(BPD-496-P)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 405; 42 CFR 410; 42 CFR 486

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Publication Not 
Expected During This Semiannual 
Period                          04/01/96

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Roberta Epps
Phone: 419 786-4503

RIN: 0938-AH02
_______________________________________________________________________




1177. MEDICARE PROGRAM: PHYSICIAN FEE SCHEDULE UPDATE FOR CALENDAR YEAR 
1996 & PHYSICIAN VOLUME PERFORMANCE STANDARD RATES OF INCREASE FOR 
FEDERAL FISCAL YEAR 1996 (BPD-828-FN)

Priority:  Other Significant

CFR Citation:  None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/08/95                    60 FR 63358

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Terrence Kay
Phone: 410 786-4497

RIN: 0938-AH03
_______________________________________________________________________




1178. PART A PREMIUM FOR 1996 FOR THE UNINSURED AGED AND FOR CERTAIN 
DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER ENTITLEMENT (OACT-051-N)

Priority:  Substantive, Nonsignificant

CFR Citation:  None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/16/95                    60 FR 53631

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: John Wandishin
Phone: 410 786-6389

RIN: 0938-AH06
_______________________________________________________________________




1179. MEDICARE PROGRAM: MONTHLY ACTUARIAL RATES AND MONTHLY 
SUPPLEMENTARY MEDICAL INSURANCE PREMIUM RATES BEGINNING JANUARY 1, 1996 
(OACT-050-N)

Priority:  Substantive, Nonsignificant

CFR Citation:  None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/16/95                    60 FR 53626

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Carter Warfield
Phone: 410 786-6396

RIN: 0938-AH07
_______________________________________________________________________




1180. INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED CARE 
SERVICES COINSURANCE AMOUNTS FOR 1996 (OACT-049-N)

Priority:  Substantive, Nonsignificant

CFR Citation:  None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/16/95                    60 FR 53625

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: John Wandishin
Phone: 410 786-6389

RIN: 0938-AH08
_______________________________________________________________________




1181. LIMITATIONS ON AGGREGATE PAYMENTS TO DISPROPORTIONATE SHARE 
HOSPITALS: FEDERAL FISCAL YEAR 1995 (MEDICAID PROGRAM) (MB-094-N)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 447.297; 42 CFR 447.298; 42 CFR 447.299

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/08/95                    60 FR 46838

Small Entities Affected: None

Government Levels Affected: State, Federal

Agency Contact: Richard Strauss
Phone: 410 786-2019

RIN: 0938-AH09
_______________________________________________________________________




1182. PROVISIONS THAT ALLOW RURAL PRIMARY CARE HOSPITALS (RPCHS) TO 
ENTER INTO SWING-BED AGREEMENTS (BPD-839-P)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 485.645

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Publication Not 
Expected During this Semi-annual 
Period.                         03/25/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: George Morey
Phone: 410 786-4653

RIN: 0938-AH20
_______________________________________________________________________




1183. TRANSFER OF ASSETS FOR LESS THAN FAIR MARKET VALUE: MEDICAID 
PROGRAM (MB-095-P)

Priority:  Other Significant

CFR Citation:  42 CFR 435; 42 CFR 436

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Publication Not 
Expected During this Semi-annual 
Period.                         03/25/96

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Roy Trudel
Phone: 410 786-3417

RIN: 0938-AH23
_______________________________________________________________________




1184. EVIDENCE OF LAWFUL PERMANENT RESIDENCE (MB-097-P)

Priority:  Other

CFR Citation:  42 CFR 435.406; 42 CFR 435.408

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Publication Not 
Expected During This Semiannual 
Period                          04/01/96

Small Entities Affected: None

[[Page 23036]]

Government Levels Affected: State, Local

Agency Contact: Robert Tomlinson
Phone: 410 786-4463

RIN: 0938-AH25
_______________________________________________________________________




1185. CLIA PROGRAM; GRANTING AND WITHDRAWAL OF AUTHORITY TO PRIVATE 
NONPROFIT ACCREDITATION ORGANIZATIONS AND OF CLIA EXEMPTION UNDER STATE 
LABORATORY PROGRAMS; TECHNICAL CORRECTIONS (HSQ-205-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.

