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


[[Page 23287]]


_______________________________________________________________________

Part VIII





Department of Health and Human Services





_______________________________________________________________________



Semiannual Regulatory Agenda

Federal Register / Vol. 60, No. 88 / Monday, May 8, 1995 / 
Unified Agenda


Federal Register / Vol. 60, No. 88 / Monday, May 8, 1995 / 
Unified Agenda
[[Page 23288]]

=======================================================================

______________________________________________________________________

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: Publication of unified agenda of regulations.

______________________________________________________________________

SUMMARY: The President's September 30, 1993, Executive order (12866) 
and the Regulatory Flexibility Act of 1980 require the Department to 
publish an agenda of significant regulations being developed and an 
indication of those regulatory actions that are being analyzed for 
their effect on small businesses. The Department published its last 
agenda on November 14, 1994. This document also describes the 
Department's plan for reviewing rules to minimize burden and improve 
effectiveness and invites comments to assist the Department in 
reviewing its regulatory processes and products.

DATES: Data, information, and views due date: May 15, 1995, for initial 
suggestions and any date thereafter for additional suggestions.

ADDRESSES: Addresses for submitting comments and information in 
response to this document are listed at the end.

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 listed at 
the end of this notice.

SUPPLEMENTARY INFORMATION:

Background

    On September 30, 1993, President Clinton issued Executive Order 
12866 to make regulations less burdensome, more effective, and in 
greater alignment with the Administration's priorities and 
regulatory principles. As part of the Department of Health and 
Human Services efforts to effectively implement the Executive 
order, we published a notice in the Federal Register, January 20, 
1994, providing a plan for periodic review of existing rules and 
inviting public comments to assist in determining the best priority 
for review.

    The Executive order and the Administration's effort toward 
implementation have proven successful by providing real progress in 
reforming regulations. Building on those successes, the President 
recently announced plans which will provide for more immediate, 
comprehensive reform.

    First, the President has directed each agency to undertake by 
June 1 an exhaustive review of all regulations with an eye toward 
eliminating or modifying those that are obsolete or which are 
otherwise in need of reform. Second, the President has directed 
each agency to change the way performance is measured--focusing on 
results, not process. Third, the President has asked his senior 
executives to convene meetings in order to establish grassroots 
partnerships which would allow greater collaboration and 
participation in reinventing the regulatory process. Finally, the 
President has requested that we further our efforts to negotiate 
more during the rulemaking process.

    As a result of the initiative discussed above, the semiannual 
unified agenda to be published in October will be different from 
the agenda published this April. The comprehensive review of our 
regulatory program will undoubtedly serve to cull the list of 
regulations included in the April agenda and will also include new 
regulatory actions designed to eliminate or streamline other 
existing agency rules. As we embark on this effort, we invite 
comments on our unified agenda entries and suggestions for 
furthering the President's regulatory reinvention strategy.

    Comments should be sent to the addresses listed below, 
depending on the regulations addressed. Comments may be sent to the 
Office of the Secretary when the responsible division is not known 
or when the comment covers several regulatory areas crossing agency 
lines.

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

    Administration on Children and Families: Madeline Mocko, 
Director, Division of Policy and Legislation, 7th Floor, 370 
L'Enfant Promenade SW., Washington, DC 20447; phone 202-401-9223.

    Administration on Aging: David Bunoski, Executive Secretariat, 
Room 4753, Wilbur H. Cohen Building, 330 Independence Avenue SW., 
Washington, DC 20201; phone 202-260-0669.

    Public Health Service (other than FDA): John Gallivan, Office 
of Assistant Secretary for Health Planning and Evaluation, Room 
740G, Hubert H. Humphrey Building, 200 Independence Avenue SW., 
Washington, DC 20201; phone 202-690-7102.

    Food and Drug Administration: Ed Dutra, Director, Regulatory 
Policy and Management Staff, (HF26), 5600 Fishers Lane, Rockville, 
Maryland 20857; phone 301-443-3480.

    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.

Claudia Cooley,

Executive Secretary to the Department.

                                  Office of the Secretary--Proposed Rule Stage                                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1065        Revisions to the Civil Money Penalty Provisions Relating to the Misuse of Certain                   
            Symbols and Emblems...................................................................    0991-AA81 
----------------------------------------------------------------------------------------------------------------


                                                                                                                
                             [[Page 23289]]
                                    Office of the Secretary--Final Rule Stage                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation  
 Sequence                                          Title                                            Identifier  
  Number                                                                                              Number    
----------------------------------------------------------------------------------------------------------------
1066        Civil Money Penalties (CMPs) for Certain Hospital Physician Incentive Plans.........     0991-AA45  
1067        Clarification of the Initial OIG Safe Harbor Provisions and Establishment of                        
            Additional Safe Harbor Provisions Under the Anti-Kickback Statute...................     0991-AA66  
1068        Safe Harbors for Protecting Health Plans............................................     0991-AA69  
1069        Revisions to the PRO Sanctions Process..............................................     0991-AA73  
1070        Amendment to Grants Management Common Rule To Raise Threshold for Simplified Small                  
            Purchases...........................................................................     0991-AA77  
1071        Proposed Amendments to Nonprocurement Debarment and Suspension Common Rule To                       
            Achieve Reciprocity With Procurement................................................     0991-AA78  
----------------------------------------------------------------------------------------------------------------


                               Office of the Secretary--Completed/Longterm Actions                              
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1072        Nondiscrimination Requirements (Including on the Basis of Sex or Religion) Applicable               
            to Block Grants and Standard Nondiscrimination Procedures Applicable to Certain Other               
            Programs..............................................................................    0991-AA02 
1073        Civil Money Penalties and Exclusions for Assistants at Cataract Surgery...............    0991-AA37 
1074        Civil Money Penalties (CMPs) for Certain Practices Relating to Medicare Supplemental                
            Policies..............................................................................    0991-AA53 
1075        Block Grant Programs..................................................................    0991-AA55 
1076        Uniform Administrative Requirements for Grants and Cooperative Agreements.............    0991-AA56 
1077        Civil Money Penalties for Physician Ownership of and Referral to Certain Health Care                
            Entities..............................................................................    0991-AA65 
1078        Governmentwide Guidance for New Restrictions on Lobbying; Interim Final Guidance......    0991-AA70 
1079        Clarification of the OIG Safe Harbor Anti-Kickback Provisions.........................    0991-AA74 
----------------------------------------------------------------------------------------------------------------


                                    Departmental Management--Final Rule Stage                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1080        Implementation of the Equal Access to Justice Act in Agency Proceedings...............    0990-AA02 
----------------------------------------------------------------------------------------------------------------


            Public Health Service--Office of Assistant Secretary for Health (OASH)--Final Rule Stage            
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1081        Standards of Compliance for Abortion-Related Services in Family Planning Service                    
            Projects..............................................................................    0905-AE03 
----------------------------------------------------------------------------------------------------------------


       Public Health Service--Office of Assistant Secretary for Health (OASH)--Completed/Longterm Actions       
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1082        Public Health Service Policies on Research Misconduct.................................    0905-AE02 
----------------------------------------------------------------------------------------------------------------


   Public Health Service--Substance Abuse and Mental Health Services Administration (SAMHSA)--Final Rule Stage  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1083        Confidentiality of Substance Abuse Patient Records....................................    0905-AD97 
1084        Block Grants for Prevention and Treatment of Substance Abuse..........................    0905-AD98 
1085        Protection and Advocacy for Individuals With Mental Illness...........................    0905-AD99 
1086        Block Grants for Prevention and Treatment of Substance Abuse (Tobacco Provisions).....    0905-AE05 
----------------------------------------------------------------------------------------------------------------


                                                                                                                
                           [[Page 23290]]
  Public Health Service--Substance Abuse and Mental Health Services Administration (SAMHSA)--Completed/Longterm 
                                                     Actions                                                    
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation  
 Sequence                                          Title                                            Identifier  
  Number                                                                                              Number    
----------------------------------------------------------------------------------------------------------------
1087        Community Mental Health Services Block Grants.......................................     0905-AE24  
----------------------------------------------------------------------------------------------------------------


            Public Health Service--Centers for Disease Control and Prevention (CDC)--Final Rule Stage           
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1088        Respiratory Protective Devices........................................................    0905-AB58 
1089        National Center for Health Statistics, Special Statistical Services; Grants for Health              
            Education/Risk Reduction; Vaccines Information and Education--Repeal..................    0905-AE67 
----------------------------------------------------------------------------------------------------------------


       Public Health Service--Centers for Disease Control and Prevention (CDC)--Completed/Longterm Actions      
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1090        Interstate Shipment of Biological Material That Contains or May Contain Infectious                  
            Substances............................................................................    0905-AC89 
1091        Medical Examination of Aliens.........................................................    0905-AD29 
----------------------------------------------------------------------------------------------------------------


                    Public Health Service--Food and Drug Administration (FDA)--Prerule Stage                    
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1092        Medical Foods.........................................................................    0905-AD91 
----------------------------------------------------------------------------------------------------------------


                 Public Health Service--Food and Drug Administration (FDA)--Proposed Rule Stage                 
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1093        Over-the-Counter (OTC) Drug Review....................................................    0905-AA06 
1094        Policies Concerning Uses of Sulfiting Agents..........................................    0905-AB52 
1095        Infant Formula Act....................................................................    0905-AC46 
1096        Reporting of Errors and Accidents Relating to Blood Safety and Withdrawal of                        
            Previously Proposed Rule..............................................................    0905-AD67 
1097        Proposed Labeling for Drug Products Based on False or Fraudulent Data.................    0905-AD71 
1098        Review of Warnings, Use Instructions, and Precautionary Information Under Section 314               
            of the National Childhood Vaccine Injury Act of 1986..................................    0905-AD72 
1099        Mammography Quality Standards Act of 1992.............................................    0905-AE19 
1100        Effective Date of Requirement for Submission of Premarket Approval Applications.......    0905-AE34 
1101        Latex Condoms/Gloves: Expiration Date Labeling........................................    0905-AE37 
1102        Amalgam Ingredient Labeling...........................................................    0905-AE39 
1103        Latex Warning.........................................................................    0905-AE40 
1104        Premarket Approval of Medical Devices; Supplemental Applications......................    0905-AE41 
1105        Medical Devices; Restricted Devices...................................................    0905-AE42 
1106        Prescription Drug Product Labeling; Medication Guide..................................    0905-AE43 
1107        Hearing Aids; Professional and Patient Labeling; Conditions for Sale..................    0905-AE46 
1108        Human Tissue Intended for Transplantation: Proposed Rule..............................    0905-AE49 
1109        Classification of Computer Software Programs That Are Medical Devices.................    0905-AE58 
1110        Iron Containing Drugs and Supplements.................................................    0905-AE59 
1111        Development of Hazard Analysis Critical Control Points for the Food Industry; Request               
            for Comments..........................................................................    0905-AE60 
1112        New Drug and Biological Product License Applications; Revisions to Existing                         
            Regulations...........................................................................    0905-AE61 
1113        Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding               
            of Drugs; Proposed Amendment of Certain Requirements for Finished Pharmaceuticals.....   0905-AE63  
                           [[Page 23291]]
                                                                                                                
1114        Public Information; Communications With State and Foreign Government Officials........    0905-AE65 
1115        Animal Drug Amendments of 1994, Extra-Label Use; Implementation.......................    0905-AE66 
----------------------------------------------------------------------------------------------------------------


                   Public Health Service--Food and Drug Administration (FDA)--Final Rule Stage                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1116        New Animal Drug Approval Process; Implementation of Title I of the Generic Animal Drug              
            and Patent Term Restoration Act.......................................................    0905-AA96 
1117        Current Good Manufacturing Practice for Blood and Blood Components; Notification of                 
            Consignees Receiving Blood and Blood Components at Increased Risk for Transmitting HIV              
            Infection.............................................................................    0905-AC90 
1118        Lead in Foods.........................................................................    0905-AC91 
1119        Fees for Certification Services; Insulin and Color Additive Certification Programs....    0905-AD34 
1120        Prescription Drug Marketing Act of 1987; Policy Information, Guidance, and                          
            Clarifications........................................................................    0905-AD44 
1121        Implementation of the Safe Medical Devices Act of 1990................................    0905-AD59 
1122        Mandatory HACCP Seafood Inspection Program............................................    0905-AD60 
1123        Bottled Water.........................................................................    0905-AD65 
1124        Recordkeeping and Reporting: Electronic Products......................................    0905-AD78 
1125        General Biological Product Standards; Alternative Procedures and Exceptions...........    0905-AD82 
1126        Medical Devices; Protective Restraints; Revocation of Exemptions From 510(k) Premarket              
            Notification Procedures and Current Good Manufacturing Practices Regulations..........    0905-AD84 
1127        Threshold of Regulation Policy for Components of Food Contact Articles................    0905-AD86 
1128        Food Labeling Review..................................................................    0905-AD89 
1129        Disqualification of Clinical Investigators............................................    0905-AD94 
1130        Investigational Device Exemption; Intraocular Lenses..................................    0905-AD95 
1131        Dietary Supplement Label Review.......................................................    0905-AD96 
1132        Specific Requirements on Content and Format of Labeling for Human Prescription Drugs;               
            Addition of ``Geriatric Use'' Subsection in the Labeling..............................    0905-AE26 
1133        Tamper-Evident Packaging Requirements for Over-The-Counter Human Drug Products........    0905-AE27 
1134        Certification of Drugs Composed Wholly or Partly of Insulin; Fees for Certification of              
            Drugs Composed Wholly or Partly of Insulin............................................    0905-AE28 
1135        Adverse Experience Reporting Requirements for Human Drug and Licensed Biological                    
            Products..............................................................................    0905-AE29 
1136        Electronic Signatures; Electronic Records.............................................    0905-AE31 
1137        Financial Disclosure by Clinical Investigators........................................    0905-AE32 
1138        Substances Prohibited for Use in Ruminant Feed........................................    0905-AE45 
----------------------------------------------------------------------------------------------------------------


              Public Health Service--Food and Drug Administration (FDA)--Completed/Longterm Actions             
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1139        Abbreviated New Drug Application Regulations (Title I of the ``Drug Price Competition               
            and Patent Term Restoration Act of 1984'')............................................    0905-AB63 
1140        Expediting Approval for Drugs Intended To Treat Life-Threatening and Severely                       
            Debilitating Illnesses................................................................    0905-AC94 
1141        Specific Requirements on Content and Format of Labeling for Human Prescription Drugs;               
            Revision of ``Pediatric Use'' Subsection in the Labeling..............................    0905-AD76 
1142        Performance Standard for the Infant Apnea Monitor.....................................    0905-AD83 
1143        Levo-Alpha-Methadol (LAAM) in Maintenance; Joint Proposed Revision of Conditions for                
            Use...................................................................................    0905-AD92 
1144        Temporomandibular Joint Implant Classification........................................    0905-AD93 
1145        Adverse Experience Reporting Required for Licensed Biological Products................    0905-AE18 
1146        Sunglasses; Labeling; Ultraviolet Radiation...........................................    0905-AE35 
1147        Investigational Device Exemption: Cost Recovery.......................................    0905-AE36 
1148        Foods Derived From New Plant Varieties; Premarket Notification........................    0905-AE50 
----------------------------------------------------------------------------------------------------------------


                                                                                                                
                           [[Page 23292]]
         Public Health Service--Health Resources and Services Administration (HRSA)--Proposed Rule Stage        
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation  
 Sequence                                          Title                                            Identifier  
  Number                                                                                              Number    
----------------------------------------------------------------------------------------------------------------
1149        National Vaccine Injury Compensation Program: Revisions and Additions to the Vaccine                
            Injury Table - II...................................................................     0905-AE52  
----------------------------------------------------------------------------------------------------------------


          Public Health Service--Health Resources and Services Administration (HRSA)--Final Rule Stage          
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1150        Organ Procurement and Transplantation Network Rules...................................    0905-AD26 
1151        Health Education Assistance Loan (HEAL) Program: Lenders'/ Holders' Performance                     
            Standards.............................................................................    0905-AD87 
1152        Grants for the Establishment of Departments of Family Medicine........................    0905-AE17 
1153        Federally Supported Health Centers Assistance Act of 1992.............................    0905-AE48 
1154        National Practitioner Data Bank for Adverse Information on Physicians, Dentists, and                
            Other Health Care Practitioners: Payment of Fees......................................    0905-AE53 
1155        Technical Amendments to the Health Professions, Nursing, and Allied Health Training                 
            Grant Programs Under 42 CFR Parts 57 and 58...........................................    0905-AE54 
----------------------------------------------------------------------------------------------------------------


     Public Health Service--Health Resources and Services Administration (HRSA)--Completed/Longterm Actions     
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1156        National Health Service Corps Loan Repayment Program; Grants for State Loan Repayment               
            Programs..............................................................................    0905-AC65 
1157        Standards for Bone Marrow Registries and Centers......................................    0905-AD51 
1158        National Vaccine Injury Compensation Program (VICP): Revisions to the Vaccine Injury                
            Table.................................................................................    0905-AD64 
1159        Grants for Faculty Training Projects in Geriatric Medicine and Dentistry..............    0905-AE13 
1160        Medical Facility Construction and Modernization Requirements for Provision of Services              
            to Persons Unable to Pay (Nursing Homes)..............................................    0905-AE33 
1161        National Practitioner Data Bank for Adverse Information on Physicians and Other Health              
            Care Practitioners: Amendment to Data Bank Regulations To Comply With Court Order.....    0905-AE38 
----------------------------------------------------------------------------------------------------------------


                     Public Health Service--Indian Health Service (IHS)--Proposed Rule Stage                    
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1162        Acquisition Under the Buy Indian Act..................................................    0905-AE09 
1163        Revision of Indian Self-Determination Regulations.....................................    0905-AE68 
----------------------------------------------------------------------------------------------------------------


                 Public Health Service--Indian Health Service (IHS)--Completed/Longterm Actions                 
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1164        Indian Health Service Loan Repayment Program Regulations..............................    0905-AC96 
1165        Indian Health Service Catastrophic Health Emergency Fund Program......................    0905-AC97 
1166        Revision of Indian Self-Determination Regulations.....................................    0905-AC98 
1167        Revision of Urban Indian Health Regulations...........................................    0905-AD20 
1168        Review of the Determination of an Indian Tribe's Resource Deficiency Level............    0905-AD21 
----------------------------------------------------------------------------------------------------------------


                                                                                                                
                           [[Page 23293]]
                 Public Health Service--National Institutes of Health (NIH)--Proposed Rule Stage                
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation  
 Sequence                                          Title                                            Identifier  
  Number                                                                                              Number    
----------------------------------------------------------------------------------------------------------------
1169        National Institutes of Health AIDS Research Loan Repayment Program..................     0905-AD18  
1170        Hazardous Substances Basic Research and Training Grants.............................     0905-AD46  
1171        National Institutes of Health Construction Grants...................................     0905-AD49  
1172        National Institutes of Health Center Grants.........................................     0905-AE00  
1173        National Institutes of Health Clinical Research Loan Repayment Program for                          
            Individuals From Disadvantaged Backgrounds..........................................     0905-AE56  
1174        Undergraduate Scholarship Program Regarding Professions Needed by the NIH...........     0905-AE57  
1175        Traineeships (Termination Policies).................................................     0905-AE62  
----------------------------------------------------------------------------------------------------------------


                  Public Health Service--National Institutes of Health (NIH)--Final Rule Stage                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1176        Grants for Research Projects..........................................................    0905-AC02 
1177        Training Grants.......................................................................    0905-AD56 
1178        Responsibilities of Public Health Service-Funded Institutions for Promoting                         
            Objectivity in Research...............................................................    0905-AE01 
1179        Grants for National Alcohol Research Centers..........................................    0905-AE08 
----------------------------------------------------------------------------------------------------------------


             Public Health Service--National Institutes of Health (NIH)--Completed/Longterm Actions             
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1180        Traineeships..........................................................................    0905-AD28 
1181        National Institute of Environmental Health Sciences Hazardous Waste Worker Training...    0905-AD69 
1182        National Heart, Lung, and Blood Institute Grants for Prevention and Control Projects..    0905-AE25 
1183        National Library of Medicine Grants...................................................    0905-AE55 
----------------------------------------------------------------------------------------------------------------


           Public Health Service--Agency for Health Care Policy and Research (AHCPR)--Final Rule Stage          
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1184        Health Services Research, Evaluation, Demonstration, and Dissemination Projects; Peer               
            Review of Grants and Contracts........................................................    0905-AD30 
----------------------------------------------------------------------------------------------------------------


                            Health Care Financing Administration--Proposed Rule Stage                           
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1185        Transfer of Resources for Less Than Fair Market Value (MB-10-P).......................    0938-AD18 
1186        Medicare Coverage of Outpatient Occupational Therapy Services (BPD-425-P).............    0938-AD32 
1187        New Minimum Standards for Medicare Supplemental (Medigap) Policies (BPD-491-P)........    0938-AD82 
1188        Fee Schedule for Payment of Clinical Psychologist Services (BPD-495-P)................    0938-AD84 
1189        ''Without Fault'' and Beneficiary Waiver of Recovery as It Applies to Medicare                      
            Overpayment Liability (BPD-719-P).....................................................    0938-AD95 
1190        Protection of Income and Resources for Community Spouse (MB-23-P).....................    0938-AE12 
1191        Alternative Sanctions for Psychiatric Hospitals (HSQ-191-P)...........................    0938-AF32 
1192        Medicaid Payment for Covered Outpatient Drugs Under Rebate Agreements (MB-046-P)......    0938-AF42 
1193        Federally Qualified Health Center Services (Medicaid) (MB-043-P)......................    0938-AF90 
1194        Revisions to Rules on Health Care Prepayment Plans (OMC-016-P)........................    0938-AF97 
1195        Conditions of Participation for Rural Health Clinics (BPD-764-P)......................    0938-AG05 
1196        Medicare Appeals of Individual Claims (BPD-453-P).....................................    0938-AG18 
1197        Appointment of Representatives for Medicare Appeals (BPO-120-P).......................   0938-AG30  
                           [[Page 23294]]
                                                                                                                
1198        Enforcement Requirements for Renal Dialysis Facilities (HSQ-204-P)....................    0938-AG31 
1199        Disclosure of Confidential PRO Information for Research Purposes (HSQ-208-P)..........    0938-AG33 
1200        Telephone and Electronic Requests for Review of Part B Initial Claim Determinations                 
            (BPO-121-P)...........................................................................    0938-AG48 
1201        Effect of Change of Ownership on Provider and Supplier Penalties, Sanctions, and                    
            Overpayments (HSQ-215-P)..............................................................    0938-AG59 
1202        Medicare Program: Limitations on Medicare Coverage of Cataract Surgery (BPD-797-PN)...    0938-AG65 
1203        New Payment Methodology for Routine Extended Care Services Provider in a Swing Bed                  
            Hospital (BPD-805-P)..................................................................    0938-AG68 
1204        Salary Equivalency Guidelines for Physical and Respiratory Therapy Services Furnished               
            Under Arrangements (BPD-808-PN).......................................................    0938-AG70 
1205        Medicaid: Optional Coverage of TB-Related Services for Individuals Infected with                    
            Tuberculosis (MB-082-P)...............................................................    0938-AG72 
1206        Revision of Medicare Hospital Conditions of Participation (BPD-745-P).................    0938-AG79 
1207        Physicians' Referrals to Health Care Entities With Which They Have Financial                        
            Relationships--Expanded to Designated Health Services (BPD-809-P).....................    0938-AG80 
1208        Home Health Agency (HHA) Conditions of Participation (BPD-819-P)......................    0938-AG81 
1209        End-Stage Renal Disease (ESRD) Conditions of Coverage (BPD-818-P).....................    0938-AG82 
1210        Criteria for Medicare Coverage of Lung Transplants (BPD-812-NC).......................    0938-AG83 
1211        Distinct Parts and Costing for Skilled Nursing Facilities and Nursing Facilities (BPD-              
            815-P)................................................................................    0938-AG84 
1212        Clinical Laboratory Improvement Amendment (CLIA) Fee Schedules (HSQ-219-FC)...........    0938-AG87 
1213        Wage Index Used To Adjust Payment Rates for Hospice Services Under the Medicare                     
            Program (BPD-820-P)...................................................................    0938-AG93 
1214        Mandatory Medigap Crossover Claims Transmittal Requirements (BPD-811-P)...............    0938-AG94 
1215        Medicare Program: Changes to the Inpatient Hospital Prospective Payment Systems and                 
            Fiscal Year 1996 Rates (BPD-825-P)....................................................    0938-AG95 
1216        Medicare Program: Revisions to Payment Policies and Adjustments to the Relative Value               
            Units (RVU) Under the Physician Fee Schedule for Calendar Year 1996 (BPD-827-P).......    0938-AG96 
1217        Categorization and Certification Requirements for a New Subcategory of Moderate                     
            Complexity Testing (HSQ-222-P)........................................................    0938-AG98 
1218        Categorization of Waived Tests (HSQ-225-P)............................................    0938-AG99 
1219        Medicaid Coverage of Personal Care Services (MB-071-P)................................    0938-AH00 
1220        Liability for Third Parties to Pay for Care and Services (MB-080-P)...................    0938-AH01 
1221        Medicare Program: Coverage of Certified Nurse-Midwife Services (BPD-496-P)............    0938-AH02 
----------------------------------------------------------------------------------------------------------------


                             Health Care Financing Administration--Final Rule Stage                             
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1222        Payment for Clinical Diagnostic Laboratory Tests (BPD-309-F)..........................    0938-AB50 
1223        Participation in CHAMPUS and CHAMPVA, Hospital Admissions for Veterans, Discharge                   
            Rights Notice, and Hospital Responsibility for Emergency Care (BPD-393-F).............    0938-AC58 
1224        Changes Concerning Suspension of Medicare Payments and Determinations of Allowable                  
            Interest Expense (BPO-118-FC).........................................................    0938-AC99 
1225        Clarifications of Medicare's Accrual Basis of Accounting Policy (BPD-366-F)...........    0938-AD01 
1226        Optional Payment System for Low Medicare Volume Skilled Nursing Facilities (BPD-409-F)    0938-AD02 
1227        Criteria and Procedures for Making Medical Services Coverage Decisions That Relate to               
            Health Care Technology (BPD-432-F)....................................................    0938-AD07 
1228        Prohibition on Unbundling of Hospital Outpatient Services (BPD-426-F).................    0938-AD33 
1229        Changes to Peer Review Organization Regulations (HSQ-135-F)...........................    0938-AD38 
1230        Payment for Durable Medical Equipment and Orthotic and Prosthetic Devices (BPD-494-F).    0938-AD65 
1231        Medicare Secondary Payer for Disabled Individuals (BPD-482-FC)........................    0938-AD73 
1232        Omnibus Nursing Home Reform Requirements (BPD-488-F)..................................    0938-AD81 
1233        HMO Organizational Structure and Services (OMC-007-F).................................    0938-AE25 
1234        Survey Requirements and Alternative Sanctions for Home Health Agencies (HSQ-169-F)....    0938-AE39 
1235        Hospital Standard for HIV Infectious Blood and Blood Products (BPD-633-F).............    0938-AE40 
1236        Medicare, Medicaid, and CLIA Programs: Regulations Implementing the Clinical                        
            Laboratory Improvement Amendments of 1988 (CLIA '88) (HSQ-226-F)......................    0938-AE47 
1237        Conditions of Coverage for Organ Procurement Organizations (BPD-646-FC)...............    0938-AE48 
1238        Resident Assessment in Long-Term Care Facilities (HSQ-180-F)..........................    0938-AE61 
1239        Post-Contract Beneficiary Protections and Other Provisions (OMC-003-F)................    0938-AE63 
1240        Employer Contributions to HMOs (OMC-004-F)............................................   0938-AE64  
                           [[Page 23295]]
                                                                                                                
