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


_______________________________________________________________________

Part VIII





Department of Health and Human Services





_______________________________________________________________________



Semiannual Regulatory Agenda

[[Page 62486]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)                          


  



_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

21 CFR Ch. I

42 CFR Chs. I-V

45 CFR Subtitle A, Chs. II, III, and XIII

Unified Agenda of Federal Regulatory and Deregulatory Actions

AGENCY: Office of the Secretary, HHS.

ACTION: Semiannual regulatory agenda.

_______________________________________________________________________

SUMMARY: The President's September 30, 1993, Executive Order 12866 and 
the Regulatory Flexibility Act of 1980 require the Department 
semiannually to publish an agenda summarizing all rulemaking under 
development and indicating those regulatory actions being analyzed for 
impact on small businesses. The Department published its last such 
agenda on May 13, 1996.

    The current agenda reflects the Department's ongoing efforts to 
reinvent its rulemaking practices in accordance with the 
President's initiative to reform the Nation's regulatory system. 
Comments are invited to assist the Department in continuing to 
review its regulatory processes and products.

FOR FURTHER INFORMATION CONTACT: Ann White, Department of Health and 
Human Services, Washington, DC 20201, (202) 690-6824, or the contact 
person for a specific division or agency of the Department as listed 
below.

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

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

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

    The most important regulations cited in the agenda are also 
described in fuller detail in the 1996 Regulatory Plan, published 
in Part II of this issue of the Federal Register. (Where a 
Regulatory Plan entry is listed in the Agenda's Table of Contents, 
a bolded indication of the Plan sequence number is also included in 
parentheses.)

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

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

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

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

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

    Agency for Health Care Policy and Research: Peggy Washburn, 
2101 East Jefferson Street, Suite 603, Rockville, Maryland 20852; 
phone 301-594-1457.

    Centers for Disease Control/Agency for Toxic Substances and 
Disease Registry: Theresa Rogers, 1600 Clifton Road NE., Mail Stop 
D-23, Atlanta, Georgia 30333; phone 404-639-7075.

    Health Resource Services Administration: Alice Wallis, 5600 
Fishers Lane, Room 14A08, Rockville, Maryland 20857; phone 301-443-
1960.

    Indian Health Service: Betty J. Penn, 12300 Twinbrook Parkway, 
Suite 450, Rockville, Maryland 20857; phone 301-443-1116.

    National Institutes of Health: Jerry Moore, 9000 Rockville 
Pike, Building 31, Room 1B25, 31 CENTER DR MSC 2075, Bethesda, 
Maryland 20205; phone 301-496-4606.

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

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

Dated: September 25, 1996.

Claudia Cooley,

Executive Secretary to the Department.

                                  Office of the Secretary--Proposed Rule Stage                                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1178        Civil Money Penalties for False Information on Drug Manufacturer Price Surveys and                  
            Rebate Agreements.....................................................................    0991-AA80 
----------------------------------------------------------------------------------------------------------------


[[Page 62487]]


                                    Office of the Secretary--Final Rule Stage                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1179        Civil Money Penalties for Physician Ownership of and Referral to Certain Health Care                
            Entities..............................................................................    0991-AA65 
1180        Clarification of the Initial OIG Safe Harbor Provisions and Establishment of                        
            Additional Safe Harbor Provisions Under the Anti-Kickback Statute.....................    0991-AA66 
1181        Reproduction and Sale of Official Forms and Publications..............................    0991-AA83 
----------------------------------------------------------------------------------------------------------------


                                   Office of the Secretary--Long-Term Actions                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1182        Civil Money Penalties (CMPs) for Certain Hospital Physician Incentive Plans...........    0991-AA45 
1183        Civil Money Penalties (CMPs) for Certain Practices Relating to Medicare Supplemental                
            Policies..............................................................................    0991-AA53 
1184        Civil Money Penalties for Notifying a Home Health Agency, or a Home or Community-Based              
            Health Care Center or Provider, of a Standard Survey..................................    0991-AA79 
1185        Senior Biomedical Research Services...................................................    0991-AA82 
----------------------------------------------------------------------------------------------------------------


                                   Office of the Secretary--Completed Actions                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1186        Medicare and State Health Care Programs and Program Fraud Civil Remedies: Fraud and                 
            Abuse; Civil Money Penalties Inflation Adjustment.....................................    0991-AA84 
----------------------------------------------------------------------------------------------------------------


                   Substance Abuse and Mental Health Services Administration--Final Rule Stage                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1187        Protection and Advocacy for Individuals With Mental Illness...........................    0930-AA02 
----------------------------------------------------------------------------------------------------------------


                  Substance Abuse and Mental Health Services Administration--Long-Term Actions                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1188        Block Grants for Prevention and Treatment of Substance Abuse..........................    0930-AA01 
----------------------------------------------------------------------------------------------------------------


                                  Departmental Management--Proposed Rule Stage                                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1189        Implementation of the Equal Access to Justice Act in Agency Proceedings...............    0990-AA02 
----------------------------------------------------------------------------------------------------------------


                                   Food and Drug Administration--Prerule Stage                                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1190        Medical Foods.........................................................................    0910-AA20 
1191        Investigational New Drug Applications; Request for Information and Comments...........    0910-AA83 

[[Page 62488]]

                                                                                                                
1192        Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter                  
            Drug Monograph System; Request for Information and Comments...........................    0910-AA96 
----------------------------------------------------------------------------------------------------------------


                                Food and Drug Administration--Proposed Rule Stage                               
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1193        Infant Formula: Good Manufacturing Practice, Quality Control Procedures, Quality                    
            Factors, Notification Requirements, and Records and Reports...........................    0910-AA04 
1194        Reporting of Errors and Accidents.....................................................    0910-AA12 
1195        Mammography Quality Standards Act of 1992 (Reg Plan Seq. No. 26)......................    0910-AA24 
1196        Hearing Aids; Professional and Patient Labeling; Conditions for Sale..................    0910-AA39 
1197        Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution....    0910-AA49 
1198        Bioavailability and Bioequivalence Requirements.......................................    0910-AA51 
1199        Drugs Used for Treatment of Narcotic Addicts..........................................    0910-AA52 
1200        Adverse Experience Reporting for Human Drug and Licensed Biological Products;                       
            Increased Frequency Reports...........................................................    0910-AA72 
1201        Investigational New Drug Applications; Clinical Holds.................................    0910-AA73 
1202        Parenteral Drug Products Containing Aluminum as an Ingredient or Contaminant; Labeling              
            Requirements; Warning Statement.......................................................    0910-AA74 
1203        Long-Term Contraceptive Drug Products and Medical Devices; Informed Consent                         
            Requirements..........................................................................    0910-AA75 
1204        Debarment Certification Regulations for Drug Applications.............................    0910-AA76 
1205        Certification of Drugs Composed Wholly or Partly of Insulin...........................    0910-AA77 
1206        Over-the-Counter Human Drugs; Labeling Requirements...................................    0910-AA79 
1207        Investigational New Drug Applications; Clinical Holds for Drugs for Life-Threatening                
            Illnesses.............................................................................    0910-AA84 
1208        Adverse Experience Reporting, Recordkeeping, and Records Access Requirements for                    
            Marketed OTC Drugs That Are Now the Subjects of Approved New Drug or Abbreviated New                
            Drug Apps.............................................................................    0910-AA86 
1209        Sterility Requirements for Inhalation Solution Products...............................    0910-AA88 
1210        Direct-to-Consumer Promotion Regulations..............................................    0910-AA90 
1211        Substances Prohibited From Use in Animal Food or Feed; Protein Derived From Ruminants               
            Prohibited in Ruminant Feed (Reg Plan Seq. No. 27)....................................    0910-AA91 
1212        Treatment Use of Investigational Device Exemptions....................................    0910-AA92 
1213        Revision of the Requirements for a Responsible Head for Biological Establishments.....    0910-AA93 
1214        Labeling for Human Prescription Drugs; Revised Format.................................   0910-AA94  
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.          


                                 Food and Drug Administration--Final Rule Stage                                 
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1215        Over-the-Counter (OTC) Drug Review....................................................    0910-AA01 
1216        New Animal Drug Approval Process; Implementation of Title I of the Generic Animal Drug              
            and Patent Term Restoration Act (GADPTRA).............................................    0910-AA02 
1217        Prescription Drug Marketing Act of 1987; Policy Information, Guidance, and                          
            Clarifications........................................................................    0910-AA08 
1218        Implementation of the Safe Medical Devices Act of 1990................................    0910-AA09 
1219        Disqualification of Clinical Investigators............................................    0910-AA21 
1220        Investigational Device Exemption; Intraocular Lenses..................................    0910-AA22 
1221        Specific Requirements on Content and Format of Labeling for Human Prescription Drugs;               
            Addition of ``Geriatric Use'' Subsection in the Labeling..............................    0910-AA25 
1222        Tamper-Evident Packaging Requirements for Over-the-Counter Human Drug Products........    0910-AA26 
1223        Adverse Experience Expedited Reporting Requirements for Human Drug and Licensed                     
            Biological Products...................................................................    0910-AA28 
1224        Electronic Signatures; Electronic Records.............................................    0910-AA29 
1225        Financial Disclosure by Clinical Investigators........................................    0910-AA30 
1226        Latex Condoms: Expiration Date Labeling...............................................    0910-AA32 
1227        Latex Warning.........................................................................    0910-AA34 
1228        Human Tissue Intended for Transplantation.............................................    0910-AA40 

[[Page 62489]]

                                                                                                                
1229        Iron Containing Drugs and Supplements.................................................    0910-AA42 
1230        Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding               
            of Drugs; Proposed Amendment of Certain Requirements for Finished Pharmaceuticals.....    0910-AA45 
1231        Consolidation of Regulations..........................................................    0910-AA53 
1232        Changes to an Approved Application (Reg Plan Seq. No. 28).............................    0910-AA57 
1233        Reinventing FDA Food Regulations......................................................    0910-AA58 
1234        New Drug Applications; Drug Master File...............................................    0910-AA78 
1235        National Environmental Policy Act; Policies and Procedures............................    0910-AA80 
1236        Current Good Manufacturing Practice for Finished Pharmaceutical; Positron Emission                  
            Tomography............................................................................    0910-AA81 
1237        Investigational New Drug Applications and New Drug Applications.......................    0910-AA82 
1238        Postmarketing Periodic Adverse Experience Reporting Requirements for Human Drug and                 
            Licensed Biological Products..........................................................    0910-AA85 
1239        New Drugs for Human Use; Clarification of Requirements for Application Supplements....    0910-AA87 
1240        Disqualification of a Clinical Investigator...........................................   0910-AA95  
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.          


                                 Food and Drug Administration--Long-Term Actions                                
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1241        Fees for Certification Services; Insulin and Color Additive Certification Programs....    0910-AA07 
1242        Review of Warnings, Use Instructions, and Precautionary Information Under Section 314               
            of the National Childhood Vaccine Injury Act of 1986..................................    0910-AA14 
1243        Food Labeling Review..................................................................    0910-AA19 
1244        Amalgam Ingredient Labeling...........................................................    0910-AA33 
1245        Prescription Drug Product Labeling; Medication Guide..................................    0910-AA37 
1246        Classification of Computer Software Programs That Are Medical Devices.................    0910-AA41 
1247        Development of Hazard Analysis Critical Control Points for the Food Industry; Request               
            for Comments..........................................................................    0910-AA43 
1248        Habit Forming Drugs...................................................................    0910-AA50 
1249        Revocation of Certain Regulations.....................................................    0910-AA54 
1250        Dietary Supplement Regulations in Response to DSHEA...................................    0910-AA59 
1251        Export Requirements for Drugs for Investigational Use in Other Countries..............    0910-AA61 
1252        Export Requirements for Medical Devices...............................................    0910-AA62 
1253        Reinvention of Administrative Procedures Regulations..................................    0910-AA69 
1254        Human Tissue Intended for Transplantation and Human Reproductive Tissue Intended for                
            Insemination, Fertilization, and Transfer.............................................    0910-AA70 
1255        Informed Consent for Human Drugs and Biologics; Determination That Informed Consent Is              
            Not Feasible..........................................................................    0910-AA89 
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Completed Actions                                
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1256        Policies Concerning Uses of Sulfiting Agents..........................................    0910-AA03 
1257        Current Good Manufacturing Practice for Blood and Blood Components; Notification of                 
            Consignees Receiving Blood and Blood Components at Increased Risk for Transmitting HIV              
            Infection.............................................................................    0910-AA05 
1258        Lead in Foods.........................................................................    0910-AA06 
1259        Bottled Water.........................................................................    0910-AA11 
1260        Dietary Supplement Label Review.......................................................    0910-AA23 
1261        Effective Date of Requirement for Premarket Approval for Class III Preamendments                    
            Devices...............................................................................    0910-AA31 
1262        Animal Medicinal Drug Use Clarification Act of 1994; Extra-Label Use; Implementation..    0910-AA47 
1263        Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco               
            Products To Protect Children and Adolescents..........................................    0910-AA48 
1264        Name and Address of Distributor.......................................................    0910-AA56 
1265        Protection of Human Subjects; Informed Consent........................................    0910-AA60 
1266        Substances Approved for Use in the Preparation of Meat and Poultry Products...........    0910-AA66 

[[Page 62490]]

                                                                                                                
1267        Food Standards of Identity, Quality, and Fill of Container; Common or Usual Name                    
            Regulations: Request for Comments on Existing Regulations.............................    0910-AA67 
1268        Elimination of Establishment License Application for Specified Biotechnology and                    
            Specified Synthetic Biological Products...............................................    0910-AA71 
----------------------------------------------------------------------------------------------------------------


                        Health Resources and Services Administration--Proposed Rule Stage                       
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1269        National Practitioner Data Bank for Adverse Information on Physicians and Other Health              
            Care Practitioners: Corporate Shield..................................................    0906-AA41 
----------------------------------------------------------------------------------------------------------------


                         Health Resources and Services Administration--Final Rule Stage                         
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1270        Organ Procurement and Transplantation Network Rules (Reg Plan Seq. No. 29)............    0906-AA32 
1271        National Vaccine Injury Compensation Program: Revisions and Additions to the Vaccine                
            Injury Table--II......................................................................    0906-AA36 
1272        Removal of Obsolete Regulations of the Title VII Grant for the Construction of                      
            Teaching Facilities for Health Professions Personnel..................................   0906-AA39  
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.          


                         Health Resources and Services Administration--Long-Term Actions                        
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1273        Health Education Assistance Loan (HEAL) Program: Lenders'/ Holders' Performance                     
            Standards.............................................................................    0906-AA33 
----------------------------------------------------------------------------------------------------------------


                         Health Resources and Services Administration--Completed Actions                        
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1274        Grants for Nurse Practitioner and Nurse Midwifery Programs............................    0906-AA40 
----------------------------------------------------------------------------------------------------------------


                                   Indian Health Service--Proposed Rule Stage                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1275        Indian Child Protection and Family Violence Prevention Act Minimum Standards of                     
            Character.............................................................................    0917-AA02 
----------------------------------------------------------------------------------------------------------------


                                     Indian Health Service--Final Rule Stage                                    
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1276        Acquisition Under the Buy Indian Act..................................................    0917-AA00 
----------------------------------------------------------------------------------------------------------------


[[Page 62491]]


                                    Indian Health Service--Completed Actions                                    
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1277        Revision of Indian Self-Determination Regulations.....................................    0917-AA01 
----------------------------------------------------------------------------------------------------------------


                          Agency for Health Care Policy and Research--Final Rule Stage                          
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1278        Health Services Research, Evaluation, Demonstration, and Dissemination Projects; Peer               
            Review of Grants and Contracts........................................................    0919-AA00 
----------------------------------------------------------------------------------------------------------------


                               National Institutes of Health--Proposed Rule Stage                               
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1279        National Institutes of Health AIDS Research Loan Repayment Program....................    0925-AA02 
1280        National Institutes of Health Clinical Research Loan Repayment Program for Individuals              
            From Disadvantaged Backgrounds........................................................    0925-AA09 
1281        Undergraduate Scholarship Program Regarding Professions Needed by the NIH.............    0925-AA10 
1282        Traineeships (Termination Policies)...................................................    0925-AA11 
1283        Additional DHHS Protections for Pregnant Women and Human Fetuses Involved as Subjects               
            in Research, and Pertaining to Human In Vitro Fertilization...........................    0925-AA14 
1284        National Research Service Awards......................................................    0925-AA16 
1285        National Institutes of Health Loan Repayment Program for Research.....................    0925-AA18 
----------------------------------------------------------------------------------------------------------------


                                 National Institutes of Health--Final Rule Stage                                
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1286        National Institutes of Health Construction Grants.....................................    0925-AA04 
1287        Removal of National Cancer Institute Clinical Cancer Education Program................    0925-AA17 
----------------------------------------------------------------------------------------------------------------


                                National Institutes of Health--Completed Actions                                
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1288        Grants for Research Projects..........................................................    0925-AA01 
1289        Hazardous Substances Basic Research and Training Grants...............................    0925-AA03 
1290        Training Grants.......................................................................    0925-AA05 
1291        National Institutes of Health Center Grants...........................................    0925-AA06 
1292        Grants for National Alcohol Research Centers..........................................    0925-AA08 
1293        Removal of Obsolete Patent Regulations................................................    0925-AA15 
----------------------------------------------------------------------------------------------------------------


                           Office of Assistant Secretary for Health--Long-Term Actions                          
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1294        Standards of Compliance for Abortion-Related Services in Family Planning Service                    
            Projects..............................................................................    0937-AA00 
----------------------------------------------------------------------------------------------------------------


[[Page 62492]]


                                    Public Health Service--Long-Term Actions                                    
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1295        Additional Requirements for Facilities Transferring or Receiving Select Infectious                  
            Agents................................................................................    0905-AE70 
----------------------------------------------------------------------------------------------------------------


                            Health Care Financing Administration--Proposed Rule Stage                           
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1296        Medicare Coverage of Outpatient Occupational Therapy Services (BPD-425-P).............    0938-AD32 
1297        ''Without Fault'' and Beneficiary Waiver of Recovery As It Applies to Medicare                      
            Overpayment Liability (BPD-719-P).....................................................    0938-AD95 
1298        Provider Reimbursement Determinations and Appeals Revisions (BPD-727-P)...............    0938-AF28 
1299        Alternative Sanctions for Psychiatric Hospitals (HSQ-191-P)...........................    0938-AF32 
1300        Assessing Interest Against Medicare Secondary Payer (MSP) Debts (BPO-108-P)...........    0938-AF87 
1301        Revisions to Rules on Health Care Prepayment Plans (OMC-016-P)........................    0938-AF97 
1302        Conditions of Participation for Rural Health Clinics (BPD-764-P)......................    0938-AG05 
1303        Appointment of Representatives for Medicare Appeals (BPO-120-P).......................    0938-AG30 
1304        Alternative Sanctions for Renal Dialysis Facilities (HSQ-204-P).......................    0938-AG31 
1305        General Criteria and Standards for Evaluating Performance of Contract Obligations (HSQ-             
            207-NC)...............................................................................    0938-AG32 
1306        Effect of Change of Ownership on Provider and Supplier Penalties, Sanctions, and                    
            Overpayments (HSQ-215-P)..............................................................    0938-AG59 
1307        Salary Equivalency Guidelines for Physical Therapy, Respiratory Therapy, Speech                     
            Pathology, and Occupational Therapy (BPD-808-PN)......................................    0938-AG70 
1308        Medicaid: Optional Coverage of TB-Related Services for Individuals Infected with                    
            Tuberculosis (MB-082-P)...............................................................    0938-AG72 
1309        Revision of Medicare Hospital Conditions of Participation (BPD-745-P) (Reg Plan Seq.                
            No. 30)...............................................................................    0938-AG79 
1310        Physicians' Referrals to Health Care Entities With Which They Have Financial                        
            Relationships--Expanded to Designated Health Services (BPD-809-P).....................    0938-AG80 
1311        Home Health Agency (HHA) Conditions of Participation (BPD-819-P) (Reg Plan Seq. No.                 
            31)...................................................................................    0938-AG81 
1312        End-Stage Renal Disease (ESRD) Conditions for Coverage (BPD-818-P) (Reg Plan Seq. No.               
            32)...................................................................................    0938-AG82 
1313        Clinical Laboratory Improvement Amendment (CLIA) Fee Schedules (HSQ-219-GNC)..........    0938-AG87 
1314        Wage Index Used To Adjust Payment Rates for Hospice Services Under the Medicare                     
            Program (BPD-820-P)...................................................................    0938-AG93 
1315        Liability for Third Parties To Pay for Care and Services (MB-080-P)...................    0938-AH01 
1316        Ambulance Services (BPD-813-P)........................................................    0938-AH13 
1317        Adjustment in Payment Amounts for New Technology Intraocular Lenses (BPD-831-P).......    0938-AH15 
1318        Definition of Skilled Nursing Facility (SNF) for Coverage of Durable Medical Equipment              
            (DME) (BPD-834-P).....................................................................    0938-AH16 
1319        Additional Supplier Standards (BPD-864-P).............................................    0938-AH19 
1320        State Plan Amendment (SPA) Reconsideration Process (MB-096-P).........................    0938-AH24 
1321        Changes in Coverage and Payment Policies for Physician Assistant Services (BPD-829-P).    0938-AH26 
1322        Hospice Care--Conditions of Participation (BPD-844-P).................................    0938-AH27 
1323        Limitations on Payment for Home Oxygen Therapy Based on Inherent Reasonableness                     
            Criteria (BPD-845-PN).................................................................    0938-AH28 
1324        Medicare Coverage of Services of Speech-Language Pathologists and Audiologists (BPD-                
            843-P)................................................................................    0938-AH37 
1325        Medicare: Amount of Payments If Customary Charges for Services Furnished Are Less Than              
            Reasonable Costs (BPD-860-P)..........................................................    0938-AH49 
1326        Changes to the Hospital Inpatient Prospective Payment System and Fiscal Year 1998                   
            Rates (BPD-878-P) (Reg Plan Seq. No. 33)..............................................    0938-AH55 
1327        Conditions for Certification of Community Mental Health Centers and Coverage                        
            Requirements for Partial Hospitalization Services (BPD-871-P).........................    0938-AH58 
1328        Allowable Costs for FICA and Other Payroll Taxes; Medicare (BPD-876-P)................    0938-AH61 
1329        Improvements to the Appeal Protections Offered by Medicare Contracting HMOs/CMPs (OMC-              
            025-P) (Reg Plan Seq. No. 34).........................................................    0938-AH62 
1330        Medicaid; Estate Recoveries (MB-083-P)................................................    0938-AH63 
1331        Utilization Control; Medicaid (MB-101-P)..............................................    0938-AH64 
1332        Medicaid Hospice Care (MB-007-P)......................................................    0938-AH65 
1333        Medicare as Secondary Payor to Liability Insurance (BPD-848-P)........................    0938-AH66 
1334        Medicare Technical Conforming Amendments (BPD-858-FC).................................    0938-AH67 
1335        Reduction and Elimination of Certain Requirements for Peer Review Organizations in the              
            Utilization and Quality Review Process (HSQ-235-P)....................................    0938-AH68 
1336        Determination of Substandard Care in SNFs and NFs (HSQ-240-P).........................    0938-AH69 
1337        Conditions of Enrollment for Non-Certified Providers (BPO-143-P)......................    0938-AH73 
1338        Use of the OASIS as Part of the Conditions of Participation for Home Health Agencies                
            (HSQ-238-P)...........................................................................   0938-AH74  
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.          