CFR Citation:  42 CFR 493.501; 42 CFR 493.506; 42 CFR 493.513; 42 CFR 
493.515; 42 CFR 493.521

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - To Be Merged Into 
RIN 0938-AE47 (HSQ-226-F)       02/12/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Josephine Simmons
Phone: 410 786-3409

RIN: 0938-AH32
_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




1186. FOSTER CARE, ADOPTION ASSISTANCE, AND CHILD WELFARE SERVICES

Priority:  Other Significant

Legal Authority:  42 USC 627; 42 USC 671; 42 USC 1320

CFR Citation:  45 CFR 1355; 45 CFR 1356; 45 CFR 1357

Legal Deadline:  NPRM, 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/96

Small Entities Affected: None

Government Levels Affected: State

Additional Information: This action was previously reported under RIN 
0980-AA08.

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
_______________________________________________________________________




1187. BLOCK GRANT PROGRAMS (LOW INCOME HOME ENERGY ASSISTANCE PROGRAM --
LIHEAP)--FY 1995 AND FY 1996 PROVISIONS

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 8621

CFR Citation:  45 CFR 96

Legal Deadline: None

Abstract: This Notice of Proposed Rulemaking will amend the DHHS block 
grant regulations to implement changes to the Low Income Home Energy 
Assistance Program (LIHEAP) statute which were made by the Human 
Services Amendments of 1994 (Pub. L. 103-252). Several of the 
provisions in the new law are self-implementing, but a few require 
implementing regulations. The major provisions requiring implementing 
regulations are: (1) Inclusion of new Assurance 16, to require grantees 
to submit as a part of their annual application a description of their 
``self-sufficiency'' activities and to submit a report to DHHS on the 
effect of these activities; (2) Inclusion of allowable uses of DOE 
rules for weatherization services provided with LIHEAP funds; (3) 
Inclusion for requirements for submission of data on households served. 
In addition, other related amendments to the regulations will be 
included, concerning the following issues: (1) Consideration of 
different weighting of factors under the allocation formula for the 
leveraging incentive program; (2) Hearing requirements for audit 
disallowances; and (3) Allotments for territories.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/96

Small Entities Affected: None

Government Levels Affected: State, Tribal

Agency Contact: Janet M. Fox, Director, Division of Energy Assistance, 
Office of Community Services, Department of Health and Human Services, 
Administration for Children and Families, 370 L'Enfant Promenade SW., 
Washington, DC 20447
Phone: 202 401-9351

RIN: 0970-AB47
_______________________________________________________________________




1188. ADMINISTRATIVE FLEXIBILITY RULE

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

CFR Citation:  45 CFR 205.31

Legal Deadline: None

Abstract: This proposed rule adds a new section 205.31 which will 
provide a simple administrative process for requesting waivers of 
certain AFDC regulatory provisions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/96

[[Page 23037]]

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Mack Storrs, Director, Division of AFDC Program, 
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-AB49
_______________________________________________________________________




1189. 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                            07/00/96

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
_______________________________________________________________________




1190. 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                            08/00/96

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
_______________________________________________________________________




1191. QUALITY STANDARDS FOR EARLY HEAD START AND HEAD START PROGRAMS

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 9801

CFR Citation:  45 CFR 1301; 45 CFR 1302; 45 CFR 1305; 45 CFR 1306; 45 
CFR 1308; 45 CFR 1309

Legal Deadline:  NPRM, Statutory, May 18, 1995.
Legal deadline only pertains to performance standards.