1241        Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Services (MB-28-F)....    0938-AE72 
1242        Payment for Nursing and Allied Health Science Education (BPD-685-F)...................    0938-AE79 
1243        Uniform Electronic Cost Reporting System for Hospitals (BPD-689-F)....................    0938-AE80 
1244        Fire Safety Standards for Hospitals, Long-Term Care Facilities, and Intermediate Care               
            Facilities for the Mentally Retarded (BPD-650-F)......................................    0938-AE97 
1245        Coverage of Screening Pap Smears (BPD-705-F)..........................................    0938-AE98 
1246        Medicare Coverage of Clinical Psychologist, Other Psychologist, and Clinical Social                 
            Worker Services--Medicare (BPD-706-F).................................................    0938-AE99 
1247        Allowing Certifications and Recertifications by Nurse Practitioners and Clinical Nurse              
            Specialists for Certain Services (BPD-709-FC).........................................    0938-AF01 
1248        Case Management (MB-27-F).............................................................    0938-AF07 
1249        Medicaid Third Party Liability: Cost Effectiveness Waivers (MB-39-F)..................    0938-AF11 
1250        Required Coverage of Nurse Practitioner Services--Medicaid (MB-41-F)..................    0938-AF12 
1251        Payment for Federally Qualified Health Center (FQHC) Services (BPD-728-F).............    0938-AF14 
1252        Presumptive Limits on Payments to HMOs, CMPs, and HCPPs (OMC-006-F)...................    0938-AF16 
1253        Physician Ownership of and Referrals to Health Care Facilities That Furnish Clinical                
            Laboratory Services and Financial Relationship Reporting Requirements (BPD-674-FC)....    0938-AF40 
1254        Medicare and Medicaid Programs; Advance Directives (BPD-718-F)........................    0938-AF50 
1255        Partial Hospitalization Services in Community Mental Health Centers (BPD-736-F).......    0938-AF53 
1256        Referral to Child Support Enforcement Agencies of Medicaid Families (MB-051-F)........    0938-AF68 
1257        Medicare and Medicaid Programs: Requirements for Physician Incentive Plans in Prepaid               
            Health Care Organizations (OMC-010-FC)................................................    0938-AF74 
1258        Part B Advance Payments to Physicians/Suppliers or Other Entities Furnishing Items or               
            Services Under Medicare Part B (BPO-105-F)............................................    0938-AF85 
1259        Retroactive Enrollment and Disenrollment in Risk Health Maintenance Organizations and               
            Competitive Medical Plans (OMC-015-F).................................................    0938-AF98 
1260        Change in Provider Agreement Regulations Related to Federal Employee Health Benefits                
            (BPD-748-F)...........................................................................    0938-AG03 
1261        Intermediary and Carrier Functions (BPO-111-F)........................................    0938-AG06 
1262        Revised Medicaid Management Information Systems (MB-38-FN)............................    0938-AG10 
1263        Clarification of Resumption of Entitlement Rules for Medicare Patients with End-Stage               
            Renal Disease (BPD-738-F).............................................................    0938-AG19 
1264        End-Stage Renal Disease (ESRD) Payment Exception Requests and Organ Procurement Costs               
            (BPD-763-F)...........................................................................    0938-AG20 
1265        Standards for Quality of Water Used in Dialysis and Revised Guidelines on Reuse of                  
            Hemodialyzer Filters for End-Stage Renal Disease Patients (BPD-766-F).................    0938-AG21 
1266        General Criteria and Standards for Evaluating Performance of Contract Obligations (HSQ-             
            207-NC)...............................................................................    0938-AG32 
1267        Withdrawal of Coverage of Diagnostic Nocturnal Penile Tumescence Testing (Impotence                 
            Testing) (BPD-780-FN).................................................................    0938-AG43 
1268        Medicare Program: Limitations on Medicare Coverage of Intermittent Positive Pressure                
            Breathing Machine Therapy (BPD-781-FN)................................................    0938-AG44 
1269        Noncoverage of Electrostimulation of Salivary Glands for the Treatment of Xerostomia                
            (Dry Mouth) (BPD-782-FN)..............................................................    0938-AG45 
1270        Date for Filing Medicare Cost Reports (BPD-794-F).....................................    0938-AG55 
1271        Categorization of CLIA Tests and Personnel Modifications (HSQ-216-FC).................    0938-AG71 
1272        Medicaid Program: Nurse-Midwife Services (MB-085-P)...................................    0938-AG73 
1273        Medicaid Program: Fees for Vaccine Administration Under Pediatric Immunization Program              
            (MB-084-N)............................................................................    0938-AG77 
1274        Medicaid: Nominal Copayments for Institutional Services for Medicaid Recipients (MB-                
            090-FC)...............................................................................    0938-AG90 
1275        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 
1276        Part A Premium for 1996 for the Uninsured Aged and for Certain Disabled Individuals                 
            Who Have Exhausted Other Entitlement (OACT-051-N).....................................    0938-AH06 
1277        Medicare Program: Monthly Actuarial Rates and Monthly Supplementary Medical Insurance               
            Premium Rates Beginning January 1, 1996 (OACT-050-N)..................................    0938-AH07 
1278        Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance                   
            Amounts for 1996 (OACT-049-N).........................................................    0938-AH08 
----------------------------------------------------------------------------------------------------------------


                        Health Care Financing Administration--Completed/Longterm Actions                        
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1279        Hospice Services (MB-7-P).............................................................   0938-AC52  
                           [[Page 23296]]
                                                                                                                
1280        Home and Community-Based Services and Respiratory Care for Ventilator-Dependent                     
            Individuals (MB-8-FC).................................................................    0938-AC55 
1281        Denial of Payment for Substandard Quality Care (HSQ-132-F)............................    0938-AC84 
1282        Revised Effective Date of Medicare/Medicaid Provider Agreement and Supplier                         
            Participation (HSQ-139-F).............................................................    0938-AC88 
1283        Revisions to Conditions of Participation for Hospitals and Conditions for Coverage of               
            Suppliers of End-Stage Renal Disease Services (BPD-421-F).............................    0938-AD11 
1284        Medicaid Eligibility of Poverty Level Groups and Extended Coverage of Services (MB-13-              
            F)....................................................................................    0938-AD17 
1285        Revisions to the Freedom of Information Regulations (OPA-1-P).........................    0938-AD60 
1286        Medicare Coverage of Home Health Services, Medicare Conditions of Participation and                 
            Home Health Aide Supervision (BPD-469-F)..............................................    0938-AD78 
1287        Appeals for Enrollees of Prepaid Health Care Plans (OMC-008-F)........................    0938-AD79 
1288        Survey and Certification of Skilled Nursing Facilities and Nursing Facilities and                   
            Enforcement Procedures (HSQ-156-F)....................................................    0938-AD94 
1289        Physician Certification and Plan of Care Requirements and Inspection of Care Reviews                
            (HSQ-178-P)...........................................................................    0938-AE17 
1290        ''Confined to the Home'' Requirements for Home Health Services (BPD-626-F)............    0938-AE34 
1291        Medicaid Payment of Medicare Cost Sharing for Qualified Medicare Beneficiaries and                  
            Qualified Disabled and Working Individuals and Specified Low-Income Medicare                        
            Beneficiaries (MB-031-P)..............................................................    0938-AE38 
1292        Preadmission Screening and Annual Resident Review (BPD-661-F).........................    0938-AE49 
1293        Extended Medicaid Eligibility for Certain Individuals (MB-026-F)......................    0938-AE51 
1294        Medicare Coverage of Prescription Drugs Used in Immunosuppressive Therapy (BPD-424-F).    0938-AE94 
1295        Coverage of Physician Assistant, Nurse Practitioner, and Clinical Nurse Specialist                  
            Services (BPD-708-P)..................................................................    0938-AF00 
1296        Changes to the Long-Term Care Facility Survey Process (HSQ-175-FC)....................    0938-AF02 
1297        OBRA '90 and Miscellaneous Managed Care Technical Amendments (OMC-018-FC).............    0938-AF15 
1298        Provider Reimbursement Determinations and Appeals Revisions (BPD-727-P)...............    0938-AF28 
1299        Medicaid Payment for Obstetrical and Pediatric Services--Adequate Payment Level                     
            Provision (MB-036-P)..................................................................    0938-AF62 
1300        Requirements for Enrollment of Medicaid Recipients Under Cost Effective Employer Based              
            Group Health Plans (MB-047-F).........................................................    0938-AF64 
1301        Medicaid: Outstationed Intake Locations for Certain Low-Income Pregnant Women, Infants              
            and Children Under Age 19 (MB-052-IFC)................................................    0938-AF69 
1302        Medicaid: Pay-in Spenddown Option (MB-055-IFC)........................................    0938-AF72 
1303        Clarification of Coverage of Inpatient Psychiatric Services (MB-060-F)................    0938-AF73 
1304        National Coverage Decisions: Rules for Risk Contracting HMOs and CMPs (OMC-019-F).....    0938-AF76 
1305        Application of Interest Charges to Medicare Secondary Payer Recoveries (BPO-108-GN)...    0938-AF87 
1306        Minimum Physician Qualifications for Certain Services (MB-059-P)......................    0938-AF92 
1307        Payment for Preadmission Services (BPD-731-F).........................................    0938-AG00 
1308        Payment for Extracorporeal Shock Wave Lithotripsy Services Furnished by Ambulatory                  
            Surgical Centers (BPD-762-FN).........................................................    0938-AG04 
1309        Income and Eligibility Verification System (MB-66-P)..................................    0938-AG12 
1310        Medicare Program: Proposed Additions to and Deletions From the Current List of Covered              
            Surgical Procedures for Ambulatory Surgical Centers (BPD-776-FNC).....................    0938-AG27 
1311        Medicare Program: Special Payment Limits for Home Blood Glucose Monitors (BPD-778-FN).    0938-AG28 
1312        Community Supported Living Arrangements Services (MB-070-P)...........................    0938-AG35 
1313        Part A Premium for 1995 for the Uninsured Aged and for Certain Disabled Individuals                 
            Who Have Exhausted Other Entitlement (OACT-046-N).....................................    0938-AG49 
1314        Medicare Program: Monthly Actuarial Rates and Monthly Supplementary Medical Insurance               
            Premium Rates Beginning January 1, 1995 (OACT-047-N)..................................    0938-AG50 
1315        Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance                   
            Amounts for 1995 (OACT-048-N).........................................................    0938-AG51 
1316        Refinements to GAF Values, Revisions to Payment Policies, Adjustments to the RVUs                   
            Under the Physician Fee Schedule for CY 95, and the 5-Year Refinements of RVUs (BPD-                
            789-FC)...............................................................................    0938-AG52 
1317        Conditions for Payment for Physicians' Services in Teaching Settings (BPD-792-P)......    0938-AG53 
1318        Schedule of Limits on Home Health Agency Costs Per Visit (BPD-793-NC).................    0938-AG54 
1319        New Look Behind for Intermediate Care Facilities for the Mentally Retarded (ICFs/MR)                
            (HSQ-214-P)...........................................................................    0938-AG58 
1320        Institutional Plan Amendment Findings (MB-078-P)......................................    0938-AG60 
1321        Freedom of Choice Waiver; Conforming Changes (OMC-021-F)..............................    0938-AG63 
1322        Effects of Generally Accepted Accounting Principles (GAAP) on Reasonable Costs                      
            Determinations (BPD-800-P)............................................................    0938-AG66 
1323        Expansion of the Definition of Eye and Ear Specialty Hospitals (BPD-804-P)............    0938-AG67 
1324        Physician Performance Standard Rates of Increase for FY 1995 and Physician Fee                      
            Schedule Update for CY 1995 (BPD-807-FN)..............................................    0938-AG69 
1325        Proposed Payments to Disproportionate Share Hospitals for FY 1995 (MB-089-N)..........   0938-AG75  
                                                                                                                               [[Page 23297]]
                                                                                                                
1326        Extension of Certain Effective Dates for Clinical Laboratory Requirements and                       
            Personnel Requirements for Cytologists (HSQ-217-FC)...................................    0938-AG86 
1327        Approval of the American Society for Histocompatibility and Immunogenetics for the                  
            Specialty of Histocompatibility (HSQ-220-N)...........................................    0938-AG88 
1328        Medicaid: Coverage of Rehabilitation Services (MB-076-P)..............................    0938-AG89 
1329        Information, Counseling, and Assistance Grants Programs: Medicare Program (OBS-001-FC)    0938-AG91 
1330        Qualified Health Maintenance Organizations: Technical Amendments (OMC-009-FC).........    0938-AG92 
----------------------------------------------------------------------------------------------------------------


                          Administration for Children and Families--Proposed Rule Stage                         
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1331        Foster Care, Adoption Assistance, and Child Welfare Services..........................    0970-AA97 
1332        Amendments to Developmental Disabilities Rules........................................    0970-AB11 
1333        Standards for Safe Transportation.....................................................    0970-AB24 
1334        Notice of Proposed Rulemaking for the Administration of Native Americans 45 CFR Part                
            1336..................................................................................    0970-AB37 
1335        Block Grant Programs (Low Income Home Energy Assistance Program --LIHEAP)--FY 1995 and              
            FY 1996 Provisions....................................................................    0970-AB47 
1336        Administrative Flexibility Rule.......................................................    0970-AB49 
1337        Designation of Alternative Agency To Serve Indian Tribal Children.....................    0970-AB52 
1338        Income Eligibility Criteria for Indian Tribes.........................................    0970-AB53 
1339        Construction of Head Start Facilities.................................................    0970-AB54 
1340        Quality Standards for Head Start Programs.............................................    0970-AB55 
1341        Head Start Fellowships Program........................................................    0970-AB56 
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Final Rule Stage                           
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1342        Block Grant Programs (Low-Income Home Energy Assistance Program --LIHEAP) FY 91 and FY              
            92 Provisions.........................................................................    0970-AB15 
1343        Block Grant Programs (Low-Income Home Energy Assistance Program--LIHEAP)--FY 93 and FY              
            94 Provisions.........................................................................    0970-AB16 
1344        Family Violence Prevention and Services...............................................    0970-AB18 
1345        Child Abuse and Neglect State Grant Program...........................................    0970-AB23 
1346        Standards for Purchase of Facilities..................................................    0970-AB31 
1347        National Voter Registration Act of 1993 Provisions Affecting Public Assistance                      
            Agencies..............................................................................    0970-AB32 
1348        Child Care--Revised Regulations.......................................................    0970-AB33 
1349        Family Preservation and Support.......................................................    0970-AB34 
1350        Statewide Automated Child Welfare Information System..................................    0970-AB38 
1351        Refugee Resettlement Program: Miscellaneous, Comprehensive Changes....................    0970-AB42 
1352        Direct Payments to Indian Tribes and Tribal Organizations Under Title IV-B, Subpart 1.    0970-AB44 
1353        Repatriation - Advance Approval of Costs..............................................    0970-AB45 
1354        Reduction of Reporting Requirements for the State Systems Advance Planning Document                 
            (APD) Process.........................................................................    0970-AB46 
1355        Reporting Overdue Support Information to Consumer Reporting Agencies..................    0970-AB57 
1356        AFCARS Data Element on Foster Care Payments...........................................    0970-AB58 
1357        Income and Resource Disregards Related to Interests of Individual Indians in Trust or               
            Restricted Lands......................................................................    0970-AB59 
----------------------------------------------------------------------------------------------------------------


                      Administration for Children and Families--Completed/Longterm Actions                      
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1358        Aid to Families With Dependent Children Program; Extension of Medicaid Eligibility                  
            When Support Collections Result in Termination of AFDC Eligibility....................    0970-AA07 
1359        Title IV-E Training...................................................................   0970-AB25  
                             [[Page 23298]]                                                         
                                                                                                                
1360        State Legalization Impact Assistance Grant............................................    0970-AB28 
1361        Child Support Enforcement Program: Paternity Establishment and Revision of Child                    
            Support Enforcement Program and Audit Regulations.....................................    0970-AB40 
1362        Interstate Case Closure...............................................................    0970-AB41 
1363        Automobile Resource Limit.............................................................    0970-AB48 
1364        Head Start Initiative on Families With Infants and Toddlers...........................    0970-AB50 
1365        Flexibility in the Utilization of Information Obtained Through the Income Eligibility               
            Verification System...................................................................    0970-AB51 
----------------------------------------------------------------------------------------------------------------


                                  Administration on Aging--Proposed Rule Stage                                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1366        Grants for State and Community Programs on Aging, Intrastate Funding Formulas;                      
            Training, Research and Discretionary Programs; Vulnerable Elder Rights; and Grants to               
            Indians & Native Hawaiians............................................................    0985-AA00 
----------------------------------------------------------------------------------------------------------------




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Office of the Secretary (OS)
______________________________________________________________________


1065.  REVISIONS TO THE CIVIL MONEY PENALTY PROVISIONS 
RELATING TO THE MISUSE OF CERTAIN SYMBOLS AND EMBLEMS

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1320b-10; PL 103-296, Sec 312

CFR Citation:  42 CFR 1003

Legal Deadline: None

Abstract: This proposed rule, as a result of amendments to section 1140 
of the Social Security Act, would make a number of technical revisions 
to the civil money penalty authority relating to the misuse of certain 
symbols, emblems and names. Among other revisions, this rule would (1) 
eliminate the annual cap on penalties, (2) include the words and 
letters of the Department and Medicaid under the prohibition, and (3) 
redefine a violation with regard to mailings. In addition, this rule 
would serve to remove references to Social Security and the Social 
Security Administration from 42 CFR 1003.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            10/00/95
NPRM Comment Period End         12/00/95

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, 202 
619-3270

RIN: 0991-AA81



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Office of the Secretary (OS)
______________________________________________________________________

1066. CIVIL MONEY PENALTIES (CMPS) FOR CERTAIN HOSPITAL PHYSICIAN 
INCENTIVE PLANS

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 1001; 42 CFR 1003

Legal Deadline: None

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

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            12/01/94                    59 FR 61571
NPRM Comment Period End         01/30/95
Final Action                    09/00/95

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 
[[Page 23299]] General, OMP, 330 Independence Avenue SW., Washington, 
DC 20201, 202 619-3270

RIN: 0991-AA45
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Office of the Secretary (OS)
______________________________________________________________________

1067. CLARIFICATION OF THE INITIAL OIG SAFE HARBOR PROVISIONS AND 
ESTABLISHMENT OF ADDITIONAL SAFE HARBOR PROVISIONS UNDER THE ANTI-
KICKBACK STATUTE

Priority:  Other Significant

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
Interim Final Rule              10/00/95

Small Entities Affected: None

Government Levels Affected: None

Additional Information: This final rule will incorporate the safe 
harbor clarification provisions previously addressed in RIN 0991-AA74.

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, 
202 619-3270

RIN: 0991-AA66
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Office of the Secretary (OS)
______________________________________________________________________

1068. SAFE HARBORS FOR PROTECTING HEALTH PLANS

Priority:  Other Significant

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

CFR Citation:  42 CFR 1001

Legal Deadline: None

Abstract: This rule establishes additional ``safe harbor'' provisions, 
as authorized by section 14 of PL 100-93. This rule protects certain 
health care plans, such as health maintenance organizations, that offer 
incentives to enrollees or that enter into negotiated price reduction 
agreements with contract health care providers.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

Final Rule With Comment Period  11/05/92                    57 FR 52723
Extension of Public Comment 
Period                          01/07/93                     58 FR 2989
Interim Final Rule              11/05/93                    57 FR 52723
Final Action                    06/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Joel Jay Schaer, Regulations Officer, Office of the 
Inspector General, OMP, Department of Health and Human Services, Office 
of the Secretary, 330 Independence Avenue SW., Washington, DC 20201, 
202 619-3270

RIN: 0991-AA69
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Office of the Secretary (OS)
______________________________________________________________________

1069. REVISIONS TO THE PRO SANCTIONS PROCESS

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302; 42 USC 1320c-5; PL 100-93, sec 6; PL 
100-93, sec 8; PL 100-93, sec 10; PL 100-203, sec 4095; PL 101-508, sec 
4205

CFR Citation:  42 CFR 1004

Legal Deadline: None

Abstract: This rule will revise and update the procedures governing the 
imposition and adjudication of sanctions predicated on recommendations 
of State Peer Review Organizations. These changes are necessitated by 
statutory revisions resulting from PL 100-93, PL 100-203, and PL 101-
508. This rule will also set forth new appeal and reinstatement 
procedures that are presently codified in 42 CFR part 1004.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            02/28/94                     59 FR 9452
NPRM Comment Period End         04/29/94
Final Action                    09/00/95

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, 202 
619-3270

RIN: 0991-AA73
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Office of the Secretary (OS)
______________________________________________________________________

1070. AMENDMENT TO GRANTS MANAGEMENT COMMON RULE TO RAISE THRESHOLD 
FOR SIMPLIFIED SMALL PURCHASES

Priority:  Substantive, Nonsignificant

Legal Authority:  5 USC 301

CFR Citation:  45 CFR 92

Legal Deadline: None

Abstract: This proposal would raise the threshold for simplified small 
purchase procedures for grantees from $25,000 to $100,000.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            10/28/94                    59 FR 53706
NPRM Comment Period End         12/27/94                    59 FR 53706
Final Action                    05/00/95
Final Action Effective          05/00/95

Small Entities Affected: None

Government Levels Affected: State, Local, Tribal

Additional Information: OMB Circular A-102

Agency Contact: Charles Gale, Director, Division of Grants Policy and 
Oversight, Department of Health and Human Services, Office of the 
Secretary, Room 517-D, 200 Independence Avenue SW., Washington, DC 
20201, 202 690-6377

RIN: 0991-AA77
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Office of the Secretary (OS)
______________________________________________________________________


1071.  PROPOSED AMENDMENTS TO NONPROCUREMENT DEBARMENT AND 
SUSPENSION COMMON RULE TO ACHIEVE RECIPROCITY WITH PROCUREMENT

Priority:  Substantive, Nonsignificant

Legal Authority:  5 USC 301; PL 103-355, Sec 2455

CFR Citation:  45 CFR 76

Legal Deadline: None

Abstract: Gives reciprocal effect to procurement and nonprocurement 
debarments. [[Page 23300]] 

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            12/20/94                    59 FR 65607
NPRM Comment Period End         02/21/95
Final Action                    08/00/95
Final Action Effective          08/00/95

Small Entities Affected: None

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: Neil Steyskal, Department of Health and Human Services, 
Office of the Secretary, 200 Independence Ave. SW., Room 517D, 
Washington, DC 20201, 202 690-5729

RIN: 0991-AA78



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Office of the Secretary (OS)
______________________________________________________________________

1072. NONDISCRIMINATION REQUIREMENTS (INCLUDING ON THE BASIS OF SEX 
OR RELIGION) APPLICABLE TO BLOCK GRANTS AND STANDARD NONDISCRIMINATION 
PROCEDURES APPLICABLE TO CERTAIN OTHER PROGRAMS

CFR Citation:  45 CFR 94

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Marcella Haynes, 202 619-0671

RIN: 0991-AA02
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Office of the Secretary (OS)
______________________________________________________________________

1073. CIVIL MONEY PENALTIES AND EXCLUSIONS FOR ASSISTANTS AT 
CATARACT SURGERY

CFR Citation:  42 CFR 1001; 42 CFR 1003

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/31/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Joel Jay Schaer, 202 619-3270

RIN: 0991-AA37
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Office of the Secretary (OS)
______________________________________________________________________

1074. CIVIL MONEY PENALTIES (CMPS) FOR CERTAIN PRACTICES RELATING 
TO MEDICARE SUPPLEMENTAL POLICIES

CFR Citation:  42 CFR 1003

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Joel Jay Schaer, 202 619-3270

RIN: 0991-AA53
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Office of the Secretary (OS)
______________________________________________________________________

1075. BLOCK GRANT PROGRAMS

CFR Citation:  45 CFR 96

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Merged With RIN 0970-AB16       03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Terrance Tychan, 202 690-6901

RIN: 0991-AA55
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Office of the Secretary (OS)
______________________________________________________________________

1076. UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND 
COOPERATIVE AGREEMENTS

CFR Citation:  45 CFR 74

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Action                    04/19/95                    60 FR 19638
Final Action Effective          05/19/95                    60 FR 19638

Small Entities Affected: None

Government Levels Affected: State, Local

Agency Contact: Charles Gale, 202 690-6377

RIN: 0991-AA56
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Office of the Secretary (OS)
______________________________________________________________________

1077. CIVIL MONEY PENALTIES FOR PHYSICIAN OWNERSHIP OF AND REFERRAL 
TO CERTAIN HEALTH CARE ENTITIES

CFR Citation:  42 CFR 1003

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Action                    03/31/95                    60 FR 16580

Small Entities Affected: Undetermined

Government Levels Affected: None

Agency Contact: Joel Jay Schaer, 202 619-3270

RIN: 0991-AA65
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Office of the Secretary (OS)
______________________________________________________________________

1078. GOVERNMENTWIDE GUIDANCE FOR NEW RESTRICTIONS ON LOBBYING; 
INTERIM FINAL GUIDANCE

CFR Citation:  45 CFR 93

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - No action 
anticipated within the next 12 
months.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Charles Gale, 202 690-6574

RIN: 0991-AA70
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Office of the Secretary (OS)
______________________________________________________________________


1079. CLARIFICATION OF THE OIG SAFE HARBOR ANTI-KICKBACK PROVISIONS

CFR Citation:  42 CFR 1001

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Merged With RIN 0991-AA66       02/01/95

Small Entities Affected: None

Government Levels Affected: None [[Page 23301]] 

Agency Contact: Joel Jay Schaer, 202 619-3270

RIN: 0991-AA74



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Departmental Management (HHSDM)
______________________________________________________________________


1080. 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                    08/00/95
Final Action Effective          08/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Timothy M. White, Acting 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, 202 619-0150

RIN: 0990-AA02



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Office of Assistant Secretary for Health 
(OASH)
______________________________________________________________________


1081. 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

Agency Contact: Gerald Bennett, Acting Deputy Assistant Secretary for 
Population Affairs, Department of Health and Human Services, Public 
Health Service, East-West Towers, Suite 200, West Bldg., 5600 Fishers 
Lane, Rockville, MD 20857, 301 594-4000

RIN: 0905-AE03



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Public Health Service (PHS)--Office of Assistant Secretary for Health 
(OASH)
______________________________________________________________________


1082. PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT

CFR Citation:  42 CFR 93

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Commission must 
issue report before NPRM can be 
published                       01/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Dr. Lawrence Rhoades, 301 443-5300

RIN: 0905-AE02


[[Page 23302]] 
______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Substance Abuse and Mental Health 
Services Administration (SAMHSA)
______________________________________________________________________

1083. CONFIDENTIALITY OF SUBSTANCE ABUSE PATIENT RECORDS

Priority:  Other Significant

Legal Authority:  42 USC 290dd-2, as amended by PL 102-321; 42 USC 
290dd-3, as amended by PL 102-321

CFR Citation:  42 CFR 2

Legal Deadline: None

Abstract: This action modifies rules at 42 CFR part 2 to clarify 
coverage of general medical facilities in light of U.S. v. Eide, 875 
F.2d 1429, 1438 (9th Cir. 1989).

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            08/18/94                    59 FR 42561
NPRM Comment Period End         10/17/94
Final Action                    04/00/95

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Tribal, Federal

Additional Information: 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, Public Health Service, 5600 Fishers Lane, 
Room 12C-15, Rockville, MD 20857, 301 443-4640

RIN: 0905-AD97
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Substance Abuse and Mental Health 
Services Administration (SAMHSA)
______________________________________________________________________

1084. 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 are effective immediately. However, 
States have 90 days from the effective date to bring previously 
submitted FY 1993 applications into substantial compliance and need to 
submit applications in the prescribed format beginning only with 1994 
applications.

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                    10/00/95

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Tribal

Additional Information: 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, Public Health Service, 5600 Fishers Lane, 
Room 12C-15, Rockville, MD 20857, 301 443-4640

RIN: 0905-AD98
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Substance Abuse and Mental Health 
Services Administration (SAMHSA)
______________________________________________________________________

1085. 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                    09/00/95

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Local

Additional Information: 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, Public Health Service, 5600 Fishers Lane, 
Room 12C-15, Rockville, MD 20857, 301 443-4640

RIN: 0905-AD99
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Substance Abuse and Mental Health 
Services Administration (SAMHSA)
______________________________________________________________________


1086. BLOCK GRANTS FOR PREVENTION AND TREATMENT OF SUBSTANCE ABUSE 
(TOBACCO PROVISIONS)

Priority:  Regulatory Plan

Legal Authority:  42 USC 300x-21

CFR Citation:  45 CFR 96; 45 CFR 130

Legal Deadline: None

Abstract: Sets procedures for the Secretary to determine compliance 
under section 1926 of the PHS Act regarding State enforcement of laws 
against sale of tobacco products to minors as a condition of full 
funding of Federal block grants for prevention and treatment of 
substance abuse.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            08/26/93                    58 FR 45156
NPRM Comment Period End         10/25/93                    58 FR 45156
Final Action                    05/00/95

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Tribal

Additional Information: Alternate Contact: Sue Martone, DLEA, SAMHSA, 
PHS, Room 12C-15, 5600 Fishers Lane, 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, 12C-15, Rockville, MD 20857, 301 
443-4640

RIN: 0905-AE05


[[Page 23303]] 
______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Public Health Service (PHS)--Substance Abuse and Mental Health 
Services Administration (SAMHSA)
______________________________________________________________________


1087. COMMUNITY MENTAL HEALTH SERVICES BLOCK GRANTS

CFR Citation:  45 CFR 96

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Joseph Faha, 301 443-4640

RIN: 0905-AE24



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Centers for Disease Control and 
Prevention (CDC)
______________________________________________________________________

1088. RESPIRATORY PROTECTIVE DEVICES

Priority:  Regulatory Plan

Legal Authority:  30 USC 842(h); 30 USC 844; 30 USC 957

CFR Citation:  30 CFR 11; 42 CFR 84

Legal Deadline: None

Abstract: The proposed rule will upgrade current respirator 
certification requirements. It will update testing requirements for 
air-purifying respirators with particulate filters. The existing 
requirements allow potentially excessive filter leakage. The proposed 
rule would also benefit health care settings implementing CDC 
recommendations for preventing the transmission of tuberculosis. These 
recommendations include performance criteria for respiratory devices. 
The proposed rule will enable the certification of a broader range of 
respirators that meet the CDC performance criteria.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            08/27/87                    52 FR 32402
First Public Hearing            01/20/88                    52 FR 37639
Second Public Hearing           01/27/88                    52 FR 37639
NPRM Public Comment Period End  03/28/88                     53 FR 5595
Second NPRM                     05/24/94                    59 FR 26850
Second NPRM Comment Period End  07/22/94                    59 FR 27257
Final Action                    05/00/95
Final Action Effective          00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Richard Metzler, Chief, Cert. & Quality Assurance Br., 
Division of Safety Research, NIOSH, Department of Health and Human 
Services, Public Health Service, Centers for Disease Control and 
Prevention, 944 Chestnut Ridge Road, Morgantown, WV 26505, 304 284-5713

RIN: 0905-AB58
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Centers for Disease Control and 
Prevention (CDC)
______________________________________________________________________


1089.  NATIONAL CENTER FOR HEALTH STATISTICS, SPECIAL 
STATISTICAL SERVICES; GRANTS FOR HEALTH EDUCATION/RISK REDUCTION; 
VACCINES INFORMATION AND EDUCATION--REPEAL

Priority:  Informational

Legal Authority:  42 USC 242k; 42 USC 300w; 42 USC 300aa-26

CFR Citation:  42 CFR 3; 42 CFR 51g; 42 CFR 110

Legal Deadline: None

Abstract: The Centers for Disease Control and Prevention reviewed its 
existing regulations for continuing usefulness and accuracy, and found 
that three regulations are no longer needed. 42 CFR Part 3 (National 
Center for Health Statistics) is repealed because its provisions are 
now specified in the Public Health Service (PHS) Act. 42 CFR Part 51g 
(Grants for Health Education/Risk Reduction) is repealed because the 
regulated grants are now a component of the Preventive Health and 
Health Services Block Grant. 42 CFR Part 110 (Vaccine Information 
Materials) is repealed because the PHS Act no longer specifies vaccine 
information materials be promulgated by regulations.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

Final Action                    05/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Rebecca B. Wolf, Program Analyst, Office of Program 
Planning and Evaluation, Department of Health and Human Services, 
Public Health Service, Centers for Disease Control and Prevention, 1600 
Clifton Rd. NE., Atlanta, GA 30333, 404 639-3243

RIN: 0905-AE67



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Public Health Service (PHS)--Centers for Disease Control and 
Prevention (CDC)
______________________________________________________________________

1090. INTERSTATE SHIPMENT OF BIOLOGICAL MATERIAL THAT CONTAINS OR 
MAY CONTAIN INFECTIOUS SUBSTANCES

CFR Citation:  42 CFR 72

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jonathan Y. Richmond, Ph.D., 404 639-2453

RIN: 0905-AC89
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Public Health Service (PHS)--Centers for Disease Control and 
Prevention (CDC)
______________________________________________________________________


1091. MEDICAL EXAMINATION OF ALIENS

CFR Citation:  42 CFR 34 [[Page 23304]] 

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Charles R. McCance, 404 639-8100

RIN: 0905-AD29



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)            Prerule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________


1092. MEDICAL FOODS

Priority:  Other Significant

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

CFR Citation:  Not yet determined

Legal Deadline: None

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

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

ANPRM                           11/00/95
ANPRM Comment Period End        01/00/96

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Agency Contact: Robert Moore, Regulatory Branch, Division of Programs 
and Enforcement Policy, Office of Spec Nut., 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, 202 205-5372

RIN: 0905-AD91



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1093. OVER-THE-COUNTER (OTC) DRUG REVIEW

Priority:  Routine and Frequent

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'' to be included in revised NPRM for ``Antimicrobial 
Products.'' NPRM for ``Alcohol (Topical) Products'' to be included in 
revised NPRM for ``Antimicrobial Products.'' The NPRM for 
``Antimicrobial Products'' is being revised because it is being 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)

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) 
[[Page 23305]] 

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)

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)

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 06/00/95

Antidiarrheal Products  ANPRM 03/21/75 (40 FR 12924)  NPRM 04/30/86 (51 
FR 16138)  Final Action 05/00/95

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)

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)

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 13614)  NPRM (Amendment)(Ephedrine) 06/00/95

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 00/00/00

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)

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) [[Page 23306]] 

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 06/00/95

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 
(Amendment)(Alcohol Warning) 07/00/95

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)

Laxative Products  ANPRM 03/21/75 (40 FR 12902)  NPRM 01/15/85 (50 FR 
2124)  NPRM (Amendment) 10/01/86 (51 FR 35136)  NPRM (Amendment) 09/02/
93 (58 FR 46589)  Final Action 09/00/95

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 (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)

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)

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)  Final Action 09/
00/95

Quinine for Malaria  NPRM 05/00/95

Reporting of Adverse Reactions  NPRM 06/00/95

Skin Bleaching Products  ANPRM 11/03/78 (43 FR 51546)  NPRM 09/03/82 
(47 FR 39108)  NPRM (Reproposed) 09/00/95

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 09/00/95

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 07/00/95

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) [[Page 23307]] 

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/
94 (59 FR 5226)

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

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

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

Weight Control Products  ANPRM 02/26/82 (47 FR 8466)  NPRM 10/30/90 (55 
FR 45788)  Final Action 08/08/91 (56 FR 37792)  NPRM (Amendment) 09/00/
95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: William E. Gilbertson, Director, Monograph Review 
Staff, Office of OTC Drug Evaluation, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research (HFD-810), 5600 Fishers Lane, Rockville, MD 20857, 301 594-
5000

RIN: 0905-AA06
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1094. 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; 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 7, 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'' based on perceived procedural defects 
in the rulemaking proceeding. The Government appealed the district 
court's decision. On May 22, 1991, the U.S. Court of Appeals for the 
Third Circuit en banc affirmed, by an equally divided vote and without 
opinion, 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.
FDA's reproposed rule will include the GRAS status of sulfiting agents 
on both minimally processed (formerly fresh) and frozen potatoes.