[[Page 62493]]


                             Health Care Financing Administration--Final Rule Stage                             
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1339        Deduction of Incurred Medical Expenses (Spenddown) (MB-020-F).........................    0938-AB07 
1340        Effective Dates for Provider Agreements and Supplier Approvals (HSQ-139-F)............    0938-AC88 
1341        Changes Concerning Suspension of Medicare Payments and Determinations of Allowable                  
            Interest Expense (BPO-118-FC).........................................................    0938-AC99 
1342        Changes to Peer Review Organization Regulations (HSQ-135-F)...........................    0938-AD38 
1343        Medicare Secondary Payer for Disabled Individuals (BPD-482-F).........................    0938-AD73 
1344        Omnibus Nursing Home Reform Requirements (BPD-488-F)..................................    0938-AD81 
1345        Revisions to Regulations Implementing CLIA (HSQ-226-F) (Reg Plan Seq. No. 35).........    0938-AE47 
1346        Resident Assessment in Long-Term Care Facilities (HSQ-180-F)..........................    0938-AE61 
1347        Post-Contract Beneficiary Protections and Other Provisions (OMC-003-F)................    0938-AE63 
1348        Payment for Nursing and Allied Health Science Education (BPD-685-F)...................    0938-AE79 
1349        Fire Safety Standards for Hospitals, Long-Term Care Facilities, and Intermediate Care               
            Facilities for the Mentally Retarded (BPD-650-FC).....................................    0938-AE97 
1350        Coverage of Screening Pap Smears (BPD-705-F)..........................................    0938-AE98 
1351        Medicare Coverage of Clinical Psychologist, Other Psychologist, and Clinical Social                 
            Worker Services--Medicare (BPD-706-F).................................................    0938-AE99 
1352        OBRA '90 and Miscellaneous Managed Care Technical Amendments (OMC-018-F)..............    0938-AF15 
1353        Medicaid Payment for Covered Outpatient Drugs Under Rebate Agreements (MB-046-F)......    0938-AF42 
1354        Referral to Child Support Enforcement Agencies of Medicaid Families (MB-051-F)........    0938-AF68 
1355        Medicaid: Outstationed Intake Locations for Certain Low-Income Pregnant Women, Infants              
            and Children Under Age 19 (MB-052-F)..................................................    0938-AF69 
1356        Medicare and Medicaid Programs: Requirements for Physician Incentive Plans in Prepaid               
            Health Care Organizations (OMC-010-F).................................................    0938-AF74 
1357        Retroactive Enrollment and Disenrollment in Risk Health Maintenance Organizations and               
            Competitive Medical Plans (OMC-015-F).................................................    0938-AF98 
1358        Payment for Preadmission Services (BPD-731-F).........................................    0938-AG00 
1359        Change in Provider Agreement Regulations Related to Federal Employee Health Benefits                
            (BPD-748-F)...........................................................................    0938-AG03 
1360        Revised Medicaid Management Information Systems (MB-38-FN)............................    0938-AG10 
1361        End-Stage Renal Disease (ESRD) Payment Exception Requests and Organ Procurement Costs               
            (BPD-763-F)...........................................................................    0938-AG20 
1362        Medicare Program: Limitations on Medicare Coverage of Intermittent Positive Pressure                
            Breathing Machine Therapy (BPD-781-FN)................................................    0938-AG44 
1363        Telephone and Electronic Requests for Review of Part B Initial Claim Determinations                 
            (BPO-121-F)...........................................................................    0938-AG48 
1364        CLIA Program: Categorization of Waived Tests (HSQ-225-F) (Reg Plan Seq. No. 36).......    0938-AG99 
1365        Medicaid Coverage of Personal Care Services (MB-071-F)................................    0938-AH00 
1366        Medicare Program: Uniform Electronic Cost Reporting for Skilled Nursing Facilities and              
            Home Health Agencies (BPD-788-F)......................................................    0938-AH12 
1367        Update of the Reasonable Compensation Equivalent Limits for Services Furnished by                   
            Physicians (BPD-816-N)................................................................    0938-AH14 
1368        Criteria and Procedures for Extending Coverage to Certain Devices and Related Services              
            (BPD-841-F)...........................................................................    0938-AH21 
1369        Delegation of Civil Money Penalties (BPO-135-FC)......................................    0938-AH22 
1370        CLIA Program: Cytology Proficiency Testing (HSQ-233-F)................................    0938-AH35 
1371        Medicare Program: Revisions to Payment Policies and Five-Year Review of and                         
            Adjustments to Relative Value Units Under the Physician Fee Schedule for Calendar Year              
            1997 (BPD-852-FC) (Reg Plan Seq. No. 37)..............................................    0938-AH40 
1372        Medicare Program: Physician Fee Schedule Update for Calendar Year 1997 and Physician                
            Volume Performance Standard Rates of Increase for Federal Fiscal Year 1997 (BPD-853-                
            FN)...................................................................................    0938-AH41 
1373        Requirements for Enrollment of Medicaid Recipients Under Cost Effective Employer-Based              
            Group Health Plans (MB-047-F).........................................................    0938-AH48 
1374        Terms, Definitions, and Addresses: Technical Amendments (BPD-877-FC)..................    0938-AH53 
1375        Home Health Agency Physician Certification Regulations (BPD-875-N)....................    0938-AH59 
1376        Initiative to Recognize Hemodialysis Facilities of Achievement (HSQ-232-N)............    0938-AH71 
1377        Waiver of Staffing Requirements for End Stage Renal Disease (ESRD) Facilities                       
            Participating in an Experiment (HSQ-236-GNC)..........................................    0938-AH72 
1378        Health Insurance Reform: Portability and Nondiscrimination in the Group Insurance                   
            Market; Portability in the Individual Insurance Market; Requirements on State for                   
            Alternative Mechanisms for Reg (Reg Plan Seq. No. 38).................................   0938-AH75  
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.          


[[Page 62494]]


                             Health Care Financing Administration--Long-Term Actions                            
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1379        Payment for Clinical Diagnostic Laboratory Tests (BPD-309-F)..........................    0938-AB50 
1380        Participation in CHAMPUS and CHAMPVA, Hospital Admissions for Veterans, Discharge                   
            Rights Notice, and Hospital Responsibility for Emergency Care (BPD-393-F).............    0938-AC58 
1381        Criteria and Procedures for Developing Medical Services Coverage Policy (BPD-432-N)...    0938-AD07 
1382        Prohibition on Unbundling of Hospital Outpatient Services (BPD-426-F).................    0938-AD33 
1383        Protection of Income and Resources for Community Spouses of Institutionalized                       
            Individuals (MB-023-P)................................................................    0938-AE12 
1384        Survey Requirements and Alternative Sanctions for Home Health Agencies (HSQ-169-F)....    0938-AE39 
1385        Conditions of Coverage for Organ Procurement Organizations (BPD-646-F)................    0938-AE48 
1386        Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Services (MB-28-F)....    0938-AE72 
1387        Changes to the Long-Term Care Facility Survey Process (HSQ-175-FC)....................    0938-AF02 
1388        Case Management (MB-27-F).............................................................    0938-AF07 
1389        Presumptive Limits on Payments to HMOs, CMPs, and HCPPs (OMC-006-F)...................    0938-AF16 
1390        Part B Advance Payments to Physicians/Suppliers or Other Entities Furnishing Items or               
            Services Under Medicare Part B (BPO-105-F)............................................    0938-AF85 
1391        Intermediary and Carrier Functions (BPO-111-F)........................................    0938-AG06 
1392        Disclosure of Confidential PRO Information for Research Purposes (HSQ-208-P)..........    0938-AG33 
1393        Noncoverage of Electrostimulation of Salivary Glands for the Treatment of Xerostomia                
            (Dry Mouth) (BPD-782-FN)..............................................................    0938-AG45 
1394        Distinct Part Requirements for Nursing Homes and Prohibition of Financial Screening of              
            Applicants for Nursing Home Admission (BPD-815-P).....................................    0938-AG84 
1395        Categorization and Certification Requirements for a New Subcategory of Moderate                     
            Complexity Testing (HSQ-222-F)........................................................    0938-AG98 
1396        Medicare Coverage of Liver Transplantation (BPD-835-PN)...............................    0938-AH17 
1397        Limits on Actual Charges of Nonparticipating Physicians (BPD-862-P)...................    0938-AH50 
1398        Limitations on Liability (BPD-859-FC).................................................    0938-AH51 
1399        Medicare Secondary Payer Clarifications and Amendments (BPD-865-P)....................    0938-AH52 
1400        Medicare Program; Schedule of Limits on HHA Costs Per Visit for Cost Reporting Periods              
            Beginning On or After July 1, 1996 (BPD-867-NC).......................................    0938-AH54 
1401        Designation of Independent Rural Primary Care Hospitals (RPCHs) (BPD-784-N)...........    0938-AH60 
----------------------------------------------------------------------------------------------------------------


                             Health Care Financing Administration--Completed Actions                            
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1402        Revisions to the Confidentiality and Disclosure Regulation (OPA-001-P)................    0938-AD60 
1403        New Minimum Standards for Medicare Supplemental (Medigap) Policies (BPD-491-P)........    0938-AD82 
1404        HMO Organizational Structure and Services (OMC-007-F).................................    0938-AE25 
1405        Hospital Standard for HIV Infectious Blood and Blood Products (BPD-633-F).............    0938-AE40 
1406        Employer Contributions to HMOs (OMC-004-F)............................................    0938-AE64 
1407        Partial Hospitalization Services in Community Mental Health Centers (BPD-736-F).......    0938-AF53 
1408        Medicare Program: Limitations on Medicare Coverage of Cataract Surgery (BPD-797-FN)...    0938-AG65 
1409        New Payment Methodology for Routine Extended Care Services Provider in a Swing Bed                  
            Hospital (BPD-805-F)..................................................................    0938-AG68 
1410        Reporting of Interest From Zero Coupon Bonds (BPD-647-F)..............................    0938-AH11 
1411        Schedule of Limits for Skilled Nursing Facility Inpatient Routine Service Costs (BPD-               
            837-NC)...............................................................................    0938-AH18 
1412        Medicaid: Limitations on Aggregate Payments to Disproportionate Share Hospitals;                    
            Federal Fiscal Year 1996 (Preliminary) (MB-098-N).....................................    0938-AH30 
1413        Medicaid Eligibility Quality Control, Staffing and Training, and Utilization Control:               
            Removal of Obsolete and Restrictive Requirements (MB-099-F)...........................    0938-AH31 
1414        Medicare Program; Special Enrollment Periods and Waiting Periods (BPD-752-FC).........    0938-AH33 
1415        Changes to the Hospital Inpatient Prospective Payment System and Fiscal Year 1997                   
            Rates (BPD-847-F).....................................................................    0938-AH34 
1416        Medicare Program: Five-Year Review of Work Relative Value Units Under the Physician                 
            Fee Schedule (BPD-846-FN).............................................................    0938-AH38 
1417        Medicare Program: Monthly Actuarial Rates and Monthly Supplementary Medical Insurance               
            Premium Rates Beginning January 1, 1997 (OACT-052-N)..................................    0938-AH42 
1418        Medicaid: Limitations on Aggregate Payments to Disproportionate Share Hospitals;                    
            Federal Fiscal Year 1996 (Final) (MB-100-N)...........................................    0938-AH44 
1419        Part A Premium for 1997 for the Uninsured Aged for Certain Disabled Individuals Who                 
            Have Exhausted Other Entitlement (OACT-053-N).........................................    0938-AH45 

[[Page 62495]]

                                                                                                                
1420        Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance                   
            Amounts for 1997 (OACT-054-N).........................................................    0938-AH46 
1421        Privacy and Security Enforcement for the Medicare Transaction System (BPO-142-P)......    0938-AH47 
1422        Schedule of Prospectively Determined Payment Rates for Skilled Nursing Facility                     
            Inpatient Routine Service Costs (BPD-842).............................................    0938-AH56 
1423        Criteria for a Rural Hospital to be Designated as as Essential Access Community                     
            Hospital (EACH) (BPD-856-F)...........................................................    0938-AH57 
----------------------------------------------------------------------------------------------------------------


                          Administration for Children and Families--Proposed Rule Stage                         
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1424        Foster Care, Adoption Assistance, and Child Welfare Services..........................    0970-AA97 
1425        Block Grant Programs (Low Income Home Energy Assistance Program --LIHEAP)--FY 1995 and              
            FY 1996 Provisions....................................................................    0970-AB47 
1426        Designation of Alternative Agency To Serve Indian Tribal Children.....................    0970-AB52 
1427        Construction of Head Start Facilities.................................................    0970-AB54 
1428        On-Site Foster Care Eligibility Reviews...............................................    0970-AB60 
1429        Data Collection and Reporting Under the Temporary Assistance for Needy Families Block               
            Grant.................................................................................    0970-AB64 
1430        Methodology for Determining Child Poverty Rates.......................................    0970-AB65 
1431        Bonus to Reward High Performance States Under the Temporary Assistance for Needy                    
            Families Block Grant..................................................................    0970-AB66 
1432        State Directory of New Hires..........................................................    0970-AB67 
1433        State Case Registry and Expansion of FPLS.............................................    0970-AB68 
1434        State Law Concerning Paternity Establishment..........................................    0970-AB69 
1435        Automated Data Processing Requirements................................................    0970-AB70 
1436        Automated Data Processing Funding Limitation..........................................    0970-AB71 
1437        Grants to States for Access and Visitation Programs...................................    0970-AB72 
1438        Child Support Enforcement for Indian Tribes...........................................    0970-AB73 
1439        Child Care Proposed Rule..............................................................    0970-AB74 
1440        TANF Program and Financial Requirements...............................................    0970-AB75 
1441        TANF Audits/Penalties and Corrective Actions (Reg Plan Seq. No. 39)...................    0970-AB76 
1442        TANF Work Requirements (Reg Plan Seq. No. 40).........................................    0970-AB77 
1443        Tribal Program Requirements...........................................................    0970-AB78 
1444        Illegitimacy Rate Reduction Bonus.....................................................   0970-AB79  
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.          


                           Administration for Children and Families--Final Rule Stage                           
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1445        Standards for Safe Transportation.....................................................    0970-AB24 
1446        Standards for Purchase of Facilities..................................................    0970-AB31 
1447        National Voter Registration Act of 1993 Provisions Affecting Public Assistance                      
            Agencies..............................................................................    0970-AB32 
1448        Family Preservation and Support.......................................................    0970-AB34 
1449        Income Eligibility Criteria for Indian Tribes.........................................    0970-AB53 
1450        Head Start Fellowship Program.........................................................    0970-AB56 
1451        Extension of Deadline for Certified Statewide Systems and Revisions for the                         
            President's Reform Initiative.........................................................    0970-AB57 
1452        Income and Resource Disregards Related to Interests of Individual Indians in Trust or               
            Restricted Lands......................................................................    0970-AB59 
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Completed Actions                          
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1453        Amendments to Developmental Disabilities Rules........................................    0970-AB11 

[[Page 62496]]

                                                                                                                
1454        Child Abuse and Neglect State Grant Program...........................................    0970-AB23 
1455        Child Care--Revised Regulations.......................................................    0970-AB33 
1456        Administration for Native Americans (ANA) 45 CFR Part 1336............................    0970-AB37 
1457        Reduction of Reporting Requirements for the State Systems Advance Planning Document                 
            (APD) Process.........................................................................    0970-AB46 
1458        Administrative Flexibility Rule.......................................................    0970-AB49 
1459        Quality Standards for Early Head Start and Head Start Programs........................    0970-AB55 
----------------------------------------------------------------------------------------------------------------


                                  Administration on Aging--Proposed Rule Stage                                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1460        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)



_______________________________________________________________________




1178. CIVIL MONEY PENALTIES FOR FALSE INFORMATION ON DRUG MANUFACTURER 
PRICE SURVEYS AND REBATE AGREEMENTS

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 1003

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/97

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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

RIN: 0991-AA80
_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




1179. CIVIL MONEY PENALTIES FOR PHYSICIAN OWNERSHIP OF AND REFERRAL TO 
CERTAIN HEALTH CARE ENTITIES

Priority:  Substantive, Nonsignificant

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

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

CFR Citation:  42 CFR 1001; 42 CFR 1003

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/20/93                    58 FR 54096
NPRM Comment Period End         12/20/93
Final Action                    03/00/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Joel Jay Schaer, Regulations Officer, Office of 
Inspector General, OMP, Department of Health

[[Page 62497]]

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

RIN: 0991-AA65
_______________________________________________________________________




1180. CLARIFICATION OF THE INITIAL OIG SAFE HARBOR PROVISIONS AND 
ESTABLISHMENT OF ADDITIONAL SAFE HARBOR PROVISIONS UNDER THE ANTI-
KICKBACK STATUTE

Priority:  Other Significant

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

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

CFR Citation:  42 CFR 1001

Legal Deadline: None

Abstract: This final rule serves both to clarify various aspects of the 
original safe harbor provisions and to add new safe harbors as 
authorized under section 14 of PL 100-93. Specifically, this rule 
modifies the original set of final safe harbor provisions (56 FR 35952, 
7/9/91) to give greater clarity to that rulemaking's original intent. 
In addition, this rule sets forth an expanded listing of safe harbor 
provisions designed to protect additional payment and business 
practices from criminal prosecution and civil sanctions under the anti-
kickback statute.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/21/93                    58 FR 49008
NPRM Comment Period End         11/22/93
Final Action                    03/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: This final rule incorporates the safe harbor 
clarification provisions previously addressed in RIN 0991-AA74 and set 
forth in proposed rulemaking (59FR37202, July 21, 1994).

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

RIN: 0991-AA66
_______________________________________________________________________




1181.  REPRODUCTION AND SALE OF OFFICIAL FORMS AND PUBLICATIONS

Priority:  Info./Admin./Other

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

CFR Citation:  45 CFR 101

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              03/00/97

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0991-AA83
_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




1182. CIVIL MONEY PENALTIES (CMPS) FOR CERTAIN HOSPITAL PHYSICIAN 
INCENTIVE PLANS

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 1001; 42 CFR 1003

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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


Next Action Undetermined

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0991-AA45
_______________________________________________________________________




1183. CIVIL MONEY PENALTIES (CMPS) FOR CERTAIN PRACTICES RELATING TO 
MEDICARE SUPPLEMENTAL POLICIES

Priority:  Substantive, Nonsignificant

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

[[Page 62498]]

4354(a)(2); PL 101-508, Sec 4355(a); PL 101-508, Sec 4357

CFR Citation:  42 CFR 1003

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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

RIN: 0991-AA53
_______________________________________________________________________




1184. CIVIL MONEY PENALTIES FOR NOTIFYING A HOME HEALTH AGENCY, OR A 
HOME OR COMMUNITY-BASED HEALTH CARE CENTER OR PROVIDER, OF A STANDARD 
SURVEY

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 1003

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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

RIN: 0991-AA79
_______________________________________________________________________




1185. SENIOR BIOMEDICAL RESEARCH SERVICES

Priority:  Info./Admin./Other

Legal Authority:  42 USC 228

CFR Citation:  42 CFR 24

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: Federal

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

RIN: 0991-AA82
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Office of the Secretary (OS)



_______________________________________________________________________




1186.  MEDICARE AND STATE HEALTH CARE PROGRAMS AND PROGRAM FRAUD 
CIVIL REMEDIES: FRAUD AND ABUSE; CIVIL MONEY PENALTIES INFLATION 
ADJUSTMENT

Priority:  Other Significant

Legal Authority:  PL 101-410; PL 104-134, sec 31001(s)

CFR Citation:  42 CFR 1003; 45 CFR 79

Legal Deadline:  Final, Statutory, October 23, 1996.

Abstract: This final rule incorporates the penalty inflation 
adjustments for the civil money penalties set forth in the Health Care 
Quality Improvement Act of 1986 and the Program Fraud Civil Remedies 
Act of 1986, in accordance with Debt Collection Improvement Act of 
1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/07/96                    61 FR 52299
Final Action Effective          11/06/96

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 62499]]

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

RIN: 0991-AA84
_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




1187. PROTECTION AND ADVOCACY FOR INDIVIDUALS WITH MENTAL ILLNESS

Priority:  Substantive, Nonsignificant

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

CFR Citation:  45 CFR 51

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Local

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

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

RIN: 0930-AA02
_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




1188. BLOCK GRANTS FOR PREVENTION AND TREATMENT OF SUBSTANCE ABUSE

Priority:  Other Significant

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

CFR Citation:  45 CFR 96

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Tribal

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

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

RIN: 0930-AA01
_______________________________________________________________________


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


Departmental Management (HHSDM)



_______________________________________________________________________




1189. 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

[[Page 62500]]

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
Second NPRM                     04/00/97
Final Action                    09/00/97

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0990-AA02
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)             Prerule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________




1190. 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                           05/00/97

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Additional Information: Previously reported under RIN 0905-AD91.