Abstract: The NPRM will establish performance standards with respect to 
services provided to children 0 to 5 years old by Early Head Start and 
Head Start Programs, including health, education, parent involvement, 
nutritional, social and transitional services, administrative and 
financial management standards and condition and location of facilities 
used to carry out activities.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/22/96                    61 FR 17754
NPRM Comment Period End         06/21/96

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-AB55
_______________________________________________________________________




1192. HEAD START FELLOWSHIP PROGRAM

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 9801

CFR Citation:  45 CFR 1311

Legal Deadline: None

Abstract: This NPRM will establish the policies and procedures to be 
used in selecting individuals to be part of the Head Start Fellowship 
Program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/96

Small Entities Affected: None

Government Levels Affected: None

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-AB56
_______________________________________________________________________




1193. ON-SITE FOSTER CARE ELIGIBILITY REVIEWS

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302

CFR Citation:  45 CFR 1356

Legal Deadline: None

Abstract: This NPRM will 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 
eligibility of foster care providers and eligibility of the children in 
foster care.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/96

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Daniel H. Lewis, Deputy Associate, Commissioner, 
Children's Bureau, Department of Health and Human Services, 
Administration for Children and Families, P.O. Box 1182, Washington, DC 
20013
Phone: 202 205-8594

RIN: 0970-AB60
_______________________________________________________________________

[[Page 23038]]




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


Administration for Children and Families (ACF)



_______________________________________________________________________




1194. AMENDMENTS TO DEVELOPMENTAL DISABILITIES RULES

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 6000 et seq

CFR Citation:  45 CFR 1385; 45 CFR 1386; 45 CFR 1387; 45 CFR 1388

Legal Deadline:  Final, Statutory, April 29, 1991.
Final, Statutory, October 3, 1994.

Abstract: This rule updates current rules with clarifications and new 
requirements to implement recent changes in the Developmental 
Disabilities Assistance and Bill of Rights Act Amendments of 1990 (Pub. 
L. 101-496) and 1994 (Pub. L. 103-230).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/18/95                    60 FR 26774
Final Action                    07/00/96

Small Entities Affected: None

Government Levels Affected: State

Additional Information: This action was previously reported under RIN 
0980-AA48.

Agency Contact: John Doyle, Director, Administration and Planning 
Staff, Administration on Developmental Disabilities, Department of 
Health and Human Services, Administration for Children and Families, 
200 Independence Avenue SW., Room 315D, Washington, DC 20201
Phone: 202 690-6590

RIN: 0970-AB11
_______________________________________________________________________




1195. CHILD ABUSE AND NEGLECT STATE GRANT PROGRAM

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 5101

CFR Citation:  45 CFR 1340

Legal Deadline: None

Abstract: The primary purpose of this rule is to revise existing 
regulations at 45 CFR 1340 in order to implement recent amendments to 
the Child Abuse Prevention and Treatment Act with respect to 
confidentiality requirements.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/18/94                    59 FR 26046
Final Action                    08/00/96

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Emily Cooke, Acting Director, National Center on Child 
Abuse and Neglect, Department of Health and Human Services, 
Administration for Children and Families, P.O. Box 1182, Washington, DC 
20013
Phone: 202 205-8586

RIN: 0970-AB23
_______________________________________________________________________




1196. STANDARDS FOR SAFE TRANSPORTATION

Priority:  Substantive, Nonsignificant

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                            08/14/95                    60 FR 31612
Final Action                    01/00/97

Small Entities Affected: Organizations

Government Levels Affected: None

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
_______________________________________________________________________




1197. 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
Final Action                    08/00/96

Small Entities Affected: Organizations

Government Levels Affected: None

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
_______________________________________________________________________




1198. NATIONAL VOTER REGISTRATION ACT OF 1993 PROVISIONS AFFECTING 
PUBLIC ASSISTANCE AGENCIES

Priority:  Other Significant

Legal Authority:  PL 103-31

CFR Citation:  45 CFR 205.50 (a)(4); 42 CFR 431.307(a); 42 CFR 431.307 
(b)