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 (51 FR 25012)

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 03/00/96

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 (51 FR 25021)

Status of the Use of Sulfiting Agents on Shrimp  NPRM 12/19/88 (53 FR 
51065)  Tentative Final Rule 12/00/95

Status of Use of Sulfit Agents on Minimally Procd & Froz Potatoes  NPRM 
12/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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, 202 254-3116

RIN: 0905-AB52
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1095. INFANT FORMULA ACT

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 the Infant Formula Act of 1986. The rule establishes 
infant formula record and record retention requirements. The agency is 
also 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:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

Final Rule                      12/24/91    56 FR 66566 [[Page 23308]] 
NPRM                            09/00/95
NPRM Comment Period End         12/00/95
Current Good Mfg. Practices; Qual Control Proc  NPRM 07/00/95

Infant Form Cons Comp, Micro Test & Recd Retention Req  NPRM 01/26/89 
(54 FR 3783)  NPRM (Comment Period End) 03/27/89  Second NPRM 00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Carolyn W. Miles, Nutritionist, Regulatory Branch, 
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, 202 205-5372

RIN: 0905-AC46
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1096. REPORTING OF ERRORS AND ACCIDENTS RELATING TO BLOOD SAFETY 
AND WITHDRAWAL OF PREVIOUSLY PROPOSED RULE

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. (cont)

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            12/00/95
NPRM Comment Period End         04/00/96

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.
Additional Information: ABSTRACT CONT: 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 their recordkeeping 
and investigation procedures are sufficient and establish reporting 
procedures. Reporting by transfusion services is expected to be 
minimal.

Agency Contact: Jean M. Olson, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Center for Biologics 
Evaluation and Research (HFM-635), 1401 Rockville Pike, Suite 200N, 
Rockville, MD 20852-1448, 301 594-3074

RIN: 0905-AD67
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1097. PROPOSED LABELING FOR DRUG PRODUCTS BASED ON FALSE OR 
FRAUDULENT DATA

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355 
to 358; 21 USC 360 to 360b; 21 USC 371; 21 USC 374; 21 USC 376; 42 USC 
216; 42 USC 241; 42 USC 262; 42 USC 263b to 263n; 42 USC 264

CFR Citation:  21 CFR 201

Legal Deadline: None

Abstract: The agency proposes to revise its regulations pertaining to 
human drug product labeling. The proposed revisions would subject drug 
products whose labeling was based in whole or in part on false or 
fraudulent data or information to the statutory requirements in section 
502(f)(1) of the Federal Food, Drug, and Cosmetic Act. The proposal 
would also interpret the term ``false or fraudulent labeling.''

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            11/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Howard Muller, Regulatory Counsel, Division of 
Regulatory Affairs, Department of Health and Human Services, Food and 
Drug Administration, Center for Drug Evaluation and Research (HFD-362), 
7500 Standish Place, Rockville, MD 20855, 301 594-1049

RIN: 0905-AD71
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1098. 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                            12/00/95

Small Entities Affected: None

Government Levels Affected: State

Additional Information: A public meeting was held on 9/18/92 on section 
[[Page 23309]] 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-635), 1401 Rockville Pike, Suite 200N, 
Rockville, MD 20852-1448, 301 594-3074

RIN: 0905-AD72
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1099. MAMMOGRAPHY QUALITY STANDARDS ACT OF 1992

Priority:  Regulatory Plan

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.

Anticipated Costs and Benefits: Direct Federal costs in fiscal year 
1994 are $13 million. There are approximately 10,000 mammography 
facilities in the United States.
Approximately 8,200 already have accreditation or have applied for 
accreditation and will not incur significant additional costs. The 
remaining 1,800 facilities will incur approximately $26 million in one-
time costs and recurring costs of about $27 million. Amortizing the 
one-time costs, the annual cost of the interim rule is about $33 
million. Across 1,800 facilities, the average cost will be about 
$18,000 a year.
There are several benefits associated with these rules. High-quality 
mammography could significantly reduce breast cancer mortality. Early 
detection could reduce the morbidity associated with treating later 
stage disease. There may be a reduction in the number of malpractice 
claims filed for failure to diagnose early breast cancer. While there 
are insufficient data available to quantify the potential benefits of 
the MQSA, the potential magnitude is substantial. Using any 
conventional method of valuing lives saved, the benefits of these 
regulations are expected to be many times greater than their costs.

Timetable:

Accrediting Bodies and Quality Standards  Notice (Advisory Committee) 
12/21/94 (59 FR 65776)  NPRM 05/00/95

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)

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

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

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Federal

Agency Contact: Richard E. Gross, Office of Health and Industry 
Programs, Department of Health and Human Services, Food and Drug 
Administration, Center for Devices and Radiological Health (HFZ-200), 
1901 Chapman Avenue, Rockville, MD 20857, 301 443-4600

RIN: 0905-AE19
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1100. 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 were 
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 and 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 proposal are devices 
which FDA believes may no longer be commercially viable. FDA is 
providing an opportunity for manufacturers to petition for 
reclassification before premarket approval is required.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

Notice                          05/06/94                    59 FR 23731
NPRM                            05/00/95

Small Entities Affected: Undetermined

Government Levels Affected: None

Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Devices and Radiological Health (HFZ-84), 2098 Gaither Road, Rockville, 
MD 20857, 301 594-4765

RIN: 0905-AE34
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1101. LATEX CONDOMS/GLOVES: EXPIRATION DATE LABELING

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 351; 21 USC 352

CFR Citation:  21 CFR 801

Legal Deadline: None

Abstract: Latex patient examination and surgeon gloves and 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 product and to place that date on their 
labeling.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            07/00/95

Small Entities Affected: Undetermined

Government Levels Affected: None

Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Devices and Radiological Health (HFZ-84), 2098 Gaither Road, Rockville, 
MD 20850, 301 594-4765

RIN: 0905-AE37
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1102. AMALGAM INGREDIENT LABELING

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 352

CFR Citation:  21 CFR 801 [[Page 23310]] 

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                            09/00/95

Small Entities Affected: Undetermined

Government Levels Affected: None

Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Devices and Radiological Health (HFZ-84), 2098 Gaither Road, Rockville, 
MD 20850, 301 594-4765

RIN: 0905-AE39
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1103. 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                            07/00/95

Small Entities Affected: Undetermined

Government Levels Affected: None

Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Devices and Radiological Health (HFZ-84), 2098 Gaither Road, Rockville, 
MD 20850, 301 594-4765

RIN: 0905-AE40
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1104. PREMARKET APPROVAL OF MEDICAL DEVICES; SUPPLEMENTAL 
APPLICATIONS

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 360e

CFR Citation:  21 CFR 814.39

Legal Deadline: None

Abstract: FDA has become aware of several situations in which a 
supplement to an approved premarket for a change in a device approval 
application (PMA) was not submitted even though FDA believed that a 
supplement was required. Therefore, FDA would propose to revise its 
regulation to clarify when a supplement is required. This would result 
in fewer unapproved changes in devices.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            09/00/95

Small Entities Affected: Undetermined

Government Levels Affected: None

Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Devices and Radiological Health (HFZ-84), 2098 Gaither Road, Rockville, 
MD 20850, 301 594-4765

RIN: 0905-AE41
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1105. MEDICAL DEVICES; RESTRICTED DEVICES

Priority:  Other Significant

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

CFR Citation:  21 CFR 801; 21 CFR 899

Legal Deadline: None

Abstract: The proposal would designate certain categories of devices as 
``restricted devices.'' Restricted devices are defined by the statute 
as devices that must be restricted in their sale, distribution or use 
because of their potential for harmful effect or collateral measures 
necessary to their use. FDA would propose to include in this category 
devices such as those that pierce or penetrate the skin, implantable 
devices, devices that introduce medicinal gas or energy into the body 
and devices that are used for diagnosis that must be interpreted or 
analyzed by a qualified health professional. Restricted devices are 
subject to certain limitations on distribution and to special labeling 
requirements. FDA also may regulate the advertising of restricted 
devices.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            09/00/95

Small Entities Affected: Undetermined

Government Levels Affected: None

Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Devices and Radiological Health (HFZ-84), 2098 Gaither Road, Rockville, 
MD 20850, 301 594-4765

RIN: 0905-AE42
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1106. PRESCRIPTION DRUG PRODUCT LABELING; MEDICATION GUIDE

Priority:  Regulatory Plan

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: To encourage and provide clear objectives for private sector 
distribution of patient information, this proposed rule would establish 
performance standards for distribution rates and quality of voluntarily 
supplied patient information. Implementation of regulations that would 
require FDA-approved patient labeling (Medication Guides) for 
distribution with most outpatient prescription drug and biological 
products would be deferred if private sector initiatives meet the 
performance standards. In concert with Healthy People 2000 goals, the 
proposed performance standards specify that useful information be 
distributed 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 taking this action to assure that the public 
receives high quality prescription drug 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 
patient drug use. [[Page 23311]] 

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

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, 301 594-6818

RIN: 0905-AE43
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1107. HEARING AIDS; PROFESSIONAL AND PATIENT LABELING; CONDITIONS 
FOR SALE

Priority:  Other Significant

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                            09/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Devices and Radiological Health (HFZ-84), 2098 Gaither Road, Rockville, 
MD 20850, 301 594-4765

RIN: 0905-AE46
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1108. HUMAN TISSUE INTENDED FOR TRANSPLANTATION: PROPOSED RULE

Priority:  Substantive, Nonsignificant

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 amending the regulations to require the registration 
of those establishments engaged in procurement, processing, storage, or 
distribution of human tissue intended for transplantation. It is also 
intended to clarify those requirements previously promulgated by the 
interim rule. FDA will be adding 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                            01/00/96
NPRM Comment Period End         03/00/96

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: Paula McKeever, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Biologics Evaluation and Research (HFM-635), 1401 Rockville Pike, Suite 
200N, Rockville, MD 20852-1448, 301 594-3074

RIN: 0905-AE49
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1109. 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. In so doing, the Agency 
anticipates promulgating relevant exemptions by using a risk-based 
approach as required under the Medical Device Amendments to the act. 
Under this approach appropriate medical software devices will be 
subject to the adulteration and misbranding provisions of the act. 
Moderate risk devices will 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. FDA is seeking comment on potential criteria 
related to the intended uses of medical software devices that might be 
used in determining the level of risk as part of this document. FDA is 
also clarifying the manner in which FDA's current statutory authorities 
govern medical software devices under the act.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            09/00/95

Small Entities Affected: Undetermined

Government Levels Affected: None

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, 301 594-4765

RIN: 0905-AE58
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1110. 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 [[Page 23312]] Education Act 
(Pub. L. 103-417), FDA is preparing 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                     60 FR 8989
Final Action                    00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: None

Agency Contact: John Hathcock, Director, Division of Applied Science 
and Technology, Department of Health and Human Services, Food and Drug 
Administration, Center for Food Safety and Applied Nutrition (HFS-465), 
200 C Street SW., Washington, DC 20204, 202 205-5365

RIN: 0905-AE59
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1111. DEVELOPMENT OF HAZARD ANALYSIS CRITICAL CONTROL POINTS FOR 
THE FOOD INDUSTRY; REQUEST FOR COMMENTS

Priority:  Regulatory Plan

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: In this advance notice, FDA is announcing for public comment 
its plans to develop 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 
imspection 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

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, 202 205-4010

RIN: 0905-AE60
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1112. NEW DRUG AND BIOLOGICAL PRODUCT LICENSE APPLICATIONS; 
REVISIONS TO EXISTING REGULATIONS

Priority:  Other Significant

Legal Authority:  21 USC 379(e); 21 USC 379(g) to 379(h)

CFR Citation:  21 CFR 314.51; 21 CFR 314.60; 21 CFR 314.61; 21 CFR 
314.71; 21 CFR 314.100; 21 CFR 314.110; 21 CFR 314.120; 21 CFR 600.3; 
21 CFR 601.2; 21 CFR 601.3; 21 CFR 611

Legal Deadline: None

Abstract: FDA is proposing new regulations and amendments to current 
regulations governing the submission of applications for marketing 
approval for human drug and biological products to specify what must be 
submitted as a separate original marketing application, what may be 
combined in a single application, what changes to an approved 
application may be submitted as a supplement, and when applicants 
should respond to FDA action letters. FDA is taking this action to 
provide clear regulatory policy to industry.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            11/00/95

Small Entities Affected: None

Government Levels Affected: State, Federal

Agency Contact: Thomas Hassall, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research (HFD-5), 5600 Fishers Lane, Rockville, MD 
20857, 301 594-6740

RIN: 0905-AE61
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1113. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, 
PROCESSING, PACKING, OR HOLDING OF DRUGS; PROPOSED AMENDMENT OF CERTAIN 
REQUIREMENTS FOR FINISHED PHARMACEUTICALS

Priority:  Substantive, Nonsignificant

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

_______________________________________________________________________

NPRM                            06/00/95

Small Entities Affected: None

Government Levels Affected: Federal

Agency Contact: Howard P. Muller, Regulatory Counsel, Division of 
[[Page 23313]] Regulatory Affairs, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research (HFD-362), 7500 Standish Place, Rockville, MD 20855, 301 594-
1046

RIN: 0905-AE63
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1114.  PUBLIC INFORMATION; COMMUNICATIONS WITH STATE AND 
FOREIGN GOVERNMENT OFFICIALS

Priority:  Informational

Legal Authority:  5 USC 552; 18 USC 1905; 19 USC 2531 to 2582; 21 USC 
321 to 393; 42 USC 241; 42 USC 242; 42 USC 242a; 42 USC 242l; 42 USC 
242n; 42 USC 243; 42 USC 262; 42 USC 263; 42 USC 263b to 263n; 42 USC 
264; 42 USC 265

CFR Citation:  21 CFR 20

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is proposing to amend 
its regulations governing communications with officials of State, local 
and foreign governments. This proposal will permit FDA to disclose to, 
and receive from, these officials certain nonpublic information without 
being compelled to disclose the information to the public generally. 
This proposal addresses the nonpublic exchange of two types of 
information. First, it allows the disclosure of nonpublic safety, 
effectiveness, or quality information concerning FDA-regulated products 
to State and local government officials. Second, it allows the 
disclosure of draft proposed rules and other nonpublic predecisional 
documents concerning regulatory requirements or activities between FDA 
and either State, local or foreign government officials. This action is 
necessary to enhance cooperation in regulatory activities, to eliminate 
unfounded contradictory regulatory requirements, and to minimize 
redundant application of similar requirements.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            01/27/95                     60 FR 5530
NPRM Comment Period End         04/27/95
Final Action                    01/00/96

Small Entities Affected: None

Government Levels Affected: State, Local, Federal

Additional Information: 42 USC 300u-300u-5 42 USC 300aa-1

Agency Contact: Linda Horton, Director, International Policy Staff, 
Department of Health and Human Services, Food and Drug Administration, 
Office of Policy (HF-23), 5600 Fishers Lane, Rockville, MD 20857, 301 
443-2831

RIN: 0905-AE65
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________


1115.  ANIMAL DRUG AMENDMENTS 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 allow licensed veterinarians to prescribe off-label use of 
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                            08/00/95
Final Action                    10/00/96

Small Entities Affected: Undetermined

Government Levels Affected: None

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, 301 594-1737

RIN: 0905-AE66



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1116. NEW ANIMAL DRUG APPROVAL PROCESS; IMPLEMENTATION OF TITLE I 
OF THE GENERIC ANIMAL DRUG AND PATENT TERM RESTORATION ACT

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 360b; 21 USC 371

CFR Citation:  21 CFR 514

Legal Deadline:  Final, Statutory, November 5, 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 
[[Page 23314]] 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 approved after 
1962.

Timetable:

New Animal Drug Approval Process  NPRM 12/17/91 (56 FR 65544)  NPRM 10/
00/95

Reporting Requirements for Marketed Animal Drugs  NPRM 12/17/91 (56 FR 
65581)  Final Action 07/00/95

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: 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, 301 594-1620

RIN: 0905-AA96
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1117. 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 concerning generic animal drugs intended 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 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 of 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                    12/00/95

Small Entities Affected: Businesses, Organizations

Government Levels Affected: Undetermined

Agency Contact: Sharon Carayiannis, Consumer Safety Officer, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Biologics Evaluation and Research (HFM-635), 1401 Rockville Pike, Suite 
200N, Rockville, MD 20852-1448, 301 594-3074

RIN: 0905-AC90
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1118. 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. FDA has identified several potential sources of 
dietary lead exposure that it intends to address in proposed rules in 
its initiatives to reduce exposure to lead in the diet.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            06/01/89                    54 FR 23485
NPRM Comment Period End         07/31/89
Prohibit Use of Lead-Soldered Food Cans  NPRM 06/21/93 (58 FR 
33860)  Final Action 06/00/95

Prohibit Use of Tin-Coated Lead Foil Capsules on Wine Bottles  NPRM 11/
25/92 (57 FR 55485)  Final Action 08/00/95

Small Entities Affected: None

Government Levels Affected: None

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, 202 205-4681

RIN: 0905-AC91
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1119. FEES FOR CERTIFICATION SERVICES; INSULIN AND COLOR ADDITIVE 
CERTIFICATION PROGRAMS

Priority:  Routine and Frequent

Legal Authority:  21 USC 356; 21 USC 371; 21 USC 379e(e)

CFR Citation:  21 CFR 80; 21 CFR 429

Legal Deadline: None [[Page 23315]] 

Abstract: In the Federal Register of October 4, 1991 (56 FR 50248), FDA 
issued an interim rule effective on November 4, 1991 with opportunity 
for public comment, revising the fee schedule for insulin certification 
services. The fees are intended to recover the full costs of operation 
of FDA's insulin certification program, including the unfunded 
liability of the Civil Service Retirement Fund and appropriate overhead 
costs of the Public Health Service and Department of Health and Human 
Services. In the Federal Register of November 29, 1994, FDA issued an 
interim final rule effective December 29, 1994, which amended the color 
additive regulations by increasing the fees for certification services. 
The change in fees will allow FDA to continue to maintain an adequate 
color certification program as required by the Federal Food, Drug, and 
Cosmetic Act. FDA is publishing a new interim rule lowering the fees, 
to reflect lower costs involved in administering the insulin 
certification program.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

Interim Final Rule (Insulin)    10/04/91                    56 FR 50248
Interim Final Rule (Color 
Additives)                      11/29/94                    59 FR 60898
Interim Final Rule (Insulin)    09/00/95

Small Entities Affected: Undetermined

Government Levels Affected: None

Agency Contact: David R. Petak, Chief, Accounting Branch, Department of 
Health and Human Services, Food and Drug Administration, Office of 
Management (HFA-120), 5600 Fishers Lane, Rockville, MD 20857, 301 443-
1766

RIN: 0905-AD34
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1120. PRESCRIPTION DRUG MARKETING ACT OF 1987; POLICY INFORMATION, 
GUIDANCE, AND CLARIFICATIONS

Priority:  Substantive, Nonsignificant

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 for emergency use; (3) ban the sale, trade, or purchase of 
drug samples; (4) ban trafficking in or counterfeiting of drug coupons; 
(5) mandate storage, handling, and recordkeeping requirements for drug 
samples; (6) require licensed practitioners to request drug samples in 
writing; (7) prohibit, with certain exceptions, the resale of 
prescription human drugs purchased by hospitals or health care 
facilities; and (8) set forth criminal and civil penalties for 
violations of these provisions. In the Federal Register of September 
14, 1990 (55 FR 38012), FDA issued a final rule setting forth Federal 
guidelines for State licensing of wholesale drug distributors. This 
proposed 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                    12/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Erica L. Keys, Regulatory Counsel, Division of 
Regulatory Affairs, Department of Health and Human Services, Food and 
Drug Administration, Center for Drug Evaluation and Research (HFD-362), 
7500 Standish Place, Rockville, MD 20855, 301 594-1049

RIN: 0905-AD44
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1121. 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, November 28, 1992, 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--This rule 
will 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. (cont)

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 05/00/
95

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) [[Page 23316]] 

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)  Final Action 09/00/95

Exemption of Humanitarian Devices  NPRM 12/21/92 (57 FR 60491)  Final 
Action 06/00/95

Medical Device Recall Authority  NPRM 06/14/94 (59 FR 30656)  NPRM 
(Correction) 06/23/94 (59 FR 32489)  Final Action 09/00/95

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 07/00/95

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 09/00/95

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 06/00/95

Small Entities Affected: None

Government Levels Affected: None

Additional Information: ABSTRACT CONT: Summaries of Safety and 
Effectiveness for Premarket Notification--A final rule will set forth 
information to be included in data summaries on which substantial 
equivalence determinations are made. Recall of Medical Devices--FDA 
will propose procedures for using its authority to order device recalls 
and notifications. Reports of Removal and Corrections--FDA will propose 
procedures for manufacturers to report to FDA health-related market 
removals and corrections of devices. Civil Money Penalties--FDA 
proposed regulations to establish 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.

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, 301 594-4765

RIN: 0905-AD59
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1122. MANDATORY HACCP SEAFOOD INSPECTION PROGRAM

Priority:  Economically Significant

Legal Authority:  21 USC 342 Federal Food, Drug, and Cosmetic Act; 21 
USC 371 Federal Food, Drug, and Cosmetic Act; 21 USC 374 Federal Food, 
Drug, and Cosmetic Act; 42 USC 264 Public Health Service Act; 21 USC 
321; 21 USC 343; 21 USC 346; 21 USC 348; 21 USC 379e; 21 USC 381; 42 
USC 241; 42 USC 242l; 42 USC 300u-l; 42 USC 216; 42 USC 243

CFR Citation:  21 CFR 123; 21 CFR 1240

Legal Deadline: None

Abstract: The Food and Drug Administration intends to issue 
requirements for the safe processing and importing of fish and fishery 
products in keeping with Hazard Analysis Critical Control Point (HACCP) 
principles. HACCP involves the identification and monitoring of 
``critical control points'' in a processing or other operation the 
failure of which can render a product adulterated. HACCP has been 
strongly endorsed by the National Academy of Sciences for use by the 
seafood industry.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            01/28/94                     59 FR 4142
NPRM Comment Period End         03/29/94
Final Action                    02/00/96

Small Entities Affected: None

Government Levels Affected: None

Additional Information: 42 USC 264; 42 USC 271

Agency Contact: Philip Spiller, Deputy Director, Office of Seafood, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Food Safety and Applied Nutrition (HFS-401), 200 C Street 
SW., Washington, DC 20204, 202 418-3133

RIN: 0905-AD60
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1123. BOTTLED WATER

Priority:  Routine and Frequent

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

CFR Citation:  21 CFR 103

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 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 09/
00/95

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 07/00/95

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

Small Entities Affected: Undetermined [[Page 23317]] 

Government Levels Affected: None

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, 202 205-4681

RIN: 0905-AD65
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1124. RECORDKEEPING AND REPORTING: ELECTRONIC PRODUCTS

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 360hh; 21 USC 360ii; 21 USC 360jj; 21 USC 
360kk; 21 USC 360ll; 21 USC 360mm; 21 USC 360nn; 21 USC 360oo

CFR Citation:  21 CFR 1000; 21 CFR 1002

Legal Deadline: None

Abstract: The final rule would amend FDA regulations on recordkeeping 
and reporting of adverse events and other information relating to 
radiation-emitting electronic products. The timing and content of 
certain reports will be revised to enhance the usefulness of the 
information. This action will result in improved protection of the 
public health while reducing the regulatory burden on manufacturers and 
distributors.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

ANPRM                           07/02/82                    47 FR 29004
ANPRM                           11/16/82                    47 FR 51706
ANPRM                           07/01/85                    50 FR 27024
NPRM                            10/25/90                    55 FR 43066
NPRM Comment Period End         01/22/91
Final Action                    04/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Devices and Radiological Health (HFZ-84), 2098 Gaither Road, Rockville, 
MD 20850, 301 594-4765

RIN: 0905-AD78
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1125. GENERAL BIOLOGICAL PRODUCT STANDARDS; ALTERNATIVE PROCEDURES 
AND EXCEPTIONS

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 262

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

Legal Deadline: None

Abstract: The Food and Drug Administration is amending its regulations 
governing biological products. This amendment would authorize the 
Director, Center for Biologics Evaluation and Research, to approve an 
exception or alternative to any regulation in 21 CFR governing 
biological products. The regulation will provide flexibility needed to 
accommodate rapid changes in biotechnology and to assure the continued 
availability of biological products.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

Final Action                    12/00/95

Small Entities Affected: None

Government Levels Affected: Undetermined

Agency Contact: Stephen Ripley, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Biologics Evaluation and Research (HFM-635), 1401 Rockville Pike, Suite 
200N, Rockville, MD 20852-1448, 301 594-3074

RIN: 0905-AD82
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1126. MEDICAL DEVICES; PROTECTIVE RESTRAINTS; REVOCATION OF 
EXEMPTIONS FROM 510(K) PREMARKET NOTIFICATION PROCEDURES AND CURRENT GOOD 
MANUFACTURING PRACTICES REGULATIONS

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 351; 21 USC 360; 21 USC 360c; 21 USC 360e; 21 
USC 360y; 21 USC 371

CFR Citation:  21 CFR 880.6760; 21 CFR 890.3910

Legal Deadline: None

Abstract: FDA has become aware through various sources of numerous 
reports of complications including permanent physical injuries, severe 
psychological disabilities, other serious injuries and deaths that have 
been attributed to incorrect supervision, handling or application of 
protective restraint devices by medical or paramedical personnel. 
Complications associated with protective restraint devices frequently 
result from misuse of the devices. To address potential misuse, 
manufacturers should include specific directions for use, to the extent 
that such directions are not currently available or not attached to or 
kept with the garment. Revocation of the premarket notification 
exemptions will allow FDA to collect information about the current 
availability and actual employment of directions for use and to monitor 
the introduction into commerce of new and changed protective 
restraints. Revocation of the exempting Current Good Manufacturing 
Practice regulation will allow FDA to require the necessary controls 
over labeling. FDA is also considering educational programs to address 
this problem. FDA anticipates total first year costs of $930,000 for 
this regulation. These costs will be offset by the saving of lives and 
reduced product liability exposure.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            06/19/92                    57 FR 27397
NPRM Comment Period End         08/18/92
Final Action                    05/00/95

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: Patricia Dubill, Department of Health and Human 
Services, Food and Drug Administration, Center for Devices and 
Radiological Health (HFZ-84), 2098 Gaither Road, Rockville, MD 20850, 
301 594-4765

RIN: 0905-AD84
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1127. THRESHOLD OF REGULATION POLICY FOR COMPONENTS OF FOOD CONTACT 
ARTICLES

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 321; 21 USC 341; 21 USC 342; 21 USC 346a; 21 
USC 348; 21 USC 371

CFR Citation:  21 CFR 170; 21 CFR 171; 21 CFR 174

Legal Deadline: None [[Page 23318]] 

Abstract: FDA is establishing a policy for determining when the 
likelihood/extent of migration of a component of a food contact article 
is so trivial as not to require regulation as a food additive. A 
substance considered under this Threshold of Regulation Policy would 
undergo an abbreviated review by FDA, as opposed to the extensive 
review and formal issuance of a regulation required for other food 
additives. This final rule lists the criteria which must be met for a 
food-contact material to be reviewed under this policy and identifies 
the types of data that FDA will need for its review. This policy will 
reduce regulatory cost and delays and thereby bring important and 
innovative products to market faster.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            10/12/93                    58 FR 52719
Final Action                    12/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Edward J. Machuga, Consumer Safety Officer, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Food Safety and Applied Nutrition (HFS-216), 200 C Street SW., 
Washington, DC 20204, 202 418-3085

RIN: 0905-AD86
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1128. 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. In developing the 
final rules that were published on January 6, 1993, the Agency 
identified three areas that should be the subject of additional 
rulemaking: a definition for the nutrient content claim ``healthy''; a 
definition for ``nonfunctional slack-fill''; and requirements for the 
identification of certain ingredients on food labels. Proposed 
regulations addressing these issues were published on January 6, 1993. 
On May 12, 1993, FDA announced that, in accordance with the NLEA, the 
regulation it proposed on January 6, 1993, on nonfunctional slack-fill 
was considered a final rule. Subsequently, on December 6, 1993, FDA 
issued a final rule responding to the comments received to the January 
6, 1993, proposal. On May 10, 1994, FDA published a final rule on the 
definition of the term ``healthy.'' FDA also 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. These actions were 
proposed following reconsideration of the provisions in question. 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.