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

RIN: 0910-AA20
_______________________________________________________________________




1191. INVESTIGATIONAL NEW DRUG APPLICATIONS; REQUEST FOR INFORMATION AND 
COMMENTS

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

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

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

CFR Citation:  21 CFR 56; 21 CFR 312

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

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

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

RIN: 0910-AA83
_______________________________________________________________________




1192.  ELIGIBILITY CRITERIA FOR CONSIDERING ADDITIONAL 
CONDITIONS IN THE OVER-THE-COUNTER DRUG MONOGRAPH SYSTEM; REQUEST FOR 
INFORMATION AND COMMENTS

Priority:  Other Significant

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

CFR Citation:  21 CFR 330

Legal Deadline: None

Abstract: The advance notice of proposed rulemaking would amend the 
regulations to include criteria under which certain additional OTC drug 
active ingredients, indications, dosage forms, dosage strengths, routes 
of administration, and active ingredient combinations may become 
eligible for inclusion in the OTC drug monograph system. The proposed 
criteria would address how OTC marketing experience could be used to 
meet the statutory definition of marketing ``to a material extent'' and 
``for a material time'' to qualify a specific OTC drug condition for 
consideration under the OTC drug monograph system.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           10/00/96
ANPRM Comment Period End        01/00/97

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Procurement: This is a procurement-related action for which there is no

[[Page 62501]]

statutory requirement. The agency has not yet determined whether there 
is a paperwork burden associated with this action.

Agency Contact: William E. Gilbertson, Divison of OTC Drug Evaluation, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Drug Evaluation and Research (HFD-560), 9200 Corporate 
Blvd., Rockville, MD 20850
Phone: 301 827-2304
Fax: 301 827-2317

RIN: 0910-AA96
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




1193. INFANT FORMULA: GOOD MANUFACTURING PRACTICE, QUALITY CONTROL 
PROCEDURES, QUALITY FACTORS, NOTIFICATION REQUIREMENTS, AND RECORDS AND 
REPORTS

Priority:  Other Significant

Legal Authority:  21 USC 350a

CFR Citation:  21 CFR 107; 21 CFR 106

Legal Deadline: None

Abstract: The agency published a proposed rule on July 9, 1996, that 
will establish current good manufacturing practice regulations, quality 
control procedures, quality factors, notification requirements, and 
reports for the production of infant formulas. This proposal was issued 
in response to the Infant Formula Act of 1986.

Timetable:

Current Good Mfg. Practices; Qual Control Proc  NPRM 07/09/96 (61 FR 
36154)  NPRM (Comment Period End) 12/06/96  Final Rule 00/00/00

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

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AC46.

Agency Contact: Carolyn W. Miles, Nutritionist, Department of Health 
and Human Services, Food and Drug Administration, Center for Food 
Safety and Applied Nutrition (HFS-456), 200 C Street SW., Washington, 
DC 20204
Phone: 202 205-5372

RIN: 0910-AA04
_______________________________________________________________________




1194. REPORTING OF ERRORS AND ACCIDENTS

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

Unfunded Mandates: Undetermined

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

CFR Citation:  21 CFR 600; 21 CFR 606

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/97
NPRM Comment Period End         04/00/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD67.

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

RIN: 0910-AA12
_______________________________________________________________________




1195. MAMMOGRAPHY QUALITY STANDARDS ACT OF 1992

Regulatory Plan:  This entry is Seq. No. 26 in Part II of this issue of 
the Federal Register.

RIN: 0910-AA24
_______________________________________________________________________




1196. HEARING AIDS; PROFESSIONAL AND PATIENT LABELING; CONDITIONS FOR 
SALE

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

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

[[Page 62502]]

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

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

CFR Citation:  21 CFR 801.420; 21 CFR 801.421

Legal Deadline: None

Abstract: FDA is considering revising its present regulation governing 
the labeling and conditions for sale of hearing aids. The present rule 
requires an examination by a physician before purchase of a hearing 
aid, but permits an informed adult to waive that requirement. There is 
some evidence that this waiver provision is being misused. FDA is 
considering eliminating the waiver provision and instead requiring a 
medical evaluation when certain previously undiagnosed medical 
conditions are found or when the prospective hearing aid user is under 
18 years of age. In addition, FDA is considering restricting the 
dispensing of a hearing aid to patients who have undergone a 
comprehensive hearing assessment within the past 12 months and 
evaluation to select and fit a hearing aid, both of which would be 
required to be conducted by hearing care professionals licensed by the 
States as competent to conduct such assessments and evaluations. FDA is 
also considering revisions to its professional and patient labeling to 
require updated information.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           11/10/93                    58 FR 59695
ANPRM Comment Period End        01/10/94
NPRM                            02/00/97

Small Entities Affected: Businesses

Government Levels Affected: State

Additional Information: Previously reported under RIN 0905-AE46.

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

RIN: 0910-AA39
_______________________________________________________________________




1197. REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN 
COMMERCIAL DISTRIBUTION

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

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

Legal Authority:  21 USC 331; 21 USC 351; 21 USC 352; 21 USC 355; 21 
USC 356; 21 USC 357; 21 USC 360; 21 USC 371

CFR Citation:  21 CFR 207

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Howard Muller, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Center for Drug 
Evaluation and Research (HFD-7), 7500 Standish Place Rockville, MD 
20855
Phone: 301 594-1049
Fax: 301 594-0152

RIN: 0910-AA49
_______________________________________________________________________




1198. BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

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

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

Legal Authority:  21 USC 321; 21 USC 351; 21 USC 352; 21 USC 355; 21 
USC 357; 21 USC 371

CFR Citation:  21 CFR 320

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/96
NPRM Comment Period End         02/00/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Erica Keys, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 7500 
Standish Place Rockville, MD 20855
Phone: 301 594-1046
Fax: 301 594-0152

RIN: 0910-AA51
_______________________________________________________________________




1199. DRUGS USED FOR TREATMENT OF NARCOTIC ADDICTS

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

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

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

CFR Citation:  21 CFR 291

Legal Deadline: None

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

[[Page 62503]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/97
NPRM Comment Period End         03/00/97

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Nicholas Reuter, Associate Director for International 
and Domestic Drug Control, Department of Health and Human Services, 
Food and Drug Administration, Office of Health Affairs (HFY-20), 5600 
Fishers Lane, Rockville, MD 20857
Phone: 301 827-1696
Fax: 301 443-1382
Email: [email protected]

RIN: 0910-AA52
_______________________________________________________________________




1200. ADVERSE EXPERIENCE REPORTING FOR HUMAN DRUG AND LICENSED 
BIOLOGICAL PRODUCTS; INCREASED FREQUENCY REPORTS

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

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

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/28/96                    61 FR 55602
NPRM Comment Period End         01/13/97
Final Action                    08/00/97

Small Entities Affected: None

Government Levels Affected: None

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

Agency Contact: Audrey Thomas, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, (HFD-7), 7500 Standish Place, Rockville, 
MD 20855
Phone: 301 594-1049
Fax: 301 594-0152

RIN: 0910-AA72
_______________________________________________________________________




1201. INVESTIGATIONAL NEW DRUG APPLICATIONS; CLINICAL HOLDS

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

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

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 
USC 353; 21 USC 355; 21 USC 356; 21 USC 357; 21 USC 371; 42 USC 262

CFR Citation:  21 CFR 312

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

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

RIN: 0910-AA73
_______________________________________________________________________




1202. PARENTERAL DRUG PRODUCTS CONTAINING ALUMINUM AS AN INGREDIENT OR 
CONTAMINANT; LABELING REQUIREMENTS; WARNING STATEMENT

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

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355 
to 358; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 379; 42 USC 216; 42 
USC 241; 42 USC 262; 21 USC 264

CFR Citation:  21 CFR 201

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/97
NPRM Comment Period End         04/00/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

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

Agency Contact: Erica L. Keys, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, (HFD-7), 7500 
Standish Place, Rockville, MD 20855
Phone: 301 594-1049
Fax: 301 594-0152

RIN: 0910-AA74

[[Page 62504]]

_______________________________________________________________________




1203. LONG-TERM CONTRACEPTIVE DRUG PRODUCTS AND MEDICAL DEVICES; 
INFORMED CONSENT REQUIREMENTS

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

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 
USC 353; 21 USC 355; 21 USC 356; 21 USC 357; 21 USC 358; 21 USC 360; 21 
USC 371; 21 USC 374; 21 USC 379; 42 USC 216; 42 USC 241; ...

CFR Citation:  21 CFR 201; 21 CFR 801

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

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

Agency Contact: Erica L. Keys, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Center for Drug 
Evaluation and Research (HFD-7), 7500 Standish Place Rockville, MD 
20855
Phone: 301 594-1049
Fax: 301 594-0152

RIN: 0910-AA75
_______________________________________________________________________




1204. DEBARMENT CERTIFICATION REGULATIONS FOR DRUG APPLICATIONS

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

Unfunded Mandates: Undetermined

Legal Authority:  15 USC 1451 to 1461; 21 USC 321; 21 USC 331; 21 USC 
335; 21 USC 351 to 353; 21 USC 355 to 357; 21 USC 360; 21 USC 371; 21 
USC 374; 21 USC 379; 21 USC 381 to 382; 42 USC 216; 42 USC 241; 42 USC 
262 to 263

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/97
NPRM Comment Period End         04/00/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

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

Agency Contact: Wayne Mitchell, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 7500 
Standish Place, Rockville, MD 20855
Phone: 301 594-1049
Fax: 301 594-0152

RIN: 0910-AA76
_______________________________________________________________________




1205. CERTIFICATION OF DRUGS COMPOSED WHOLLY OR PARTLY OF INSULIN

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

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

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 356; 21 USC 357; 21 USC 358; 21 USC 360; 21 USC 371; 21 USC 
374; 21 USC 375

CFR Citation:  21 CFR 200; 21 CFR 429

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/97
NPRM Comment Period End         05/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

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

Agency Contact: Wayne Mitchell, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research (HFD-7), 7500 Standish Place Rockville, MD 
20855
Phone: 301 594-1049
Fax: 301 594-0152

RIN: 0910-AA77
_______________________________________________________________________




1206. OVER-THE-COUNTER HUMAN DRUGS; LABELING REQUIREMENTS

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

Unfunded Mandates: Undetermined

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

CFR Citation:  21 CFR 330

Legal Deadline: None

Abstract: The proposed rule would provide standardized format and 
content requirements for OTC drug product labeling, including 
legibility and design features of such information as the uses for the 
drug, directions for use, warnings, drug interactions, precautions, 
active ingredients and other information that the consumer

[[Page 62505]]

would need to know to use the product safely and effectively.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/96
NPRM Comment Period End         03/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

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

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

RIN: 0910-AA79
_______________________________________________________________________




1207. INVESTIGATIONAL NEW DRUG APPLICATIONS; CLINICAL HOLDS FOR DRUGS 
FOR LIFE-THREATENING ILLNESSES

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

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 
USC 353; 21 USC 355; 21 USC 356; 21 USC 357; 21 USC 371; 42 USC 262

CFR Citation:  21 CFR 312

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/97
NPRM Comment Period End         04/00/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: Undetermined

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

Agency Contact: Audrey Thomas, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research (HFD-7), 7500 Standish Place, Rockville, 
MD 20855
Phone: 301 594-1049
Fax: 301 594-0152

RIN: 0910-AA84
_______________________________________________________________________




1208. ADVERSE EXPERIENCE REPORTING, RECORDKEEPING, AND RECORDS ACCESS 
REQUIREMENTS FOR MARKETED OTC DRUGS THAT ARE NOW THE SUBJECTS OF 
APPROVED NEW DRUG OR ABBREVIATED NEW DRUG APPS

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

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 
USC 353; 21 USC 355; 21 USC 356; 21 USC 357; 21 USC 358; 21 USC 360; 21 
USC 371; 21 USC 374; 21 USC 375; 21 USC 379; 42 USC 216; ...

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

Legal Deadline: None

Abstract: The proposed rule would require manufacturers, packers, and 
distributors of marketed nonprescription human drug products that are 
not the subjects of approved applications to report to FDA information 
they receive about adverse experiences associated with the use of their 
drug products; to maintain records of adverse drug experiences; and to 
permit access by FDA to adverse drug experience records.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/97
NPRM Comment Period End         05/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

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

Agency Contact: Audrey Thomas, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research (HFD-7), 7500 Standish Place, Rockville, 
MD 20855
Phone: 301 594-1049
Fax: 301 594-0152

RIN: 0910-AA86
_______________________________________________________________________




1209. STERILITY REQUIREMENTS FOR INHALATION SOLUTION PRODUCTS

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

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355 
to 358; 21 USC 360; 21 USC 371; 21 USC 374 to 375

CFR Citation:  21 CFR 200

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/96
NPRM Comment Period End         03/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

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

Agency Contact: Howard Muller, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research, (HFD-7), 7500 
Standish Place, Rockville, MD 20855
Phone: 301 594-2041
Fax: 301 594-0152

RIN: 0910-AA88

[[Page 62506]]

_______________________________________________________________________




1210. DIRECT-TO-CONSUMER PROMOTION REGULATIONS

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

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 334; 21 USC 351; 21 
USC 352; 21 USC 353; 21 USC 355; 21 USC 356; 21 USC 357; 21 USC 358; 21 
USC 360e to 360i; 21 USC 360k; 21 USC 361; 21 USC 362; 21 USC 371; ...

CFR Citation:  21 CFR 200; 21 CFR 800

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0910-AA90
_______________________________________________________________________




1211.  SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED; 
PROTEIN DERIVED FROM RUMINANTS PROHIBITED IN RUMINANT FEED

Regulatory Plan:  This entry is Seq. No. 27 in Part II of this issue of 
the Federal Register.

RIN: 0910-AA91
_______________________________________________________________________




1212.  TREATMENT USE OF INVESTIGATIONAL DEVICE EXEMPTIONS

Priority:  Substantive, Nonsignificant

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

Legal Authority:  21 USC 360j(g)

CFR Citation:  21 CFR 812

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/97

Small Entities Affected: Undetermined

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

RIN: 0910-AA92
_______________________________________________________________________




1213.  REVISION OF THE REQUIREMENTS FOR A RESPONSIBLE HEAD FOR 
BIOLOGICAL ESTABLISHMENTS

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

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

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/96

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

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

RIN: 0910-AA93
_______________________________________________________________________




1214.  LABELING FOR HUMAN PRESCRIPTION DRUGS; REVISED FORMAT

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

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

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 
USC 353; 21 USC 355; 21 USC 356; 21 USC 357; 21 USC 358; 21 USC 360; 21 
USC 360b; 21 USC 360gg to 360ss; 21 USC 371; 21 USC 374; 21 USC 379e

[[Page 62507]]

CFR Citation:  1 CFR 201

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/97
NPRM Comment Period End         06/00/97

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Nancy Ostrove, Division of Drug Marketing, Advertising, 
and, Communications, Department of Health and Human Services, Food and 
Drug Administration, Center for Drug Evaluation and Research, 5600 
Fishers Lane, Rockville, MD 20857
Phone: 301 827-2828
Fax: 301 594-6759

RIN: 0910-AA94
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




1215. OVER-THE-COUNTER (OTC) DRUG REVIEW

Priority:  Routine and Frequent

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

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

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

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. NOTE: NPRM for 
``Antidotes, Toxic Ingestion Products'' was combined with NPRM for 
``Emetic Products'' and reproposed as ``Poison Treatment Products.'' 
NPRM for ``Astringent (Wet Dressings) Products'' was included in the 
NPRM for ``Skin Protectant Products.'' NPRM for ``Diaper Rash 
Products'' was included in NPRMs for ``Antifungal,'' ``Antimicrobial,'' 
``External Analgesic'' and ``Skin Protectant Products.'' NPRM for 
``Fever Blister/Cold Sore Products (External)'' was included in NPRMs 
for ``External Analgesic'' and ``Skin Protectant Products.'' NPRM for 
``Insect Bites and Stings (Relief) Products'' was included in NPRMs for 
``External Analgesic'' and ``Skin Protectant Products.'' ``Poison Ivy/
Oak/Sumac Prevention'' was included in NPRMs for ``External Analgesic'' 
and ``Skin Protectant Products.'' NPRM for ``Mercurial (Topical) 
Products'' was included in revised NPRM for ``Antimicrobial Products.'' 
NPRM for ``Alcohol (Topical) Products'' was included in revised NPRM 
for ``Antimicrobial Products.'' The NPRM for ``Antimicrobial Products'' 
was updated and split into two sections: First Aid Products and Health 
Care Products.
SMALL ENTITIES AFFECTED: The effects, if any, vary depending on the 
individual rulemaking. However, the Agency anticipates that the rules 
would not have a significant economic impact on a substantial number of 
small entities as defined by the Regulatory Flexibility Act.

Timetable:

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

Alcohol (Oral) in OTC Drug Products  NPRM 10/21/93 (58 FR 54466)  Final 
Action 03/13/95 (60 FR 13590)  NPRM (Amendment) 05/10/96 (61 FR 
21392)  Final Action (Amendment) 11/00/96

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

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

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

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

Antibiotic First Aid Products  ANPRM 04/01/77 (42 FR 17642)  NPRM 07/
09/82 (47 FR 29986)  Final Action 12/11/87 (52 FR 47312)  NPRM 
(Amendment) 08/18/89 (54 FR 34188)  Final Action 03/15/90 (55 FR 
9721)  NPRM (Amendment) 05/11/90 (55 FR 19868)  NPRM (Amendment) 06/08/
90 (55 FR 23450)  Final Action (Amendment) 10/03/90 (55 FR 
40379)  Final Action (Amendment) 12/05/90 (55 FR 50171)  NPRM 
(Amendment) (Warning) 02/14/96 (61 FR 5918)  Final Action 
(Amendment)(Warning) 11/00/96

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

Antidiarrheal Products  ANPRM 03/21/75 (40 FR 12924)  NPRM 04/30/86 (51 
FR 16138)  NPRM (Amendment)(Trev. Diav.) 02/00/97  Final Action 02/00/
97

[[Page 62508]]

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

Antiemetic Products  ANPRM 03/21/75 (40 FR 12934)  NPRM 07/13/79 (44 FR 
41064)  Final Action 04/30/87 (52 FR 15886)  NPRM (Amendment) 08/26/93 
(58 FR 45216)  Final Action 04/11/94 (59 FR 16981)  NPRM 
(Amendment)(Warning) 02/00/97

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

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

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

Antiperspirant Products  ANPRM 10/10/78 (43 FR 46694)  NPRM 08/20/82 
(47 FR 36492)  Final Action 03/00/97

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

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

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

Aspirin (Heart Labeling)  NPRM 10/20/93 (58 FR 54224)

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

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

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

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

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

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

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

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

Cough/Cold (Antihistamine) Products  ANPRM 09/09/76 (41 FR 38312)  NPRM 
01/15/85 (50 FR 2200)  NPRM (Amendment) 08/24/87 (52 FR 31892)  Final 
Action 12/09/92 (57 FR 58356)  Final Action (Amendment)(Warning) 01/28/
94 (59 FR 4216)  NPRM (Amendment)(Warning) 02/00/97

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

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

Cough/Cold (Combination) Products  ANPRM 09/09/76 (41 FR 38312)  NPRM 
08/12/88 (53 FR 30522)  NPRM (Amendment)(DPH Combinations) 02/23/95 (60 
FR 10286)  Final Action Theophylline 07/27/95 (60 FR 38636)  Final 
Action 03/00/97

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

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

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

Cough/Cold (Nasal Decongestant) Products  ANPRM 09/09/76 (41 FR 
38312)  NPRM 01/15/85 (50 FR 2220)  NPRM (Amendment) 06/19/92 (57 FR 
27658)  Final Action 08/23/94 (59 FR 43386)  Final Action; Partial Stay 
03/08/96 (61 FR 9570)  NPRM (Phenylpropanolamine) 03/00/97

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

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

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

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

Eligibility Criteria for Additional Conditions  ANPRM 10/03/96 (61 FR 
51625)

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

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

External Analgesic Products  ANPRM 12/04/79 (44 FR 69768)  NPRM 02/08/
83 (48 FR 5852)  NPRM (Amendment) (Dandruff) 07/30/86 (51 FR 
27360)  NPRM (Amendment) (Anorectal) 08/25/88 (53 FR 32592)  NPRM 
(Amendment) (Poison Ivy) 10/03/89 (54 FR 40818)  NPRM (Amendment) (Fvr 
Blister/Ext) 01/31/90 (55 FR 3370)  NPRM (Amendment) (1%Hydrocortisone) 
02/27/90 (55 FR 6932)  NPRM (Amendment) (Diaper Rash) 06/20/90 (55 FR 
25234)  Final Action (Diaper Rash) 12/18/92 (57 FR 60426)  NPRM 
(Amendment)(Warning) 02/00/97  Final Action 00/00/00

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

[[Page 62509]]

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

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

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

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

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

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

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

Internal Analgesic Products  ANPRM 07/08/77 (42 FR 35346)  NPRM 11/16/
88 (53 FR 46204)  NPRM (Amendment) (Overindulgence) 12/24/91 (56 FR 
66762)  NPRM (Amdt.)(Sodium Bicarbonate) 02/02/94 (59 FR 5068)  NPRM 
(Prof. Labeling)(Acute MI) 06/13/96 (61 FR 30002)  Final Action 
(Cardio/Cerebrvasclar) 01/00/97  NPRM (Amendment)(Alcohol Warning) 03/
00/97  NPRM (Labeling-revised indications) 03/00/97

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

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

Labeling of Drug Products for OTC Use  NPRM 04/05/93 (58 FR 
17553)  Final Action 01/28/94 (59 FR 3998)  NPRM (Do not mix drugs) 08/
03/94 (59 FR 39499)  NPRM (Amendment) (Do not mix drugs) 10/04/95 (60 
FR 52058)  NPRM (Unless a doctor tells you) 03/04/96 (61 FR 8450)  NPRM 
(Calcium/Magnesium/Potassium) 04/22/96 (61 FR 17807)  NPRM (Format/
Examples) 01/00/97  Final Action 03/00/97

Laxative Products  ANPRM 03/21/75 (40 FR 12902)  NPRM 01/15/85 (50 FR 
2124)  NPRM (Amendment) (Directions/Bulk) 10/01/86 (51 FR 35136)  NPRM 
(Amendment) (Docusate Salts) 09/02/93 (58 FR 46589)  NPRM 
(Amendment)(Sodium Phosphates) 03/31/94 (59 FR 15139)  Final Action 
(Sodium Phosphates) 12/00/96  NPRM (Amendment)(Phosphates Label.) 12/
00/96  Final Action 03/00/97