Legal Deadline: None

Abstract: Incorporates general guidance for public assistance agencies 
regarding registration procedures to be carried out by State Public 
Assistance offices. It removes former prohibitions from distributing 
such materials in these offices.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/22/94                    59 FR 60109
Final Action                    07/00/96

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State, Local

Agency Contact: Mack Storrs, Director, Division of AFDC Program, 
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-AB32
_______________________________________________________________________




1199. CHILD CARE--REVISED 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:  42 USC 1302

CFR Citation:  45 CFR 98.255; 45 CFR 98.256; 45 CFR 98.257

Legal Deadline: None

Abstract: The Administration for Children and Families will amend

[[Page 23039]]

existing regulations which govern the administration of child care 
programs under Title IV-A of the Social Security Act (AFDC Child Care, 
Transitional Child Care, At-Risk Child Care) and the Child Care and 
Development Block Grant. Based on recent legislative changes, as well 
as comments from state and tribal program administrators, child care 
advocates and other interested parties, we are examining a number of 
specific regulatory provisions. The purpose of this regulatory package 
will be to implement legislative changes, reduce program differences, 
and promote better program coordination. We do not expect these changes 
to result in significant program costs; administrative savings may 
result.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/11/94                    59 FR 24510
Final Action                    09/00/96

Small Entities Affected: None

Government Levels Affected: Undetermined

Agency Contact: Olivia M. Golden, Commissioner, Administration on 
Children, Youth and Families, Department of Health and Human Services, 
Administration for Children and Families, P.O. Box 1182, Washington, DC 
20013
Phone: 202 205-8572

RIN: 0970-AB33
_______________________________________________________________________




1200. 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.

Legal Authority:  42 USC 430 to 435

CFR Citation:  45 CFR 1355; 45 CFR 1356; 45 CFR 1357

Legal Deadline: None

Abstract: This rule will amend the requirements under title IV-B 
subpart 1 for the Child and Family Services State plan and set forth 
the requirements the State must adhere to in the development and 
submission of its comprehensive five year plan under title IV-B, 
subpart 2, family preservation and support services. The submission of 
this jointly developed plan is required in order to receive both child 
and family services funds under subpart 1 and family preservation and 
support services funds under subpart 2 for fiscal years 1995 and 
following.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/04/94                    59 FR 50646
Final Action                    07/00/96

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State, Tribal

Agency Contact: Daniel H. Lewis, Deputy Associate Commissioner, 
Children's Bureau, ACYF, Department of Health and Human Services, 
Administration for Children and Families, P.O. Box 1182, Washington, DC 
20013
Phone: 202 205-8618

RIN: 0970-AB34
_______________________________________________________________________




1201. ADMINISTRATION FOR NATIVE AMERICANS (ANA) 45 CFR PART 1336

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 2991, et seq

CFR Citation:  45 CFR 1336

Legal Deadline:  Final, Statutory, March 29, 1993.

Abstract: This regulation amends 45 CFR part 1336. It will incorporate 
an appeals procedure affording applicants the opportunity to appeal ANA 
ineligibility determinations to the HHS Departmental Appeals Board. 
Native American organizations are expected to welcome these procedural 
changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/21/95                    60 FR 19994
Final Action                    07/00/96

Small Entities Affected: Organizations

Government Levels Affected: Tribal

Agency Contact: R. Denise Rodriguez, J.D., Program Specialist, 
Department of Health and Human Services, Administration for Children 
and Families, 200 Independence Ave SW., Washington, DC 20201
Phone: 202 690-6265