Timetable:

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

Nutrient Content Claims and Health Claims; Restaurant Foods  NPRM 06/
15/93 (58 FR 33055)  Final Action 05/00/95

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

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 06/00/
95

Small Business Exemption, Nutrition Labeling  NPRM 03/14/94 (59 FR 
11872)  Final Action 12/00/95

Voluntary Guidelines for Nutrition Labeling Produce  NPRM 07/18/94 (59 
FR 36379)  Final Action 09/00/95

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Agency Contact: F. Edward Scarbrough, Director, Office of Food 
Labeling, Department of Health and Human Services, Food and Drug 
Administration, Center for Food Safety and Applied Nutrition (HFS-150), 
200 C Street SW., Washington, DC 20204, 202 205-4561

RIN: 0905-AD89
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1129. 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                    06/00/95

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Devices and Radiological Health (HFZ-84), 2098 Gaither Road, Rockville, 
MD 20850, 301 594-4765

RIN: 0905-AD94
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1130. INVESTIGATIONAL DEVICE EXEMPTION; INTRAOCULAR LENSES

Priority:  Informational

Legal Authority:  21 USC 360j(g) [[Page 23319]] 

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 (IOL's). IOL's 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                    06/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Devices and Radiological Health (HFZ-84), 2098 Gaither Road, Rockville, 
MD 20850, 301 594-4765

RIN: 0905-AD95
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1131. DIETARY SUPPLEMENT LABEL REVIEW

Priority:  Routine and Frequent

Legal Authority:  15 USC 1453; 15 USC 1454; 15 USC 1455; 21 USC 321; 21 
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 5 
nutrient/disease relationships: (1) Dietary fiber and cancer (2) 
Dietary Fiber and CVD, (3) Antioxidants and Cancer, (4) Omega-3 fatty 
acids and CHD, (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 (cont)

Timetable:

Health Claims and Label Statements; Dietary Supplements  NPRM Folic 
Acid and Neural Tube Def 10/14/93 (58 FR 53254)  Final Action 01/04/94 
(59 FR 433)  Final Action Effective 07/01/94

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)

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 12/
06/94 (59 FR 62644)

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Additional Information: ABSTRACT CONT: stating that it considered the 
proposals to be final regulations by operational statute. 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.

Agency Contact: John Hathcock, Director, Division of Science and 
Applied Technology, Office of Special Nutritionals, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Food Safety and Applied Nutrition (HFS-465), 200 C Street SW., 
Washington, DC 20204, 202 205-5365

RIN: 0905-AD96
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1132. SPECIFIC REQUIREMENTS ON CONTENT AND FORMAT OF LABELING FOR 
HUMAN PRESCRIPTION DRUGS; ADDITION OF ``GERIATRIC USE'' SUBSECTION IN THE 
LABELING

Priority:  Substantive, Nonsignificant

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 Agency is reviewing the public comments submitted in 
response to the proposed rule and preparing a final rule.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            11/01/90                    55 FR 46134
NPRM Comment Period End         12/31/90
Final Action                    11/00/95

Small Entities Affected: Undetermined

Government Levels Affected: None

Agency Contact: Erica L. Keys, Regulatory Counsel, Division of 
Regulatory Affairs, Department of Health and Human Services, Food and 
Drug Administration, Center for Drug Evaluation and Research (HFD-362), 
7500 Standish Place, Rockville, MD 20855, 301 594-1046

RIN: 0905-AE26


______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

[[Page 23320]]
1133. 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

Abstract: On January 18, 1994 (59 FR 2542), the Agency proposed to 
amend its tamper-resistant packaging requirements 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 tamper 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                    12/00/95

Small Entities Affected: Undetermined

Government Levels Affected: None

Agency Contact: Howard P. Muller, Regulatory Counsel, Division of 
Regulatory Affairs, Department of Health and Human Services, Food and 
Drug Administration, Center for Drug Evaluation and Research (HFD-362), 
7500 Standish Place, Rockville, MD 20855, 301 594-1049

RIN: 0905-AE27
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1134. CERTIFICATION OF DRUGS COMPOSED WHOLLY OR PARTLY OF INSULIN; 
FEES FOR CERTIFICATION OF DRUGS COMPOSED WHOLLY OR PARTLY OF INSULIN

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 352; 21 USC 356; 21 USC 371

CFR Citation:  21 CFR 429.40; 21 CFR 429.55

Legal Deadline: None

Abstract: The Food and Drug Administration intends to issue an interim 
rule, with opportunity for public comment, to announce that it will no 
longer routinely perform tests and assays on insulin samples prior to 
certification where there is a testing and marketing history sufficient 
to establish that precertification testing is no longer necessary. The 
interim rule will also revise the fee schedule for insulin 
certification services to reflect the change in FDA's certification 
policy.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

Interim Final Rule              10/00/95
NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Division of 
Regulatory Affairs, Department of Health and Human Services, Food and 
Drug Administration, Center for Drug Evaluation and Research (HFD-362), 
7500 Standish Place, Rockville, MD 20855, 301 594-1049

RIN: 0905-AE28
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1135. ADVERSE EXPERIENCE REPORTING REQUIREMENTS FOR HUMAN DRUG AND 
LICENSED BIOLOGICAL PRODUCTS

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 216; 21 USC 262; 21 USC 263; 21 
USC 263a; 21 USC 264; 21 USC 300aa-25

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

Legal Deadline: None

Abstract: The final rule will amend its adverse experience reporting 
regulations for human drug products and licensed biological products to 
make the requirements consistent with a new single unified form (FDA 
Form 3500A) and require the use of this new reporting form. The new 
form was announced as part of FDA's MedWatch program. The proposed 
regulations would 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 proposal would amend the regulations governing the design 
of, and the analysis and reporting of data from, clinical studies. 
These proposed amendments are intended to provide more complete and 
accurate information that would enable sponsors, investigators, and FDA 
to determine early on the toxicity of investigational drugs during 
clinical studies.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            10/27/94                    59 FR 54046
NPRM Comment Period End         01/25/95
Final Action                    10/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Howard P. Muller, Regulatory Counsel, Division of 
Regulatory Affairs, Department of Health and Human Services, Food and 
Drug Administration, Center for Drug Evaluation and Research (HFD-362), 
7500 Standish Place, Rockville, MD 20855, 301 594-1049

RIN: 0905-AE29
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1136. ELECTRONIC SIGNATURES; ELECTRONIC RECORDS

Priority:  Other Significant

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

CFR Citation:  21 CFR 11

Legal Deadline: None

Abstract: FDA is proposing 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 [[Page 23321]] 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 is being 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

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, 301 594-1089

RIN: 0905-AE31
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1137. 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 addresses 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 requires 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 are 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 proposed 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                    04/00/96

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: John S. Ensign, Department of Health and Human 
Services, Food and Drug Administration, Office of Health Affairs (HFY-
20), 5600 Fishers Lane, Rockville, MD 20857, 301 443-1382

RIN: 0905-AE32
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________


1138. SUBSTANCES PROHIBITED FOR USE IN RUMINANT FEED

Priority:  Substantive, Nonsignificant

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

CFR Citation:  21 CFR 589.2000

Legal Deadline: None

Abstract: The Food and Drug Administration is considering a proposal to 
ban the feeding of certain materials to ruminants. Epidemiological 
evidence developed in the United Kingdom suggests increased vigilance 
and precautionary practices are necessary to assure that Bovine 
Spongiform Encephalopathy (BSE) is not introduced among cattle herds in 
the United States. This same evidence has suggested that the feeding of 
certain animal derived materials caused the BSE epidemic in the United 
Kingdom.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            08/29/94                    59 FR 44584
Final Action                    10/00/95

Small Entities Affected: Undetermined

Government Levels Affected: None

Agency Contact: John P. Honstead, Veterinary Medical Officer, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Veterinary Medicine (HFV-222), 7500 Standish Place, 
Rockville, MD 20855, 301 594-1728

RIN: 0905-AE45


[[Page 23322]] 
______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1139. ABBREVIATED NEW DRUG APPLICATION REGULATIONS (TITLE I OF THE 
``DRUG PRICE COMPETITION AND PATENT TERM RESTORATION ACT OF 1984'')

CFR Citation:  21 CFR 10; 21 CFR 310; 21 CFR 314; 21 CFR 320

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Action                    10/03/94                    59 FR 50338
Final Action Effective          11/02/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Wayne H. Mitchell, 301 594-1049

RIN: 0905-AB63
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1140. EXPEDITING APPROVAL FOR DRUGS INTENDED TO TREAT LIFE-
THREATENING AND SEVERELY DEBILITATING ILLNESSES

CFR Citation:  21 CFR 312

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - No further action 
planned at this time.           01/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Howard P. Muller, 301 594-1049

RIN: 0905-AC94
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1141. SPECIFIC REQUIREMENTS ON CONTENT AND FORMAT OF LABELING FOR 
HUMAN PRESCRIPTION DRUGS; REVISION OF ``PEDIATRIC USE'' SUBSECTION IN THE 
LABELING

CFR Citation:  21 CFR 201

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Action                    12/13/94                    59 FR 64240
Final Action Effective          01/12/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Erica L. Keys, 301 594-1049

RIN: 0905-AD76
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1142. PERFORMANCE STANDARD FOR THE INFANT APNEA MONITOR

CFR Citation:  21 CFR 800

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/23/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: James J. McCue, Jr., 301 594-4765

RIN: 0905-AD83
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1143. LEVO-ALPHA-METHADOL (LAAM) IN MAINTENANCE; JOINT PROPOSED 
REVISION OF CONDITIONS FOR USE

CFR Citation:  21 CFR 291

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - No further action is 
planned for the next 12 months. 01/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Wayne H. Mitchell, 301 594-1046

RIN: 0905-AD92
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1144. TEMPOROMANDIBULAR JOINT IMPLANT CLASSIFICATION

CFR Citation:  21 CFR 872.3940; 21 CFR 872.3950; 21 CFR 872.3960; 21 
CFR 872.3970

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Action                    12/20/94                    59 FR 65475
Final Action Effective          01/19/95

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AD93
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1145. ADVERSE EXPERIENCE REPORTING REQUIRED FOR LICENSED BIOLOGICAL 
PRODUCTS

CFR Citation:  21 CFR 600

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Action                    10/27/94                    59 FR 54034
Final Action Effective          12/27/94

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Paula McKeever, 301 594-3074

RIN: 0905-AE18
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1146. SUNGLASSES; LABELING; ULTRAVIOLET RADIATION

CFR Citation:  21 CFR 801

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - No action planned in 
the next 12 months              01/20/95

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AE35
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________

1147. INVESTIGATIONAL DEVICE EXEMPTION: COST RECOVERY

CFR Citation:  21 CFR 812.7

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - No further action 
planned at this time            01/20/95

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AE36
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Public Health Service (PHS)--Food and Drug Administration (FDA)
______________________________________________________________________


1148. FOODS DERIVED FROM NEW PLANT VARIETIES; PREMARKET 
NOTIFICATION

CFR Citation:  None

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - No further action 
planned at this time.           02/15/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: James H. Maryanski, 202 205-4359

RIN: 0905-AE50


[[Page 23323]] 
______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
______________________________________________________________________


1149. 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 proposes to amend 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. These proposed regulations would have effect only for 
petitions for compensation under the National Vaccine Injury 
Compensation Program (VICP) filed after the new regulations become 
effective.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            09/00/95

Small Entities Affected: None

Government Levels Affected: None

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, 301 443-6593

RIN: 0905-AE52



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
______________________________________________________________________

1150. ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK RULES

Priority:  Regulatory Plan

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                    59 FR 46482
Final Action                    03/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Judy Braslow, Director, Division of Organ 
Transplantation, Bureau of Health Resources Development, Department of 
Health and Human Services, Public Health Service, Room 7-18 Parklawn 
Bldg., 5600 Fishers Lane, Rockville, MD 20857, 301 443-7577

RIN: 0905-AD26
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
______________________________________________________________________

1151. 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
Final Action                    09/00/95

Small Entities Affected: None

Government Levels Affected: None

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, 301 443-
1173

RIN: 0905-AD87
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
______________________________________________________________________

1152. GRANTS FOR THE ESTABLISHMENT OF DEPARTMENTS OF FAMILY 
MEDICINE

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 216; 42 USC 293k

CFR Citation:  42 CFR 57, subpart R

Legal Deadline: None

Abstract: This final rule amends the Grants for the Establishment of 
Departments of Family Medicine regulations to expand the definition of 
``academic administrative unit'' to clarify which academic 
administrative [[Page 23324]] units are eligible for support under the 
authority of section 747 of the Public Health Service Act.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            07/19/94                    59 FR 36733
NPRM Comment Period End         08/18/94                    59 FR 36733
Final Action                    06/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Marc L. Rivo, M.D., Director, Division of Medicine, 
Bureau of Health Professions, Department of Health and Human Services, 
Health Resources and Services Administration, Room 9A-27, Parklawn 
Building, 5600 Fishers Lane, Rockville, MD 20857, 301 443-6190

RIN: 0905-AE17
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
______________________________________________________________________

1153. FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE ACT OF 1992

Priority:  Other Significant

Legal Authority:  42 USC 216; 42 USC 233

CFR Citation:  42 CFR 6

Legal Deadline: None

Abstract: These regulations clarify that the range of health care 
services provided by eligible entities and individuals would be covered 
under the Federal Tort Claims Act (FTCA). As a result, health centers 
would not have to purchase private insurance policies to cover gaps of 
malpractice liability exposure. The intended effect of this proposed 
rule is to save funds for PHS grantees and invest such savings into 
providing additional health services to the medically underserved 
populations of covered health centers and their health professionals. 
The Domestic Policy Council staff requested the publication of these 
rules in an expeditious manner to facilitate full implementation of the 
1992 legislation.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            08/19/94                    59 FR 42790
NPRM Comment Period End         09/19/94
Final Action                    06/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Libby Merrill, Legislative Analyst, Office of Program 
and Policy Development, Bureau of Primary Health Care, Department of 
Health and Human Services, Public Health Service, East-West Tower 
Bldg., 4350 East-West Highway, 7th Floor, Bethesda, MD 20814, 301 594-
4060

RIN: 0905-AE48
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
______________________________________________________________________

1154. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON 
PHYSICIANS, DENTISTS, AND OTHER HEALTH CARE PRACTITIONERS: PAYMENT OF 
FEES

Priority:  Informational

Legal Authority:  42 USC 11101 et seq

CFR Citation:  45 CFR 60

Legal Deadline: None

Abstract: This final rule would modify section 60.12(c), ``Assessing 
and collecting fees,'' of the Data Bank regulations by removing the the 
regulatory restriction on allowable methods of payment to provide Data 
Bank customers several alternative ways to pay the fee(s) associated 
with querying the Data Bank. The regulation currently prescribes that 
``fees must be paid by check or money order made payable to 'U.S. 
Department of Health and Human Services' or to the unit stated in the 
billing.'' Those options would also include payment by credit card and 
other electronic means (e.g., automated clearinghouse).

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

Final Action                    06/00/95

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AE53
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
______________________________________________________________________


1155. TECHNICAL AMENDMENTS TO THE HEALTH PROFESSIONS, NURSING, AND 
ALLIED HEALTH TRAINING GRANT PROGRAMS UNDER 42 CFR PARTS 57 AND 58

Priority:  Informational

Legal Authority:  42 USC 293; 42 USC 293c; 42 USC 293d; 42 USC 293j; 42 
USC 293k; 42 USC 293l; 42 USC 293m; 42 USC 293n; 42 USC 294; 42 USC 
294b; 42 USC 294i; 42 USC 294o

CFR Citation:  42 CFR 57; 42 CFR 58

Legal Deadline: None

Abstract: This final rule amends various Public Health Service (PHS) 
health professions, nursing, and allied health training grant 
regulations, codified at 42 CFR parts 57 and 58, to bring these 
programs into conformity with statutory amendments made by the Health 
Professions Extension Amendments of 1992 to the various sections of the 
PHS Act under titles VII and VIII. Technical changes being made to the 
regulations are: (1) the renumbering of PHS section numbers and their 
corresponding United States Code numbers within the regulations; (2) 
the removal of the reference to the National Advisory Council on Health 
Professions Education and the requirements for the Council's review of 
title VII grants; (3) the removal of the reference to section 705 of 
the PHS Act concerning audit and inspection requirements, which is 
redundant to the requirements that are covered under 45 CFR part 74; 
(4) the removal of repealed and inactive title VII and VIII health 
professions, nursing, and allied health training grant program 
regulations; and (5) other technical changes which are clarifying or 
editorial changes in nature.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

Final Action                    09/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Betty B. Hambleton, Chief, Planning, Evaluation and 
Legislation Branch, Office of Research & Planning/BHPr, Department of 
Health and Human Services, Health Resources and Services 
Administration, Room 8-67, Parklawn Building, 5600 Fishers Lane, 
Rockville, MD 20857, 301 443-1590

RIN: 0905-AE54


[[Page 23325]] 
______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
______________________________________________________________________

1156. NATIONAL HEALTH SERVICE CORPS LOAN REPAYMENT PROGRAM; GRANTS 
FOR STATE LOAN REPAYMENT PROGRAMS

CFR Citation:  42 CFR 62.21 to 62.30; 42 CFR 62.51 to 62.58

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn                       01/18/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Rhoda Abrams, 301 594-4060

RIN: 0905-AC65
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
______________________________________________________________________

1157. STANDARDS FOR BONE MARROW REGISTRIES AND CENTERS

CFR Citation:  42 CFR 122

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Judith Braslow, 301 443-7577

RIN: 0905-AD51
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
______________________________________________________________________

1158. NATIONAL VACCINE INJURY COMPENSATION PROGRAM (VICP): 
REVISIONS TO THE VACCINE INJURY TABLE

CFR Citation:  42 CFR 100

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Action                    02/08/95                     60 FR 7678

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AD64
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
______________________________________________________________________

1159. GRANTS FOR FACULTY TRAINING PROJECTS IN GERIATRIC MEDICINE 
AND DENTISTRY

CFR Citation:  42 CFR 57, subpart PP

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Action                    12/12/94                    59 FR 61554

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Neil H. Sampson, 301 443-6853

RIN: 0905-AE13
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
______________________________________________________________________

1160. MEDICAL FACILITY CONSTRUCTION AND MODERNIZATION REQUIREMENTS 
FOR PROVISION OF SERVICES TO PERSONS UNABLE TO PAY (NURSING HOMES)

CFR Citation:  42 CFR 124 subpart F

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Action                    03/31/95                    60 FR 16754
Final Action Effective          05/01/95                    60 FR 16754

Small Entities Affected: Organizations

Government Levels Affected: None

Agency Contact: Charlotte G. Pascoe, 301 443-5656

RIN: 0905-AE33
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
______________________________________________________________________


1161. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON 
PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: AMENDMENT TO DATA BANK 
REGULATIONS TO COMPLY WITH COURT ORDER

CFR Citation:  45 CFR 60

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Action                    12/01/94                    59 FR 61554

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AE38



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--Indian Health Service (IHS)
______________________________________________________________________

1162. 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                            08/00/95
NPRM Comment Period End         11/00/95

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.

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

RIN: 0905-AE09
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--Indian Health Service (IHS)
______________________________________________________________________


1163.  REVISION OF INDIAN SELF-DETERMINATION REGULATIONS

Priority:  Regulatory Plan

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 [[Page 23326]] 

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

Legal Deadline:  Final, Statutory, March 1996.

Abstract: Public Law 93-638, passed in 1975, requires the 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 ten 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, Public Law 103-413 was enacted. 
These amendments superseded the published NPRM and authorized the 
Secretaries of Interior and HHS 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 the passage of the authorizing legislation.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            07/00/95
NPRM Comment Period End         11/00/95

Small Entities Affected: None

Government Levels Affected: Tribal

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

RIN: 0905-AE68



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Public Health Service (PHS)--Indian Health Service (IHS)
______________________________________________________________________

1164. INDIAN HEALTH SERVICE LOAN REPAYMENT PROGRAM REGULATIONS

CFR Citation:  42 CFR 36

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Action not 
anticipated within next 12 
months                          01/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Linus Everling, 301 443-6197

RIN: 0905-AC96
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Public Health Service (PHS)--Indian Health Service (IHS)
______________________________________________________________________

1165. INDIAN HEALTH SERVICE CATASTROPHIC HEALTH EMERGENCY FUND 
PROGRAM

CFR Citation:  42 CFR 36

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Action not 
anticipated within next 12 
months                          01/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Betty J. Penn, 301 443-1116

RIN: 0905-AC97
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Public Health Service (PHS)--Indian Health Service (IHS)
______________________________________________________________________

1166. REVISION OF INDIAN SELF-DETERMINATION REGULATIONS

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

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Regulation 
superseded by PL 103-413        01/20/95

Small Entities Affected: None

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: Betty J. Penn, 301 443-1116

RIN: 0905-AC98
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Public Health Service (PHS)--Indian Health Service (IHS)
______________________________________________________________________

1167. REVISION OF URBAN INDIAN HEALTH REGULATIONS

CFR Citation:  42 CFR 36

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Action not 
anticipated within next 12 
months                          01/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Betty J. Penn, 301 443-1116

RIN: 0905-AD20
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Public Health Service (PHS)--Indian Health Service (IHS)
______________________________________________________________________


1168. REVIEW OF THE DETERMINATION OF AN INDIAN TRIBE'S RESOURCE 
DEFICIENCY LEVEL

CFR Citation:  42 CFR 36

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Action not 
anticipated within next 12 
months                          01/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Betty J. Penn, 301 443-1116

RIN: 0905-AD21


[[Page 23327]] 
______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
______________________________________________________________________

1169. 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                            06/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Marc Horowitz, Director, NIH AIDS Research Loan 
Repayment Program, Department of Health and Human Services, Public 
Health Service, Office of AIDS Research, National Institutes of Health, 
9000 Rockville Pike, Bethesda, MD 20892, 301 496-0357

RIN: 0905-AD18
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
______________________________________________________________________

1170. HAZARDOUS SUBSTANCES BASIC RESEARCH AND TRAINING GRANTS

Priority:  Informational

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                    60 FR 12525
Final Action                    09/00/95

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AD46
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
______________________________________________________________________

1171. NATIONAL INSTITUTES OF HEALTH CONSTRUCTION GRANTS

Priority:  Informational

Legal Authority:  42 USC 216; 42 USC 285a-2; 42 USC 285a-3; 42 USC 
285a-4; 42 USC 285b-3; 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                            05/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, Public Health Service, National Institutes 
of Health, 9000 Rockville Pike, Bldg. 31, Rm 1B25, Center DR MSC 2075, 
Bethesda, MD 20892-2075, 301 496-4606

RIN: 0905-AD49
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
______________________________________________________________________

1172. NATIONAL INSTITUTES OF HEALTH CENTER GRANTS

Priority:  Informational

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.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            02/17/95                     60 FR 9560
NPRM Comment Period End         04/18/95                     60 FR 9560
Final Action                    09/00/95

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Additional Legal Authorities: 42 USC 286a-
7(c)(1)(G)

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, Public Health Service, National Institutes 
of Health, 9000 Rockville Pike, Bldg 31, Rm 1B25, Center DR MSC 2075, 
Bethesda, MD 20892-2075, 301 496-4606

RIN: 0905-AE00
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
______________________________________________________________________

1173. 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 payments under the NIH Clinical Research Loan 
Repayment Program for [[Page 23328]] 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                            06/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Marc Horowitz, Dir., Clinical Research Loan Repayment 
Prog., Individuals from Disadvantaged Backgrounds, Department of Health 
and Human Services, Public Health Service, Office of AIDS Research, 
9000 Rockville Pike, Bethesda, MD 20892, 301 402-0852

RIN: 0905-AE56
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
______________________________________________________________________

1174. UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING PROFESSIONS 
NEEDED BY THE NIH

Priority:  Informational

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 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                            12/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Marc Horowitz, Dir., NIH AIDS Research Loan Repayment 
Program, Department of Health and Human Services, Public Health 
Service, Office of AIDS Research, NIH, 9000 Rockville Pike, Bethesda, 
MD 20892, 301 402-0852

RIN: 0905-AE57
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
______________________________________________________________________


1175. TRAINEESHIPS (TERMINATION POLICIES)

Priority:  Informational

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                            08/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, Public Health Service, National Institutes 
of Health, 9000 Rockville Pike, Bldg 31, Rm 1B25, Center DR MSC 2075, 
Bethesda, MD 20892-2075, 301 496-4606

RIN: 0905-AE62



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
______________________________________________________________________

1176. GRANTS FOR RESEARCH PROJECTS

Priority:  Substantive, Nonsignificant

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                    06/00/95

Small Entities Affected: Undetermined

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 9000 
Rockville Pike, Room 1B25, Center DR MSC 2075, Bethesda, MD 20892-2075, 
301 496-4606

RIN: 0905-AC02
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
______________________________________________________________________

1177. TRAINING GRANTS

Priority:  Informational

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                     60 FR 4742
Final Action                    11/00/95                [[Page 23329]] 

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, Public Health Service, National Institutes 
of Health, 9000 Rockville Pike, Bldg. 31, Rm 1B25, Center DR MSC 2075, 
Bethesda, MD 20892-2075, 301 496-4606

RIN: 0905-AD56
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
______________________________________________________________________

1178. RESPONSIBILITIES OF PUBLIC HEALTH SERVICE-FUNDED INSTITUTIONS 
FOR PROMOTING OBJECTIVITY IN RESEARCH

Priority:  Regulatory Plan

Legal Authority:  42 USC 216; 42 USC 289b-1; 42 USC 299c-3

CFR Citation:  42 CFR 50, subpart F; 42 CFR 94

Legal Deadline:  Final, Statutory, December 8, 1993.
Final rules implementing 42 U.S.C. 289b-1 must be issued not later than 
180 days after June 10, l993.