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

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

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

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

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

Nighttime Sleep Aid Products  ANPRM 12/08/75 (40 FR 57292)  NPRM 06/13/
78 (43 FR 25544)  Final Action 02/14/89 (54 FR 6814)  NPRM (Amendment) 
08/26/93 (58 FR 45217)  Final Action (Amendment) 04/11/94 (59 FR 
16982)  NPRM (Amendment)(Warning) 02/00/97

NDA Labeling Exclusivity  NPRM 11/09/93 (58 FR 59622)  Final Action 03/
00/97

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

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

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

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

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

Otic Products (Dry Water-Clogged Ears)  NPRM (Amendment) 02/00/97

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

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

Overindulgence Remedies  ANPRM 10/01/82 (47 FR 43540)  NPRM 12/24/91 
(56 FR 66742)  NPRM (Amendment)(Warning) 05/05/93 (58 FR 26886)

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

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

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

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

Poison Treatment Products  NPRM 01/15/85 (50 FR 2244)  NPRM (Amendment) 
01/00/97  Final Action 03/00/97

Quinine for Malaria  NPRM 04/19/95 (60 FR 19650)  Final Action 02/00/97

Reporting of Adverse Reactions  NPRM 12/00/96

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

Skin Protectant Products  ANPRM 08/04/78 (43 FR 34628)  NPRM 02/15/83 
(48 FR 6820)  NPRM (Amendment) (Astringent) 04/03/89 (54 FR 
13490)  NPRM (Amendment) (Poison Ivy) 10/03/89 (54 FR 40808)  NPRM 
(Amendment) (Fvr Blister/Ext) 01/31/90 (55 FR 3362)  NPRM (Amendment) 
(Diaper Rash) 06/20/90 (55 FR 25204)  Final Action (Astringent) 10/21/
93 (58 FR 54466)  Final Action (Witch Hazel) 06/03/94 (59 FR 
28767)  Final Action (Poison Ivy) 02/00/97  Final Action 02/00/97

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

Sodium Labeling  NPRM 04/25/91 (56 FR 19222)  Final Action 04/22/96 (61 
FR 17798)  NPRM 03/00/97  Final Action (Technical Amendment) 03/00/97

[[Page 62510]]

Status of Certain Category II and III Ingredients  NPRM 05/16/90 (55 FR 
20434)  Final Action 11/07/90 (55 FR 46914)  NPRM 08/25/92 (57 FR 
38568)  Final Action 05/10/93 (58 FR 27636)  NPRM 02/00/97

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

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

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

Sunscreen Products  ANPRM 08/25/78 (43 FR 38206)  NPRM 05/12/93 (58 FR 
28194)  NPRM (Amendment) 06/08/94 (59 FR 29706)  NPRM 
(Amendment)(Avobenzone) 09/16/96 (61 FR 48645)

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

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

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

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

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

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

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

Weight Control Products  ANPRM 02/26/82 (47 FR 8466)  NPRM 10/30/90 (55 
FR 45788)  Final Action 08/08/91 (56 FR 37792)  NPRM (Amendment) 03/00/
97

Small Entities Affected: None

Government Levels Affected: None

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

Agency Contact: William E. Gilbertson, Assoc. Director for OTC Drug 
Monographs, Office of Drug Evaluation V, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research (HFD-105), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2304

RIN: 0910-AA01
_______________________________________________________________________




1216. NEW ANIMAL DRUG APPROVAL PROCESS; IMPLEMENTATION OF TITLE I OF THE 
GENERIC ANIMAL DRUG AND PATENT TERM RESTORATION ACT (GADPTRA)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  21 USC 360b; 21 USC 371

CFR Citation:  21 CFR 514

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

Abstract: On December 17, 1991, the Agency published a proposed 
revision of the existing regulations that is consistent with the 
current procedural regulations for human drugs where appropriate. The 
New Animal Drug Application (NADA) revisions articulate general 
requirements in regulations containing performance standards and would 
complement them through detailed guidelines on, among other matters, 
appropriate ways of meeting requirements for submission of chemistry, 
pharmacology, and statistical data that would better address the 
intricate scientific issues involved. A separate proposed rule for 
reporting requirements for marketed animal drugs also was published on 
that date. The agency intends to repropose the NADA proposed rule to 
incorporate some recent changes in procedure. The Agency also proposes 
to amend its regulations to implement Title I of the Generic Animal 
Drug and Patent Term Restoration Act, which established new standards 
for marketing approval of generic copies of animal drugs approved after 
1962.

Timetable:

New Animal Drug Approval Process  NPRM 12/17/91 (56 FR 65544)  NPRM 04/
00/97

Reporting Requirements for Marketed Animal Drugs  NPRM 12/17/91 (56 FR 
65581)  Final Action 01/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AA96.
For information concerning reporting requirements for marketed animal 
drugs, contact William C. Keller, Director, Division of Surveillance, 
Center for Veterinary Medicine, Food and Drug Administration, 7500 
Standish Place, Rockville, MD 20855, (301) 594-1722. For further 
information concerning generic animal drugs, contact Lonnie W. Luther, 
Chief, Generic Animal Drug and Quality Control Staff, Center for 
Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, 
Rockville, MD 20855, (301) 594-1623.

Agency Contact: George A. Mitchell, Deputy Director, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Veterinary Medicine (HFV-1), 7500 Standish Place, Rockville, MD 20855
Phone: 301 594-1740

RIN: 0910-AA02
_______________________________________________________________________




1217. PRESCRIPTION DRUG MARKETING ACT OF 1987; POLICY INFORMATION, 
GUIDANCE, AND CLARIFICATIONS

Priority:  Other Significant

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

CFR Citation:  21 CFR 203

Legal Deadline: None

Abstract: The Prescription Drug Marketing Act of 1987 (PDMA) amended 
the Federal Food, Drug, and Cosmetic Act to: (1) require State 
licensing of wholesale distributors of prescription human drugs under 
Federal guidelines including minimum standards for storage, handling, 
and recordkeeping; (2) ban the reimportation of prescription human 
drugs produced in the United States, except when reimported by the 
manufacturer or for emergency use; 3) ban the sale, trade, or purchase 
of drug

[[Page 62511]]

samples; (4) ban trafficking in or counterfeiting of drug coupons; (5) 
mandate storage, handling, and recordkeeping requirements for drug 
samples; (6) require licensed practitioners to request drug samples in 
writing; (7) prohibit, with certain exceptions, the resale of 
prescription human drugs purchased by hospitals or health care 
facilities; and (8) set forth criminal and civil penalties for 
violations of these provisions. In the Federal Register of September 
14, 1990 (55 FR 38012), FDA issued a final rule setting forth Federal 
guidelines for State licensing of wholesale drug distributors. The 
final rule would provide information, guidance, and clarification of 
those sections of PDMA that are not related to State licensing of 
wholesale distributors.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/14/94                    59 FR 11842
NPRM Comment Period End         08/01/94
Final Action                    04/00/97

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: Previously reported under RIN 0905-AD44.

Agency Contact: Lee D. Korb, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 7500 
Standish Place, Rockville, MD 20855
Phone: 301 594-1049
Fax: 301 594-0152

RIN: 0910-AA08
_______________________________________________________________________




1218. IMPLEMENTATION OF THE SAFE MEDICAL DEVICES ACT OF 1990

Priority:  Other Significant

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

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

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

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

Timetable:

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

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

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

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

Distributor Reporting  NPRM 12/00/96

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

Medical Device Recall Authority  NPRM 06/14/94 (59 FR 30656)  NPRM 
(Correction) 06/23/94 (59 FR 32489)  Final Action 11/00/96

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

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

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

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

Reports of Removals and Corrections of Medical Devices  NPRM 06/04/94 
(59 FR 13828)  Final Action 01/00/97

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

[[Page 62512]]

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

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

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Federal

Additional Information: Previously reported under RIN 0905-AD59.

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

RIN: 0910-AA09
_______________________________________________________________________




1219. 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                    02/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD94.

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

RIN: 0910-AA21
_______________________________________________________________________




1220. INVESTIGATIONAL DEVICE EXEMPTION; INTRAOCULAR LENSES

Priority:  Info./Admin./Other

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

Legal Authority:  21 USC 360j(g)

CFR Citation:  21 CFR 813; 21 CFR 812

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/06/93                    58 FR 52142
Final Action                    12/00/96

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD95.

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

RIN: 0910-AA22
_______________________________________________________________________




1221. SPECIFIC REQUIREMENTS ON CONTENT AND FORMAT OF LABELING FOR HUMAN 
PRESCRIPTION DRUGS; ADDITION OF ``GERIATRIC USE'' SUBSECTION IN THE 
LABELING

Priority:  Other Significant

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

CFR Citation:  21 CFR 201

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/01/90                    55 FR 46134
NPRM Comment Period End         12/31/90
Final Action                    12/00/96

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE26.

Agency Contact: Thomas Kuchenberg, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 7500 
Standish Place, Rockville, MD 20855
Phone: 301 594-1046
Fax: 301 594-0152

RIN: 0910-AA25
_______________________________________________________________________




1222. TAMPER-EVIDENT PACKAGING REQUIREMENTS FOR OVER-THE-COUNTER HUMAN 
DRUG PRODUCTS

Priority:  Substantive, Nonsignificant

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

CFR Citation:  21 CFR 211

Legal Deadline: None

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

[[Page 62513]]

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                    12/00/96

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE27.

Agency Contact: Thomas Kuchenberg, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 7500 
Standish Place, Rockville, MD 20855
Phone: 301 594-1049
Fax: 301 594-0152

RIN: 0910-AA26
_______________________________________________________________________




1223. ADVERSE EXPERIENCE EXPEDITED REPORTING REQUIREMENTS FOR HUMAN DRUG 
AND LICENSED BIOLOGICAL PRODUCTS

Priority:  Other Significant

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

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/27/94                    59 FR 54046
NPRM Comment Period End         01/25/95
Final Action                    12/00/96

Small Entities Affected: None

Government Levels Affected: None

Procurement: This is a procurement-related action for which there is no 
statutory requirement. There is a paperwork burden associated with this 
action.
Additional Information: Previously reported under RIN 0905-AE29.

Agency Contact: Audrey Thomas, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research (HFD-7), 7500 Standish Place, Rockville, 
MD 20855
Phone: 301 594-1049
Fax: 301 594-0152

RIN: 0910-AA28
_______________________________________________________________________




1224. ELECTRONIC SIGNATURES; ELECTRONIC RECORDS

Priority:  Other Significant

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

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

CFR Citation:  21 CFR 11

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           07/21/92                    57 FR 32185
ANPRM Comment Period End        10/19/92
NPRM                            08/31/94                    59 FR 45160
NPRM Comment Period End         11/29/94
Final Action                    12/00/96

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: Federal

Additional Information: Previously reported under RIN 0905-AE31.

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

RIN: 0910-AA29
_______________________________________________________________________




1225. 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

[[Page 62514]]

314.94; 21 CFR 314.200; 21 CFR 314.300; 21 CFR 320.36; 21 CFR 330.10; 
21 CFR 601.2; 21 CFR 807.31; 21 CFR 807.87; 21 CFR 807.100; ...

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/22/94                    59 FR 47807
NPRM Comment Period End         12/21/94
Final Action                    02/00/97

Small Entities Affected: None

Government Levels Affected: None

Procurement: This is a procurement-related action for which there is no 
statutory requirement. There is a paperwork burden associated with this 
action.
Additional Information: Previously reported under RIN 0905-AE32.

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

RIN: 0910-AA30
_______________________________________________________________________




1226. LATEX CONDOMS: EXPIRATION DATE LABELING

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

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 351; 21 USC 352

CFR Citation:  21 CFR 801

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: Previously reported under RIN 0905-AE37.

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

RIN: 0910-AA32
_______________________________________________________________________




1227. LATEX WARNING

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 352

CFR Citation:  21 CFR 801

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: Previously reported under RIN 0905-AE40.

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

RIN: 0910-AA34
_______________________________________________________________________




1228. HUMAN TISSUE INTENDED FOR TRANSPLANTATION

Priority:  Other Significant

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

CFR Citation:  21 CFR 1270

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              12/14/93

[[Page 62515]]

Interim Final Rule Opportunity 
for Comment                     12/14/93                    58 FR 65514
Interim Final Rule Comment 
Period End                      03/14/94
Final Action                    12/00/96

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE49.

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

RIN: 0910-AA40
_______________________________________________________________________




1229. 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, and FDA 
is proposing to do so . Because of recent changes in the laws 
regulating dietary supplements brought about by the Dietary Supplement 
Health and Education Act (Pub. L. 103-417), FDA published a 
supplemental proposal on February 16, 1995, that set forth its revised 
legal authority.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/06/94                    59 FR 51030
NPRM Correction                 11/14/94                    59 FR 56573
NPRM Comment Period End         12/20/94
Supplemental NPRM               02/16/95                     60 FR 8989
Supplemental NPRM Comment Period 
End                             04/17/95
Final Action                    02/00/97

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE59.

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

RIN: 0910-AA42
_______________________________________________________________________




1230. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, 
PACKING, OR HOLDING OF DRUGS; PROPOSED AMENDMENT OF CERTAIN REQUIREMENTS 
FOR FINISHED PHARMACEUTICALS

Priority:  Other Significant

Legal Authority:  21 USC 321; 21 USC 351 to 352; 21 USC 355 to 357; 21 
USC 360b; 21 USC 371; 21 USC 374

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/03/96                    61 FR 20104
NPRM Comment Period End         09/30/96
Final Action                    04/00/97

Small Entities Affected: None

Government Levels Affected: Federal

Additional Information: Previously reported under RIN 0905-AE63.

Agency Contact: Thomas Kuchenberg, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 7500 
Standish Place, Rockville, MD 20855
Phone: 301 594-1046
Fax: 301 594-0152

RIN: 0910-AA45
_______________________________________________________________________




1231. CONSOLIDATION OF REGULATIONS

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

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

Legal Authority:  21 USC 371

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/11/96                    61 FR 29502
NPRM Comment Period End         08/26/96
Final Action                    01/00/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Mary E. Catchings, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug

[[Page 62516]]

Evaluation and Research (HFD-7), 7500 Standish Place Rockville, MD 
20855
Phone: 301 594-2041
Fax: 301 594-0152

RIN: 0910-AA53
_______________________________________________________________________




1232. CHANGES TO AN APPROVED APPLICATION

Regulatory Plan:  This entry is Seq. No. 28 in Part II of this issue of 
the Federal Register.

RIN: 0910-AA57
_______________________________________________________________________




1233. REINVENTING FDA FOOD REGULATIONS

Priority:  Substantive, Nonsignificant

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

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

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

Legal Deadline: None

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

Timetable:

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

Food and Color Additive Regulations; Plan for Revisions  ANPRM 06/12/96 
(61 FR 29701)  Comment Period Ends 09/10/96  Final Action 03/00/97

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

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

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

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

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

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

Revocation of Lower Fat Milk Standards  NPRM 11/09/95 (60 FR 
5654)  Comment Period Ends 01/23/96  Final Action 01/00/97

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

Small Entities Affected: Businesses

Government Levels Affected: State

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

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

RIN: 0910-AA58
_______________________________________________________________________




1234. NEW DRUG APPLICATIONS; DRUG MASTER FILE

Priority:  Substantive, Nonsignificant

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

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

CFR Citation:  21 CFR 314

Legal Deadline: None

Abstract: The final rule would eliminate Type I Drug Master Files, 
which contain information about manufacturing sites, facilities, 
operating procedures, and personnel, because

[[Page 62517]]

these files contain outdated information, duplicate information 
contained in marketing applications, and are not used by application 
review divisions or field inspectors.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/03/95                    60 FR 34486
NPRM Comment Period End         10/02/95
Final Action                    02/00/97

Small Entities Affected: None

Government Levels Affected: None

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

Agency Contact: Thomas Kuchenburg, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, (HFD-7), 7500 Standish Place, Rockville, 
MD 20855
Phone: 301 594-1049
Fax: 301 594-0152

RIN: 0910-AA78
_______________________________________________________________________




1235. NATIONAL ENVIRONMENTAL POLICY ACT; POLICIES AND PROCEDURES

Priority:  Other Significant

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

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

CFR Citation:  21 CFR 25

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/03/96                    61 FR 14922
NPRM Comment Period End         11/21/96                    61 FR 54746
Final Action                    01/00/97

Small Entities Affected: Undetermined

Government Levels Affected: Federal

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

RIN: 0910-AA80
_______________________________________________________________________




1236. CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICAL; 
POSITRON EMISSION TOMOGRAPHY

Priority:  Substantive, Nonsignificant

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

Legal Authority:  21 USC 321; 21 USC 351; 21 USC 352; 21 USC 355; 21 
USC 356; 21 USC 357; 21 USC 360; 21 USC 371; 21 USC 374

CFR Citation:  21 CFR 211

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/27/95                    60 FR 10517
NPRM Comment Period End         03/29/95
Final Action                    01/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

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

Agency Contact: Thomas Kuchenberg, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research (HFD-7), 7500 Standish Place Rockville, MD 
20855
Phone: 301 594-1049
Fax: 301 594-0152

RIN: 0910-AA81
_______________________________________________________________________




1237. INVESTIGATIONAL NEW DRUG APPLICATIONS AND NEW DRUG APPLICATIONS

Priority:  Substantive, Nonsignificant

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

CFR Citation:  21 CFR 312; 21 CFR 314

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/08/95                    60 FR 46794
NPRM Comment Period End         12/07/95
Final Action                    03/00/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

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

Agency Contact: Audrey Thomas, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, (HFD-7), 7500 Standish Place, Rockville, 
MD 20855
Phone: 301 594-1049
Fax: 301 594-0152

RIN: 0910-AA82

[[Page 62518]]

_______________________________________________________________________




1238. POSTMARKETING PERIODIC ADVERSE EXPERIENCE REPORTING REQUIREMENTS 
FOR HUMAN DRUG AND LICENSED BIOLOGICAL PRODUCTS

Priority:  Other Significant

Legal Authority:  21 USC 216; 21 USC 262; 21 USC 263; 21 USC 264; 21 
USC 300; 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 353; 21 
USC 355; 21 USC 356; 21 USC 357; 21 USC 371; 21 USC 374; ...

CFR Citation:  21 CFR 314; 21 CFR 600

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/27/94                    59 FR 54046
Final Action                    04/00/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

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

Agency Contact: Audrey Thomas, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research (HFD-7), 7500 Standish Place, Rockville, 
MD 20855
Phone: 301 594-1049
Fax: 301 594-0152

RIN: 0910-AA85
_______________________________________________________________________




1239. NEW DRUGS FOR HUMAN USE; CLARIFICATION OF REQUIREMENTS FOR 
APPLICATION SUPPLEMENTS

Priority:  Substantive, Nonsignificant

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

CFR Citation:  21 CFR 314

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/04/86                    51 FR 20310
Final Action                    01/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Erica L. Keys, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Center for Drug 
Evaluation and Research, (HFD-7), 7500 Standish Place, Rockville, MD 
20855
Phone: 301 594-1049
Fax: 301 594-0152

RIN: 0910-AA87
_______________________________________________________________________




1240.  DISQUALIFICATION OF A CLINICAL INVESTIGATOR

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 
USC 353; 21 USC 355; 21 USC 356; 21 USC 357; 21 USC 371

CFR Citation:  21 CFR 312

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/16/96                     61 FR 6177
NPRM Comment Period End         05/16/96
Final Action                    01/00/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Thomas Kuchenberg, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research (HFD-7), 7500 Standish Place, Rockville, 
MD 20855
Phone: 301 594-1049
Fax: 301 594-0152

RIN: 0910-AA95
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




1241. FEES FOR CERTIFICATION SERVICES; INSULIN AND COLOR ADDITIVE 
CERTIFICATION PROGRAMS

Priority:  Routine and Frequent

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

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

CFR Citation:  21 CFR 80; 21 CFR 429

Legal Deadline: None

Abstract: Insulin Certification Program:
In the Federal Register of October 4, 1991 (56 FR 50248), FDA issued an 
interim rule effective on November 4, 1991, with opportunity for public 
comment, revising the fee schedule for insulin certification services. 
In the Federal Register of November 9, 1995

[[Page 62519]]

(60 FR 56515), FDA issued an interim final rule, which was effective 
December 11, 1995. This interim final rule decreased the fees charged 
for insulin certification services due to lower program and 
administrative costs. The public had the opportunity to submit written 
comments to FDA by February 7, 1996.
Color Certification Program:
In the Federal Register of November 29, 1994, FDA issued an interim 
rule effective December 29, 1994, which amended the color additive 
regulations by increasing the fees for certification services. In the 
Federal Register of February 1, 1996 (61 FR 3571), FDA issued a final 
rule, effective March 4, 1996, which incorporated comments FDA received 
from the International Association of Color Manufacturers (IACM) on the 
interim rule. FDA received an objection from IACM to an annual 
escalator provision which would have allowed FDA to increase the fees 
for color certification services by a rate proportional with Federal 
salary increases. After considering the objection, FDA decided not to 
implement this provision.

Timetable:

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

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


Next Action Undetermined

Small Entities Affected: Undetermined

Government Levels Affected: None

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

Agency Contact: David R. Petak, Director, Division of Accounting, 
Department of Health and Human Services, Food and Drug Administration, 
Office of Management (HFA-120), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 443-1766
Fax: 301 443-6242

RIN: 0910-AA07
_______________________________________________________________________




1242. REVIEW OF WARNINGS, USE INSTRUCTIONS, AND PRECAUTIONARY 
INFORMATION UNDER SECTION 314 OF THE NATIONAL CHILDHOOD VACCINE INJURY 
ACT OF 1986

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

Unfunded Mandates: Undetermined

Legal Authority:  PL 99-660, sec 314

CFR Citation:  None

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: State

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

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

RIN: 0910-AA14
_______________________________________________________________________




1243. FOOD LABELING REVIEW

Priority:  Routine and Frequent

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

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

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

Legal Deadline: None

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

[[Page 62520]]

health claims to remove the provisions that exempted restaurant menus 
from the requirements for how nutrient content claims and health claims 
are to be made. FDA published a final rule on August 7, 1996, 
describing provisions for an exemption for small businesses from the 
requirements for nutrition labeling and providing instructions on how 
to file a notice claiming the exemption. FDA published on August 16, 
1996, final guidelines in the voluntary declaration of (cont)
Timetable:

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

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

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

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

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

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

Protein Hydrolysates; Broth in Tuna; and/or Labeling  NPRM (Declaration 
of Ingredients) 01/06/93 (58 FR 2950)  Final Action (Dec. of 
Ingredients) 00/00/00

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

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

Voluntary Guidelines for Nutrition Labeling Produce  NPRM 07/18/94 (59 
FR 36379)  Final Action 08/16/96 (61 FR 42742)
Small Entities Affected: Businesses
Government Levels Affected: State, Federal
Additional Information: Previously reported under RIN 0905-AD89. 
ABSTRACT CONT: nutrition labeling for raw produce and fish.
Agency Contact: F. Edward Scarbrough, Director, Office of Food 
Labeling, Department of Health and Human Services, Food and Drug 
Administration, Center for Food Safety and Applied Nutrition (HFS-150), 
200 C Street SW., Washington, DC 20204
Phone: 202 205-4561
Fax: 202 205-4594

RIN: 0910-AA19
_______________________________________________________________________




1244. AMALGAM INGREDIENT LABELING

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 352

CFR Citation:  21 CFR 801

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE39.