RIN: 0970-AB37
_______________________________________________________________________




1202. REDUCTION OF REPORTING REQUIREMENTS FOR THE STATE SYSTEMS ADVANCE 
PLANNING DOCUMENT (APD) PROCESS

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

CFR Citation:  45 CFR 95.600

Legal Deadline: None

Abstract: These rules decrease the reporting burden on States and 
increase their flexibility within the State systems APD process by 
increasing the threshold under which APDs and related procurement 
documents need not be submitted for Federal approval. Additionally, 
States will no longer be required to submit biennial security plans for 
Federal review and approval.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/24/95                    60 FR 34858
NPRM Comment Period End         09/22/95
Final Action                    07/00/96

Small Entities Affected: Undetermined

Government Levels Affected: None

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

Agency Contact: Bill Davis, Management Analyst, Department of Health 
and Human Services, Administration for Children and Families, 370 
L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 401-6404

RIN: 0970-AB46
_______________________________________________________________________




1203. 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

[[Page 23040]]

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                    09/00/96

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
_______________________________________________________________________




1204. MAKING INFORMATION AVAILABLE TO CONSUMER REPORTING AGENCIES: 
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.

Legal Authority:  PL 103-432; PL 104-35

CFR Citation:  45 CFR 301; 45 CFR 302; 45 CFR 303; 45 CFR 304; 45 CFR 
306; 45 CFR 307

Legal Deadline: None

Abstract: This rule contains provisions regarding required State laws 
for reporting information concerning unpaid child support obligations 
to consumer reporting agencies. These provisions implement the 
requirements of section 212 of the Social Security Act Amendments of 
1994, which amend title IV-D of the Social Security Act. These 
provisions require States to adopt procedures for periodic reporting of 
information to consumer reporting agencies. This rule implements PL 
104-35; enacted October 12, 1995, which revises section 454(24) of the 
Social Security Act. This rule also includes technical changes to other 
child support regulations to support the President's Regulatory 
Reinvention Initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/29/96                     61 FR 2774
NPRM Comment Period End         03/29/96
Final Action                    12/00/96

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State, Local

Agency Contact: Marianne Upton, Branch Chief, Policy Division, Office 
of Child Support Enforcement, Department of Health and Human Services, 
Administration for Children and Families, 370 L'Enfant Promenade SW., 
Washington, DC 20447
Phone: 202 401-5373

RIN: 0970-AB57
_______________________________________________________________________




1205. INCOME AND RESOURCE DISREGARDS RELATED TO INTERESTS OF INDIVIDUAL 
INDIANS IN TRUST OR RESTRICTED LANDS

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 103-66

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. 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/25/94                    59 FR 51536
Final Action                    08/00/96

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
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Administration for Children and Families (ACF)



_______________________________________________________________________




1206. FAMILY VIOLENCE PREVENTION AND SERVICES

Priority:  Substantive, Nonsignificant

CFR Citation:  45 CFR 1370

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    02/22/96                     61 FR 6791

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Local

Agency Contact: Margaret Washnitzer
Phone: 202 401-2333

RIN: 0970-AB18
_______________________________________________________________________

[[Page 23041]]




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


Administration on Aging (AOA)



_______________________________________________________________________




1207. 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, sec 202(a)(10); PL 102-375, sec 
202(a)(14); PL 102-375, sec 305(a); PL 102-375, sec 305(a)(1); PL 102-
375, sec 305(a)(2)(c); PL 102-375, sec 305(a)(2); PL 102-375, sec 
305(a)(2)(D); PL 102-375, sec 305(a)(1)(E); PL 102-375, sec 
305(a)(2)(E); PL 102-375, secs 305(d)(1) to 305(d)(4); PL 102-375, sec 
305(a)(A)(i); PL 102-375, sec 306(a)(6)(O)(i); PL 102-375, sec 
306(a)(13); PL 102-375, sec 307(a)(1); PL 102-375, sec 307(a)(C)(i)

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:

OAA Amendments in FY '96  NPRM 08/00/97

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 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 Development 
and Operations, 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. 96-9132 Filed 05-10-96; 8:45 am]
BILLING CODE 4150-04-F