Abstract: PHS proposes to issue regulations requiring the institutions 
that apply for research funding under the PHS Act to assume full 
responsibility for ensuring that the financial interests of the 
respective institution and the employees of the institution do not 
compromise the objectivity with which PHS-funded research is conducted 
or reported.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            06/28/94                    59 FR 33242
NPRM Comment Period End         08/29/94                    59 FR 33242
Final Action                    06/00/95

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Dr. George J. Galasso, Associate Director for 
Extramural Affairs, Department of Health and Human Services, Public 
Health Service, NIH, Shannon Building, Room 152, Bethesda, MD 20892, 
301 496-5356

RIN: 0905-AE01
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
______________________________________________________________________


1179. GRANTS FOR NATIONAL ALCOHOL RESEARCH CENTERS

Priority:  Informational

Legal Authority:  42 USC 216; 42 USC 285n-2

CFR Citation:  42 CFR 54a

Legal Deadline: None

Abstract: Regulations governing grants for alcohol abuse and alcoholism 
prevention, treatment, and rehabilitation services, and National 
Alcohol Research Centers will be amended to set forth changes 
necessitated by enactment of the ADAMHA Reorganization Act, Public Law 
102-321, and other changes necessary to update the regulations.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            08/19/94                    59 FR 42793
NPRM Comment Period End         10/18/94                    59 FR 42793
Final Action                    09/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, Public Health Service, National Institutes 
of Health, Bldg. 31, Rm. 3B-11, 9000 Rockville Pike, Bethesda, MD 
20892, 301 496-2832

RIN: 0905-AE08



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Public Health Service (PHS)--National Institutes of Health (NIH)
______________________________________________________________________

1180. TRAINEESHIPS

CFR Citation:  42 CFR 63

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Action                    02/27/95                    60 FR 10718
Final Action Effective          03/29/95                    60 FR 10718

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: John Migliore, 301 496-4606

RIN: 0905-AD28
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Public Health Service (PHS)--National Institutes of Health (NIH)
______________________________________________________________________

1181. NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES HAZARDOUS 
WASTE WORKER TRAINING

CFR Citation:  42 CFR 65

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Action                    12/13/94                    59 FR 64139
Final Action Effective          01/12/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: John J. Migliore, 301 496-4606

RIN: 0905-AD69
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Public Health Service (PHS)--National Institutes of Health (NIH)
______________________________________________________________________

1182. NATIONAL HEART, LUNG, AND BLOOD INSTITUTE GRANTS FOR 
PREVENTION AND CONTROL PROJECTS

CFR Citation:  42 CFR 52e

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Action                    11/17/94                    59 FR 59371
Final Action Effective          11/17/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: John J. Migliore, 301 496-2832

RIN: 0905-AE25
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Public Health Service (PHS)--National Institutes of Health (NIH)
______________________________________________________________________


1183. NATIONAL LIBRARY OF MEDICINE GRANTS

CFR Citation:  42 CFR 59a

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Action                    11/16/94                    59 FR 59167
Final Action Effective          11/16/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: John J. Migliore, 301 496-4606

RIN: 0905-AE55


[[Page 23330]] 
______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Public Health Service (PHS)--Agency for Health Care Policy and 
Research (AHCPR)
______________________________________________________________________


1184. 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 
governing grants for health services research and grants for health 
services research centers made by the former National Center for Health 
Services Research and Health Care Technology Assessment (NCHSR). Public 
Law 101-239, enacted on December 19, 1989, established the Agency for 
Health Care Policy and Research to replace the NCHSR, and in title IX 
of the PHS Act and section 1142 of the Social Security Act provided the 
Agency with a much expanded role in health services research. The final 
rule will also reflect the applicable provisions of the amendments of 
P.L. 102-410.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            11/16/93                    58 FR 60510
NPRM Comment Period End         01/18/94
Final Action                    10/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Phyllis Zucker, Acting Dir., Office of Program 
Development, Agency for Health Care Policy and Research, Department of 
Health and Human Services, Public Health Service, Suite 603, 2101 East 
Jefferson Street, Rockville, MD 20852, 301 594-2453

RIN: 0905-AD30



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1185. TRANSFER OF RESOURCES FOR LESS THAN FAIR MARKET VALUE (MB-10-
P)

Priority:  Other Significant

Legal Authority:  42 USC 1396p(c)

CFR Citation:  42 CFR 435; 42 CFR 436

Legal Deadline: None

Abstract: These regulations would conform the Medicaid regulations to 
section 1917(c) and (d) of the Social Security Act, as amended by 
section 13611 of OBRA 1993. Section 1917(c) of the Act addresses the 
treatment of transfers of assets for less than fair market value. The 
regulations implementing this provision would specify the conditions 
that would result in the denial of coverage for certain medical 
services to otherwise eligible institutionalized or 
noninstitutionalized individuals who transfer assets for less than fair 
market value. The regulations implementing section 1917(d) of the Act 
would set forth the rules under which a trust must be considered in 
determining eligibility for Medicaid. The provisions would apply to any 
individual who establishes a trust and who is an applicant for or 
recipient of Medicaid.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: State, Local

Agency Contact: Marinos Svolos, Director, Division of Eligibility 
Policy, Medicaid Bureau, Department of Health and Human Services, 
Health Care Financing Administration, Room 323, EHR, 6325 Security 
Blvd., Baltimore, MD 21207, 410 966-4451

RIN: 0938-AD18
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1186. MEDICARE COVERAGE OF OUTPATIENT OCCUPATIONAL THERAPY SERVICES 
(BPD-425-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395x(g); 42 USC 1395x(p); 42 USC 1395x(w)(1)

CFR Citation:  42 CFR 400.202; 42 CFR 410; 42 CFR 424; 42 CFR 484; 42 
CFR 485; 42 CFR 489

Legal Deadline: None

Abstract: This rule would implement section 9337 of OBRA '86 which 
provides Medicare coverage for outpatient occupational therapy services 
furnished by providers and independent practitioners, identical to the 
coverage for outpatient physical therapy. It also would implement 
section 6133(a) of OBRA '89 which increased the payment limit for 
outpatient occupational therapy services provided by independent 
practitioners.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Marsha Klamner, Health Insurance Specialist, BPD, 
Department of Health and Human Services, Health Care Financing 
Administration, Room 401, EHR, 6325 Security Blvd., Baltimore, MD 
21207, 410 966-4632

RIN: 0938-AD32
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1187. NEW MINIMUM STANDARDS FOR MEDICARE SUPPLEMENTAL (MEDIGAP) 
POLICIES (BPD-491-P)

Priority:  Substantive, Nonsignificant

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.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            10/00/95

Small Entities Affected: Undetermined [[Page 23331]] 

Government Levels Affected: Undetermined

Agency Contact: Julie Walton, Health Insurance Specialist, Long Term 
Care Branch, Bureau of Policy Development, Department of Health and 
Human Services, Health Care Financing Administration, Room 401, EHR 
Bldg., 6325 Security Boulevard, Baltimore, MD 21207, 410 966-4622

RIN: 0938-AD82
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1188. FEE SCHEDULE FOR PAYMENT OF CLINICAL PSYCHOLOGIST SERVICES 
(BPD-495-P)

Priority:  Other Significant

Legal Authority:  42 USC 1395k(a)(2)(B)(iii); 42 USC 1395x(hh); 42 USC 
1395w-4; 42 USC 1395x(b); 42 USC 1395l(a)(1)(L); 42 USC 1395x(s)

CFR Citation:  42 CFR 414

Legal Deadline: None

Abstract: This proposed rule would establish fee schedules for payment 
of clinical psychologist services furnished under Medicare Part B. It 
implements a portion of section 4077(b) of OBRA '87 as amended. It 
further implements section 6113(a) of OBRA '89 and section 4157 of OBRA 
'90.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            05/00/95

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Elisa Tunanidas, Health Insurance Specialist, Office of 
Physician & Ambulatory Care Policy, Department of Health and Human 
Services, Health Care Financing Administration, Room 1-H-5, ELR Bldg., 
6325 Security Blvd., Baltimore, MD 21207, 410 966-4505

RIN: 0938-AD84
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1189. ``WITHOUT FAULT'' AND BENEFICIARY WAIVER OF RECOVERY AS IT 
APPLIES TO MEDICARE OVERPAYMENT LIABILITY (BPD-719-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395gg

CFR Citation:  42 CFR 405; 42 CFR 401; 20 CFR 404.506 to 510; 42 CFR 
411.23(a); 42 CFR 411.28; 42 CFR 466.86(a)(5); 42 CFR 473.14(c)(2)

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 proposed rule would 
incorporate in HCFA regulations pertinent portions of Social Security 
Administration regulations dealing with ``without fault.''

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            07/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Valerie Hart, Health Insurance Specialist, Office of 
Chronic Care & Insurance Policy, Department of Health and Human 
Services, Health Care Financing Administration, Room 401, EHR, 6325 
Security Blvd., Baltimore, MD 21207, 410 966-4485

RIN: 0938-AD95
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1190. PROTECTION OF INCOME AND RESOURCES FOR COMMUNITY SPOUSE (MB-
23-P)

Priority:  Other Significant

Legal Authority:  42 USC 1396r-5

CFR Citation:  42 CFR 435.630; 42 CFR 435.632; 42 CFR 435.634; 42 CFR 
435.636; 42 CFR 435.638; 42 CFR 435.640; 42 CFR 435.642; 42 CFR 
435.644; 42 CFR 435.646; 42 CFR 435.648

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 and section 4714 of OBRA '90. 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                            08/00/95

Small Entities Affected: Undetermined

Government Levels Affected: State, Local

Agency Contact: Wanda White, Medicaid Bureau, Department of Health and 
Human Services, Health Care Financing Administration, Room 323, EHR, 
6325 Security Boulevard, Baltimore, MD 21207, 410 966-4453

RIN: 0938-AE12
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1191. 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: These regulations 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. These alternative sanctions could be 
imposed instead of 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 purpose of the legislation is to encourage correction of 
deficiencies that do not jeopardize patient health and safety before 
termination becomes necessary.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            11/00/95

Small Entities Affected: Undetermined

Government Levels Affected: State, Federal

Agency Contact: Pam Vocke, Director, Division of Program Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, Room 2-D-2, ME, 6325 [[Page 23332]] Security Boulevard, 
Baltimore, MD 21207, 410 966-7089

RIN: 0938-AF32
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1192. MEDICAID PAYMENT FOR COVERED OUTPATIENT DRUGS UNDER REBATE 
AGREEMENTS (MB-046-P)

Priority:  Other Significant

Legal Authority:  42 USC 1396a(a); 42 USC 1396b(i); 42 USC 1396r-8; 42 
USC 1396b(a)

CFR Citation:  42 CFR 447; 42 CFR 441

Legal Deadline: None

Abstract: This rule would 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 would 
also reflect statutory revisions mandated by the Veteran's Health Care 
Act of 1992 and OBRA '93.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            04/00/95

Small Entities Affected: Businesses

Government Levels Affected: State

Agency Contact: Larry Reed, Chief, Medicaid Noninstitutional Payment 
Policy Branch, Department of Health and Human Services, Health Care 
Financing Administration, Room 273 EHR Bldg., 6325 Security Blvd., 
Baltimore, MD 21207, 410 966-0830

RIN: 0938-AF42
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1193. FEDERALLY QUALIFIED HEALTH CENTER SERVICES (MEDICAID) (MB-
043-P)

Priority:  Other Significant

Legal Authority:  42 USC 1396a(a)(13); 42 USC 1396b(m); 42 USC 
1396d(l); 42 USC 1396n(b)

CFR Citation:  42 CFR 440; 42 CFR 447

Legal Deadline: None

Abstract: These regulations would establish a new category of 
facilities known as federally Qualified Health Centers (FQHCs) and a 
new category of Medicaid services known as FQHC services. This new type 
of facility includes community health centers, migrant health centers 
and health care for the homeless programs, which are receiving or are 
eligible to receive certain grants from the Public Health Service, and 
health programs or facilities operated by an Indian tribe or tribal 
organization. These regulations would establish requirements for 
coverage and payment of FQHC services under the Medicaid program. These 
regulations would implement section 6404 of OBRA '89 and section 4704 
of OBRA '90 and reflect statutory revisions mandated.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            07/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Bernard Truffer, Director, Division of Payment Policy, 
Department of Health and Human Services, Health Care Financing 
Administration, Room 291, EHR, 6325 Security Boulevard, Baltimore, MD 
21207, 410 966-1357

RIN: 0938-AF90
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1194. 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                            07/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Tracy Jensen, Health Insurance Specialist, Office of 
Managed Care, Department of Health and Human Services, Health Care 
Financing Administration, Room 4360, Cohen Building, 330 Independence 
Avenue SW., Washington, DC 20201, 202 619-2158

RIN: 0938-AF97
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1195. CONDITIONS OF PARTICIPATION FOR RURAL HEALTH CLINICS (BPD-
764-P)

Priority:  Other Significant

Legal Authority:  42 USC 1395l(a); 42 USC 1395l(b); 42 USC 1395l(d); 42 
USC 1395x(aa); 42 USC 1395oo(j); 42 USC 1395ww(a)(4); 42 USC 
1395(a)(13)

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 Public Laws 
100-203, 101-239, and 101-508 (the 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.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            08/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Helen Klein, Office of Physician & Ambulatory Care 
Policy, Department of Health and Human Services, Health Care Financing 
Administration, Room 1-A-5, EHR Bldg., 6325 Security Boulevard, 
Baltimore, MD 21207, 410 966-4641

RIN: 0938-AG05
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1196. MEDICARE APPEALS OF INDIVIDUAL CLAIMS (BPD-453-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395ff

CFR Citation:  42 CFR 405.732; 42 CFR 405.801; 42 CFR 405.837; 42 CFR 
[[Page 23333]] 405.838; 42 CFR 405.839; 42 CFR 405.840

Legal Deadline: None

Abstract: This rule would implement section 9341 of OBRA '86. Section 
9341 extends to Medicare Part B claimants the right to a hearing before 
an administrative law judge if the amount in controversy is at least 
$500 and to judicial review, provided the amount in controversy is at 
least $1000. Section 9341 also limits the review of national coverage 
determinations and prohibits judicial review of any regulation or 
instruction, initially issued before January 1, 1981, relating to a 
method of determining the amount of payment under Part B.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Paul Olenick, Director, Division of Beneficiary & 
Insurance Issues, Department of Health and Human Services, Health Care 
Financing Administration, Room 401, EHR Building, 6325 Security 
Boulevard, Baltimore, MD 21207, 410 966-4472

RIN: 0938-AG18
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1197. APPOINTMENT OF REPRESENTATIVES FOR MEDICARE APPEALS (BPO-120-
P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395ff

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                            00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Betsy Horn, Health Insurance Specialist, Bureau of 
Program Operations, Department of Health and Human Services, Health 
Care Financing Administration, Room G-C-1 Meadows East Building, 6325 
Security Boulevard, Baltimore, MD 21207, 410 966-0973

RIN: 0938-AG30
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1198. ENFORCEMENT REQUIREMENTS FOR RENAL DIALYSIS FACILITIES (HSQ-
204-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395rr(h)

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 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 does not immediately jeopardize patient health and safety. 
Alternative sanctions provide HCFA with a more flexible response to 
facility deficiencies short of termination.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            11/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Debbie Schoenemann, Health Insurance Specialist, Office 
of Survey & Certification, Department of Health and Human Services, 
Health Care Financing Administration, 6325 Security Boulevard, 
Baltimore, MD 21207, 410 966-6771

RIN: 0938-AG31
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1199. DISCLOSURE OF CONFIDENTIAL PRO INFORMATION FOR RESEARCH 
PURPOSES (HSQ-208-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1320c-9

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 case there are circumstances the Secretary shall by 
regulations provide to assure adequate protection of the rights 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                            05/00/95

Small Entities Affected: None

Government Levels Affected: State, Federal

Agency Contact: Mike Rappaport, Director, Division of Systems 
Management, Health Standards Quality Bureau, Department of Health and 
Human Services, Health Care Financing Administration, Room 2-D-3, 
Meadows East Building, 6325 Security Boulevard, Baltimore, MD 21207, 
410 966-6759

RIN: 0938-AG33
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1200. TELEPHONE AND ELECTRONIC REQUESTS FOR REVIEW OF PART B 
INITIAL CLAIM DETERMINATIONS (BPO-121-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395hh

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 would [[Page 23334]] allow a 
beneficiary to appeal an initial payment determination either in 
writing or by telephone.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            04/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Rosalind Little, Health Insurance Specialist, Bureau of 
Program Operations, Department of Health and Human Services, Health 
Care Financing Administration, Room, G-C-1 Meadows East Building, 6325 
Security Boulevard, Baltimore, MD 21207, 410 966-6972

RIN: 0938-AG48
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1201. EFFECT OF CHANGE OF OWNERSHIP ON PROVIDER AND SUPPLIER 
PENALTIES, SANCTIONS, AND OVERPAYMENTS (HSQ-215-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395hh

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

Legal Deadline: None

Abstract: This rule would amend regulations on provider agreements to 
clarify the effect a change of ownership has on penalties and sanctions 
incurred by Medicare providers and suppliers. It would state 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 amend the regulations on provider overpayments to require the new 
owner of a provider or a supplier to be liable for any Medicare 
overpayments paid to the previous owner. Finally, we would clarify the 
effect a leasing arrangement has on a provider agreement and on 
supplier approval.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            07/00/95

Small Entities Affected: None

Government Levels Affected: Undetermined

Agency Contact: Irene Gibson, Deputy Director, Office of Survey & 
Certification, Department of Health and Human Services, Health Care 
Financing Administration, Room 2-D-2, ME Building, 6325 Security 
Boulevard, Baltimore, MD 21207, 410 966-6763

RIN: 0938-AG59
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1202. MEDICARE PROGRAM: LIMITATIONS ON MEDICARE COVERAGE OF 
CATARACT SURGERY (BPD-797-PN)

Priority:  Other Significant

Legal Authority:  42 USC 1395x; 42 USC 1395y

CFR Citation:  None

Legal Deadline: None

Abstract: This notice announces the Medicare program's proposal to 
define 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                 05/00/95

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: Karen McVearry, Health Insurance Specialist, Technology 
& Special Analysis Staff, Department of Health and Human Services, 
Health Care Financing Administration, Room 660, EHR, 6325 Security 
Boulevard, Baltimore, MD 21297, 410 966-4643

RIN: 0938-AG65
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1203. 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 per patient day paid 
by Medicare for routine care services provided in a free standing 
skilled nursing facility (SNF) 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                            09/00/95

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, Room 
1-F-5, ELR, 6325 Security Boulevard, Baltimore, MD 21207, 410 966-7278

RIN: 0938-AG68
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1204. SALARY EQUIVALENCY GUIDELINES FOR PHYSICAL AND RESPIRATORY 
THERAPY SERVICES FURNISHED UNDER ARRANGEMENTS (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 for the salary equivalency 
guidelines for Medicare payment for the reasonable costs of physical 
and respiratory therapy services and other therapy services furnished 
by providers under arrangements with an outside contractor. The 
guidelines are used by Medicare fiscal intermediaries to determine the 
maximum allowable costs of those services.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

Proposed Notice                 08/00/95

Small Entities Affected: Undetermined

Government Levels Affected: None

Agency Contact: Jacqueline Gordon, Program Analyst, Payment Policy 
Branch, Department of Health and Human Services, Health Care Financing 
Administration, Room 1-F-5, ELR, 6325 [[Page 23335]] Security 
Boulevard, Baltimore, MD 21207, 410 966-4517

RIN: 0938-AG70
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1205. 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

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                            10/00/95

Small Entities Affected: None

Government Levels Affected: State, Local

Agency Contact: Joe Dulany, Medicaid Bureau, Department of Health and 
Human Services, Health Care Financing Administration, Room 400, EHR, 
6325 Security Boulevard, Baltimore, MD 21207, 410 966-0665

RIN: 0938-AG72
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1206. REVISION OF MEDICARE HOSPITAL CONDITIONS OF PARTICIPATION 
(BPD-745-P)

Priority:  Regulatory Plan

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 regulations containing 
Medicare hospital conditions of participation to reflect innovations in 
quality health care that have emerged in the last decade. Since the 
hospital conditions of participation have not been revised since 1986, 
there is a need to revise the conditions of participation to center on 
the patient, look at cross-functional hospital performance, reflect 
quality improvement, and be outcome-oriented. Specific areas for 
revision include patient assessment, patient rights information 
management, continuous improvement in quality, discharge planning and 
administration of organizational environment.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            12/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Tzvi Hefter, Director, Division of Hospital Services, 
Department of Health and Human Services, Health Care Financing 
Administration, Room 1-H-1 ELR, 6325 Security Boulevard, Baltimore, MD 
21207, 410 966-1364

RIN: 0938-AG79
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1207. PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY 
HAVE FINANCIAL RELATIONSHIPS--EXPANDED TO DESIGNATED HEALTH SERVICES 
(BPD-809-P)

Priority:  Regulatory Plan

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                            09/00/95

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Betty Burrier, Health Insurance Specialist, Bureau of 
Policy Development, Department of Health and Human Services, Health 
Care Financing Administration, Room 401, EHR, 6325 Security Boulevard, 
Baltimore, MD 21207, 410 966-4649

RIN: 0938-AG80
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1208. HOME HEALTH AGENCY (HHA) CONDITIONS OF PARTICIPATION (BPD-
819-P)

Priority:  Regulatory Plan

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 OBRA '87 to develop a patient-
centered, outcome-oriented survey process which focuses on the 
organization and delivery of quality care services.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            10/00/95

Small Entities Affected: Businesses, Organizations

Government Levels Affected: Undetermined

Agency Contact: Janice Flaherty, Director, Division of Home Care & 
Therapy, Department of Health and Human Services, Health Care Financing 
Administration, Room 401, EHR, 6325 Security Boulevard, Baltimore, MD 
21207, 410 966-4637

RIN: 0938-AG81


______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

[[Page 23336]]
1209. END-STAGE RENAL DISEASE (ESRD) CONDITIONS OF COVERAGE (BPD-
818-P)

Priority:  Regulatory Plan

Legal Authority:  42 USC 1395rr

CFR Citation:  42 CFR 405

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.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            00/00/00

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, Room 1-A-5, ELR Bldg., 6325 Security Boulevard, 
Baltimore, MD 21207, 410 966-4652

RIN: 0938-AG82
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1210. CRITERIA FOR MEDICARE COVERAGE OF LUNG TRANSPLANTS (BPD-812-
NC)

Priority:  Other Significant

Legal Authority:  42 USC 1395y

CFR Citation:  None

Legal Deadline: None

Abstract: This notice announces Medicare criteria for coverage of lung 
transplants under certain circumstances. We have determined, based on 
results of an assessment conducted by the Public Health Service, that 
lung transplants are a medically reasonable and necessary service when 
furnished to patients with progressive end-stage pulmonary or 
cardiopulmonary disease and when furnished by participating facilities 
that meet specific criteria. Facilities electing to seek Medicare 
coverage will be required to submit information establishing that the 
criteria are met for evaluation by HCFA.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

Notice With Comment Period      02/02/95                     60 FR 6537
Public Comment Period End       04/03/95                     60 FR 6537
Final Notice                    00/00/00

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Claude Mone, Health Insurance Specialist, Office of 
Hospital Policy, Department of Health and Human Services, Health Care 
Financing Administration, Room 400, EHR, 6325 Security Boulevard, 
Baltimore, MD 21207, 410 966-4671

RIN: 0938-AG83
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1211. DISTINCT PARTS AND COSTING FOR SKILLED NURSING FACILITIES AND 
NURSING FACILITIES (BPD-815-P)

Priority:  Other Significant

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

CFR Citation:  42 CFR 409; 42 CFR 483

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. This rule also proposes 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.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            07/00/95

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, Room 401, EHR Bldg., 6325 Security Blvd, 
Baltimore, MD 21207, 401 966-5667

RIN: 0938-AG84
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1212. CLINICAL LABORATORY IMPROVEMENT AMENDMENT (CLIA) FEE 
SCHEDULES (HSQ-219-FC)

Priority:  Other Significant

Legal Authority:  42 USC 263a(m)

CFR Citation:  42 CFR 493.638; 42 CFR 493.649

Legal Deadline: None

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.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            06/00/95

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Ed Mortimore, Health Insurance Specialist, Survey & 
Certification, Department of Health and Human Services, Health Care 
Financing Administration, Meadowwood East Bldg, 6325 Security Blvd, 
Baltimore, MD 21207, 410 597-2140

RIN: 0938-AG87
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1213. WAGE INDEX USED TO ADJUST PAYMENT RATES FOR HOSPICE SERVICES 
UNDER THE MEDICARE PROGRAM (BPD-820-P)

Priority:  Other Significant

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. We are 
undertaking development of this proposed rule through a ``negotiated 
rulemaking'' proceeding under the Negotiated Rulemaking Act of 1990. 
[[Page 23337]] 

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

Notice of Intent                10/14/94                    59 FR 52129
NPRM                            00/00/00

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Janice Flaherty, Director, Division of Home Care & 
Therapy, Department of Health and Human Services, Health Care Financing 
Administration, Room 401, EHR Bldg., 6325 Security Boulevard, 
Baltimore, MD 21207, 410 966-4637

RIN: 0938-AG93
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1214.  MANDATORY MEDIGAP CROSSOVER CLAIMS TRANSMITTAL 
REQUIREMENTS (BPD-811-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395ss

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

Legal Deadline: None

Abstract: This regulation proposes to require Medicare supplemental 
issuers to accept from Medicare carriers direct transmittal of claims 
submitted for services furnished to Part B Medicare beneficiaries by 
participating physicians and suppliers; pay user fees associated with 
this claims transmittal requirement; and meet certain other 
requirements.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: None

Agency Contact: Thomas Hoyer, Director, Office of Chronic Care & 
Insurance Policy, Department of Health and Human Services, Health Care 
Financing Administration, Room 401, EHR Bldg., 6325 Security Bldg., 
Baltimore, MD 21207, 410 966-5661

RIN: 0938-AG94
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1215.  MEDICARE PROGRAM: CHANGES TO THE INPATIENT HOSPITAL 
PROSPECTIVE PAYMENT SYSTEMS AND FISCAL YEAR 1996 RATES (BPD-825-P)

Priority:  Other Significant

Legal Authority:  42 USC 1395ww

CFR Citation:  42 CFR 412; 42 CFR 413

Legal Deadline:  NPRM, Statutory, May 1995. Final, Statutory, September 
1995.

Abstract: This rule would make revisions to the inpatient hospital 
prospective payment systems for operating costs and capital-related 
costs. It also would include changes in the methods amounts and factors 
used to determine the prospective payment rates applicable to 
discharges occurring during FY 1996. In addition, the rule would set 
forth the rate of increase limits for hospitals and hospital units 
excluded from the prospective payment systems.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            05/00/95

Small Entities Affected: Businesses, Organizations

Government Levels Affected: State, Federal

Agency Contact: Nancy Edwards, Director, Division of Prospective 
Payment Systems, Department of Health and Human Services, Health Care 
Financing Administration, Room 1-H-1, ELR Bldg., 6325 Security Blvd., 
Baltimore, MD 21207, 410 966-4531

RIN: 0938-AG95
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1216.  MEDICARE PROGRAM: REVISIONS TO PAYMENT POLICIES AND 
ADJUSTMENTS TO THE RELATIVE VALUE UNITS (RVU) UNDER THE PHYSICIAN FEE 
SCHEDULE FOR CALENDAR YEAR 1996 (BPD-827-P)

Priority:  Other Significant

Legal Authority:  42 USC 1395w-4

CFR Citation:  42 CFR 414

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

Abstract: This proposed rule with comment period would revise various 
payment policies for specific physician services and the relative value 
units (RVUs) for certain existing procedure codes. It also establishes 
interim RVUs for new and revised procedure codes. The rule implements 
section 1848 of the Social Security Act.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            05/00/95
Final Rule With Comment Period  05/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Terrence Kay, Director, Division of Physician Services, 
Office of Physician & Ambulatory Care Policy, Department of Health and 
Human Services, Health Care Financing Administration, Room 1-H-4, ELR 
Bldg., 6325 Security Blvd., Baltimore, MD 21207, 410 966-4497

RIN: 0938-AG96
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1217.  CATEGORIZATION AND CERTIFICATION REQUIREMENTS FOR A 
NEW SUBCATEGORY OF MODERATE COMPLEXITY TESTING (HSQ-222-P)

Priority:  Other Significant

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 add a subcategory of moderate complexity 
tests called ``accurate and precise technology'' tests that clinical 
laboratories may perform under the CLIA program. These tests would have 
to meet less stringent requirements because they will have demonstrated 
accuracy and precision through scientific studies.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            05/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Anthony Tirone, Director, Division of Survey and 
Certification, Department of Health and Human Services, Health Care 
Financing Administration, Room 2-D-2, ME Bldg., 6325 Security Blvd., 
Baltimore, MD 21207, 410 966-6763

RIN: 0938-AG98
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1218.  CATEGORIZATION OF WAIVED TESTS (HSQ-225-P)

Priority:  Other Significant

Legal Authority:  42 USC 263a

CFR Citation:  42 CFR 493.2; 42 CFR 493.7; 42 CFR 493.9; 42 CFR 493.15; 
[[Page 23338]] 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 establish criteria for use in determining 
whether to categorize specific laboratory tests as waived from certain 
requirements of CLIA. This rule would also revise the requirements that 
laboratories performing waived tests must meet.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            06/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Anthony Tirone, Director, Division of Survey and 
Certification, Department of Health and Human Services, Health Care 
Financing Administration, Room 2-D-2, ME Bldg., 6325 Security Blvd., 
Baltimore, MD 21207, 410 966-6763

RIN: 0938-AG99
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1219.  MEDICAID COVERAGE OF PERSONAL CARE SERVICES (MB-071-
P)

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 is 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                            06/00/95

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Linda Sizelove, Chief, Medicaid Coverage Policy Branch, 
Medicaid Bureau, Department of Health and Human Services, Health Care 
Financing Administration, Room 400, EHR Bldg., 6325 Security Blvd., 
Baltimore, MD 21207, 410 966-4626

RIN: 0938-AH00
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1220.  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 152

Legal Deadline: None

Abstract: This rule would amend the regulations governing third party 
liability as required by OBRA '93. 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                            10/00/95

Small Entities Affected: Undetermined

Government Levels Affected: State, Federal

Agency Contact: Robert Nakielny, Health Insurance Specialist, Medicaid 
Bureau, Department of Health and Human Services, Health Care Financing 
Administration, Room 200, EHR Bldg., 6325 Security Blvd., Baltimore, MD 
21207, 410 966-4466

RIN: 0938-AH01
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________


1221.  MEDICARE PROGRAM: COVERAGE OF CERTIFIED NURSE-
MIDWIFE SERVICES (BPD-496-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302; 42 USC 1395l; 42 USC 1395x(s); 42 USC 
1395x(gg)

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

Legal Deadline: None

Abstract: This rule would specify that Medicare part B coverage 
includes the services of a certified nurse-midwife furnished 
independent of the supervision of a physician (if that practice is 
allowed under the State law of the State in which the service is 
furnished). Section 4073 of the OBRA '87, as amended by section 411(h) 
of the MCCA '88, established separate Medicare Part B coverage of 
certified nurse-midwife services furnished after June 30, 1988. Section 
13554 of OBRA '93 eliminates the limitation on coverage of certified-
nurse midwife services. Services provided by a certified nurse-midwife 
outside the maternity cycle will now be covered under this provision.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            11/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Debra McKeldin, Health Insurance Specialist, Office of 
Physician & Ambulatory Care Policy, Department of Health and Human 
Services, Health Care Financing Administration, Room 1-A-5, ELR Bldg., 
6325 Security Blvd., Baltimore, MD 21207, 419 966-9671

RIN: 0938-AH02


[[Page 23339]] 
______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1222. PAYMENT FOR CLINICAL DIAGNOSTIC LABORATORY TESTS (BPD-309-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395l(a)(1)(D); 42 USC 1395l(a)(2)(D); 42 USC 
1395l(b)(3); 42 USC 1395l(h); 42 USC 1395cc(a)(2)(A); 42 USC 
1396b(i)(7)

CFR Citation:  42 CFR 405.501; 42 CFR 405.502; 42 CFR 405.505; 42 CFR 
405.506; 42 CFR 405.511; 42 CFR 405.556; 42 CFR 405.1310; 42 CFR 
413.170; 42 CFR 414.350 to 414.378; 42 CFR 424.55; 42 CFR 424.64; 42 
CFR 431.54; 42 CFR 447.10; 42 CFR 447.300; 42 CFR 447.321

Legal Deadline: None

Abstract: This rule will incorporate provisions of DEFRA, COBRA, OBRA 
'86, OBRA '87, the Technical and Miscellaneous Revenue Act of 1988, 
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                    58 FR 43156
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Additional Information: 
TIMETABLE: Pending publication of RIN 0938-AF40 (BPD-674-FC).