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

RIN: 0910-AA33
_______________________________________________________________________




1245. PRESCRIPTION DRUG PRODUCT LABELING; MEDICATION GUIDE

Priority:  Other Significant

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Additional Information: Previously reported under RIN 0905-AE43.

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

RIN: 0910-AA37
_______________________________________________________________________




1246. CLASSIFICATION OF COMPUTER SOFTWARE PROGRAMS THAT ARE MEDICAL 
DEVICES

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

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 321(h); 21 USC 351; 21 USC 352; 21 USC 360(c)

CFR Citation:  None

Legal Deadline: None

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

[[Page 62521]]

addition, the agency will use existing exemptions from regulation where 
appropriate. Under this approach low risk medical software devices 
would be subject only to the adulteration and misbranding provisions of 
the act. Moderate risk devices would additionally be subject to the 
registration, listing, and good manufacturing practice requirements for 
adverse events and complaints. High risk devices would be the only 
products to require premarket submissions or premarket approval. FDA is 
also seeking comment on potential criteria related to the intended uses 
of medical software devices that might be used in determining the level 
of risk.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE58.

Agency Contact: Chuck Furfine, Regulatory Review Scientist/Software 
Expert, Department of Health and Human Services, Food and Drug 
Administration, Center for Devices and Radiological Health (HFZ-84), 
2098 Gaither Road, Rockville, MD 20850
Phone: 301 594-4765

RIN: 0910-AA41
_______________________________________________________________________




1247. DEVELOPMENT OF HAZARD ANALYSIS CRITICAL CONTROL POINTS FOR THE 
FOOD INDUSTRY; REQUEST FOR COMMENTS

Priority:  Other Significant

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

CFR Citation:  None

Legal Deadline: None

Abstract: FDA announced on April 4, 1994, its plans to consider 
developing regulations that would establish requirements for a new 
comprehensive food safety assurance program for both domestically 
produced and imported foods that would be based on the principles of 
Hazard Analysis Critical Control Points (HACCP). The new food safety 
program would respond to new challenges, such as new food processing 
and packaging technologies, new food distribution and consumption 
patterns, exposure to industrial chemicals and chemical waste, the 
increasing importation of foods, new microbial pathogens, and resource 
constraints. The most serious of these challenges is presented by food 
pathogens. The number of recognized food-borne pathogens has broadened 
considerably, as has awareness of long-term complications from certain 
food-borne illnesses--such as arthritis, heart disease, and kidney and 
neurological damage. To meet such challenges, FDA intends to shift the 
focus of its food safety assurance program away from periodic visual 
inspection and end-product testing and toward prevention of food safety 
risks and problems, utilizing the HACCP state-of-the-art preventive 
approach.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: Previously reported under RIN 0905-AE60.

Agency Contact: John E. Kvenberg, Strategic Manager, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Food Safety and Applied Nutrition (HFS-10), 200 C Street SW., 
Washington, DC 20204
Phone: 202 205-4010

RIN: 0910-AA43
_______________________________________________________________________




1248. HABIT FORMING DRUGS

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

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

Legal Authority:  21 USC 352; 21 USC 353; 21 USC 355; 21 USC 371

CFR Citation:  21 CFR 329

Legal Deadline: None

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

Timetable: Next Action Undetermined

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 7500 
Standish Place, Rockville, MD 20855
Phone: 301 594-1049
Fax: 301 594-0152

RIN: 0910-AA50
_______________________________________________________________________




1249. REVOCATION OF CERTAIN REGULATIONS

Priority:  Other Significant

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

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

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

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is proposing to revoke 
certain regulations that either do not achieve public health goals or 
do not need to be codified as regulations to do so. These regulations 
include regulations that are actually statements of policy or guidance, 
that are duplicative, that are obsolete, or that have been made 
inaccurate by changes in legislation and technology.
FDA is taking this action in response to President Clinton's directive 
of March 4, 1995, to all Federal agencies to conduct a page-by-page 
review of their regulations and to eliminate or revise those that are 
outdated or

[[Page 62522]]

otherwise in need of reform. As a result of its regulations review, FDA 
is proposing to eliminate 36 percent of its regulations that it has 
determined are obsolete or no longer necessary to achieve public health 
goals (735 pages of which will first require Congressional action). In 
addition, FDA plans to revise or modify an additional 45 percent of its 
remaining regulations to ease the burden on regulated industry and the 
consumer without sacrificing public health protection. For those 
regulations requiring Congressional permission to eliminate or reform, 
the Administration is seeking legislation. This proposal contains 
deletions that can be accomplished administratively. Examples include 
regulations that refer to substances no longer used in product 
formulations or to products that are no longer marketed; and 
regulations that codify product standards that can be more flexibly 
handled and updated within the context of the review process. FDA is 
providing a 90-day period for public comment on these proposed 
deletions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

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

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

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

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

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

Small Entities Affected: Businesses

Government Levels Affected: Federal

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

RIN: 0910-AA54
_______________________________________________________________________




1250. DIETARY SUPPLEMENT REGULATIONS IN RESPONSE TO DSHEA

Priority:  Routine and Frequent

Major: Undetermined

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

CFR Citation:  21 CFR 101

Legal Deadline: None

Abstract: On January 4, 1994, FDA published final rules relative to 
nutrition labeling, nutrient content claims and health claims for 
dietary supplements. The Dietary Supplement Health and Education Act 
(DSHEA) was enacted on October 25, 1994, modifying the provisions for 
labeling of dietary supplements. FDA has initiated rulemaking to modify 
its regulations for dietary supplements accordingly. One proposal would 
modify the nutrition labeling and ingredient declaration requirements. 
A second proposal would provide for the disclaimer to accompany 
statements of nutritional support. A third proposal would define the 
terms ``high potency'' and ``antioxidant.'' These three proposals were 
published in the Federal Register on December 28, 1995.

Timetable:

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

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

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

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

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

RIN: 0910-AA59
_______________________________________________________________________




1251. EXPORT REQUIREMENTS FOR DRUGS FOR INVESTIGATIONAL USE IN OTHER 
COUNTRIES

Priority:  Substantive, Nonsignificant

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

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

CFR Citation:  21 CFR 312.110

Legal Deadline: None

Abstract: FDA is proposing to amend its regulations on investigational 
new drug products to streamline requirements for exports of unapproved 
drugs for investigational use to foreign countries. The proposal would 
permit an unapproved new drug product to be exported without prior FDA 
approval if the product is to be exported for use in a clinical 
investigation in any country. Persons exporting such products to 
countries not on the list of 25 countries in the recent Export Reform 
Act would be required to report to FDA at the time of export. Thus, the 
proposal would eliminate the need to submit a written request to FDA 
and to obtain FDA approval before exporting an unapproved new drug 
product for use in a clinical investigation in a foreign country. The 
proposal is relevant to the President's and Vice-President's ``National 
Performance Review'' for drugs and is consistent with recent 
Congressional initiatives.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0910-AA61

[[Page 62523]]

_______________________________________________________________________




1252. EXPORT REQUIREMENTS FOR MEDICAL DEVICES

Priority:  Substantive, Nonsignificant

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

Legal Authority:  21 USC 331; 21 USC 351 to 353; 21 USC 355 to 357; 21 
USC 360; 21 USC 360c to 360f; 21 USC 360h to 360j; 21 USC 371; 21 USC 
372; 21 USC 374; 21 USC 379e; 21 USC 381; 42 USC 393; 42 USC 216; 42 
USC 241; 42 USC 2421; ...

CFR Citation:  21 CFR 812.18

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) has proposed to amend 
its regulations for investigational devices to describe streamlined 
requirements for exports of unapproved medical devices. Under the 
proposed rule, an approved investigational device exemption (IDE) would 
constitute an agency determination that the export of the unapproved 
device is not contrary to the public health or safety. Countries could 
notify FDA that they do not object to the importation of unapproved 
devices with an approved IDE into their countries. Thus, for devices 
with an FDA-approved IDE, the proposal would eliminate the need for FDA 
to make independent determinations either that exportation is not 
contrary to the public health or safety or that an importing country 
does not object to the importation of a specific device. The proposed 
rule is intended to codify and to simplify export requirements for 
certain unapproved devices pursuant to the President's and Vice-
President's ``National Performance Review,'' as reflected in the April 
1995 report titled, ``Reinventing Drug & Medical Device Regulations.'' 
It is also consistent with recent Congressional initiatives.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/27/95                    60 FR 58308
Comment Period Reopened         00/00/00

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0910-AA62
_______________________________________________________________________




1253. REINVENTION OF ADMINISTRATIVE PROCEDURES REGULATIONS

Priority:  Other Significant

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

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Tribal, Federal

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

RIN: 0910-AA69
_______________________________________________________________________




1254. HUMAN TISSUE INTENDED FOR TRANSPLANTATION AND HUMAN REPRODUCTIVE 
TISSUE INTENDED FOR INSEMINATION, FERTILIZATION, AND TRANSFER

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

Unfunded Mandates: Undetermined

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

CFR Citation:  21 CFR 1270

Legal Deadline: None

Abstract: The proposed rule will propose the registration of all 
establishments engaged in the recovery, processing, storage, or 
distribution of human tissue intended for transplantation and human 
reproductive tissue intended for insemination, fertilization, and 
transfer. The proposed rule would propose specific requirements for the 
screening, and testing of human reproductive tissue donors. The 
proposed rule would add an urgent medical need provision to part 1270. 
The proposed rule would also require error, accident, and disease 
transmission reporting for all human tissue and human reproductive 
tissue. The tracking of all human tissue and human reproductive tissue 
from donor to recipient or final disposition would also be required 
under this proposed rule. Finally, the proposed rule would extend the 
existing recordkeeping, import, recall and destruction provisions of 
part 1270 to human reproductive tissue intended for insemination, 
fertilization and transfer.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Steven F. Falter, Director, Division of Regulations and 
Policy, Department of Health and Human Services, Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852
Phone: 301 594-3074
Fax: 301 443-3874
Email: [email protected]

RIN: 0910-AA70

[[Page 62524]]

_______________________________________________________________________




1255. INFORMED CONSENT FOR HUMAN DRUGS AND BIOLOGICS; DETERMINATION THAT 
INFORMED CONSENT IS NOT FEASIBLE

Priority:  Other Significant

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

CFR Citation:  21 CFR 50

Legal Deadline: None

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

Timetable: Next Action Undetermined

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0910-AA89
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Food and Drug Administration (FDA)



_______________________________________________________________________




1256. POLICIES CONCERNING USES OF SULFITING AGENTS

Priority:  Other Significant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - No further action 
within the next 12 months.      08/07/96

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: JoAnn Ziyad
Phone: 202 418-3116

RIN: 0910-AA03
_______________________________________________________________________




1257. 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

CFR Citation:  21 CFR 606; 21 CFR 610

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/09/96                    61 FR 47413

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Sharon Carayiannis
Phone: 301 594-3074

RIN: 0910-AA05
_______________________________________________________________________




1258. LEAD IN FOODS

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

Unfunded Mandates: Undetermined

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - No further action 
within the next 12 months.      08/07/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Michael E. Kashtock
Phone: 202 205-4681

RIN: 0910-AA06
_______________________________________________________________________




1259. BOTTLED WATER

Priority:  Routine and Frequent

Unfunded Mandates: Undetermined
Major: Undetermined

CFR Citation:  21 CFR 103; 21 CFR 165

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - No further action 
within the next 12 months.      08/07/96

Small Entities Affected: Undetermined

Government Levels Affected: None

Agency Contact: Michael E. Kashtock
Phone: 202 205-4681

RIN: 0910-AA11
_______________________________________________________________________




1260. DIETARY SUPPLEMENT LABEL REVIEW

Priority:  Routine and Frequent

CFR Citation:  21 CFR 101

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/04/94                      59 FR 436

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Agency Contact: F. Edward Scarbrough
Phone: 202 205-4561

RIN: 0910-AA23
_______________________________________________________________________




1261. EFFECTIVE DATE OF REQUIREMENT FOR PREMARKET APPROVAL FOR CLASS III 
PREAMENDMENTS DEVICES

Priority:  Substantive, Nonsignificant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/27/96                    61 FR 50704
Final Action Effective          09/27/96

Small Entities Affected: None

Government Levels Affected: None

[[Page 62525]]

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

RIN: 0910-AA31
_______________________________________________________________________




1262. ANIMAL MEDICINAL DRUG USE CLARIFICATION ACT OF 1994; EXTRA-LABEL 
USE; IMPLEMENTATION

Priority:  Substantive, Nonsignificant

CFR Citation:  21 CFR 530

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/07/96                    61 FR 57732
Final Action Effective          12/09/96

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Richard L. Arkin
Phone: 301 594-1737

RIN: 0910-AA47
_______________________________________________________________________




1263. REGULATIONS RESTRICTING THE SALE AND DISTRIBUTION OF CIGARETTES 
AND SMOKELESS TOBACCO PRODUCTS TO PROTECT CHILDREN AND ADOLESCENTS

Priority:  Economically Significant. Major under 5 USC 801.

Unfunded Mandates: This action may affect the private sector under       
    PL 104-4.

CFR Citation:  21 CFR 801; 21 CFR 803; 21 CFR 804; 21 CFR 820; 21 CFR 
897

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/28/96                    61 FR 44396

Small Entities Affected: Businesses

Government Levels Affected: State, Local

Agency Contact: Philip L. Chao
Phone: 301 827-3380

RIN: 0910-AA48
_______________________________________________________________________




1264. NAME AND ADDRESS OF DISTRIBUTOR

Priority:  Other Significant

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

CFR Citation:  21 CFR 610.64 (Revision)

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/06/96                    61 FR 57328
Final Action Effective          11/18/96

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Gloria Hicks
Phone: 301 594-3074

RIN: 0910-AA56
_______________________________________________________________________




1265. PROTECTION OF HUMAN SUBJECTS; INFORMED CONSENT

Priority:  Other Significant

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

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/02/96                    61 FR 51498
Final Action Effective          11/01/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Glen D. Drew
Phone: 301 443-1382

RIN: 0910-AA60
_______________________________________________________________________




1266. SUBSTANCES APPROVED FOR USE IN THE PREPARATION OF MEAT AND POULTRY 
PRODUCTS

Priority:  Other Significant

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

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Added to RIN 0910-
AA58.                           08/07/96

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: Federal

Agency Contact: George Pauli
Phone: 202 418-3090

RIN: 0910-AA66
_______________________________________________________________________




1267. FOOD STANDARDS OF IDENTITY, QUALITY, AND FILL OF CONTAINER; COMMON 
OR USUAL NAME REGULATIONS: REQUEST FOR COMMENTS ON EXISTING REGULATIONS

Priority:  Other Significant

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

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - This document is 
listed under RIN 0910-AA58.     08/07/96

Small Entities Affected: Businesses, Organizations

Government Levels Affected: State, Federal

Agency Contact: F. Edward Scarbrough
Phone: 202 205-4561

RIN: 0910-AA67
_______________________________________________________________________




1268. ELIMINATION OF ESTABLISHMENT LICENSE APPLICATION FOR SPECIFIED 
BIOTECHNOLOGY AND SPECIFIED SYNTHETIC BIOLOGICAL PRODUCTS

Priority:  Other Significant

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

CFR Citation:  21 CFR 600.3; 21 CFR 601.2; 21 CFR 601.22

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/14/96                    61 FR 24227

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Sharon Carayiannis
Phone: 301 594-3074

[[Page 62526]]

Fax: 301 443-3874

RIN: 0910-AA71
_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1269.  NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION 
ON PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: CORPORATE SHIELD

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 11131

CFR Citation:  45 CFR 60

Legal Deadline: None

Abstract: This NPRM proposes to require that in addition to reporting 
the National Practitioner Data Bank medical malpractice payments made 
where physicians or other health care practitioners are named in 
judgments or settlements, payments be reported where they are made for 
the benefit of physicians or other health care practitioners not named 
in the judgements or settlements but who furnished or failed to furnish 
the health care services upon which the actions or claims were based. 
The purpose of this NPRM is to prevent the evasion of the medical 
malpractice payment reporting requirement of the Data Bank through the 
agreement of the parties to a lawsuit to use the ``corporate shield'' 
to prevent the health care practitioner from being reported.
It would also allow, in very limited circumstances when it is 
impossible to identify the practitioner who furnished or failed to 
furnish the health care services upon which the actions or claims were 
based, to report why the practitioner could not be identified, the name 
of the hospital or health care organization for whose benefit the 
payment was made, the amount of payment, and the name (if known) of any 
hospital or health care organization with which the practitioner is 
affiliated or associated.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/97

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0906-AA41
_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1270. ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK RULES

Regulatory Plan:  This entry is Seq. No. 29 in Part II of this issue of 
the Federal Register.

RIN: 0906-AA32
_______________________________________________________________________




1271. 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. These were 
based on the information obtained from the Institute of Medicine in 
partnership with the American Academy of Pediatrics. Based on these 
findings, the Secretary amends the Vaccine Injury Table by regulation 
pursuant to section 313 of the National Childhood Vaccine Injury Act of 
1986 and section 2114(c) of the Public Health Service Act. This final 
rule would have effect only for petitions for compensation under the 
National Vaccine Injury Compensation Program (VICP) filed after the 
final regulations become effective.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE52.

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

RIN: 0906-AA36
_______________________________________________________________________




1272. REMOVAL OF OBSOLETE REGULATIONS OF THE TITLE VII GRANT FOR THE 
CONSTRUCTION OF TEACHING FACILITIES FOR HEALTH PROFESSIONS PERSONNEL

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 292 et seq

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

Legal Deadline: None

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

[[Page 62527]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/00/96

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0906-AA39
_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1273. HEALTH EDUCATION ASSISTANCE LOAN (HEAL) PROGRAM: LENDERS'/ 
HOLDERS' PERFORMANCE STANDARDS

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 60

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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


Next Action Undetermined

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD87.

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

RIN: 0906-AA33
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1274.  GRANTS FOR NURSE PRACTITIONER AND NURSE MIDWIFERY 
PROGRAMS

Priority:  Info./Admin./Other

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

Legal Authority:  42 USC 296m

CFR Citation:  42 CFR 57, subpart Y

Legal Deadline: None

Abstract: A technical amendment is necessary to bring the Grants for 
Nurse Practitioner and Nurse Midwifery Program regulations up to date 
with program and departmental policy. Section 57.2405(c) of the program 
regulations currently makes provision for a requirement for projects to 
collect, evaluate and make available to the Secretary data concerning 
the education program being conducted. This project requirement is 
being deleted as the specified data is no longer needed by the 
Department.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/04/96                    61 FR 51787

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jennifer Burks, Chief, Planning, Evaluatin, and 
Legislation, Branch, ORP, Bureau of Health Professions, Department of 
Health and Human Services, Health Resources and Services 
Administration, 5600 Fishers Lane, Room 8-67, Parklawn Building, 
Rockville, MD 20857
Phone: 301 443-1530

RIN: 0906-AA40
_______________________________________________________________________


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


Indian Health Service (IHS)



_______________________________________________________________________




1275. INDIAN CHILD PROTECTION AND FAMILY VIOLENCE PREVENTION ACT MINIMUM 
STANDARDS OF CHARACTER

Priority:  Info./Admin./Other

Legal Authority:  25 USC 3201 et seq

CFR Citation:  42 CFR 36

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/97
NPRM Comment Period End         03/00/97

Small Entities Affected: None

Government Levels Affected: Tribal

[[Page 62528]]

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

RIN: 0917-AA02
_______________________________________________________________________


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


Indian Health Service (IHS)



_______________________________________________________________________




1276. ACQUISITION UNDER THE BUY INDIAN ACT

Priority:  Substantive, Nonsignificant

Legal Authority:  25 USC 47

CFR Citation:  48 CFR ch 3, app A

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/00/97

Small Entities Affected: None

Government Levels Affected: Tribal

Procurement: This is a procurement-related action for which there is a 
statutory requirement. The agency has not yet determined whether there 
is a paperwork burden associated with this action.
Additional Information: Previously reported under RIN 0905-AE09.

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

RIN: 0917-AA00
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Indian Health Service (IHS)



_______________________________________________________________________




1277. REVISION OF INDIAN SELF-DETERMINATION REGULATIONS

Priority:  Other Significant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/24/96                    61 FR 32482
Final Action Effective          08/23/96

Small Entities Affected: None

Government Levels Affected: Tribal

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

RIN: 0917-AA01
_______________________________________________________________________


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


Agency for Health Care Policy and Research (AHCPR)



_______________________________________________________________________




1278. HEALTH SERVICES RESEARCH, EVALUATION, DEMONSTRATION, AND 
DISSEMINATION PROJECTS; PEER REVIEW OF GRANTS AND CONTRACTS

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 67

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/16/93                    58 FR 60510
NPRM Comment Period End         01/18/94
Final Action                    12/00/96

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD30.

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

RIN: 0919-AA00

[[Page 62529]]

_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




1279. 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                            03/00/97

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: Previously reported under RIN 0905-AD18.

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

RIN: 0925-AA02
_______________________________________________________________________




1280. NATIONAL INSTITUTES OF HEALTH CLINICAL RESEARCH LOAN REPAYMENT 
PROGRAM FOR INDIVIDUALS FROM DISADVANTAGED BACKGROUNDS

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 68a

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/96

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE56.

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

RIN: 0925-AA09
_______________________________________________________________________




1281. UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING PROFESSIONS NEEDED BY 
THE NIH

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 68b

Legal Deadline: None

Abstract: Section 487D of the PHS Act, as added by the NIH 
Revitalization Act of 1993, creates a program offering scholarships, in 
an amount not to exceed $20,000 per year of academic study, to 
individuals from disadvantaged backgrounds who are enrolled as full-
time students at accredited institutions pursuing academic programs 
appropriate for careers in professions needed by the NIH. For each year 
of scholarship support, the recipient agrees to service (employment), 
after graduation at the NIH, for one year. Additionally, the individual 
agrees to at least ten consecutive weeks of service (employment) at the 
NIH during which the individual is attending the institution and 
receiving the NIH scholarship. The proposed new regulations will cover 
this program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE57.

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

RIN: 0925-AA10
_______________________________________________________________________




1282. TRAINEESHIPS (TERMINATION POLICIES)

Priority:  Info./Admin./Other

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

CFR Citation:  42 CFR 63

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE62.

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

RIN: 0925-AA11
_______________________________________________________________________




1283. ADDITIONAL DHHS PROTECTIONS FOR PREGNANT WOMEN AND HUMAN FETUSES 
INVOLVED AS SUBJECTS IN RESEARCH, AND PERTAINING TO HUMAN IN VITRO 
FERTILIZATION

Priority:  Other Significant

Legal Authority:  5 USC 301; 42 USC 289

CFR Citation:  45 CFR 46, subpart B

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/96

[[Page 62530]]

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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

RIN: 0925-AA14
_______________________________________________________________________




1284. NATIONAL RESEARCH SERVICE AWARDS

Priority:  Info./Admin./Other

Legal Authority:  42 USC 216; 42 USC 288

CFR Citation:  45 CFR 66

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/97

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0925-AA16
_______________________________________________________________________




1285.  NATIONAL INSTITUTES OF HEALTH LOAN REPAYMENT PROGRAM FOR 
RESEARCH

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 288-3

CFR Citation:  42 CFR 68d

Legal Deadline: None

Abstract: Regulations will be issued to govern the awarding of 
educational loan repayments for research authorized under section 487C 
of the Public Health Service Act, as added by provisions of the NIH 
Revitalization Act of 1993.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/97

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0925-AA18
_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




1286. NATIONAL INSTITUTES OF HEALTH CONSTRUCTION GRANTS

Priority:  Other Significant

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

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

CFR Citation:  42 CFR 52b

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/06/95                    60 FR 35266
NPRM Comment Period End         09/05/95
Final Action                    03/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD49.

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

RIN: 0925-AA04
_______________________________________________________________________




1287. REMOVAL OF NATIONAL CANCER INSTITUTE CLINICAL CANCER EDUCATION 
PROGRAM

Priority:  Info./Admin./Other

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

Legal Authority:  42 USC 216

CFR Citation:  42 CFR 52d

Legal Deadline: None

Abstract: Current regulations relating to the National Cancer Institute 
Clinical Cancer Education Program will be rescinded because the 
regulations are obsolete. Current guidelines

[[Page 62531]]

communicated by NCI with respect to the care of cancer patients no 
longer reflect the type of program described in the current 
regulations. This action will not affect the authority of the Director, 
NCI, to support appropriate programs of education and training, 
including clinical research training set forth in section 414 of the 
Public Health Service Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    04/00/97

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0925-AA17
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


National Institutes of Health (NIH)



_______________________________________________________________________




1288. GRANTS FOR RESEARCH PROJECTS

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 52

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/24/96                    61 FR 55102
Final Action Effective          11/25/96

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0925-AA01
_______________________________________________________________________




1289. HAZARDOUS SUBSTANCES BASIC RESEARCH AND TRAINING GRANTS

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 65a

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/24/96                    61 FR 55113
Final Action Effective          11/25/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Dr. William A. Suk
Phone: 919 541-0797

RIN: 0925-AA03
_______________________________________________________________________




1290. TRAINING GRANTS

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 63a

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/24/96                    61 FR 55110
Final Action Effective          11/25/96

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0925-AA05
_______________________________________________________________________




1291. NATIONAL INSTITUTES OF HEALTH CENTER GRANTS

Priority:  Info./Admin./Other

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

CFR Citation:  42 CFR 52a

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/24/96                    61 FR 55106
Final Action Effective          11/25/96

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0925-AA06
_______________________________________________________________________




1292. GRANTS FOR NATIONAL ALCOHOL RESEARCH CENTERS

Priority:  Info./Admin./Other

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

CFR Citation:  42 CFR 54a

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/24/96                    61 FR 55106
Final Action Effective          11/25/96

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0925-AA08
_______________________________________________________________________




1293. REMOVAL OF OBSOLETE PATENT REGULATIONS

Priority:  Info./Admin./Other

CFR Citation:  45 CFR 6; 45 CFR 8

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/22/96                    61 FR 54743
Final Action Effective          10/22/96

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0925-AA15

[[Page 62532]]

_______________________________________________________________________


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


Office of Assistant Secretary for Health (OASH)



_______________________________________________________________________




1294. STANDARDS OF COMPLIANCE FOR ABORTION-RELATED SERVICES IN FAMILY 
PLANNING SERVICE PROJECTS

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 300a-4

CFR Citation:  42 CFR 59

Legal Deadline: None

Abstract: This rule would return the Family Planning Service Program, 
funded under title X of the Public Health Service Act, to the 
compliance standards operative prior to February 2, l988, with regard 
to the statutory provision prohibiting abortion as a method of family 
planning in projects funded under that title.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/05/93                     58 FR 7464
NPRM Comment Period End         08/09/93                    58 FR 34024
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: State

Additional Information: Previously reported under RIN 0905-AE03.

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

RIN: 0937-AA00
_______________________________________________________________________


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


Public Health Service (PHS)



_______________________________________________________________________




1295.  ADDITIONAL REQUIREMENTS FOR FACILITIES TRANSFERRING OR 
RECEIVING SELECT INFECTIOUS AGENTS

Priority:  Info./Admin./Other

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

CFR Citation:  42 CFR 72.6

Legal Deadline: None

Abstract: In this rule, HHS implements statutory requirements to 
regulate the transfer of select agents that are capable of causing 
substantial harm to human health.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/10/96                    61 FR 29327
NPRM Comment Period End         07/10/96
Final Action                    00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Dr. Jonathan Y. Richmond, Director, Office of Health 
and Safety, Centers for Disease Control and Prevention, Department of 
Health and Human Services, Public Health Service, 1600 Clifton Road, 
N.E. Mailstop F05, Atlanta, GA 30333
Phone: 404 639-2453

RIN: 0905-AE70
_______________________________________________________________________


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


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1296. MEDICARE COVERAGE OF OUTPATIENT OCCUPATIONAL THERAPY SERVICES 
(BPD-425-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395k; 42 USC 1395l; 42 USC 1395w-4; 42 USC 
1395x(s); 42 USC 1395x(p); 42 USC 1395cc(e)

CFR Citation:  42 CFR 410; 42 CFR 485; 42 CFR 486

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-425

Agency Contact: Sheridan Gladhill, Bureau of Policy Development, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-03-18, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-1782

RIN: 0938-AD32
_______________________________________________________________________




1297. ``WITHOUT FAULT'' AND BENEFICIARY WAIVER OF RECOVERY AS IT APPLIES 
TO MEDICARE OVERPAYMENT LIABILITY (BPD-719-P)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1395gg

CFR Citation:  42 CFR 405; 42 CFR 401; 42 CFR 466.94; 42 CFR 411.23; 42 
CFR 411.28; 42 CFR 466.86; 42 CFR 473.14; 42 CFR 413.20; 42 CFR 413.153

Legal Deadline: None

Abstract: This rule would amend the Medicare regulations to clarify our 
interpretation of ``without fault'' as it applies to physician, 
provider, supplier and beneficiary liability for

[[Page 62533]]

overpayments. This definition would result in greater uniformity of 
determinations by carriers and intermediaries. Additionally, this rule 
would amend the Medicare regulations governing liability for 
overpayments to eliminate application of certain regulations of the 
Social Security Administration and to replace them with HCFA 
regulations more specific to circumstances involving Medicare 
overpayments. This rule is part of HCFA's regulatory reform initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-719

Agency Contact: David Walczak, Health Insurance Specialist, Office of 
Chronic Care & Insurance Policy, Department of Health and Human 
Services, Health Care Financing Administration, C4-07-07, 7500 Security 
Blvd., Baltimore, MD 21244
Phone: 410 786-4475

RIN: 0938-AD95
_______________________________________________________________________




1298. PROVIDER REIMBURSEMENT DETERMINATIONS AND APPEALS REVISIONS (BPD-
727-P)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1302; 42 USC 1395f(b); 42 USC 1395g(a); 42 USC 
1395l; 42 USC 1395x(u); 42 USC 1395hh; 42 USC 1395jj; 42 USC 1395oo; 42 
USC 1395ww

CFR Citation:  42 CFR 405.1801; 42 CFR 405.1803; 42 CFR 405.1811; 42 
CFR 405.1834; 42 CFR 405.1835; 42 CFR 405.1837; 42 CFR 405.1839; 42 CFR 
405.1841 to 1843; 42 CFR 405.1845; 42 CFR 405.1853; 42 CFR 405.1873; 42 
CFR 405.1875; 42 CFR 405.1877

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-727

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

RIN: 0938-AF28
_______________________________________________________________________




1299. ALTERNATIVE SANCTIONS FOR PSYCHIATRIC HOSPITALS (HSQ-191-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395cc; 42 USC 1396a

CFR Citation:  42 CFR 488

Legal Deadline: None

Abstract: This proposed rule would provide an alternative to 
terminating a psychiatric hospital's participation in the Medicare and 
Medicaid programs for facilities found to be out of compliance with 
participation requirements. The alternative sanctions could be imposed 
instead of, or in addition to, terminating a psychiatric hospital's 
participation in the Medicare and Medicaid programs where deficiencies 
do not present immediate jeopardy to the health and safety of 
psychiatric hospital patients. These amendments are necessary to 
conform HCFA regulations to changes made by section 6020 of OBRA '89 
and section 4755 of OBRA '90. The statutory and regulatory revisions 
are intended to encourage correction of deficiencies that do not 
jeopardize patient health and safety before termination of a facility 
becomes necessary.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/97

Small Entities Affected: Undetermined

Government Levels Affected: State, Federal

Additional Information: HSQ-191

Agency Contact: Anthony J. Tirone, Deputy Director for Survey & 
Certification, Health Standards and Quality Bureau, Department of 
Health and Human Services, Health Care Financing Administration, S2-14-
27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6810

RIN: 0938-AF32
_______________________________________________________________________




1300. ASSESSING INTEREST AGAINST MEDICARE SECONDARY PAYER (MSP) DEBTS 
(BPO-108-P)

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 411.24(m); 42 CFR 405.376

Legal Deadline: None

Abstract: This proposed rule would establish CFR provisions concerning 
interest charges on amounts owed to the Federal government when an 
overpayment occurs because Medicare was billed and made payment as the 
primary payer, rather than as the secondary payer. We also propose to 
clarify the date of determination that an overpayment has occurred so 
that all parties would have a clear understanding of the period subject 
to payment of interest charges.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BP0-108

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

RIN: 0938-AF87

[[Page 62534]]

_______________________________________________________________________




1301. 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                            03/00/97

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: OMC-016

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

RIN: 0938-AF97
_______________________________________________________________________




1302. CONDITIONS OF PARTICIPATION FOR RURAL HEALTH CLINICS (BPD-764-P)

Priority:  Other Significant

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

Legal Authority:  42 USC 1395l(a); 42 USC 1395x(aa); 42 USC 
1395y(a)(14); 42 USC 1396a(a)(13)(E); 42 USC 263a

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: Undetermined

Additional Information: BPD-764

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

RIN: 0938-AG05
_______________________________________________________________________




1303. APPOINTMENT OF REPRESENTATIVES FOR MEDICARE APPEALS (BPO-120-P)

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 405

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPO-120

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

RIN: 0938-AG30
_______________________________________________________________________




1304. ALTERNATIVE SANCTIONS FOR RENAL DIALYSIS FACILITIES (HSQ-204-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395rr(g)

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

Legal Deadline: None

Abstract: This proposal would set forth the circumstances under which 
HCFA could impose denial of payment as a sanction instead of 
terminating coverage when an ESRD facility is not in substantial 
compliance with the conditions for coverage, but its deficiencies do 
not pose immediate jeopardy to patient health or safety. Before section 
1881 of the Social Security Act was amended by section 12 of the 
Medicare and Medicaid Patient and Program Protection Act of 1987 
(Public Law 100-93), HCFA was authorized to impose alternative 
sanctions only when an ESRD facility failed to cooperate in the goals 
and activities of the ESRD network for the area in which the facility 
is located.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/97

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: HSQ-204

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

RIN: 0938-AG31

[[Page 62535]]

_______________________________________________________________________




1305. GENERAL CRITERIA AND STANDARDS FOR EVALUATING PERFORMANCE OF 
CONTRACT OBLIGATIONS (HSQ-207-NC)

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 462

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice With Comment Period      02/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: HSQ-207

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

RIN: 0938-AG32
_______________________________________________________________________




1306. EFFECT OF CHANGE OF OWNERSHIP ON PROVIDER AND SUPPLIER PENALTIES, 
SANCTIONS, AND OVERPAYMENTS (HSQ-215-P)

Priority:  Substantive, Nonsignificant

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/97

Small Entities Affected: None

Government Levels Affected: Undetermined

Additional Information: HSQ-215
Legal Authority (Continued) 42 USC 1395f(b) 42 USC 1395l 42 USC 1395ww

Agency Contact: Mike Goldman, Health Standarads and Quality Bureau, 
Department of Health and Human Services, Health Care Financing 
Administration, S2-14-27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6768

RIN: 0938-AG59
_______________________________________________________________________




1307. SALARY EQUIVALENCY GUIDELINES FOR PHYSICAL THERAPY, RESPIRATORY 
THERAPY, SPEECH PATHOLOGY, AND OCCUPATIONAL THERAPY (BPD-808-PN)

Priority:  Other Significant

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

CFR Citation:  42 CFR 413.106

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: BPD-808

Agency Contact: Jacqueline Gordon, Health Insurance Specialist, 
Division of Home Care and Therapy, Department of Health and Human 
Services, Health Care Financing Administration, C4-07-14, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4517

RIN: 0938-AG70
_______________________________________________________________________




1308. MEDICAID: OPTIONAL COVERAGE OF TB-RELATED SERVICES FOR INDIVIDUALS 
INFECTED WITH TUBERCULOSIS (MB-082-P)

Priority:  Other Significant

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

CFR Citation:  42 CFR 435.219; 42 CFR 435.201; 42 CFR 440.250; 42 CFR 
436.201; 42 CFR 436.219; 42 CFR 440.164

Legal Deadline: None

Abstract: This rule would provide for optional Medicaid coverage of 
low-income individuals infected with tuberculosis (TB). These 
individuals would be eligible only for specified TB-related services. 
The rule would incorporate and interpret provisions of section 13603 of 
OBRA '93.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/97

Small Entities Affected: None

Government Levels Affected: State, Local

Additional Information: MB-082

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

RIN: 0938-AG72

[[Page 62536]]

_______________________________________________________________________




1309. REVISION OF MEDICARE HOSPITAL CONDITIONS OF PARTICIPATION (BPD-
745-P)

Regulatory Plan:  This entry is Seq. No. 30 in Part II of this issue of 
the Federal Register.

RIN: 0938-AG79
_______________________________________________________________________




1310. PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY HAVE 
FINANCIAL RELATIONSHIPS--EXPANDED TO DESIGNATED HEALTH SERVICES (BPD-
809-P)

Priority:  Other Significant

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

CFR Citation:  42 CFR 411

Legal Deadline: None

Abstract: This proposed rule would provide that a physician who has (or 
has a family member who has) a financial relationship with a health 
care entity may not make referrals to that entity for certain services 
(designated health services) under the Medicare program, except under 
specified circumstances. This proposed rule would also deny payment to 
a State for expenditures for designated health services furnished on 
the basis of a physician referral that, all things being equal, would 
result in denial of payment under Medicare. The provisions of the 
proposed rule are based on sections 13562 and 13624 of the OBRA '93, as 
amended by SSA '94.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/97

Small Entities Affected: Businesses

Government Levels Affected: State

Additional Information: BPD-809

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

RIN: 0938-AG80
_______________________________________________________________________




1311. HOME HEALTH AGENCY (HHA) CONDITIONS OF PARTICIPATION (BPD-819-P)

Regulatory Plan:  This entry is Seq. No. 31 in Part II of this issue of 
the Federal Register.

RIN: 0938-AG81
_______________________________________________________________________




1312. END-STAGE RENAL DISEASE (ESRD) CONDITIONS FOR COVERAGE (BPD-818-P)

Regulatory Plan:  This entry is Seq. No. 32 in Part II of this issue of 
the Federal Register.

RIN: 0938-AG82
_______________________________________________________________________




1313. CLINICAL LABORATORY IMPROVEMENT AMENDMENT (CLIA) FEE SCHEDULES 
(HSQ-219-GNC)

Priority:  Other Significant

Legal Authority:  42 USC 263a(m)

CFR Citation:  42 CFR 493.638; 42 CFR 493.649

Legal Deadline: None

Abstract: The preamble to this general notice 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: HSQ-219

Agency Contact: Judy Yost, Health Standards and Quality Bureau, 
Department of Health and Human Services, Health Care Financing 
Administration, S2-09-28, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-3531

RIN: 0938-AG87
_______________________________________________________________________




1314. WAGE INDEX USED TO ADJUST PAYMENT RATES FOR HOSPICE SERVICES UNDER 
THE MEDICARE PROGRAM (BPD-820-P)

Priority:  Other Significant

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

Legal Authority:  42 USC 1395f(i); 5 USC 561 to 590

CFR Citation:  42 CFR 418

Legal Deadline: None

Abstract: The Medicare hospice benefit has been in effect since 1983. 
This rule would update the wage index used to adjust payment rates to 
reflect local differences in area wage levels. This proposed rule is 
the successful result of a ``negotiated rulemaking'' proceeding under 
the Negotiated Rulemaking Act of 1990, and is part of the Department's 
regulatory reinvention initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice of Intent                10/14/94                    59 FR 52129
NPRM                            09/04/96                    61 FR 46579
NPRM Comment Period End         11/04/96
Final Action                    00/00/00

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-820

Agency Contact: Janice Flaherty, Director, Division of Home Care & 
Therapy, Department of Health and Human Services, Health Care Financing 
Administration, C4-05-27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4637

RIN: 0938-AG93
_______________________________________________________________________




1315. LIABILITY FOR THIRD PARTIES TO PAY FOR CARE AND SERVICES (MB-080-
P)

Priority:  Other Significant

Legal Authority:  42 USC 1396a(a)(25)(A); 42 USC 1396b(o)

CFR Citation:  42 CFR 433.135 to 433.152

Legal Deadline: None

Abstract: This rule would incorporate provisions of OBRA '93 by 
amending the regulations governing third party liability. It would add 
ERISA plans, service benefit plans, and health maintenance 
organizations to the definition of liable third parties. It would 
require States to prohibit any health insurer from taking into account, 
when enrolling or making payments,

[[Page 62537]]

that an individual is eligible for or receiving Medicaid. It would also 
require States to enact a law under which the State is deemed to have 
acquired a recipient's right to payment by a third party.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/97

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Additional Information: MB-080

Agency Contact: Robert Nakielny, Health Insurance Specialist, Medicaid 
Bureau, Department of Health and Human Services, Health Care Financing 
Administration, C4-21-01, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4466

RIN: 0938-AH01
_______________________________________________________________________




1316. AMBULANCE SERVICES (BPD-813-P)

Priority:  Other Significant

Legal Authority:  42 USC 1302; 42 USC 1395hh

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/96

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: None

Additional Information: BPD-813

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

RIN: 0938-AH13
_______________________________________________________________________




1317. ADJUSTMENT IN PAYMENT AMOUNTS FOR NEW TECHNOLOGY INTRAOCULAR 
LENSES (BPD-831-P)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1395k(a)(2); 42 USC 1395l; 42 USC 1395z; 42 
USC 1395aa; 42 USC 2630

CFR Citation:  42 CFR 416

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

Abstract: This rule would establish a process under which interested 
parties could request, with respect to a class of new technology 
intraocular lenses (IOLs), a review of the appropriateness of the 
current payment amount for IOLs furnished by Medicare-participating 
ambulatory surgical centers. This rule is part of HCFA's regulatory 
reform initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-831

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

RIN: 0938-AH15
_______________________________________________________________________




1318. DEFINITION OF SKILLED NURSING FACILITY (SNF) FOR COVERAGE OF 
DURABLE MEDICAL EQUIPMENT (DME) (BPD-834-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395x(n)

CFR Citation:  42 CFR 409; 42 CFR 410

Legal Deadline: None

Abstract: This proposed rule would define skilled nursing facilities 
(SNFs) for purposes of Medicare coverage of durable medical equipment 
(DME) and home health services. A Medicare SNF (as defined under 
section 1819 of the Act) can not be considered a home under Medicare 
Part B for DME and home health coverage. This proposed rule would 
presume that all Medicaid nursing facilities are section 1819(a)(1) 
facilities and thus would not be considered a home for DME. This rule 
would identify non-Medicare nursing homes as skilled facilities based 
upon the receipt of skilled care by a proportion of its resident 
population that is at least comparable to the proportion typically 
found in participating Medicare SNFs. This proposed rule is part of the 
Department's regulatory reinvention initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/97

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: BPD-834

Agency Contact: Thomas Hoyer, Director, Office of Chronic Care and 
Insurance Policy, Department of Health and Human Services, Health Care 
Financing Administration, C4-02-16, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4605

RIN: 0938-AH16
_______________________________________________________________________




1319. ADDITIONAL SUPPLIER STANDARDS (BPD-864-P)

Priority:  Other Significant

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

[[Page 62538]]

Legal Authority:  42 USC 1395cc; 42 USC 1395m(j); 42 USC 1302; 42 USC 
1395x(n); 42 USC 1395hh; 42 USC 1395ii

CFR Citation:  42 CFR 424.57; 42 CFR 405.371(d)

Legal Deadline: None

Abstract: This rule would establish additional standards for entities 
seeking to qualify as Medicare suppliers for purposes of submitting 
claims for durable medical equipment and supplies. This rule is part of 
HCFA's regulatory reform initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-864