Agency Contact: Charles Spalding, Director, Division of Ambulatory Care 
Services, Department of Health and Human Services, Health Care 
Financing Administration, Room 1-H-5, ELR, 6325 Security Blvd., 
Baltimore, MD 21207, 410 966-4496

RIN: 0938-AB50
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1223. 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 requires Medicare participating hospitals 
with emergency departments to provide upon request medical examinations 
and treatments for individuals with emergency medical conditions and 
women in labor. A participating hospital that has specialized 
capabilities or facilities (such as burn, shock trauma, or neonatal 
intensive care units) must accept an appropriate transfer if they have 
the capacity to treat the individual. Hospitals failing to meet those 
requirements may have their Medicare provider agreements terminated, 
and hospitals and responsible physicians may be subject to civil money 
penalties. Under section 9122 of COBRA '85, Medicare participating 
hospitals are required to accept CHAMPUS and CHAMPVA payment as payment 
in full for services provided to CHAMPUS and CHAMPVA beneficiaries. 
These regulations also implement section 9305(b) of OBRA '86, which 
requires Medicare hospitals to give patients a notice of their 
discharge rights.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            06/16/88                    53 FR 22513
NPRM Comment Period End         08/15/88                    53 FR 22513
Final Rule With Comment Period  06/22/94                    59 FR 32086
Effective Date                  07/22/94                    59 FR 32086
Comment Period End              08/22/94                    59 FR 32086
Final Rule                      00/00/00

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Tzvi Hefter, Division of Hospital Service, Department 
of Health and Human Services, Health Care Financing Administration, 
Room 401 EHR Bldg., 6325 Security Blvd., Baltimore, MD 21207, 410 966-
4635

RIN: 0938-AC58
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1224. 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 405.377; 42 CFR 413.5; 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 makes 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 
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                    53 FR 31888
Final Rule With Comment Period  00/00/00

Small Entities Affected: None

Government Levels Affected: None

Additional Information: 
TIMETABLE: Pending resolution of complex administrative issues.

Agency Contact: Sam Guida, Director, Div. of Acct. Mgmnt. & 
Collections, Division of Payment and Reporting Policy, Department of 
Health and Human Services, Health Care Financing Administration, Room 
1-E-6, Meadows [[Page 23340]] East Bldg., 6325 Security Blvd., 
Baltimore, MD 21207, 410 966-7495

RIN: 0938-AC99
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1225. CLARIFICATIONS OF MEDICARE'S ACCRUAL BASIS OF ACCOUNTING 
POLICY (BPD-366-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395x(v)(1)(A)

CFR Citation:  42 CFR 413.24; 42 CFR 413.100

Legal Deadline: None

Abstract: This final rule revises the Medicare regulations to clarify 
the concept of ``accrual basis of accounting'' to indicate that 
expenses must be incurred by a provider of health care services before 
Medicare will pay its share of those expenses. This change incorporates 
into the regulations Medicare's longstanding policy regarding the 
circumstances under which we recognize, for the purposes of program 
payment, a provider's claim for costs for which it has not actually 
expended funds during the current cost reporting period.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            10/09/91                    56 FR 50834
NPRM Comment Period End         12/09/91                    56 FR 50834
Final Action                    06/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: John Eppinger, Office of Hospital Policy, Department of 
Health and Human Services, Health Care Financing Administration, Room 
1-F-5 ELR Bldg., 6325 Security Blvd., Baltimore, MD 21207, 410 966-4518

RIN: 0938-AD01
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1226. OPTIONAL PAYMENT SYSTEM FOR LOW MEDICARE VOLUME SKILLED 
NURSING FACILITIES (BPD-409-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395yy(d)

CFR Citation:  42 CFR 413.300; 42 CFR 413.302; 42 CFR 413.304; 42 CFR 
413.308; 42 CFR 413.310; 42 CFR 413.312; 42 CFR 413.314; 42 CFR 
413.316; 42 CFR 413.320; 42 CFR 413.321; 42 CFR 413.1; 42 CFR 413.24

Legal Deadline: None

Abstract: This rule will allow skilled nursing facilities (SNFs) that 
provide fewer than 1,500 days of care to Medicare beneficiaries in a 
cost reporting period to have the option of receiving prospectively 
determined payment rates in the following cost reporting period. The 
prospectively determined payment rates are based on components of SNF 
costs such as routine operating costs, capital-related costs, and a 
return on equity for proprietary facilities for routine services 
furnished before October 1, 1993. This rule also specifies that the 
return on equity provision for proprietary SNFs is eliminated for 
services furnished on or after October 1, 1993.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            06/08/94                    59 FR 29578
NPRM Comment Period End         08/08/94                    59 FR 29578
Final Action                    06/00/95

Small Entities Affected: None

Government Levels Affected: Undetermined

Agency Contact: Bob Kuhl, Director, Office of Chronic Care and 
Insurance Policy, Department of Health and Human Services, Health Care 
Financing Administration, Room 1-F-5 ELR Bldg., 6325 Security Blvd., 
Baltimore, MD 21207, 410 966-4513

RIN: 0938-AD02
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1227. CRITERIA AND PROCEDURES FOR MAKING MEDICAL SERVICES COVERAGE 
DECISIONS THAT RELATE TO HEALTH CARE TECHNOLOGY (BPD-432-F)

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 establishes in regulations generally 
applicable criteria and procedures for determining whether a service is 
``reasonable and necessary'' under the Medicare program; it sets forth 
the coverage decisionmaking process; and it summarizes and provides an 
analysis of the public comments that we received in response to the 
January 30, 1989 proposed rule (54 FR 4302). 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                     54 FR 4302
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Additional Information: 
TIMETABLE: Pending resolution of complex policy issues.

Agency Contact: David Higbee, Technical Assistant, Technology & Special 
Analysis Staff, Department of Health and Human Services, Health Care 
Financing Administration, Room 660, EHR, 6325 Security Blvd., 
Baltimore, MD 21207, 410 966-4643

RIN: 0938-AD07
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1228. PROHIBITION ON UNBUNDLING OF HOSPITAL OUTPATIENT SERVICES 
(BPD-426-F)

Priority:  Regulatory Plan

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, issued jointly by HCFA and the OIG, 
prohibits 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 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 [[Page 23341]] 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                    53 FR 29486
Final Action                    07/00/95

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Carolyn Mullen, Health Insurance Specialist, Office of 
Physician & Ambulatory Care Policy, Department of Health and Human 
Services, Health Care Financing Administration, Room 1-F-5 EHR, 6325 
Security Blvd., Baltimore, MD 21207, 410 966-4589

RIN: 0938-AD33
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1229. CHANGES TO PEER REVIEW ORGANIZATION REGULATIONS (HSQ-135-F)

Priority:  Substantive, Nonsignificant

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 66.1; 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                     53 FR 8654
Final Action                    08/00/95

Small Entities Affected: None

Government Levels Affected: Undetermined

Agency Contact: Harvey Brook, Deputy Director, Office of Quality 
Improvement Programs, Department of Health and Human Services, Health 
Care Financing Administration, Room 2-D-2, Meadows East Bldg., 6325 
Security Blvd., Baltimore, MD 21207, 410 966-6853

RIN: 0938-AD38
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1230. PAYMENT FOR DURABLE MEDICAL EQUIPMENT AND ORTHOTIC AND 
PROSTHETIC DEVICES (BPD-494-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 414.220; 42 CFR 414.222; 42 CFR 414.226; 42 CFR 
414.228; 42 CFR 414.229; 42 CFR 414.232

Legal Deadline: None

Abstract: This final rule responds to comments received in response to 
the final rule with comment period (57 FR 57675) implementing section 
4062(b) of OBRA '87, sections 4152 and 4153 of OBRA '90. That rule 
established fee schedules and payment methodologies that govern 
payments for six categories of durable medical equipment and orthotic 
and prosthetic devices. If changes are warranted based on our 
evaluation of comments, they will be incorporated in this final rule. 
This rule also reflects changes required by sections 13542 through 
13546 of OBRA '93.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

Interim Final Rule              12/07/92                    57 FR 57675
Effective Date                  01/06/93                    57 FR 57675
Public Comment Period End       02/05/93                    57 FR 57675
Final Action                    06/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: William Long, Health Insurance Specialist, Office of 
Chronic Care & Insurance Policy, Department of Health and Human 
Services, Health Care Financing Administration, Room 1-H-5, EHR, 6325 
Security Blvd., Baltimore, MD 21207, 410 966-5655

RIN: 0938-AD65
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1231. MEDICARE SECONDARY PAYER FOR DISABLED INDIVIDUALS (BPD-482-
FC)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395y(b)

CFR Citation:  42 CFR 411

Legal Deadline: None

Abstract: This rule implements 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 a tax penalty. 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                     55 FR 8491
Final Action                    05/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Herbert Pollock, Chief, Medicare Benefit Coordination 
Policy Branch, Department of Health and Human Services, Health Care 
Financing Administration, Room 401, EHR, 6325 Security Blvd., 
Baltimore, MD 21207, 410 966-4474

RIN: 0938-AD73
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1232. OMNIBUS NURSING HOME REFORM REQUIREMENTS (BPD-488-F)

Priority:  Other Significant

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

CFR Citation:  42 CFR 418; 42 CFR 440; 42 CFR 441; 42 CFR 482; 42 CFR 
483; 42 CFR 488; 42 CFR 431

Legal Deadline: None

Abstract: This final rule responds to public comments on the February 
5, 1992, proposed rule that established the way we will implement 
several provisions of OBRA '87 that concern services to residents of 
nursing homes. [[Page 23342]] 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, notices of Medicaid rights to be given to persons 
admitted to nursing facilities, and other technical changes.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            02/05/92                     57 FR 4516
NPRM Comment Period End         04/06/92                     57 FR 4516
Final Rule With Comment Period  00/00/00

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, Room 401, EHR Bldg., 6325 Security 
Boulevard, Baltimore, MD 21207, 410 966-5667

RIN: 0938-AD81
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1233. HMO ORGANIZATIONAL STRUCTURE AND SERVICES (OMC-007-F)

Priority:  Other Significant

Legal Authority:  42 USC 300e(a); 42 USC 300e(b)(1); 42 USC 
300e(b)(3)(A); 42 USC 300e(c)

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 regulation will provide organizations which operate 
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 regulation would 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                    12/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Maureen Miller, Health Insurance Specialist, Department 
of Health and Human Services, Health Care Financing Administration, 
Room 4360, Cohen Bldg., 330 Independence Avenue SW., Washington, DC 
20201, 202 619-0129

RIN: 0938-AE25
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1234. SURVEY REQUIREMENTS AND ALTERNATIVE SANCTIONS FOR HOME HEALTH 
AGENCIES (HSQ-169-F)

Priority:  Other Significant

Legal Authority:  42 USC 1395w-2; 42 USC 1395bbb

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                    56 FR 37054
Final Action                    06/00/95

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Local, Federal

Agency Contact: Pam Vocke, Director, Division of Program Operations, 
Office of Survey and Certification, Department of Health and Human 
Services, Health Care Financing Administration, Room 2-D-2, Meadows 
East, 6300 Security Blvd., Baltimore, MD 21207, 410 966-7089

RIN: 0938-AE39
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1235. 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                    58 FR 34977
Final Action                    09/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Joanne Sinsheimer, Office of Chronic Care & Insurance 
Policy, Bureau of Policy Development, Department of Health and Human 
Services, Health Care Financing Administration, Room 401, EHR Bldg., 
6325 Security Blvd., Baltimore, MD 21207, 410 966-4620

RIN: 0938-AE40
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1236. MEDICARE, MEDICAID, AND CLIA PROGRAMS: REGULATIONS 
IMPLEMENTING THE CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 (CLIA 
'88) (HSQ-226-F)

Priority:  Regulatory Plan

Legal Authority:  42 USC 263a

CFR Citation:  42 CFR 493

Legal Deadline: None

Abstract: Historically the Department regulated laboratories by 
``location,'' rather than by types of tests they perform. CLIA '88 
changed this approach. CLIA '88 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 [[Page 23343]] standards for all laboratories 
based on complexity and responded to public comments on the proposed 
standards. The regulation was revised by a rule with comment period 
published on January 19, 1993, 56 FR 5215. The comment period for this 
rule ended March 22, 1993. A final rule, which will respond to public 
comments on the February 28, 1992, rule and the January 19, 1993, rule, 
will also be issued.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            05/21/90                    55 FR 20896
NPRM Comment Period End         09/21/90                    55 FR 34289
Final Rule With Comment Period  02/28/92                     57 FR 7002
Public Comment Period End       04/28/92                     57 FR 7002
Effective Date                  09/01/92                     57 FR 7002
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                     58 FR 6215
Final Action                    00/00/00

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Agency Contact: Anthony J. Tirone, Director, Office of Survey and 
Certification, HSQB, Department of Health and Human Services, Health 
Care Financing Administration, 6325 Security Boulevard, Room 2-D-2, ME, 
Baltimore, MD. 21207, 410 966-6763

RIN: 0938-AE47
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1237. CONDITIONS OF COVERAGE FOR ORGAN PROCUREMENT ORGANIZATIONS 
(BPD-646-FC)

Priority:  Other Significant

Legal Authority:  42 USC 1395x

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

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

Abstract: This final rule 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 performance criteria for OPOs; clarify 
operational policy for certification and recertification of OPOs, 
competition for open areas, and, appeals of the Secretary's decisions.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

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

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, Room 
401, EHR, 6325 Security Boulevard, Baltimore, MD 21207, 410 966-5666

RIN: 0938-AE48
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1238. RESIDENT ASSESSMENT IN LONG-TERM CARE FACILITIES (HSQ-180-F)

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 483

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, as 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 would 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                    57 FR 61614
Final Action                    10/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Sue Nonemaker, Health Insurance Specialist, Health 
Standards Quality Bureau, Department of Health and Human Services, 
Health Care Financing Administration, 2-D-2, ME, 6325 Security 
Boulevard, Baltimore, MD 21207, 410 966-6825

RIN: 0938-AE61
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1239. 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 provide Medicare beneficiaries with certain 
coverage for pre-existing conditions under supplemental insurance after 
non-renewal or termination of a Medicare health maintenance 
organization (HMO) or competitive medical plan (CMP) contract; 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                    12/00/95

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Tracy Jensen, Health Insurance Specialist, Office of 
Managed Care, Department of Health and Human Services, Health Care 
Financing Administration, Room 4360, Cohen [[Page 23344]] Building, 330 
Independence Ave. SW., Washington, DC 20201, 202 619-2158

RIN: 0938-AE63
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1240. 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 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
Public Comment Period End       09/03/91                    56 FR 30723
Final Action                    08/00/95

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, Room 
4360, Cohen Building, 330 Independence Ave. SW., Washington, DC 20201, 
202 205-9582

RIN: 0938-AE64
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1241. EARLY AND PERIODIC SCREENING, DIAGNOSTIC, AND TREATMENT 
(EPSDT) SERVICES (MB-28-F)

Priority:  Regulatory Plan

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 6403 of OBRA '89 defines in new section 1905(r) of 
the Social Security Act the following EPSDT services: screening 
services, vision services, dental services and hearing services. It 
also extends EPSDT services 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 and 
illnesses and conditions discovered by the screening services whether 
or not the services are covered under the State plan. Section 6403 also 
amended section 1902(a)(43) of the Act to require 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                    58 FR 51288
Final Action                    09/00/95

Small Entities Affected: Undetermined

Government Levels Affected: State, Local

Agency Contact: Robert Wardwell, Director, Division of Coverage Policy, 
Department of Health and Human Services, Health Care Financing 
Administration, Room 400, EHR, 6325 Security Boulevard, Baltimore, MD 
21207, 410 966-5659

RIN: 0938-AE72
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1242. PAYMENT FOR NURSING AND ALLIED HEALTH SCIENCE EDUCATION (BPD-
685-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 101-239, Sec 6205; PL 101-508, Sec 4004; PL 101-
508, Sec 4159; 42 USC 1395x note

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, an action 
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 have been 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 clarify 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                    57 FR 43659
Final Action                    07/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Nancy Edwards, Director, Division of Prospective 
Payment System, Department of Health and Human Services, Health Care 
Financing Administration, 1-H-1 ELR Bldg., 6325 Security Blvd., 
Baltimore, MD 21207, 410 966-4531

RIN: 0938-AE79
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1243. UNIFORM ELECTRONIC COST REPORTING SYSTEM FOR HOSPITALS (BPD-
689-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395ww(f)(1)(B); 42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 413.24

Legal Deadline: None

Abstract: This final rule responds to comments on the May 25, 1994, 
final rule with comment period that implemented a standardized 
electronic cost reporting system for all hospitals under the Medicare 
program. In that rule, we solicited comments on the requirement that 
cost reporting software be able to detect changes made to the 
electronic file after the provider has submitted it to the fiscal 
intermediary. This final rule responds to comments on that requirement 
and clarifies that although changes to the ``as-filed'' electronic cost 
report are prohibited, an intermediary makes a working copy of the as-
filed electronic cost report for use in the settlement process.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            08/19/91                    56 FR 41110
Comment Period End              10/18/91    56 FR 41110 [[Page 23345]] 
Final Rule With Comment Period  05/25/94                    59 FR 26960
Effective Date                  06/24/94                    59 FR 26960
Comment Period End              07/25/94                    59 FR 26960
Final Action                    07/00/95

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, Room 1-F-5, ELR Bldg., 6325 Security Blvd., Baltimore, 
MD 21207, 410 966-4592

RIN: 0938-AE80
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1244. FIRE SAFETY STANDARDS FOR HOSPITALS, LONG-TERM CARE 
FACILITIES, AND INTERMEDIATE CARE FACILITIES FOR THE MENTALLY RETARDED 
(BPD-650-F)

Priority:  Substantive, Nonsignificant

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)

Legal Deadline: None

Abstract: This rule amends the fire safety standards for hospitals, 
long term care facilities, and intermediate care facilities for the 
mentally retarded. It deletes references to the 1967 and 1973 editions 
of the Life Safety Code of the National Fire Protection Association and 
requires compliance with either the 1981 or 1985 editions depending on 
the date when the facility was first certified to participate in 
Medicare or Medicaid. This rule creates a uniform policy for all types 
of facilities that participate in the Medicare and Medicaid programs.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Joanne Sinsheimer, Division of Home Care & Therapy, 
Department of Health and Human Services, Health Care Financing 
Administration, Room 401, EHRBldg., 6325 Security Blvd., Baltimore, MD 
21207, 410 966-4620

RIN: 0938-AE97
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1245. COVERAGE OF SCREENING PAP SMEARS (BPD-705-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395x(s)(14); 42 USC 1395x(nn)

CFR Citation:  42 CFR 410.10; 42 CFR 411.15; 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 and 
related medically necessary services (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                    58 FR 62312
Final Action                    11/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: William Larson, Health Insurance Specialist, Bureau of 
Policy Development, Department of Health and Human Services, Health 
Care Financing Administration, Room 401, EHR Bldg., 6325 Security 
Blvd., Baltimore, MD 21207, 410 966-4639

RIN: 0938-AE98
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1246. 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 requires CPs to agree to consult with the patient's 
primary care or attending physician. Also, it eliminates 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.''

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            12/29/93                    58 FR 68829
NPRM Comment Period End         02/28/94                    58 FR 68829
Final Action                    10/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Regina Walker, Health Insurance Specialist, Bureau of 
Policy Development, Department of Health and Human Services, Health 
Care Financing Administration, Room 401, EHR, 6325 Security Blvd., 
Baltimore, MD 21207, 410 966-6735

RIN: 0938-AE99
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1247. ALLOWING CERTIFICATIONS AND RECERTIFICATIONS BY NURSE 
PRACTITIONERS AND CLINICAL NURSE SPECIALISTS FOR CERTAIN SERVICES (BPD-
709-FC)

Priority:  Other Significant

Legal Authority:  42 USC 1395f(a)

CFR Citation:  42 CFR 424

Legal Deadline: None

Abstract: This final regulation implements section 6028 of OBRA '89. It 
allows nurse practitioners and clinical nurse specialists working in 
collaboration with a physician to certify and recertify that extended 
care services are needed or continue to be needed.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            06/28/91                    56 FR 29609
NPRM Comment Period End         08/27/91                    56 FR 29609
Final Action                    04/00/95

Small Entities Affected: None

Government Levels Affected: None [[Page 23346]] 

Agency Contact: Debra McKeldin, Health Insurance Specialist, Division 
of Ambulatory Care Services, Department of Health and Human Services, 
Health Care Financing Administration, Room 401, EHR Bldg., 6325 
Security Blvd., Baltimore, MD 21207, 410 966-4485

RIN: 0938-AF01
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1248. 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, TMRA '88 and OBRA '87 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                    01/00/96

Small Entities Affected: None

Government Levels Affected: State, Local

Agency Contact: Robert Wardwell, Director, Division of Coverage Policy, 
Medicaid Bureau, Department of Health and Human Services, Health Care 
Financing Administration, Room 400, EHR, 6325 Security Blvd., 
Baltimore, MD 21207, 410 966-5659

RIN: 0938-AF07
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1249. MEDICAID THIRD PARTY LIABILITY: COST EFFECTIVENESS WAIVERS 
(MB-39-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396a(a)(25)

CFR Citation:  42 CFR 433.138; 42 CFR 433.139; 42 CFR 433.137

Legal Deadline: None

Abstract: This rule will provide States with the opportunity to request 
waivers of certain third party liability requirements if the State has 
more cost effective methods than those required under current 
regulations. These requirements relate to methods and procedures for 
determining liability of third parties to pay for services furnished 
under Medicaid and for paying claims. The waivers will apply to 
administratively imposed requirements, not statutory requirements.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            02/02/94                     59 FR 4880
NPRM Comment Period End         05/03/94                     59 FR 4880
Final Action                    04/00/95

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Richard Friedman, Director, Division of Payment 
Systems, Department of Health and Human Services, Health Care Financing 
Administration, Room 273, EHR Bldg., 6325 Security Blvd., Baltimore, MD 
21207, 410 966-3292

RIN: 0938-AF11
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1250. REQUIRED COVERAGE OF NURSE PRACTITIONER SERVICES--MEDICAID 
(MB-41-F)

Priority:  Other Significant

Legal Authority:  42 USC 1396d(a)(21)

CFR Citation:  42 CFR 440

Legal Deadline: None

Abstract: This regulation will require direct payment to certified 
pediatric and family nurse practitioners to the extent that these 
providers are authorized to practice under State laws. It would 
implement section 6405 of OBRA '89 (PL 101-239) which became effective 
July 1, 1990.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            12/23/91                    56 FR 66392
NPRM Comment Period End         02/22/92                    56 FR 66392
Final Action                    04/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Robert Wardwell, Director, Division of Coverage Policy, 
Department of Health and Human Services, Health Care Financing 
Administration, Room 400, EHR Bldg., 6325 Security Blvd., Baltimore, MD 
21207, 410 966-5659

RIN: 0938-AF12
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1251. PAYMENT FOR FEDERALLY QUALIFIED HEALTH CENTER (FQHC) SERVICES 
(BPD-728-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395x(s)(2)(E); 42 USC 1395x(aa)(3); 42 USC 
1395x(aa)(4); 42 USC 1395k(a)(2)(D)(ii); 42 USC 1395l(b)(5)

CFR Citation:  42 CFR 405; 42 CFR 491

Legal Deadline: None

Abstract: This final rule will respond to comments received as a result 
of our publication of a final rule with comment period (57 FR 24961) 
which established a new category of facility known as an FQHC, the 
services of which are covered under the Medicare program. Those 
regulations also established requirements for coverage and payment of 
FQHC services under Medicare. They implemented section 4704 of PL 101-
508. This final rule will clarify or change policy, as appropriate, 
based on our evaluation of public comments.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

Effective Date                  06/12/92                    57 FR 24961
Final Rule with Comment Period  06/12/92                    57 FR 24961
Public Comment Period End       08/11/92                    57 FR 24961
Final Action                    08/00/95

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Bernadette Schumaker, Acting Director, Office of 
Physician and Ambulatory Care Policy, Department of Health and Human 
Services, Health Care Financing Administration, Room 441, EHR Bldg., 
6325 Security Blvd., Baltimore, MD 21207, 410 966-4568

RIN: 0938-AF14
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1252. 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) 
[[Page 23347]] 

Legal Deadline: None

Abstract: This rule will establish presumptive limits for Medicare 
payments to Health Maintenance Organizations and Competitive Medical 
Plans, and to Health Care Prepayment Plans (HCPPs) that furnishes 
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.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            02/22/94                     59 FR 8435
NPRM Comment Period End         04/25/94                     59 FR 8435
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, 1-G-2 
Oak Meadows, 6325 Security Boulevard, Baltimore, MD 21207, 410 966-7610

RIN: 0938-AF16
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1253. PHYSICIAN OWNERSHIP OF AND REFERRALS TO HEALTH CARE 
FACILITIES THAT FURNISH CLINICAL LABORATORY SERVICES AND FINANCIAL 
RELATIONSHIP REPORTING REQUIREMENTS (BPD-674-FC)

Priority:  Regulatory Plan

Legal Authority:  42 USC 1395nn

CFR Citation:  42 CFR 411

Legal Deadline:  Final, Statutory, October 1, 1991.

Abstract: This rule will incorporate into regulations the provisions of 
section 1877 of the Social Security Act (as established by section 6204 
of OBRA '89 and as subsequently amended by section 4207(e) of OBRA '90, 
section 13562 of OBRA '93, and section 152 of SSA '94) that have an 
effective date of January 1, 1992. It will govern whether a physician 
who has a financial relationship (or who has an immediate family member 
with a financial relationship) with an entity can make referrals to 
that entity for furnishing of clinical laboratory services under the 
Medicare program.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            03/11/92                     57 FR 8588
NPRM Comment Period End         05/11/92                     57 FR 8588
Final Action                    04/00/95

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Betty Burrier, Health Insurance Specialist, Bureau of 
Policy Development, Department of Health and Human Services, Health 
Care Financing Administration, Room 401, EHR Bldg., 6325 Security 
Boulevard, Baltimore, MD 21207, 410 966-4649

RIN: 0938-AF40
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1254. MEDICARE AND MEDICAID PROGRAMS; ADVANCE DIRECTIVES (BPD-718-
F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395cc

CFR Citation:  42 CFR 417.436; 42 CFR 417.801; 42 CFR 431.20; 42 CFR 
431.107; 42 CFR 434.28; 42 CFR 483.10; 42 CFR 484.10; 42 CFR 489.10; 42 
CFR 489.100; 42 CFR 489.104; 42 CFR 498.3; 42 CFR 417.472; 42 CFR 
489.102

Legal Deadline: None

Abstract: The final rules will make minor changes in the interim rule, 
which implemented statutory provisions effective in December 1991. They 
will amend the Medicare and Medicaid regulations governing provider 
agreements and contracts to establish requirements for States, 
hospitals, nursing facilities, skilled nursing facilities, providers of 
home health care or personal care services, hospice programs and 
prepaid health plans concerning advance directives. An advance 
directive is a written instruction, such as a living will or durable 
power of attorney for health care, recognized under State law, relating 
to the provision of health care when an individual's condition makes 
him or her unable to express his or her wishes. The intent of these 
provisions is to enhance an individual's control over medical treatment 
decisions. These rules implement sections 4206 and 4751 of OBRA '90.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

Interim Final Rule With Comment 
Period                          03/06/92                     57 FR 8194
Public Comment Period End       05/05/92                     57 FR 8194
Final Action                    06/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Thomas Hoyer, Director, Office of Chronic Care & 
Insurance Policy, Department of Health and Human Services, Health Care 
Financing Administration, Room 401, EHR, 6325 Security Boulevard, 
Baltimore, MD 21207, 410 966-5661

RIN: 0938-AF50
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1255. 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 interim 
final rule sets forth the coverage criteria and payment methodology for 
partial hospitalization services furnished in community mental health 
centers. It also specifies the requirements a community mental health 
center must meet in order to enter into a Medicare provider agreement 
to furnish partial hospitalization services.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

Interim Final Rule              02/11/94                     59 FR 6570
Interim Final Rule Effective    03/13/94                     59 FR 6570
Comment Period End              04/12/94                     59 FR 6570
Final Action                    09/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Joanne Sinsheimer, Division of Home Care & Therapy, 
Department of Health and Human Services, Health Care Financing 
Administration, Room 401, EHRBldg., 6325 Security Boulevard, Baltimore, 
MD 21207, 410 966-4620

RIN: 0938-AF53


______________________________________________________________________


______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

[[Page 23348]]
1256. 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                    58 FR 49272
Final Action                    07/00/95

Small Entities Affected: None

Government Levels Affected: State

Additional Information: MB-041-F will incorporate response to public 
comments made on 0938-AF65, MB-048-F.