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

RIN: 0938-AH19
_______________________________________________________________________




1320. STATE PLAN AMENDMENT (SPA) RECONSIDERATION PROCESS (MB-096-P)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1396a(a)

CFR Citation:  42 CFR 430.18; 42 CFR 430.60

Legal Deadline: None

Abstract: This proposed rule would revise and streamline the State Plan 
Amendment (SPA) reconsideration process. Currently, when a State 
requests reconsideration of a denied SPA, a hearing is held in all 
cases, even when the only dispute is over the interpretation of the 
statute. Under the proposed regulation, the State and HCFA could avoid 
the cost and delay of the hearing process when the only issue is 
interpretation of the statute by taking the issue directly to court. 
The reconsidered decision would then be made without a hearing. This 
rule is part of the Department's regulatory reinvention initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/97

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: MB-096

Agency Contact: Robert Tomlinson, Office of Beneficiary Services, 
Medicaid Bureau, Department of Health and Human Services, Health Care 
Financing Administration, C4-20-21, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4463

RIN: 0938-AH24
_______________________________________________________________________




1321. CHANGES IN COVERAGE AND PAYMENT POLICIES FOR PHYSICIAN ASSISTANT 
SERVICES (BPD-829-P)

Priority:  Substantive, Nonsignificant

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-829

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

RIN: 0938-AH26
_______________________________________________________________________




1322. HOSPICE CARE--CONDITIONS OF PARTICIPATION (BPD-844-P)

Priority:  Other Significant

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

Legal Authority:  42 USC 1395x(dd)

CFR Citation:  42 CFR 418

Legal Deadline: None

Abstract: This proposed rule would revise the Medicare conditions of 
participation for hospices to help ensure the provision of quality care 
through an emphasis on patient-centered outcomes. Areas of change would 
include, among others, assessment of patient needs, clarification of 
physician roles, coordination of care for hospice patients residing in 
nursing homes, clarification of nursing roles, patient rights, and 
provision of services. This rule is part of the Department's regulatory 
reinvention initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/97

Small Entities Affected: Businesses

Government Levels Affected: State, Local

Additional Information: BPD-844

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

RIN: 0938-AH27
_______________________________________________________________________




1323. LIMITATIONS ON PAYMENT FOR HOME OXYGEN THERAPY BASED ON INHERENT 
REASONABLENESS CRITERIA (BPD-845-PN)

Priority:  Other Significant

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

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

Legal Deadline: None

Abstract: This proposed notice sets forth our rationale for determining 
that

[[Page 62539]]

Medicare's Part B payment allowances for home oxygen are grossly 
excessive and specifies the proposed change in our methodology for 
determining home oxygen payment amounts.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Notice                 01/00/97

Small Entities Affected: Businesses

Government Levels Affected: Federal

Additional Information: BPD-845

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

RIN: 0938-AH28
_______________________________________________________________________




1324. MEDICARE COVERAGE OF SERVICES OF SPEECH-LANGUAGE PATHOLOGISTS AND 
AUDIOLOGISTS (BPD-843-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302; 42 USC 1395x; 42 USC 1395x(cc)(1); 42 
USC 1395x(ll)

CFR Citation:  42 CFR 484; 42 CFR 485

Legal Deadline: None

Abstract: This proposed rule would implement SSA '94 to provide 
coverage for speech-language provision pathology services furnished by 
a qualified pathologist.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-843

Agency Contact: Jackie Gordon, Bureau of Policy Development, Department 
of Health and Human Services, Health Care Financing Administration, C4-
07-14, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4517

RIN: 0938-AH37
_______________________________________________________________________




1325. MEDICARE: AMOUNT OF PAYMENTS IF CUSTOMARY CHARGES FOR SERVICES 
FURNISHED ARE LESS THAN REASONABLE COSTS (BPD-860-P)

Priority:  Other Significant

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

Legal Authority:  42 USC 1395f(b); 42 USC 1395l(a); 42 USC 1395m(a)

CFR Citation:  42 CFR 413.13

Legal Deadline: None

Abstract: A provider whose charges are lower than its reasonable costs 
for those services in any cost reporting period beginning January 1, 
1974 but before April 28, 1988 may carry forward costs that are 
unreimbursed for two succeeding cost reporting periods. Sufficient time 
has passed since the publication of this provision to warrant the 
deletion from the regulation text of any reference to the carryover 
provision. Since payment for durable medical equipment (DME) provided 
by home health agencies (HHAs) is no longer based on the lesser of the 
reasonable cost or reasonable charge but rather on 80% of the lesser of 
the actual charge for the item or the payment amount recognized under 
the DME fee schedule and, for nominal charge HHAs, on 80% of the DME 
fee schedule amount, the lesser of costs or charges (LCC) provision no 
longer applies and should be deleted from the CFR.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/97

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: BPD-860

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

RIN: 0938-AH49
_______________________________________________________________________




1326.  CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT 
SYSTEM AND FISCAL YEAR 1998 RATES (BPD-878-P)

Regulatory Plan:  This entry is Seq. No. 33 in Part II of this issue of 
the Federal Register.

RIN: 0938-AH55
_______________________________________________________________________




1327.  CONDITIONS FOR CERTIFICATION OF COMMUNITY MENTAL HEALTH 
CENTERS AND COVERAGE REQUIREMENTS FOR PARTIAL HOSPITALIZATION SERVICES 
(BPD-871-P)

Priority:  Other Significant

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/97

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: BPD-871

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

RIN: 0938-AH58

[[Page 62540]]

_______________________________________________________________________




1328.  ALLOWABLE COSTS FOR FICA AND OTHER PAYROLL TAXES; 
MEDICARE (BPD-876-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395x(v)

CFR Citation:  42 CFR 413.100

Legal Deadline: None

Abstract: The proposed rule would specify the providers' share of the 
costs of FICA and other payroll taxes for employees that will be 
allowable under Medicare when the payroll period ends subsequent to the 
end of the reporting period. Our new policy will be to allow that 
portion of employees FICA or other taxes that have accrued up to the 
end of the reporting period to be credited as allowable cost in the 
current reporting period and the remainder in the following period.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-876

Agency Contact: John Eppinger, Office of Hospital Policy, Bureau of 
Policy Development, Department of Health and Human Services, Health 
Care Financing Administration, C5-03-18, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-4518

RIN: 0938-AH61
_______________________________________________________________________




1329.  IMPROVEMENTS TO THE APPEAL PROTECTIONS OFFERED BY 
MEDICARE CONTRACTING HMOS/CMPS (OMC-025-P)

Regulatory Plan:  This entry is Seq. No. 34 in Part II of this issue of 
the Federal Register.

RIN: 0938-AH62
_______________________________________________________________________




1330.  MEDICAID; ESTATE RECOVERIES (MB-083-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396a; 42 USC 1396p

CFR Citation:  42 CFR 433.36

Legal Deadline: None

Abstract: This proposed rule is being developed as a result of the OBRA 
1993 provisions that mandated States to seek adjustment or recovery 
from the estates of Medicaid beneficiaries for amounts correctly spent 
by Medicaid on permanently institutionalized individuals (any age) and 
individuals age 55 or older for certain services. The OBRA 1993 
provision also defines ``estate,'' and further requires States to 
establish hardship procedures, in accordance with standards specified 
by the Secretary for waiver of recovery in cases where undue hardship 
would result.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/97

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: MB-083

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

RIN: 0938-AH63
_______________________________________________________________________




1331.  UTILIZATION CONTROL; MEDICAID (MB-101-P)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1396a(a)(30); 42 USC 1396(a)(44); 42 USC 
1396b(g)(i)(4)

CFR Citation:  42 CFR 400; 42 CFR 440; 42 CFR 441; 42 CFR 456; 42 CFR 
483

Legal Deadline: None

Abstract: This proposed rule would codify in regulations the statutory 
requirements that make physician certification and development of a 
plan of care (formerly utilization control requirements) State plan 
requirements under the Medicaid program. States would no longer be 
required to make quarterly showings that they have complied with those 
requirements or with the utilization review requirements. Obsolete 
provisions would be removed.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/97

Small Entities Affected: None

Government Levels Affected: State

Additional Information: MB-101

Agency Contact: Robert Weaver, Health Insurance Specialist, Medicaid 
Bureau, Department of Health and Human Services, Health Care Financing 
Administration, C4-16-13, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5914

RIN: 0938-AH64
_______________________________________________________________________




1332.  MEDICAID HOSPICE CARE (MB-007-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395c; 42 USC 1395d(a)(4) and (d); 42 USC 
1395e(a)(4); 42 USC 1395f(a)(7) and (i); 42 USC 1395g(e); 42 USC 
1395h(e)(5); 42 USC 1395x(dd); 42 USC 1302; 42 USC 1396a(a)(10); 42 USC 
1396a(a)(13)(D) and (d); 42 USC 1396d(a)(18)

CFR Citation:  42 CFR 418.24; 42 CFR 418.28; 42 CFR 418.98; 42 CFR 
435.218; 42 CFR 435.722; 42 CFR 435.725; 42 CFR 435.726; 42 CFR 
435.733; 42 CFR 435.735; 42 CFR 435.832; 42 CFR 436

Legal Deadline: None

Abstract: This proposed rule would provide for optional Medicaid 
coverage of hospice care for terminally ill recipients who elect to 
receive care from a participating hospice, establish eligibility 
requirements, covered services, reimbursement procedures, and 
conditions that a hospice must meet to provide services to Medicaid 
recipients, and makes conforming technical revisions to the Medicare 
regulations governing hospice care.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/97

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Local

Additional Information: MB-007

Agency Contact: Terry Pratt, Health Insurance Specialist, Medicaid 
Bureau, Department of Health and Human

[[Page 62541]]

Services, Health Care Financing Administration, C4-19-28, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-5831

RIN: 0938-AH65
_______________________________________________________________________




1333.  MEDICARE AS SECONDARY PAYOR TO LIABILITY INSURANCE (BPD-
848-P)

Priority:  Other Significant

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

Legal Authority:  42 USC 1302; 42 USC 1395x; 42 USC 1395aa; 42 USC 
1395cc; 42 USC 1395dd; 42 USC 1395hh; 42 USC 1395ww

CFR Citation:  42 CFR 411; 42 CFR 489

Legal Deadline: None

Abstract: This proposed rule would revise current regulations to 
require that providers and suppliers attempt to collect payment from 
the proceeds of liability insurance during the ``promptly period.'' 
This rule would also permit providers and suppliers to choose either to 
pursue collection of payment from the proceeds of liability insurance 
after the ``promptly period'' has ended.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-848

Agency Contact: Anita Heygster, Office of Chronic Care & Insurance 
Policy, Bureau of Policy Development, Department of Health and Human 
Services, Health Care Financing Administration, C4-08-25, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4486

RIN: 0938-AH66
_______________________________________________________________________




1334.  MEDICARE TECHNICAL CONFORMING AMENDMENTS (BPD-858-FC)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1302; 42 USC 1395(k)

CFR Citation:  42 CFR 409.50; 42 CFR 409.61; 42 CFR 410.152

Legal Deadline: None

Abstract: This rule will update our regulations to reflect that payment 
for durable medical equipment is on the basis of a fee schedule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-858

Agency Contact: Martha Kuespert, Office of Chronic Care & Insurance 
Policy, Bureau of Policy Development, Department of Health and Human 
Services, Health Care Financing Administration, C4-02-16, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4605

RIN: 0938-AH67
_______________________________________________________________________




1335.  REDUCTION AND ELIMINATION OF CERTAIN REQUIREMENTS FOR 
PEER REVIEW ORGANIZATIONS IN THE UTILIZATION AND QUALITY REVIEW PROCESS 
(HSQ-235-P)

Priority:  Substantive, Nonsignificant

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

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

Legal Deadline: None

Abstract: This proposed rule would eliminate the requirement that Peer 
Review Organizations (PROs) conduct quarterly sample reviews and that 
they change hospital codes and recalculate Medicare payments when 
reviews reveal incorrect DRG coding. It would also change the period 
for PRO contracts from 2 years to 3 years and would eliminate certain 
notification requirements regarding contract awards.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: HSQ-235

Agency Contact: Bill Roskey, Health Insurance Policy Specialist, Health 
Standards and Quality Bureau, Department of Health and Human Services, 
Health Care Financing Administration, S1-09-18, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-0433

RIN: 0938-AH68
_______________________________________________________________________




1336.  DETERMINATION OF SUBSTANDARD CARE IN SNFS AND NFS (HSQ-
240-P)

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 488.301

Legal Deadline: None

Abstract: This proposed rule would revise the definition of 
``substandard quality of care'' as it applies to skilled nursing 
facilities, in the Medicare program, and nursing facilities, in the 
Medicaid program. ``Substandard quality of care'' is one type of 
noncompliance with Federal participation requirements that may result 
in sanctions. The purpose of this proposed revision is to improve the 
long term care survey and enforcement process by making a more 
meaningful distinction between a facility that provides quality 
resident care and one that provides poor resident care.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/97

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: HSQ-240

Agency Contact: Pat Miller, Health Insurance Specialist, Health 
Standards & Quality Bureau, Department of Health and Human Services, 
Health Care Financing Administration, S2-19-14, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6780

RIN: 0938-AH69

[[Page 62542]]

_______________________________________________________________________




1337.  CONDITIONS OF ENROLLMENT FOR NON-CERTIFIED PROVIDERS 
(BPO-143-P)

Priority:  Other Significant

Legal Authority:  42 USC 1395hh

CFR Citation:  42 CFR 489

Legal Deadline: None

Abstract: This proposed rule would establish new supplier standards to 
avoid abuse of a Medicare billing number. This would ensure that 
legitimate suppliers' information would not be used by fraudulent 
suppliers to obtain Medicare billing numbers, thereby protecting both 
beneficiaries and legitimate suppliers from fraudulent and unprincipled 
suppliers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPO-143

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

RIN: 0938-AH73
_______________________________________________________________________




1338.  USE OF THE OASIS AS PART OF THE CONDITIONS OF 
PARTICIPATION FOR HOME HEALTH AGENCIES (HSQ-238-P)

Priority:  Other Significant

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

CFR Citation:  42 CFR 484

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/97

Small Entities Affected: Businesses

Government Levels Affected: Local

Additional Information: HSQ-238

Agency Contact: Wayne Smith, PH D, Director, Division of Hospitals & 
AmbulatoryServices, Department of Health and Human Services, Health 
Care Financing Administration, S2-11-07, 7500 Security Boulevard, 
Baltimore, MD 21224
Phone: 410 786-6762

RIN: 0938-AH74
_______________________________________________________________________


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


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1339. DEDUCTION OF INCURRED MEDICAL EXPENSES (SPENDDOWN) (MB-020-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302

CFR Citation:  42 CFR 435.831; 42 CFR 436.831

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: None

Additional Information: MB-020

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

RIN: 0938-AB07
_______________________________________________________________________




1340. EFFECTIVE DATES FOR PROVIDER AGREEMENTS AND SUPPLIER APPROVALS 
(HSQ-139-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302; 42 USC 1395hh

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/08/92                    57 FR 46362

[[Page 62543]]

NPRM Comment Period End         12/07/92
Final Action                    01/00/97

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Additional Information: HSQ-139

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

RIN: 0938-AC88
_______________________________________________________________________




1341. CHANGES CONCERNING SUSPENSION OF MEDICARE PAYMENTS AND 
DETERMINATIONS OF ALLOWABLE INTEREST EXPENSE (BPO-118-FC)

Priority:  Substantive, Nonsignificant

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/22/88                    53 FR 31888
NPRM Comment Period End         10/21/88
Final Rule With Comment Period  11/00/96

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPO-118

Agency Contact: James Conrad, Overpayment & Medicare Secondary Payer 
Collection Unit,Bureau of Program Operations, Department of Health and 
Human Services, Health Care Financing Administration, S3-05-07, 7500 
Security Blvd., Baltimore, MD 21244
Phone: 410 786-6976

RIN: 0938-AC99
_______________________________________________________________________




1342. CHANGES TO PEER REVIEW ORGANIZATION REGULATIONS (HSQ-135-F)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1395y(a); 42 USC 1320c; 42 USC 1396a(a)(30); 
42 USC 1395cc(a)

CFR Citation:  42 CFR 400.200; 42 CFR 411.15; 42 CFR 431.630; 42 CFR 
433.15; 42 CFR 462.1; 42 CFR 462.101; 42 CFR 462.102; 42 CFR 462.106; 
42 CFR 462.107; 42 CFR 466.1; 42 CFR 466.71; 42 CFR 466.76; 42 CFR 
466.78; 42 CFR 466.83

Legal Deadline: None

Abstract: This rule will set forth several changes to regulations that 
govern Peer Review Organizations (PROs) and is based on statutory 
changes contained in COBRA '85 and OBRA '86. In addition, several 
technical changes will be included as a result of experience gained 
with the PRO program by HCFA. This rule also implements the new quality 
review requirements for certain Medicaid Health Maintenance 
Organization contracts.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/16/88                     53 FR 8654
NPRM Comment Period End         05/16/88
Final Action                    08/00/97

Small Entities Affected: None

Government Levels Affected: Undetermined

Additional Information: HSQ-135

Agency Contact: Harvey Brook, Office of Quality Improvement Programs, 
Health Standards and Quality Bureau, Department of Health and Human 
Services, Health Care Financing Administration, S1-13-07, 7500 Security 
Blvd., Baltimore, MD 21244
Phone: 410 786-6852

RIN: 0938-AD38
_______________________________________________________________________




1343. MEDICARE SECONDARY PAYER FOR DISABLED INDIVIDUALS (BPD-482-F)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1395y(b)

CFR Citation:  42 CFR 411

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/08/90                     55 FR 8491
NPRM Comment Period End         05/08/90
Final Rule With Comment Period  08/31/95                    60 FR 45344
Effective Date                  10/02/95
Final Action                    06/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-482

Agency Contact: Herbert Pollock, Office of Chronic Care & Insurance

[[Page 62544]]

Policy, Bureau of Policy Development, Department of Health and Human 
Services, Health Care Financing Administration, C4-08-14, 7500 Security 
Blvd., Baltimore, MD 21244
Phone: 410 786-4474

RIN: 0938-AD73
_______________________________________________________________________




1344. OMNIBUS NURSING HOME REFORM REQUIREMENTS (BPD-488-F)

Priority:  Other Significant. Major under 5 USC 801.

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

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

CFR Citation:  42 CFR 418; 42 CFR 440; 42 CFR 441; 42 CFR 482; 42 CFR 
483; 42 CFR 431; 42 CFR 405; 42 CFR 413; 42 CFR 430; 42 CFR 434 to 436; 
42 CFR 447; 42 CFR 466; 42 CFR 498

Legal Deadline: None

Abstract: This final rule will implement several provisions of OBRA '87 
that concern services to residents of nursing homes. This rule will 
implement provisions that include Federal standards for evaluating 
State waivers of nursing facility nurse staffing requirements, use of 
physical and chemical restraints in nursing facilities, qualifications 
of facility administrators, notice of Medicaid rights to be given to 
persons admitted to nursing facilities, and other technical changes. 
This rule is part of the Department's regulatory reinvention 
initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/05/92                     57 FR 4516
NPRM Comment Period End         04/06/92
Final Action                    03/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-488

Agency Contact: Bill Ullman, Health Insurance Specialist, Bureau of 
Policy Development, Department of Health and Human Services, Health 
Care Financing Administration, C4-11-06, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-5667

RIN: 0938-AD81
_______________________________________________________________________




1345. REVISIONS TO REGULATIONS IMPLEMENTING CLIA (HSQ-226-F)

Regulatory Plan:  This entry is Seq. No. 35 in Part II of this issue of 
the Federal Register.

RIN: 0938-AE47
_______________________________________________________________________




1346. RESIDENT ASSESSMENT IN LONG-TERM CARE FACILITIES (HSQ-180-F)

Priority:  Other Significant

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

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

CFR Citation:  42 CFR 483

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/28/92                    57 FR 61614
NPRM Comment Period End         02/26/93
Final Action                    03/00/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: HSQ-180

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

RIN: 0938-AE61
_______________________________________________________________________




1347. POST-CONTRACT BENEFICIARY PROTECTIONS AND OTHER PROVISIONS (OMC-
003-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395mm

CFR Citation:  42 CFR 417

Legal Deadline: None

Abstract: This rule will require health maintenance organizations 
(HMOs) or competitive medical plans (CMPs) that cease to contract with 
HCFA under section 1876 to provide Medicare beneficiaries with certain 
coverage for pre-existing conditions under supplemental insurance; 
provide a 30-day open enrollment period for individuals who would 
otherwise lose prepaid Medicare coverage as a result of termination, 
non-renewal or reduction in service area of a risk contract; accelerate 
the deadline for risk contracting HMOs and CMPs to submit adjusted 
community rate proposals; require all HMOs and CMPs to furnish a copy 
of an executed enrollment application form to Medicare applicants; and, 
require health care prepayment plans (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                    03/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

[[Page 62545]]

Additional Information: OMC-003

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

RIN: 0938-AE63
_______________________________________________________________________




1348. PAYMENT FOR NURSING AND ALLIED HEALTH SCIENCE EDUCATION (BPD-685-
F)

Priority:  Other Significant

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

CFR Citation:  42 CFR 413

Legal Deadline:  Final, Statutory, June 30, 1990.