Agency Contact: Marinos Svolos, Director, Division of Eligibility 
Policy, Department of Health and Human Services, Health Care Financing 
Administration, Room 323 EHR, 6325 Security Boulevard, Baltimore, MD 
21207, 410 966-4451

RIN: 0938-AF68
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1257. MEDICARE AND MEDICAID PROGRAMS: REQUIREMENTS FOR PHYSICIAN 
INCENTIVE PLANS IN PREPAID HEALTH CARE ORGANIZATIONS (OMC-010-FC)

Priority:  Regulatory Plan

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 would 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
Public Comment Period End       04/13/93                     58 FR 8568
Final Action                    04/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Tony Hausner, Program Analyst, Office of Managed Care, 
Department of Health and Human Services, Health Care Financing 
Administration, Room 4360, Cohen Building, 330 Independence Avenue SW., 
Washington, DC 20201, 202 619-2755

RIN: 0938-AF74
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1258. 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(c)

CFR Citation:  42 CFR 421.212

Legal Deadline: None

Abstract: This rule would amend Medicare regulations to provide advance 
payment to physicians, suppliers, or entities that furnish items or 
services under Medicare Part B. These payments could 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 is intended to 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                    59 FR 36415
Final Action                    00/00/00

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Bob Shaw, Health Insurance Specialist, Bureau of 
Program Operations, Department of Health and Human Services, Health 
Care Financing Administration, Room 1-E-6, ME Building, 6325 Security 
Boulevard, Baltimore, MD 21207, 410 966-7671

RIN: 0938-AF85
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1259. 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

Legal Deadline: None

Abstract: This regulation will allow retroactive enrollment of up to 90 
days for individuals enrolling with an eligible organization (which has 
a risk-sharing contract under section 1876 of the Social Security Act) 
under a health benefit plan operated, sponsored, or contributed to, by 
the individual's employer or former employer (or the employer or former 
employer of the individual's spouse). The regulation implements section 
4204(e) of OBRA '90. 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
Public Comment Period End       02/25/94                    58 FR 68366
Final Action                    07/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Tracy Jensen, Health Insurance Specialist, Office of 
Managed Care, Department of Health and Human Services, Health Care 
Financing Administration, Room 4360, Cohen [[Page 23349]] Building, 330 
Independence Avenue SW., Washington, DC 20201, 202 619-2158

RIN: 0938-AF98
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1260. CHANGE IN PROVIDER AGREEMENT REGULATIONS RELATED TO FEDERAL 
EMPLOYEE HEALTH BENEFITS (BPD-748-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  5 USC 8904(b)

CFR Citation:  42 CFR 489

Legal Deadline: None

Abstract: This rule will amend current Medicare regulations to require 
that payment for inpatient hospital services furnished to retired 
Federal workers age 65 and older who are enrolled in a Federal Employee 
Health Benefits (FEHB) plan but who are not covered under Medicare Part 
A (Hospital Insurance) may not exceed the hospital payments established 
for Medicare purposes for inpatient hospital services. The rule will 
also amend current Medicare regulations to authorize HCFA to consider 
termination or nonrenewal of a hospital's Medicare provider agreement 
for knowingly and willfully failing to accept, on a repeated basis, the 
Medicare rate as payment in full from an FEHB plan. This rule will 
implement section 7002(f) of OBRA '90, enacted November 5, 1990.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

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

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, Room 401, EHR Bldg., 6325 Security Boulevard, 
Baltimore, MD 21207, 410 966-4472

RIN: 0938-AG03
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1261. INTERMEDIARY AND CARRIER FUNCTIONS (BPO-111-F)

Priority:  Substantive, Nonsignificant

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.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            02/22/94                     59 FR 8446
NPRM Comment Period End         04/25/94                     59 FR 8446
Notice to Reopen Comment Period 07/17/94                    59 FR 35664
Comment Period End              10/11/94                    59 FR 35664
Final Action                    10/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Alan Bromberg, Health Insurance Specialist, Bureau of 
Program Operations, Department of Health and Human Services, Health 
Care Financing Administration, Room 3-F-1, ME Building, 6325 Security 
Boulevard, Baltimore, MD 21207, 410 966-7441

RIN: 0938-AG06
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1262. REVISED MEDICAID MANAGEMENT INFORMATION SYSTEMS (MB-38-FN)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396b(r)

CFR Citation:  42 CFR 433.1; 42 CFR 431.17; 42 CFR 447.10; 42 CFR 
447.45; 42 CFR 74.20; 42 CFR 74.21

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
Public Comment Period End       01/21/94                    58 FR 61692
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Richard Friedman, Director, Division of Payment 
Systems, Medicaid Bureau, Department of Health and Human Services, 
Health Care Financing Administration, Room 273, EHR Bldg., 6325 
Security Boulevard, Baltimore, MD 21207, 410 966-3292

RIN: 0938-AG10
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1263. CLARIFICATION OF RESUMPTION OF ENTITLEMENT RULES FOR MEDICARE 
PATIENTS WITH END-STAGE RENAL DISEASE (BPD-738-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 426-1

CFR Citation:  42 CFR 406.13

Legal Deadline: None

Abstract: This rule specifies that Medicare enrollment resumes for 
individuals who begin a regular course of renal dialysis treatments 
after a previous course is terminated (with or without kidney 
transplant) and includes the same considerations for those who have a 
second transplant.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            01/06/94                      59 FR 714
NPRM Comment Period End         03/07/94                      59 FR 714
Final Action                    04/00/95

Small Entities Affected: None

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, Room 401, EHR Building, 6325 Security 
Boulevard, Baltimore, MD 21207, 410 966-4472

RIN: 0938-AG19


______________________________________________________________________


______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

[[Page 23350]]
1264. END-STAGE RENAL DISEASE (ESRD) PAYMENT EXCEPTION REQUESTS AND 
ORGAN PROCUREMENT COSTS (BPD-763-F)

Priority:  Substantive, Nonsignificant

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: These regulations 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.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            08/26/94                    59 FR 44097
NPRM Comment Period End         10/25/94                    59 FR 44097
Final Action                    08/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Michael Powell, Health Insurance Specialist, Division 
of End-Stage Renal Disease, Department of Health and Human Services, 
Health Care Financing Administration, Room 1-A-5, EHR Building, 6325 
Security Boulevard, Baltimore, MD 21207, 410 966-4557

RIN: 0938-AG20
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1265. STANDARDS FOR QUALITY OF WATER USED IN DIALYSIS AND REVISED 
GUIDELINES ON REUSE OF HEMODIALYZER FILTERS FOR END-STAGE RENAL DISEASE 
PATIENTS (BPD-766-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395rr

CFR Citation:  42 CFR 405.2140; 42 CFR 405.2150

Legal Deadline: None

Abstract: This rule incorporates by reference, in our regulations, the 
Association for the Advancement of Medical Instrumentation (AAMI) 
guidelines for monitoring the quality of water used in dialysis as 
published in ``Hemodialyzers System, Second Edition.'' It also updates 
an existing incorporation by reference to reflect the 1992 edition AAMI 
voluntary guidelines and standards on ``Recommended Practice for Reuse 
of Hemodialyzers.'' These guidelines clarify certain issues and reflect 
current medically acceptable dialysis standards and techniques.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            02/14/94                     59 FR 6937
NPRM Comment Period End         04/15/94                     59 FR 6937
Final Action                    08/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jackie Sheridan, Technical Assistant, Office of 
Hospital Policy, Department of Health and Human Services, Health Care 
Financing Administration, Room 401, EHR Building, 6325 Security 
Boulevard, Baltimore, MD 21207, 410 966-4635

RIN: 0938-AG21
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1266. GENERAL CRITERIA AND STANDARDS FOR EVALUATING PERFORMANCE OF 
CONTRACT OBLIGATIONS (HSQ-207-NC)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1320c-2(h)(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, 1993, by the 53 PROs.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

Notice With Comment Period      10/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Lucy Steinmetz, Health Insurance Specialist, Health 
Standards & Quality Bureau, Department of Health and Human Services, 
Health Care Financing Administration, Room 2-D-2, Meadows East 
Building, 6325 Security Boulevard, Baltimore, MD 21207, 410 966-7216

RIN: 0938-AG32
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1267. WITHDRAWAL OF COVERAGE OF DIAGNOSTIC NOCTURNAL PENILE 
TUMESCENCE TESTING (IMPOTENCE TESTING) (BPD-780-FN)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395y

CFR Citation:  None

Legal Deadline: None

Abstract: This notice announces the Medicare program's intent to 
withdraw coverage for diagnostic nocturnal penile tumescence (NPT) 
testing in the sleep disorder clinic and to exclude coverage for 
nocturnal penile tumescence testing by plethysmography and other 
monitoring devices in all settings. Public Health Service studies show 
that NPT testing is not a reliable index for evaluating impotence. 
Therefore, it does not meet HCFA's criteria for effectiveness.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

Proposed Notice                 01/04/94                      59 FR 308
Public Comment Period End       03/07/94                      59 FR 309
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Bob Ulikowski, Health Insurance Specialist, Office of 
Physician & Ambulatory Care Policy, Department of Health and Human 
Services, Health Care Financing Administration, Room 1-H-5, ELR Bldg., 
6325 Security Boulevard, Baltimore, MD 21207, 410 966-5721

RIN: 0938-AG43
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1268. MEDICARE PROGRAM: LIMITATIONS ON MEDICARE COVERAGE OF 
INTERMITTENT POSITIVE PRESSURE BREATHING MACHINE THERAPY (BPD-781-FN)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395x; 42 USC 1395y

CFR Citation:  None

Legal Deadline: None

Abstract: Intermittent positive pressure breathing (IPPB) machine 
therapy is currently covered under Medicare as [[Page 23351]] durable 
medical equipment for patients whose ability to breathe is severally 
impaired. Based on a Public Health Service recommendation, we propose 
to 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                    59 FR 33520
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Francine Spencer, Health Insurance Specialist, Office 
of Chronic Care & Insurance Policy, Department of Health and Human 
Services, Health Care Financing Administration, Room 401, EHR Building, 
6325 Security Boulevard, Baltimore, MD 21207, 410 966-4614

RIN: 0938-AG44
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1269. NONCOVERAGE OF ELECTROSTIMULATION OF SALIVARY GLANDS FOR THE 
TREATMENT OF XEROSTOMIA (DRY MOUTH) (BPD-782-FN)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395y

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                    59 FR 26653
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Francina Spencer, Health Insurance Specialist, Office 
of Chronic Care & Insurance Policy, Department of Health and Human 
Services, Health Care Financing Administration, Room 401, EHR Building, 
6325 Security Boulevard, Baltimore, MD 21207, 410 966-4614

RIN: 0938-AG45
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1270. DATE FOR FILING MEDICARE COST REPORTS (BPD-794-F)

Priority:  Informational

Legal Authority:  42 USC 1395g

CFR Citation:  42 CFR 405.376; 42 CFR 413.24

Legal Deadline: None

Abstract: This rule will extend the time frame providers have to file 
cost reports from no later than 3 months after the close of the period 
covered by the report to no later than 5 months after the close of that 
period. This change is necessary to ensure that providers have an 
adequate amount of time to file complete and accurate cost reports. 
This final rule also defines what HCFA considers to be an 
``acceptable'' cost report submission.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            05/25/94                    59 FR 26998
Public Comment Period End       07/25/94                    59 FR 26998
Final Action                    07/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Katie Walker, Health Insurance Specialist, Bureau of 
Policy Development, Department of Health and Human Services, Health 
Care Financing Administration, Room 1-F-5, ELR, 6325 Security 
Boulevard, Baltimore, MD 21207, 410 966-7278

RIN: 0938-AG55
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1271. CATEGORIZATION OF CLIA TESTS AND PERSONNEL MODIFICATIONS 
(HSQ-216-FC)

Priority:  Other Significant

Legal Authority:  42 USC 263a; 42 USC 1302; 42 USC 1395

CFR Citation:  42 CFR 493.2; 42 CFR 493.3; 42 CFR 493.5; 42 CFR 493.45; 
42 CFR 493.9; 42 CFR 493.47; 42 CFR 493.18; 42 CFR 493.19; 42 CFR 
493.20; 42 CFR 493.49; 42 CFR 493.25; 42 CFR 493.35; 42 CFR 493.37; 42 
CFR 493.39; 42 CFR 493.43; ...

Legal Deadline: None

Abstract: This final rule with comment period responds to comments 
received concerning two previously published rules (57 FR 7002 and 58 
FR 5215) for implementing CLIA. In this rule, we expand personnel 
requirements so that more people are qualified to perform high 
complexity tests and physician-performed (now called provider-
performed) microscopy procedures and to supervise high complexity 
testing.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

Final Rule With Comment Period  04/00/95

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Judith Yost, Chief Laboratory & Home Health Services 
Branch, HSQB, Department of Health and Human Services, Health Care 
Financing Administration, Room 1-C-2 MWE, 6325 Security Boulevard, 
Baltimore, MD 21207, 410 597-5907

RIN: 0938-AG71
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1272. MEDICAID PROGRAM: NURSE-MIDWIFE SERVICES (MB-085-P)

Priority:  Other Significant

Legal Authority:  PL 103-66, Sec 13605

CFR Citation:  42 CFR 440

Legal Deadline: None

Abstract: This rule would expand coverage of nurse-midwife services 
under the Medicaid program by including coverage for those services the 
nurse-midwives perform outside the maternity cycle as allowed by State 
law and regulation. The provisions of this rule conform the regulations 
to the legislative provisions of OBRA '93.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            07/18/94                    59 FR 36419
NPRM Comment Period End         09/16/94                    59 FR 36419
Final Action                    10/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: William Hickman, Director, Office of Medicaid Policy, 
Medicaid Bureau, Department of Health and Human Services, Health Care 
Financing Administration, Room 323, EHR, 6325 Security Boulevard, 
Baltimore, MD 21207, 410 966-3235

RIN: 0938-AG73


______________________________________________________________________


______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

[[Page 23352]]
1273. MEDICAID PROGRAM: FEES FOR VACCINE ADMINISTRATION UNDER 
PEDIATRIC IMMUNIZATION PROGRAM (MB-084-N)

Priority:  Regulatory Plan

Legal Authority:  PL 103-66, sec 13631; 42 USC 1396a(a)(62); 42 USC 
1396s

CFR Citation:  None

Legal Deadline: None

Abstract: This notice establishes a regional maximum fee that a 
Medicaid provider may charge for the administration of qualified 
pediatric vaccines under the Medicaid Pediatric Immunization Program. 
It also specifies the methodology used to develop this maximum fee and 
allows a State to pay a rate lower than the maximum fee if the State 
can ensure federally vaccine-eligible children adequate access to the 
vaccines at the lower rate. This notice implements section 
1928(c)(2)(C)(ii) of the Social Security Act, as added by section 13631 
of OBRA '93.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

Effective Date                  10/01/94                    59 FR 50235
Notice With Comment Period      10/03/94                    59 FR 50235
Public Comment Period End       12/12/94                    59 FR 50235
Final Action                    04/00/95

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State

Agency Contact: Marge Sciulli, Health Insurance Specialist, Medicaid 
Bureau, Department of Health and Human Services, Health Care Financing 
Administration, Room 349, EHR, 6325 Security Blvd., Baltimore, MD 
21207, 410 966-0691

RIN: 0938-AG77
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1274. MEDICAID: NOMINAL COPAYMENTS FOR INSTITUTIONAL SERVICES FOR 
MEDICAID RECIPIENTS (MB-090-FC)

Priority:  Other Significant

Legal Authority:  42 USC 1396a(a)(14); 42 USC 1396o

CFR Citation:  42 CFR 447.54; 42 CFR 447.55

Legal Deadline: None

Abstract: This final rule with comment period redefines the nominal 
maximum deductible, coinsurance, or copayment charge that a State may 
impose on certain Medicaid recipients for each admission for inpatient 
hospital services. This revision of the copayment amount will help 
prevent undue hardships on Medicaid recipients who have low or no 
income by limiting the impact of rising health care costs.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

Final Rule With Comment Period  05/00/95

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Marinos Svolos, Office Director, Medicaid Eligibility 
Policy, Medicaid Bureau, Department of Health and Human Services, 
Health Care Financing Administration, Room 323, EHR, 6325 Security 
Blvd, Baltimore, MD 21207, 410 966-4451

RIN: 0938-AG90
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1275.  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:  Regulatory Plan

Legal Authority:  42 USC 1302; 42 USC 1395w-4; 42 USC 1395hh

CFR Citation:  None

Legal Deadline:  Other, Statutory, October 31, 1995.
Annual update required.

Abstract: This notice announces the calendar year 1996 updates to the 
Medicare physician fee schedule and the federal fiscal year 1996 
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                    10/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Terrence Kay, Director, Division of Physician Services, 
Office of Physician & Ambulatory Care Policy, Department of Health and 
Human Services, Health Care Financing Administration, Room 1-H-5, ELR, 
6325 Security Blvd., Baltimore, MD 21207, 410 966-4497

RIN: 0938-AH03
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

1276.  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

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

CFR Citation:  None

Legal Deadline:  Other, Statutory, September 30, 1995.
Other deadline is for publication of Notice.

Abstract: This notice announces the hospital insurance premium for 
calendar year 1996 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

_______________________________________________________________________

Notice                          09/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: John Wandishin, Director, Division of Hospital 
Insurance, Department of Health and Human Services, Health Care 
Financing Administration, Room M-1, 1705 Whitehead Bldg., 6325 Security 
Blvd., Baltimore, MD 21207, 410 966-6389

RIN: 0938-AH06


______________________________________________________________________


______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________

[[Page 23353]]
1277.  MEDICARE PROGRAM: MONTHLY ACTUARIAL RATES AND 
MONTHLY SUPPLEMENTARY MEDICAL INSURANCE PREMIUM RATES BEGINNING JANUARY 
1, 1996 (OACT-050-N)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395r

CFR Citation:  None

Legal Deadline:  Other, Statutory, September 1995.
Other deadline is for publication of Notice.

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, 1996. It also announces the monthly SMI premium 
rate to be paid by all enrollees during the 12 months beginning January 
1, 1996.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

Notice                          09/00/95                     59 FR 6162

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Carter Warfield, Director, Division of Supplementary 
Medical Insurance, Department of Health and Human Services, Health Care 
Financing Administration, Room M-1, 1705 Whitehead Bldg., 6325 Security 
Blvd., Baltimore, MD 21207, 410 966-6396

RIN: 0938-AH07
______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Health Care Financing Administration (HCFA)
______________________________________________________________________


1278.  INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND 
EXTENDED CARE SERVICES COINSURANCE AMOUNTS FOR 1996 (OACT-049-N)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395e

CFR Citation:  None

Legal Deadline:  Other, Statutory, September 15, 1995.
Other deadline is for publication of Notice.

Abstract: This notice announces the inpatient hospital deductible and 
the hospital and extended care services coinsurance amounts for 
services furnished in calendar year 1996 under Medicare's hospital 
insurance program (Medicare Part A). The Medicare statute specifies the 
formulae to be used to determine these amounts.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

Notice                          09/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: John Wandishin, Director, Division of Hospital 
Insurance, Department of Health and Human Services, Health Care 
Financing Administration, Room M-1, 1705 Whitehead Bldg., 6325 Security 
Blvd., Baltimore, MD 21207, 410 966-6389

RIN: 0938-AH08



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1279. HOSPICE SERVICES (MB-7-P)

CFR Citation:  42 CFR 418; 42 CFR 435; 42 CFR 436; 42 CFR 440; 42 CFR 
441; 42 CFR 447

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Robert Wardwell, 410 966-5659

RIN: 0938-AC52
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1280. HOME AND COMMUNITY-BASED SERVICES AND RESPIRATORY CARE FOR 
VENTILATOR-DEPENDENT INDIVIDUALS (MB-8-FC)

CFR Citation:  42 CFR 435.726; 42 CFR 435.735; 42 CFR 440.180; 42 CFR 
441.301; 42 CFR 441.302; 42 CFR 441.303; 42 CFR 441.304; 42 CFR 
441.305; 42 CFR 441.306; 42 CFR 441.307; 42 CFR 441.308; 42 CFR 
441.310; 42 CFR 440.185; 42 CFR 440.250

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn                       12/21/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Robert Wardwell, 410 966-5659

RIN: 0938-AC55
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1281. DENIAL OF PAYMENT FOR SUBSTANDARD QUALITY CARE (HSQ-132-F)

CFR Citation:  42 CFR 462.105; 42 CFR 466; 42 CFR 473; 42 CFR 476; 42 
CFR 489.21

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/31/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Harvey Brook, 410 966-6853

RIN: 0938-AC84
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1282. REVISED EFFECTIVE DATE OF MEDICARE/MEDICAID PROVIDER 
AGREEMENT AND SUPPLIER PARTICIPATION (HSQ-139-F)

CFR Citation:  42 CFR 440.10; 42 CFR 440.70; 42 CFR 442.13; 42 CFR 
488.11; 42 CFR 489.13; 42 CFR 498.3

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/31/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Kathy Lochary, 410 966-6770

RIN: 0938-AC88


______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

[[Page 23354]]
1283. REVISIONS TO CONDITIONS OF PARTICIPATION FOR HOSPITALS AND 
CONDITIONS FOR COVERAGE OF SUPPLIERS OF END-STAGE RENAL DISEASE SERVICES 
(BPD-421-F)

CFR Citation:  42 CFR 405; 42 CFR 482

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Action                    12/12/94                    59 FR 64141
Final Action Effective          01/12/95                    59 FR 64141

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jacqueline Sheridan, 410 966-4635

RIN: 0938-AD11
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1284. MEDICAID ELIGIBILITY OF POVERTY LEVEL GROUPS AND EXTENDED 
COVERAGE OF SERVICES (MB-13-F)

CFR Citation:  42 CFR 431; 42 CFR 435; 42 CFR 436; 42 CFR 440; 42 CFR 
447

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Judith Rhoades, 410 966-9539

RIN: 0938-AD17
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1285. REVISIONS TO THE FREEDOM OF INFORMATION REGULATIONS (OPA-1-P)

CFR Citation:  42 CFR 401.101 to 401.102; 42 CFR 401.110 to 401.116; 42 
CFR 401.120 to 401.123; 42 CFR 401.125 to 401.126; 42 CFR 401.105 to 
108

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Martha DiSario, 202 690-6113

RIN: 0938-AD60
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1286. MEDICARE COVERAGE OF HOME HEALTH SERVICES, MEDICARE 
CONDITIONS OF PARTICIPATION AND HOME HEALTH AIDE SUPERVISION (BPD-469-F)

CFR Citation:  42 CFR 409; 42 CFR 413; 42 CFR 418; 42 CFR 484

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Action                    12/20/94                    59 FR 65482
Final Action Effective          02/21/95                    59 FR 65482

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: John Thomas, 410 966-4623

RIN: 0938-AD78
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1287. APPEALS FOR ENROLLEES OF PREPAID HEALTH CARE PLANS (OMC-008-
F)

CFR Citation:  42 CFR 405; 42 CFR 417; 42 CFR 482

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Action                    11/21/94                    59 FR 59933
Final Action Effective          12/21/94                    59 FR 59933

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Maureen Miller, 202 619-0129

RIN: 0938-AD79
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1288. SURVEY AND CERTIFICATION OF SKILLED NURSING FACILITIES AND 
NURSING FACILITIES AND ENFORCEMENT PROCEDURES (HSQ-156-F)

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

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Action                    11/10/94                    59 FR 56116
Final Action Effective          07/01/95

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Agency Contact: Pam Vocke, 410 966-7089

RIN: 0938-AD94
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1289. PHYSICIAN CERTIFICATION AND PLAN OF CARE REQUIREMENTS AND 
INSPECTION OF CARE REVIEWS (HSQ-178-P)

CFR Citation:  42 CFR 400; 42 CFR 440; 42 CFR 441; 42 CFR 456; 42 CFR 
483

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Helene Fredeking, 410 966-6807

RIN: 0938-AE17
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1290. ``CONFINED TO THE HOME'' REQUIREMENTS FOR HOME HEALTH 
SERVICES (BPD-626-F)

CFR Citation:  42 CFR 409.42

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: John Thomas, 410 966-4623

RIN: 0938-AE34
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1291. MEDICAID PAYMENT OF MEDICARE COST SHARING FOR QUALIFIED 
MEDICARE BENEFICIARIES AND QUALIFIED DISABLED AND WORKING INDIVIDUALS AND 
SPECIFIED LOW-INCOME MEDICARE BENEFICIARIES (MB-031-P)

CFR Citation:  42 CFR 431.625; 42 CFR 435; 42 CFR 436; 42 CFR 441.256; 
42 CFR 447.600 to 447.620; 42 CFR 447.51; 42 CFR 447.53

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/31/95

Small Entities Affected: None [[Page 23355]] 

Government Levels Affected: None

Agency Contact: Marinos Svolos, 410 966-4451

RIN: 0938-AE38
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1292. PREADMISSION SCREENING AND ANNUAL RESIDENT REVIEW (BPD-661-F)

CFR Citation:  42 CFR 483

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn                       07/28/93

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jan Earle, 410 966-0103

RIN: 0938-AE49
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1293. EXTENDED MEDICAID ELIGIBILITY FOR CERTAIN INDIVIDUALS (MB-
026-F)

CFR Citation:  42 CFR 435; 42 CFR 436; 42 CFR 440; 42 CFR 447

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Marinos Svolos, 410 966-4451

RIN: 0938-AE51
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1294. MEDICARE COVERAGE OF PRESCRIPTION DRUGS USED IN 
IMMUNOSUPPRESSIVE THERAPY (BPD-424-F)

CFR Citation:  42 CFR 410

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Action                    02/16/95                     60 FR 8915
Final Action Effective          01/01/95                     60 FR 8915

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Debra McKeldin, 410 966-9671

RIN: 0938-AE94
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1295. COVERAGE OF PHYSICIAN ASSISTANT, NURSE PRACTITIONER, AND 
CLINICAL NURSE SPECIALIST SERVICES (BPD-708-P)

CFR Citation:  42 CFR 405; 42 CFR 410

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Debra McKeldin, 410 966-9671

RIN: 0938-AF00
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1296. CHANGES TO THE LONG-TERM CARE FACILITY SURVEY PROCESS (HSQ-
175-FC)

CFR Citation:  42 CFR 442; 42 CFR 488

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Pam Vocke, 410 966-7089

RIN: 0938-AF02
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1297. OBRA '90 AND MISCELLANEOUS MANAGED CARE TECHNICAL AMENDMENTS 
(OMC-018-FC)

CFR Citation:  42 CFR 434.21 to 44; 42 CFR 447.361; 42 CFR 447.362

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jane McClard, 410 966-5321

RIN: 0938-AF15
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1298. PROVIDER REIMBURSEMENT DETERMINATIONS AND APPEALS REVISIONS 
(BPD-727-P)

CFR Citation:  42 CFR 405

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Morty Marcus, 410 966-4477

RIN: 0938-AF28
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1299. MEDICAID PAYMENT FOR OBSTETRICAL AND PEDIATRIC SERVICES--
ADEQUATE PAYMENT LEVEL PROVISION (MB-036-P)

CFR Citation:  42 CFR 430.12; 42 CFR 430.16; 42 CFR 447.204; 42 CFR 
447.300; 42 CFR 447.301; 42 CFR 447.393; 42 CFR 447.397

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Bernard Truffer, 410 966-0691

RIN: 0938-AF62
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1300. REQUIREMENTS FOR ENROLLMENT OF MEDICAID RECIPIENTS UNDER COST 
EFFECTIVE EMPLOYER BASED GROUP HEALTH PLANS (MB-047-F)

CFR Citation:  42 CFR 435.2; 42 CFR 435.3; 42 CFR 435.10; 42 CFR 
435.186; 42 CFR 435.188

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None [[Page 23356]] 

Agency Contact: Marinos Svolos, 410 966-4451

RIN: 0938-AF64
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1301. MEDICAID: OUTSTATIONED INTAKE LOCATIONS FOR CERTAIN LOW-
INCOME PREGNANT WOMEN, INFANTS AND CHILDREN UNDER AGE 19 (MB-052-IFC)

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

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Robert Tomlinson, 410 966-4463

RIN: 0938-AF69
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1302. MEDICAID: PAY-IN SPENDDOWN OPTION (MB-055-IFC)

CFR Citation:  42 CFR 435; 42 CFR 436; 42 CFR 435.4; 42 CFR 435.121; 42 
CFR 435.301; 42 CFR 435.831; 42 CFR 435.1007; 42 CFR 436.3; 42 CFR 
436.301; 42 CFR 436.831; 42 CFR 436.1002

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Wanda White, 410 966-4453

RIN: 0938-AF72
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1303. CLARIFICATION OF COVERAGE OF INPATIENT PSYCHIATRIC SERVICES 
(MB-060-F)

CFR Citation:  42 CFR 440; 42 CFR 441

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Robert Wardwell, 410 966-5659

RIN: 0938-AF73
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1304. NATIONAL COVERAGE DECISIONS: RULES FOR RISK CONTRACTING HMOS 
AND CMPS (OMC-019-F)

CFR Citation:  42 CFR 417

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Tracy Jensen, 202 619-2158

RIN: 0938-AF76
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1305. APPLICATION OF INTEREST CHARGES TO MEDICARE SECONDARY PAYER 
RECOVERIES (BPO-108-GN)

CFR Citation:  42 CFR 401.601; 42 CFR 405.376; 45 CFR 30.16; 45 CFR 
30.13

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: John Albert, 410 966-7457

RIN: 0938-AF87
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1306. MINIMUM PHYSICIAN QUALIFICATIONS FOR CERTAIN SERVICES (MB-
059-P)

CFR Citation:  42 CFR 441

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Linda Sizelove, 410 966-4626

RIN: 0938-AF92
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1307. PAYMENT FOR PREADMISSION SERVICES (BPD-731-F)

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

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Nancy Edwards, 410 966-4531

RIN: 0938-AG00
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1308. PAYMENT FOR EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY SERVICES 
FURNISHED BY AMBULATORY SURGICAL CENTERS (BPD-762-FN)

CFR Citation:  42 CFR 416.120; 42 CFR 416.125; 42 CFR 416.130

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Joan H. Sanow, 410 966-5723

RIN: 0938-AG04
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1309. INCOME AND ELIGIBILITY VERIFICATION SYSTEM (MB-66-P)

CFR Citation:  42 CFR 435.940; 42 CFR 435.945; 42 CFR 435.948; 42 CFR 
435.952; 42 CFR 435.953; 42 CFR [[Page 23357]] 435.955; 42 CFR 435.960; 
42 CFR 435.965

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Donna Jarosinski, 410 966-5928

RIN: 0938-AG12
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1310. MEDICARE PROGRAM: PROPOSED ADDITIONS TO AND DELETIONS FROM 
THE CURRENT LIST OF COVERED SURGICAL PROCEDURES FOR AMBULATORY SURGICAL 
CENTERS (BPD-776-FNC)

CFR Citation:  None

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - No further action 
necessary.                      03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Vivian Braxton, 410 966-4564

RIN: 0938-AG27
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1311. MEDICARE PROGRAM: SPECIAL PAYMENT LIMITS FOR HOME BLOOD 
GLUCOSE MONITORS (BPD-778-FN)

CFR Citation:  None

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Action                    01/17/95                     60 FR 3405

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Joel Kaiser, 410 966-4499

RIN: 0938-AG28
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1312. COMMUNITY SUPPORTED LIVING ARRANGEMENTS SERVICES (MB-070-P)

CFR Citation:  42 CFR 435.3; 42 CFR 435.260; 42 CFR 440.1; 42 CFR 
440.190; 42 CFR 441.400; 42 CFR 441.402; 42 CFR 441.404; 42 CFR 
441.406; 42 CFR 441.408; 42 CFR 441.410; 42 CFR 441.412; 42 CFR 441.414

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Mary Jean Duckett, 410 966-5640

RIN: 0938-AG35
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1313. PART A PREMIUM FOR 1995 FOR THE UNINSURED AGED AND FOR 
CERTAIN DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER ENTITLEMENT (OACT-
046-N)

CFR Citation:  None

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Action                    12/01/94                    59 FR 61626
Final Action Effective          01/01/95                    59 FR 61626

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: John Wandishin, 410 966-6389

RIN: 0938-AG49
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1314. MEDICARE PROGRAM: MONTHLY ACTUARIAL RATES AND MONTHLY 
SUPPLEMENTARY MEDICAL INSURANCE PREMIUM RATES BEGINNING JANUARY 1, 1995 
(OACT-047-N)

CFR Citation:  None

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Action                    10/01/94                    59 FR 61629
Final Action Effective          01/01/95                    59 FR 61629

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Carter Warfield, 410 966-6396

RIN: 0938-AG50
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1315. INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED CARE 
SERVICES COINSURANCE AMOUNTS FOR 1995 (OACT-048-N)

CFR Citation:  None

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Action                    12/01/94                    59 FR 61628
Final Action Effective          01/01/95                    59 FR 61628

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: John Wandishin, 410 966-6389

RIN: 0938-AG51
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1316. REFINEMENTS TO GAF VALUES, REVISIONS TO PAYMENT POLICIES, 
ADJUSTMENTS TO THE RVUS UNDER THE PHYSICIAN FEE SCHEDULE FOR CY 95, AND 
THE 5-YEAR REFINEMENTS OF RVUS (BPD-789-FC)

CFR Citation:  42 CFR 410; 42 CFR 414

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Public comments will 
be considered in RIN 0938-AG96. 03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Elizabeth Holland, 410 966-1309

RIN: 0938-AG52
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1317. CONDITIONS FOR PAYMENT FOR PHYSICIANS' SERVICES IN TEACHING 
SETTINGS (BPD-792-P)

CFR Citation:  42 CFR 405; 42 CFR 415; 42 CFR 400

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: William Morse, 410 966-4520

RIN: 0938-AG53
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1318. SCHEDULE OF LIMITS ON HOME HEALTH AGENCY COSTS PER VISIT 
(BPD-793-NC)

CFR Citation:  None [[Page 23358]] 

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Action                    02/14/95                     60 FR 8389
Final Action Effective          02/14/95                     60 FR 8389

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Michael Bussacca, 410 966-4602

RIN: 0938-AG54
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1319. NEW LOOK BEHIND FOR INTERMEDIATE CARE FACILITIES FOR THE 
MENTALLY RETARDED (ICFS/MR) (HSQ-214-P)

CFR Citation:  42 CFR 442.116

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Withdrawn by agency.03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Pamela V. Vocke, 410 966-7089

RIN: 0938-AG58
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1320. INSTITUTIONAL PLAN AMENDMENT FINDINGS (MB-078-P)

CFR Citation:  42 CFR 430; 42 CFR 447

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn                       12/23/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Bernie Truffer, 410 966-1357

RIN: 0938-AG60
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1321. FREEDOM OF CHOICE WAIVER; CONFORMING CHANGES (OMC-021-F)

CFR Citation:  42 CFR 431.55; 42 CFR 431.57

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Tracy Jensen, 202 619-2158

RIN: 0938-AG63
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1322. EFFECTS OF GENERALLY ACCEPTED ACCOUNTING PRINCIPLES (GAAP) ON 
REASONABLE COSTS DETERMINATIONS (BPD-800-P)

CFR Citation:  42 CFR 413.20; 42 CFR 413.24

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: John Eppinger, 410 966-4518

RIN: 0938-AG66
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1323. EXPANSION OF THE DEFINITION OF EYE AND EAR SPECIALTY 
HOSPITALS (BPD-804-P)

CFR Citation:  42 CFR 413

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/24/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Carolyn Mullen, 410 966-4589

RIN: 0938-AG67
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1324. PHYSICIAN PERFORMANCE STANDARD RATES OF INCREASE FOR FY 1995 
AND PHYSICIAN FEE SCHEDULE UPDATE FOR CY 1995 (BPD-807-FN)

CFR Citation:  None

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Action                    01/01/95                     59 FR 6363

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Bernard Patashnik, 410 966-4497

RIN: 0938-AG69
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1325. PROPOSED PAYMENTS TO DISPROPORTIONATE SHARE HOSPITALS FOR FY 
1995 (MB-089-N)

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

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Action                    01/13/95                     60 FR 3250

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Richard Strauss, 410 966-2019

RIN: 0938-AG75
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1326. EXTENSION OF CERTAIN EFFECTIVE DATES FOR CLINICAL LABORATORY 
REQUIREMENTS AND PERSONNEL REQUIREMENTS FOR CYTOLOGISTS (HSQ-217-FC)

CFR Citation:  42 CFR 493.855; 42 CFR 493.1201; 42 CFR 493.1202; 42 CFR 
493.1203; 42 CFR 493.1213; 42 CFR 493.1215; 42 CFR 493.1217; 42 CFR 
493.1218; 42 CFR 493.1223; 42 CFR 493.1443

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Action                    12/06/94                    59 FR 62606

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Kathleen Kremann, 410 597-5906

RIN: 0938-AG86
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1327. APPROVAL OF THE AMERICAN SOCIETY FOR HISTOCOMPATIBILITY AND 
IMMUNOGENETICS FOR THE SPECIALTY OF HISTOCOMPATIBILITY (HSQ-220-N)

CFR Citation:  42 CFR 493.501

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Action                    10/20/94                    59 FR 52968
Final Action Effective          10/20/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Anthony Tirone, 410 966-6763

RIN: 0938-AG88


______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

[[Page 23359]]
1328. MEDICAID: COVERAGE OF REHABILITATION SERVICES (MB-076-P)

CFR Citation:  42 CFR 440.130; 42 CFR 440.110; 42 CFR 440.90

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn                       01/25/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Linda Sizelove, 410 966-4626

RIN: 0938-AG89
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________

1329. INFORMATION, COUNSELING, AND ASSISTANCE GRANTS PROGRAMS: 
MEDICARE PROGRAM (OBS-001-FC)

CFR Citation:  42 CFR 403

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Rule With Comment Period  10/07/94                    59 FR 51125

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Eric Lang, 410 966-3193

RIN: 0938-AG91
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Health Care Financing Administration (HCFA)
______________________________________________________________________


1330. QUALIFIED HEALTH MAINTENANCE ORGANIZATIONS: TECHNICAL 
AMENDMENTS (OMC-009-FC)

CFR Citation:  42 CFR 417

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Tracy Jensen, 202 619-2158

RIN: 0938-AG92



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Administration for Children and Families (ACF)
______________________________________________________________________

1331. FOSTER CARE, ADOPTION ASSISTANCE, AND CHILD WELFARE SERVICES

Priority:  Other Significant

Legal Authority:  42 USC 627

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

Legal Deadline: None

Abstract: This NPRM will propose criteria the Department will use to 
verify that a State has met statutory requirements and is eligible to 
receive additional funds under section 427 of the Social Security Act. 
The proposed rule will contain the specific criteria by which State 
performance in meeting the requirements of section 427 is determined, 
the percentage levels and other standards for case record compliance, 
and procedures for conducting compliance reviews.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            07/00/95

Small Entities Affected: None

Government Levels Affected: State

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

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

RIN: 0970-AA97
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Administration for Children and Families (ACF)
______________________________________________________________________

1332. 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 NPRM will propose to update 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                            04/00/95

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, 202 690-
5504

RIN: 0970-AB11
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Administration for Children and Families (ACF)
______________________________________________________________________

1333. STANDARDS FOR SAFE TRANSPORTATION

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 9801 et seq

CFR Citation:  45 CFR 1310

Legal Deadline: None

Abstract: The NPRM will propose 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 enroute and loading and unloading of vehicles.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            06/00/95

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, 202 
205-8569

RIN: 0970-AB24


______________________________________________________________________



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Administration for Children and Families (ACF)
______________________________________________________________________

[[Page 23360]]
1334. NOTICE OF PROPOSED RULEMAKING FOR THE ADMINISTRATION OF 
NATIVE AMERICANS 45 CFR PART 1336

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 2991

CFR Citation:  45 CFR 1336

Legal Deadline:  NPRM, Statutory, March 30, 1993.

Abstract: The regulations propose to amend 45 CFR part 1336 to 
implement new legislative requirements. It will incorporate an appeals 
procedure affording applicants the opportunity to appeal based on 
organizational ineligibility or activities deemed ineligible, when 
determined by the ANA Commissioner. Native American organizations are 
expected to welcome these changes which provide for an appeal of 
appeals decisions and comport with recent amendments to the statute.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            04/00/95

Small Entities Affected: Organizations

Government Levels Affected: Tribal

Agency Contact: Sharon McCully, Director, Planning and Support, 
Department of Health and Human Services, Administration for Children 
and Families, 200 Independence Ave SW., Washington, DC 20201, 020 690-
5780

RIN: 0970-AB37
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Administration for Children and Families (ACF)
______________________________________________________________________

1335. 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 adult 
disallowances; (3) Allotments for territories; and, (4) Standards for 
reviewing grantee interpretations of statutory requirements.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            07/00/95

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, 202 401-9351

RIN: 0970-AB47
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Administration for Children and Families (ACF)
______________________________________________________________________

1336. ADMINISTRATIVE FLEXIBILITY RULE

Priority:  Other Significant

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. Such waivers will give States more 
flexibility to devise procedures for the effective and efficient 
administration of their AFDC programs. The major provisions for which 
waivers will be granted are: (1) the requirements for prospective 
budgeting of income; (2) the time period for calculating the total 
amount of overpayment and the determination of when the initial 
overpayment begins; and (3) other provisions on various disregards and 
self-employment business expenses.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            10/00/95

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, 202 
401-9289

RIN: 0970-AB49
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Administration for Children and Families (ACF)
______________________________________________________________________

1337. DESIGNATION OF ALTERNATIVE AGENCY TO SERVE INDIAN TRIBAL 
CHILDREN

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 9801

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                            08/00/95

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, 202 
205-8569

RIN: 0970-AB52
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Administration for Children and Families (ACF)
______________________________________________________________________

1338. INCOME ELIGIBILITY CRITERIA FOR INDIAN TRIBES

Priority:  Substantive, Nonsignificant

Legal Authority:  45 USC 9801

CFR Citation:  45 CFR 1305

Legal Deadline: None

Abstract: This NPRM 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 23361]] children whose 
families do not meet Head Start's income criteria than would otherwise 
be possible.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            09/00/95

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, 202 
205-8569

RIN: 0970-AB53
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Administration for Children and Families (ACF)
______________________________________________________________________

1339. CONSTRUCTION OF HEAD START FACILITIES

Priority:  Other Significant

Legal Authority:  42 USC 9801

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                            10/00/95

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, 202 
205-8569

RIN: 0970-AB54
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Administration for Children and Families (ACF)
______________________________________________________________________

1340. QUALITY STANDARDS FOR HEAD START PROGRAMS

Priority:  Regulatory Plan

Legal Authority:  42 USC 9801

CFR Citation:  45 CFR 1301; 45 CFR 1304; 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 Head Start Programs 
including health, education, parent involvement, nutritional, social 
and transitional services, administrative and financial management 
standards and standards relating to the condition and location of 
facilities used to carry out Head Start activities. This rule 
incorporates provisions previously considered in our rulemaking 
entitled ``Performance Standards for Infants and Toddlers''.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            06/00/95

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, 202 
205-8569

RIN: 0970-AB55
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Administration for Children and Families (ACF)
______________________________________________________________________


1341. HEAD START FELLOWSHIPS 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                            06/00/95

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, 202 
205-8569

RIN: 0970-AB56



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Administration for Children and Families (ACF)
______________________________________________________________________

1342. BLOCK GRANT PROGRAMS (LOW-INCOME HOME ENERGY ASSISTANCE 
PROGRAM --LIHEAP) FY 91 AND FY 92 PROVISIONS

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 8621 et seq

CFR Citation:  45 CFR 96

Legal Deadline: None

Abstract: This final rule amends the Department's regulations governing 
the administration of block grant programs; this rule applies to the 
Low-Income Home Energy Assistance Program (LIHEAP). The rule revises 
provisions included in an interim final rule published 01/16/92, that 
amended the block grant regulations and implemented changes to the 
LIHEAP statute which were made by the Augustus F. Hawkins Human 
Services Reauthorization Act of 1990 (Pub. L. 101-501). These changes 
involve the Department's response to formal complaints, a reduction in 
the percent of LIHEAP funds that grantees may carry forward from one 
fiscal year to the next, waiver authority to increase the percent of 
LIHEAP funds that grantees may use for weatherization from 15% to 25%, 
a requirement for additional outreach and intake services under certain 
circumstances, and a new leveraging incentive program. This final rule 
also makes several related, largely technical amendments to the block 
grant regulations.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

Interim Final Rule              01/16/92                     57 FR 1960
Final Action                    04/00/95

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Janet M. Fox, Director, Division of Energy Assistance, 
Office of Community Services, Department of Health and Human Services, 
Administration for Children [[Page 23362]] and Families, 370 L'Enfant 
Promenade SW., Washington, DC 20447, 202 401-9351

RIN: 0970-AB15
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Administration for Children and Families (ACF)
______________________________________________________________________

1343. BLOCK GRANT PROGRAMS (LOW-INCOME HOME ENERGY ASSISTANCE 
PROGRAM--LIHEAP)--FY 93 AND FY 94 PROVISIONS

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 8621 et seq

CFR Citation:  45 CFR 96

Legal Deadline: None

Abstract: The final rule 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 Augustus F. Hawkins Services 
Reauthorization Act (HRSA) of 1990 (Pub. L. 101-501) and language in 
the fiscal year 1993 appropriations statute (Pub. L. 102-394) that will 
affect grantee administration of the LIHEAP program in fiscal years 
1993 and 1994. The major changes effective FY 93 and FY 94 is: -- 
Ending of authority to transfer LIHEAP funds to other block grant 
programs. This rule also contains proposed requirements for an 
application completion date in order for Indian tribes and tribal 
organizations to receive Community Service Block Grant program funds. 
The rule includes certain submission and completion dates for States 
applying for Community Services, Social Services and LIHEAP block grant 
funds to cover requirements under the Cash Management Improvement Act 
of 1990, P.L. 101-453.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            11/16/93                    58 FR 60498
Final Action                    08/00/95

Small Entities Affected: None

Government Levels Affected: State

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, 202 401-9351

RIN: 0970-AB16
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Administration for Children and Families (ACF)
______________________________________________________________________

1344. FAMILY VIOLENCE PREVENTION AND SERVICES

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 10407

CFR Citation:  45 CFR 1370

Legal Deadline:  NPRM, Statutory, August 26, 1992. Final, Statutory, 
September 25, 1992.

Abstract: Would implement the requirements under the Family Violence 
Prevention and Services Act which provides various grants related to 
domestic violence.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            12/10/93                    58 FR 64920
Final Action                    07/00/95

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Local

Agency Contact: Margaret Washnitzer, Director, Division of State 
Assistance, Office of Community Services, Department of Health and 
Human Services, Administration for Children and Families, 370 L'Enfant 
Promenade SW., Washington, DC 20447, 202 401-2333

RIN: 0970-AB18
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Administration for Children and Families (ACF)
______________________________________________________________________

1345. 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                    06/00/95

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: David W. Lloyd, 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, 202 205-8586

RIN: 0970-AB23
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Administration for Children and Families (ACF)
______________________________________________________________________

1346. 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 will propose 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                    09/00/95

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, 202 
205-8569

RIN: 0970-AB31
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Administration for Children and Families (ACF)
______________________________________________________________________

1347. 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); 45 CFR 206.10; 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                    09/00/95

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State, Local

Agency Contact: Mack Storrs, Director, Division of AFDC Program, 
[[Page 23363]] Department of Health and Human Services, Administration 
for Children and Families, 370 L'Enfant Promenade SW., Washington, DC 
20447, 202 401-9289

RIN: 0970-AB32
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Administration for Children and Families (ACF)
______________________________________________________________________

1348. CHILD CARE--REVISED REGULATIONS

Priority:  Other Significant

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 
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                    05/00/95

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, 202 205-8572

RIN: 0970-AB33
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Administration for Children and Families (ACF)
______________________________________________________________________

1349. FAMILY PRESERVATION AND SUPPORT

Priority:  Other Significant

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 Welfare 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 welfare 
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                    06/00/95

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, 202 205-8618

RIN: 0970-AB34
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Administration for Children and Families (ACF)
______________________________________________________________________

1350. STATEWIDE AUTOMATED CHILD WELFARE INFORMATION SYSTEM

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 103-66

CFR Citation:  45 CFR 1355; 45 CFR 1356

Legal Deadline: None

Abstract: These interim final rules implement section 13713 of the 
Omnibus Budget Reconciliation Act of 1993, Public Law 103-66, signed by 
the President on August 10, 1993.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

Interim Final Rule              12/22/93                    58 FR 87939
Final Action                    04/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Naomi B. Marr, Director, Office of Information Systems 
Mgmt, Department of Health and Human Services, Administration for 
Children and Families, 300 E Hubert Humphrey Building, 200 Independence 
Ave. SW., Washington, DC 20201, 202 401-6960

RIN: 0970-AB38
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Administration for Children and Families (ACF)
______________________________________________________________________

1351. REFUGEE RESETTLEMENT PROGRAM: MISCELLANEOUS, COMPREHENSIVE 
CHANGES

Priority:  Other Significant

Legal Authority:  8 USC 1522

CFR Citation:  45 CFR 400

Legal Deadline: None

Abstract: We are proposing to make miscellaneous, comprehensive changes 
to existing regulations at 45 CFR part 400.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            08/12/94                    59 FR 41417
Final Action                    06/00/95

Small Entities Affected: None

Government Levels Affected: State, Local

Agency Contact: Toyo A. Biddle, Deputy Director, Division of Policy 
Analysis, Department of Health and Human Services, Administration for 
Children and Families, 370 L'Enfant Promenade SW., Washington, D.D. 
20447, 202 401-9250

RIN: 0970-AB42
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Administration for Children and Families (ACF)
______________________________________________________________________

1352. DIRECT PAYMENTS TO INDIAN TRIBES AND TRIBAL ORGANIZATIONS 
UNDER TITLE IV-B, SUBPART 1

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 628

CFR Citation:  45 CFR 1357.40

Legal Deadline: None

Abstract: This NPRM will propose to amend the regulations governing 
direct payments to Indian Tribes and Indian Tribal Organizations (ITOs) 
for child welfare services under title IV-B, subpart 1. It will 
eliminate the requirement that to be eligible, Indian Tribes and ITOs 
must provide services under contract (or grant) with the Secretary of 
the Interior under section 102 of the Indian Self-Determination Act. It 
will also add a description of the formula used to calculate the amount 
of Federal funds available to eligible Tribes and ITOs under title IV-
B, subpart 1. [[Page 23364]] 

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            10/20/94                    59 FR 52591
Final Action                    08/00/95

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State, Tribal

Agency Contact: Michael Ambrose, Director, Division of Child Welfare, 
Children's Bureau, ACYF, Department of Health and Human Services, 
Administration for Children and Families, P.O. Box 1182, Washington, DC 
20013, 202 205-8618

RIN: 0970-AB44
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Administration for Children and Families (ACF)
______________________________________________________________________

1353. REPATRIATION - ADVANCE APPROVAL OF COSTS

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1313

CFR Citation:  45 CFR 212

Legal Deadline: None

Abstract: This document proposes to amend the regulations concerning 
the U.S. Repatriate Program. The proposal is to require agencies 
providing assistance to groups of United States citizens who are 
returned from foreign countries to the United States by the Department 
of State due to war, threat of war, civil disorder, or natural disaster 
to request advance approval from the Administration of Children and 
Families to incur expenses for preparing to implement group 
repatriation plans. This action is necessary in order for the 
Department to control the limited funding available for such 
activities.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

NPRM                            08/19/94                    59 FR 42795
Final Action                    08/00/95

Small Entities Affected: None

Government Levels Affected: Undetermined

Agency Contact: David B. Smith, Director, Division of State 
Legalization and Repatriation, Department of Health and Human Services, 
Administration for Children and Families, 370 L'Enfant Promenade SW., 
Washington, DC 20447, 202 401-9255

RIN: 0970-AB45
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Administration for Children and Families (ACF)
______________________________________________________________________

1354. REDUCTION OF REPORTING REQUIREMENTS FOR THE STATE SYSTEMS 
ADVANCE PLANNING DOCUMENT (APD) PROCESS

Priority:  Other Significant

Legal Authority:  42 USC 1302

CFR Citation:  45 CFR 95.600

Legal Deadline: None

Abstract: These proposed rules will 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

_______________________________________________________________________

Interim Final Rule              05/00/95

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, 202 401-6404

RIN: 0970-AB46
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Administration for Children and Families (ACF)
______________________________________________________________________

1355.  REPORTING OVERDUE SUPPORT INFORMATION TO CONSUMER 
REPORTING AGENCIES

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 103-432

CFR Citation:  45 CFR 302; 45 CFR 303

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.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

Interim Final Rule              10/00/95

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, 202 401-5373

RIN: 0970-AB57
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Administration for Children and Families (ACF)
______________________________________________________________________

1356.  AFCARS DATA ELEMENT ON FOSTER CARE PAYMENTS

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 670

CFR Citation:  45 CFR 1355

Legal Deadline: None

Abstract: This regulation will add a financial data element to the 
AFCARS Appendices regarding the monthly amount of State and Federal 
foster care benefits; this data element was requested by OMB and is 
addressed in the preamble to the NPRM.

Timetable:
_______________________________________________________________________

Action                            Date                      FR Cite

_______________________________________________________________________

Final Action                    06/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Daniel H. Lewis, Associate Commissioner, Children's 
Bureau, Department of Health and Human Services, Administration for 
Children and Families, P.O. Box 1182, Washington, DC 20013, 202 205-
8619

RIN: 0970-AB58
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Final Rule Stage
Administration for Children and Families (ACF)
______________________________________________________________________


1357.  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 [[Page 23365]] 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                    09/00/95

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, 202 401-9289

RIN: 0970-AB59



______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Administration for Children and Families (ACF)
______________________________________________________________________

1358. AID TO FAMILIES WITH DEPENDENT CHILDREN PROGRAM; EXTENSION OF 
MEDICAID ELIGIBILITY WHEN SUPPORT COLLECTIONS RESULT IN TERMINATION OF 
AFDC ELIGIBILITY

CFR Citation:  42 CFR 435; 42 CFR 436; 45 CFR 233

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Action                    11/17/94                    59 FR 59372

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Mack A. Storrs, 202 401-9289

RIN: 0970-AA07
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Administration for Children and Families (ACF)
______________________________________________________________________

1359. TITLE IV-E TRAINING

CFR Citation:  45 CFR 235; 45 CFR 1356.60

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Publication not 
expected during this semiannual 
period.                         03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Daniel H. Lewis, 202 205-8618

RIN: 0970-AB25
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Administration for Children and Families (ACF)
______________________________________________________________________

1360. STATE LEGALIZATION IMPACT ASSISTANCE GRANT

CFR Citation:  45 CFR 402

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Action                    12/24/94                    59 FR 65723

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: David B. Smith, 202 401-9255

RIN: 0970-AB28
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Administration for Children and Families (ACF)
______________________________________________________________________

1361. CHILD SUPPORT ENFORCEMENT PROGRAM: PATERNITY ESTABLISHMENT 
AND REVISION OF CHILD SUPPORT ENFORCEMENT PROGRAM AND AUDIT REGULATIONS

CFR Citation:  45 CFR 301; 45 CFR 302; 45 CFR 303; 45 CFR 305

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Final Action                    12/23/94                    59 FR 66204

Small Entities Affected: None

Government Levels Affected: State, Local, Federal

Agency Contact: Marianne Upton, 202 401-5373

RIN: 0970-AB40
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Administration for Children and Families (ACF)
______________________________________________________________________

1362. INTERSTATE CASE CLOSURE

CFR Citation:  45 CFR 303

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn                       04/01/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Susan Notar, 202 401-4606

RIN: 0970-AB41
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Administration for Children and Families (ACF)
______________________________________________________________________

1363. AUTOMOBILE RESOURCE LIMIT

CFR Citation:  45 CFR 233

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn                       04/01/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Mack A. Storrs, 202 401-9289

RIN: 0970-AB48
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Administration for Children and Families (ACF)
______________________________________________________________________

1364. HEAD START INITIATIVE ON FAMILIES WITH INFANTS AND TODDLERS

CFR Citation:  45 CFR 1307

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn - Combined with RIN 
0970-AB55                       09/12/94                    59 FR 46806

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Douglas Klafehn, 202 025-8569

RIN: 0970-AB50
______________________________________________________________________




______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHSCompleted/Longterm Actions
Administration for Children and Families (ACF)
______________________________________________________________________


1365. FLEXIBILITY IN THE UTILIZATION OF INFORMATION OBTAINED 
THROUGH THE INCOME ELIGIBILITY VERIFICATION SYSTEM

CFR Citation:  45 CFR 205.55; 45 CFR 205.56; 45 CFR 205.60; 45 CFR 
205.62

Completed:
_______________________________________________________________________

Reason                            Date                      FR Cite

_______________________________________________________________________

Withdrawn                       04/01/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Mack Storrs, 202 401-9289

RIN: 0970-AB51


[[Page 23366]] 
______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)      Proposed Rule Stage
Administration on Aging (AOA)
______________________________________________________________________


1366. 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:  Other Significant

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:  NPRM, Statutory, April 1, 1993. Final, Statutory, June 
1, 1993.
120 days after 09/30/92, per PL 102-375, Section 902.

Abstract: The Administration on Aging (AoA) is proposing to revise the 
current rules governing State agencies, area agencies on aging, Indian 
tribes, organizations serving older individuals who are Hawaiian 
Natives, and service providers providing services and advocating on 
behalf of older individuals who are eligible for supportive and 
nutrition services under the Older Americans Act of 1965, as amended.
The purpose of these revisions is to provide a structure for the 
operation of the Act's Title VII program for vulnerable elder rights 
protection activities under a new 45 CFR part 1327 of these 
regulations; establish competitive guidelines and procedures for the 
making of Title IV grants and contracts, under a new 45 CFR part 1324 
of these regulations; and clarify new program and policy directions in 
the development of intrastate funding formulas, as well as past 
omissions, under 45 CFR parts 1321, 1326, and 1328 of these current 
regulations. We believe that these additions and revisions will assist 
State agencies, area agencies on aging, Indian tribes, organizations 
serving older individuals who are Hawaiian Natives, and service (cont)

Timetable:

Balance of OAA Amendments  NPRM 08/01/95

Elder Rights Protection  NPRM 11/15/94 (59 FR 59056)  NPRM Comment 
Period End 01/17/95 (59 FR 59056)  Final Action 08/01/95

Intrastate Funding Formulas  NPRM 03/17/94 (59 FR 12728)  NPRM Comment 
Period End 05/16/94  Final Action 08/01/95

Small Entities Affected: Organizations

Government Levels Affected: State, Tribal

Additional Information: ABSTRACT CONT: providers in the development and 
provision of community-based services.

Agency Contact: William F. Benson, Deputy Assistant Secretary for 
Aging, Department of Health and Human Services, Administration on 
Aging, 330 Independence Avenue SW., Room 4760, Cohen Bldg., Washington, 
DC 20201, 202 619-0556

RIN: 0985-AA00
[FR Doc. 95-8531 Filed 05-05-95; 8:45 am]
BILLING CODE 4150-04-F