Abstract: This rule will set forth our policy for the payment of the 
costs of approved nursing and allied health science programs, as 
directed by section 6205(b)(2) of OBRA '89. For the most part, the 
provisions set forth in this rule restate or clarify our current 
policies governing these costs, which were previously set forth in the 
provider reimbursement manual and other documents, but have never been 
included in the regulations. In addition, we are amending the list of 
approved programs and clarifying payment rules for certified registered 
nurse anesthetist programs. This rule will also implement section 4004 
of OBRA '90 which provides that, effective with cost reporting periods 
beginning on or after October 1, 1990, under certain conditions, costs 
incurred by a hospital or educational institution related to the 
hospital for clinical training are treated as pass-through costs and 
paid on the basis of reasonable cost even though the hospital does not 
operate the education programs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/22/92                    57 FR 43659
NPRM Comment Period End         11/23/92
Final Action                    12/00/96

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-685

Agency Contact: Marc Hartstein, Health Insurance Specialist, Division 
of Hospital Services, Department of Health and Human Services, Health 
Care Financing Administration, C5-08-27, 7500 Security Blvd., 
Baltimore, MD 21244
Phone: 410 786-4539

RIN: 0938-AE79
_______________________________________________________________________




1349. FIRE SAFETY STANDARDS FOR HOSPITALS, LONG-TERM CARE FACILITIES, 
AND INTERMEDIATE CARE FACILITIES FOR THE MENTALLY RETARDED (BPD-650-FC)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1302; 42 USC 1395hh; 42 USC 1395x(e); 42 USC 
1395l-3; 42 USC 1396d; 42 USC 1396r

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

Legal Deadline: None

Abstract: This final rule with comment period revises the fire safety 
certification standards for hospitals, long-term care facilities, and 
intermediate care facilities for the mentally retarded under the 
Medicare and Medicaid programs. It requires compliance with the 1994 
edition of the Life Safety Code of the National Fire Protection 
Association rather than with previous provisions that are now outdated. 
The revisions in this final rule update the health and safety 
requirements that health care facilities furnishing services to 
Medicare beneficiaries must meet to ensure that patients, residents and 
personnel are safe from fire. This is a part of the Department's 
regulatory reinvention initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/01/90                    55 FR 31196
NPRM Comment Period End         10/01/90
Final Rule With Comment Period  02/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-650

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

RIN: 0938-AE97
_______________________________________________________________________




1350. COVERAGE OF SCREENING PAP SMEARS (BPD-705-F)

Priority:  Other Significant

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

CFR Citation:  42 CFR 410.10; 42 CFR 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 
(including a physician's interpretation of the test results) provided 
to a woman for the early detection of cervical cancer.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/26/93                    58 FR 62312
NPRM Comment Period End         01/24/94
Final Action                    12/00/96

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-705

Agency Contact: Joyce Eng, Office of Physician & Ambulatory Care 
Policy, Bureau of Policy Development, Department of Health and Human 
Services, Health Care Financing Administration, C4-02-26, 7500 Security 
Blvd., Baltimore, MD 21244
Phone: 410 786-4619

RIN: 0938-AE98
_______________________________________________________________________




1351. 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

[[Page 62546]]

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-706

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

RIN: 0938-AE99
_______________________________________________________________________




1352. OBRA '90 AND MISCELLANEOUS MANAGED CARE TECHNICAL AMENDMENTS (OMC-
018-F)

Priority:  Substantive, Nonsignificant

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/09/94                    59 FR 23820
NPRM Comment Period End         07/08/94
Final Action                    03/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: OMC-018

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

RIN: 0938-AF15
_______________________________________________________________________




1353. MEDICAID PAYMENT FOR COVERED OUTPATIENT DRUGS UNDER REBATE 
AGREEMENTS (MB-046-F)

Priority:  Other Significant

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

Legal Authority:  42 USC 1396a(a); 42 USC 1396b(i); 42 USC 1396r-8; 42 
USC 1396b(a); 42 USC 1302

CFR Citation:  42 CFR 447; 42 CFR 441

Legal Deadline: None

Abstract: This rule will incorporate section 4401 of OBRA '90 to add 
specific requirements for Medicaid payment for covered outpatient 
drugs. The requirements concern: denial of Federal financial 
participation unless rebate agreements and drug use review are in 
effect; prohibiting some State plan drug access limitations for drugs 
covered under a rebate agreement; and the content of the rebate 
agreements. (The drug rebate agreement was previously published in the 
Federal Register on February 21, 1991 (56 FR 7049)). This rule will 
also reflect statutory revisions mandated by the Veteran's Health Care 
Act of 1992 and OBRA '93. Revision of the drug rebate dispute 
resolution process is part of the Department's regulatory reinvention 
initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/19/95                    60 FR 48442
NPRM Comment Period End         11/20/95
Final Action                    12/00/96

Small Entities Affected: Businesses

Government Levels Affected: State

Additional Information: MB-046

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

RIN: 0938-AF42
_______________________________________________________________________




1354. REFERRAL TO CHILD SUPPORT ENFORCEMENT AGENCIES OF MEDICAID 
FAMILIES (MB-051-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396k

CFR Citation:  42 CFR 433.160; 42 CFR 433.135; 42 CFR 433.137; 42 CFR 
433.151

Legal Deadline: None

Abstract: This rule will require State Medicaid agencies to refer 
Medicaid families with an absent parent to child support enforcement 
(CSE) agencies. Section 9142 of OBRA '87 required CSE agencies to 
provide all CSE services to such Medicaid families who have assigned to 
the State their rights to medical support. The purpose of these rules 
is to require States to make this referral to State CSE agencies to 
ensure that those recipients requiring CSE services receive them.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/22/93                    58 FR 49272
NPRM Comment Period End         11/22/93
Final Action                    04/00/97

Small Entities Affected: None

Government Levels Affected: State

Additional Information: MB-051

Agency Contact: Randy Graydon, Director, Division of Benenficiary 
Services, Department of Health and Human Services, Health Care 
Financing

[[Page 62547]]

Administration, C4-22-27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4451

RIN: 0938-AF68
_______________________________________________________________________




1355. MEDICAID: OUTSTATIONED INTAKE LOCATIONS FOR CERTAIN LOW-INCOME 
PREGNANT WOMEN, INFANTS AND CHILDREN UNDER AGE 19 (MB-052-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396a(a)(55)

CFR Citation:  42 CFR 435.901; 42 CFR 435.902; 42 CFR 435.903; 42 CFR 
435.904; 42 CFR 435.907; 42 CFR 436.2; 42 CFR 436.3; 42 CFR 435.3

Legal Deadline: None

Abstract: This rule implements a statutory requirement that State 
Medicaid agencies must provide for receipt and initial processing of 
Medicaid applications filed by certain low-income pregnant women, 
infants, and children under age 19, at locations which are other than 
those used for receipt and processing of applications for cash 
assistance under title IV-A of the Social Security Act.
The rule is based on section 1902(a)(55) of the Social Security Act as 
added by section 4602 of OBRA '90, PL 101-508.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              09/23/94                    59 FR 48805
Interim Final Rule With Comment 
Period                          09/23/94                    59 FR 48805
Effective Date                  10/24/94
Comment Period End              11/22/94
Final Action                    03/00/97

Small Entities Affected: None

Government Levels Affected: State

Additional Information: MB-052

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

RIN: 0938-AF69
_______________________________________________________________________




1356. MEDICARE AND MEDICAID PROGRAMS: REQUIREMENTS FOR PHYSICIAN 
INCENTIVE PLANS IN PREPAID HEALTH CARE ORGANIZATIONS (OMC-010-F)

Priority:  Other Significant

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

CFR Citation:  42 CFR 417

Legal Deadline: None

Abstract: This rule will address comments received on the rule 
published on March 27, 1996. That rule amended the regulations 
governing Federally qualified health maintenance organizations (HMOs) 
and competitive medical plans contracting with the Medicare program, 
and certain HMOs and health insurance organizations contracting with 
States under the Medicaid program, to implement the requirements in 
sections 4204(a) and 4731 of the Omnibus Budget Reconciliation Act of 
1990 that concern physician incentive plans.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: OMC-010

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

RIN: 0938-AF74
_______________________________________________________________________




1357. RETROACTIVE ENROLLMENT AND DISENROLLMENT IN RISK HEALTH 
MAINTENANCE ORGANIZATIONS AND COMPETITIVE MEDICAL PLANS (OMC-015-F)

Priority:  Other Significant

Legal Authority:  42 USC 1395mm

CFR Citation:  42 CFR 417.448; 42 CFR 417.450; 42 CFR 417.456; 42 CFR 
417.460; 42 CFR 417.461; 42 CFR 417.462; 42 CFR 417.464; 42 CFR 
417.584; 42 CFR 417.436

Legal Deadline: None

Abstract: This rule will implement section 4204(e) of OBRA '90. It will 
permit HCFA to make retroactive payments for up to 90 days when there 
is a delay in notifying HCFA that a beneficiary has enrolled under a 
section 1876 (of the Social Security Act) risk contract through an 
employer health plan. In addition, the rule will permit the Secretary 
to authorize retroactive disenrollment in specific cases.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/27/93                    58 FR 68366
Comment Period End              02/25/94
Final Action                    03/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: OMC-015

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

RIN: 0938-AF98
_______________________________________________________________________




1358. PAYMENT FOR PREADMISSION SERVICES (BPD-731-F)

Priority:  Substantive, Nonsignificant

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: None

[[Page 62548]]

Government Levels Affected: None

Additional Information: BPD-731

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

RIN: 0938-AG00
_______________________________________________________________________




1359. CHANGE IN PROVIDER AGREEMENT REGULATIONS RELATED TO FEDERAL 
EMPLOYEE HEALTH BENEFITS (BPD-748-F)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  5 USC 8904(b)

CFR Citation:  42 CFR 489

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: BPD-748

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

RIN: 0938-AG03
_______________________________________________________________________




1360. REVISED MEDICAID MANAGEMENT INFORMATION SYSTEMS (MB-38-FN)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396b(r)

CFR Citation:  None

Legal Deadline: None

Abstract: This notice sets forth revised general functional 
requirements for the Medicaid Management Information System (MMIS). The 
MMIS consists of software and hardware used to process Medicaid claims 
and to retrieve and produce utilization and management information 
about services that are required by the Medicaid agency or Federal 
Government for administrative or audit purposes. The revised 
requirements allow States more flexibility to exercise variations in 
the implementation.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Notice                 11/22/93                    58 FR 61692
Comment Period End              01/21/94
Final Action                    04/00/97

Small Entities Affected: None

Government Levels Affected: State

Additional Information: MB-038

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

RIN: 0938-AG10
_______________________________________________________________________




1361. END-STAGE RENAL DISEASE (ESRD) PAYMENT EXCEPTION REQUESTS AND 
ORGAN PROCUREMENT COSTS (BPD-763-F)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1395rr

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/26/94                    59 FR 44097
NPRM Comment Period End         10/25/94
Final Action                    03/00/97

Small Entities Affected: Businesses

Government Levels Affected: State

Additional Information: BPD-763

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

RIN: 0938-AG20

[[Page 62549]]

_______________________________________________________________________




1362. MEDICARE PROGRAM: LIMITATIONS ON MEDICARE COVERAGE OF INTERMITTENT 
POSITIVE PRESSURE BREATHING MACHINE THERAPY (BPD-781-FN)

Priority:  Substantive, Nonsignificant

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

CFR Citation:  None

Legal Deadline: None

Abstract: Intermittent positive pressure breathing (IPPB) machine 
therapy is currently covered under Medicare as durable medical 
equipment for patients whose ability to breathe is severely impaired. 
Based on an Office of Health Technology Assessment recommendation, we 
will place limitations on Medicare coverage of IPPB machine therapy.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Notice                 06/29/94                    59 FR 33520
Comment Period End              08/29/94
Final Action                    10/00/96

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-781

Agency Contact: Francine Spencer, Office of Chronic Care & Insurance 
Policy, Bureau of Policy Development, Department of Health and Human 
Services, Health Care Financing Administration, C4-04-05, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4614

RIN: 0938-AG44
_______________________________________________________________________




1363. TELEPHONE AND ELECTRONIC REQUESTS FOR REVIEW OF PART B INITIAL 
CLAIM DETERMINATIONS (BPO-121-F)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1395hh; 42 USC 1395ff

CFR Citation:  42 CFR 405.807

Legal Deadline: None

Abstract: This rule will make it easier for beneficiaries, providers, 
and Medicare Part B providers (physicians and suppliers) to appeal an 
initial adverse determination by a Medicare carrier under the 
supplementary medical insurance program (Medicare Part B). Currently, 
these appeals must be in writing. This expanded rule will also allow 
appeals to be made by telephone or electronically, which will avoid 
formal hearings, shorten the appeal process, and save time and costs 
for all parties. Allowing the use of telephone and electronic requests 
will supplement, not replace, the current review procedures. By 
providing quick and easy access to the appeals process, this rule will 
also improve carrier relationships with providers and beneficiaries.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/10/95                    60 FR 35544
NPRM Comment Period End         09/08/95
Final Action                    03/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPO-121

Agency Contact: Rosalind Little, Bureau of Program Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, S1-05-18, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6972

RIN: 0938-AG48
_______________________________________________________________________




1364. CLIA PROGRAM: CATEGORIZATION OF WAIVED TESTS (HSQ-225-F)

Regulatory Plan:  This entry is Seq. No. 36 in Part II of this issue of 
the Federal Register.

RIN: 0938-AG99
_______________________________________________________________________




1365. MEDICAID COVERAGE OF PERSONAL CARE SERVICES (MB-071-F)

Priority:  Other Significant

Legal Authority:  42 USC 1396d(a)(24)

CFR Citation:  42 CFR 440.70; 42 CFR 440.167; 42 CFR 440.170

Legal Deadline: None

Abstract: This rule will revise the Medicaid regulations by 
incorporating the OBRA '93 provisions relating to coverage of personal 
care services. Personal care services furnished to an individual who is 
not an inpatient or resident of a hospital, nursing facility, 
intermediate care facility for the mentally retarded or an institution 
for mental disease are an optional Medicaid benefit, effective October 
1, 1994. The services may be furnished both in the home and in other 
locations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/08/96                     61 FR 9405
NPRM Comment Period End         05/07/96
Final Action                    03/00/97

Small Entities Affected: None

Government Levels Affected: State

Additional Information: MB-071

Agency Contact: Terese Klitenic, Office of Long Term Care Services, 
Medicaid Bureau, Department of Health and Human Services, Health Care 
Financing Administration, C4-25-02, 7500 Security Blvd., Baltimore, MD 
21244
Phone: 410 786-5942

RIN: 0938-AH00
_______________________________________________________________________




1366. MEDICARE PROGRAM: UNIFORM ELECTRONIC COST REPORTING FOR SKILLED 
NURSING FACILITIES AND HOME HEALTH AGENCIES (BPD-788-F)

Priority:  Other Significant

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

CFR Citation:  42 CFR 413.24

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/05/95                    60 FR 62237
NPRM Comment Period End         02/05/96
Final Action                    11/00/96

Small Entities Affected: None

[[Page 62550]]

Government Levels Affected: None

Additional Information: BPD-788

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

RIN: 0938-AH12
_______________________________________________________________________




1367. UPDATE OF THE REASONABLE COMPENSATION EQUIVALENT LIMITS FOR 
SERVICES FURNISHED BY PHYSICIANS (BPD-816-N)

Priority:  Other Significant

Legal Authority:  42 USC 1395xx

CFR Citation:  42 CFR 405.482(f)

Legal Deadline: None

Abstract: This notice sets forth updated payment limits on the amount 
of allowable compensation for services furnished by physicians to 
providers that are not covered by the prospective payment system or per 
resident payments for graduate medical education. These services are 
paid by Medicare on a reasonable cost basis. The revised reasonable 
compensation equivalent limits are based on updated economic index data 
and replace the limits that were published in the Federal Register on 
February 20, 1985.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/00/96

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-816

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

RIN: 0938-AH14
_______________________________________________________________________




1368. CRITERIA AND PROCEDURES FOR EXTENDING COVERAGE TO CERTAIN DEVICES 
AND RELATED SERVICES (BPD-841-F)

Priority:  Other Significant

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

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

CFR Citation:  42 CFR 405; 42 CFR 411

Legal Deadline: None

Abstract: In his National Performance Review, Vice President Gore 
directed the health agencies of the Department of Health and Human 
Services (HHS) to review their policies and processes to determine 
which requirements could be reduced or eliminated without lowering 
health and safety standards. In accordance with this directive, FDA 
reviewed its current regulatory approval processes and HCFA reviewed 
its Medicare coverage policies for medical devices that have not 
received full FDA approval. As a result, a final rule with comment 
period published on August 18, 1995 and effective November 1, 1995, 
provided that certain medical devices with an investigational device 
exemption (IDE) approved by the Food and Drug Administration (FDA) may 
be covered under Medicare. It will set forth the process by which the 
FDA will assist HCFA in identifying nonexperimental investigational 
devices that may be potentially covered under Medicare. It is intended 
to provide Medicare beneficiaries with greater access to advances in 
medical technology.
The intent is to devise ways to assure Medicare beneficiaries greater 
access to advances in proven medical technology, to encourage clinical 
researchers to conduct high-quality studies, and to clarify Medicare 
coverage of reasonable and necessary medical services during clinical 
trials for investigational devices. A final rule that will respond to 
public comments on the August 1995 rule and make any necessary 
revisions will complete this rulemaking proceeding.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule With Comment Period  08/19/95                    60 FR 48417
Comment Period End              10/20/95
Effective Date                  11/01/95
Final Action                    04/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-841

Agency Contact: Sharon Hippler, Bureau of Policy Development, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-11-04, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4633

RIN: 0938-AH21
_______________________________________________________________________




1369. DELEGATION OF CIVIL MONEY PENALTIES (BPO-135-FC)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 405(a); 42 USC 1302; 42 USC 1320a-7a; 42 USC 
1395cc; 42 USC 1395u(j)(2); 42 USC 1395hh; 42 USC 1395ii

CFR Citation:  42 CFR 402

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    02/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPO-135

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

RIN: 0938-AH22
_______________________________________________________________________




1370. CLIA PROGRAM: CYTOLOGY PROFICIENCY TESTING (HSQ-233-F)

Priority:  Other Significant

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

CFR Citation:  42 CFR 493.855

Legal Deadline: None

Abstract: In publishing this notice of proposed rulemaking (NPRM), HHS 
is complying with a court order requiring publication of an NPRM that 
would require that cytology proficiency testing be conducted to the 
extent practicable, under normal working conditions. We proposed to 
revise regulations to require that proficiency testing be conducted at 
a pace corresponding to

[[Page 62551]]

the maximum workload rate for individuals examining slides. We also 
solicited comments on the use of computer facsimile representations of 
cytology specimens, as an alternative to glass-slide proficiency 
testing.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/30/95                    60 FR 61509
NPRM Comment Period End         01/29/96
Final Action                    06/00/97

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Additional Information: HSQ-233

Agency Contact: Rhonda Whalen, Senior Health Scientist, Department of 
Health and Human Services, Centers for Disease Control and Prevention, 
4770 Buford Highway, NE., MS F 11, Atlanta, GA 30341-3724
Phone: 770 488-7670

RIN: 0938-AH35
_______________________________________________________________________




1371. MEDICARE PROGRAM: REVISIONS TO PAYMENT POLICIES AND FIVE-YEAR 
REVIEW OF AND ADJUSTMENTS TO RELATIVE VALUE UNITS UNDER THE PHYSICIAN 
FEE SCHEDULE FOR CALENDAR YEAR 1997 (BPD-852-FC)

Regulatory Plan:  This entry is Seq. No. 37 in Part II of this issue of 
the Federal Register.

RIN: 0938-AH40
_______________________________________________________________________




1372. MEDICARE PROGRAM: PHYSICIAN FEE SCHEDULE UPDATE FOR CALENDAR YEAR 
1997 AND PHYSICIAN VOLUME PERFORMANCE STANDARD RATES OF INCREASE FOR 
FEDERAL FISCAL YEAR 1997 (BPD-853-FN)

Priority:  Other Significant

Legal Authority:  42 USC 1395w-4

CFR Citation:  None

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/00/96

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-853

Agency Contact: Don Thompson, Office of Physician & Ambulatory Care 
Policy, Bureau of Policy Development, Department of Health and Human 
Services, Health Care Financing Administration, C4-10-26, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4586

RIN: 0938-AH41
_______________________________________________________________________




1373. REQUIREMENTS FOR ENROLLMENT OF MEDICAID RECIPIENTS UNDER COST 
EFFECTIVE EMPLOYER-BASED GROUP HEALTH PLANS (MB-047-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396a(a)10; 42 USC 1396a(u)(1); 42 USC 
1396d(a); 42 USC 1396a(a)(25); 42 USC 1396a(e); 42 USC 1396e

CFR Citation:  42 CFR 435.2; 42 CFR 435.3; 42 CFR 435.10; 42 CFR 
435.186; 42 CFR 435.188

Legal Deadline: None

Abstract: This rule will provide for continuation of payment of health 
insurance premiums for individuals who are entitled to elect COBRA 
continuation coverage under a group health plan provided by an employer 
with 75 or more employees; require Medicaid recipients to apply for 
enrollment in employer-based cost effective group health plans as a 
condition of Medicaid eligibility; require State agencies to pay for 
premiums, deductibles, coinsurances and other cost sharing obligations 
under employer-based cost effective group health plans, and define 
``COBRA continuation coverage'' and ``COBRA beneficiaries.''

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/04/94                    59 FR 31569
NPRM Comment Period End         08/19/94
Final Action                    01/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: MB-047

Agency Contact: Mark Ross, Health Insurance Specialist, Medicaid 
Bureau, Department of Health and Human Services, Health Care Financing 
Administration, C4-20-20, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5855

RIN: 0938-AH48
_______________________________________________________________________




1374. TERMS, DEFINITIONS, AND ADDRESSES: TECHNICAL AMENDMENTS (BPD-877-
FC)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1302; 42 USC 1395x(v)(1)(A); 42 USC 1395hh

CFR Citation:  42 CFR 413.118; 42 CFR 413.122

Legal Deadline: None

Abstract: This final rule with comment period will remove from the CFR 
obsolete formulas for determining the aggregate and blended amounts 
that HCFA pays for ambulatory surgical center facility services, 
outpatient radiology services, and other diagnostic procedures 
furnished to Medicare beneficiaries.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule With Comment Period  01/00/97

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-877

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

RIN: 0938-AH53
_______________________________________________________________________




1375.  HOME HEALTH AGENCY PHYSICIAN CERTIFICATION REGULATIONS 
(BPD-875-N)

Priority:  Other Significant

Legal Authority:  42 USC 1395nn; 42 USC 1395hh; 42 USC 1395f; 42 USC 
1395n

[[Page 62552]]

CFR Citation:  42 CFR 424.22

Legal Deadline: None

Abstract: This notice will announce our decision regarding the 
applicability of current Medicare regulations pertaining to the 
indirect compensation of physicians who certify or recertify the need 
for home health services or who establish or review the home plan of 
care. We are withdrawing recent interpretations regarding indirect 
compensation arrangements where the physicians are salaried employees 
of, or have a contractual arrangement to obtain services with an entity 
that also owns the home health agency. We need to evaluate the 
interaction between the current home health regulations and the related 
provisions of section 1877 of the Social Security Act, thereby ensuring 
consistent application of Medicare policy among providers of services.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          12/00/96

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: BPD-875

Agency Contact: Jennifer Carter, Office of Chronic Care & Insurance 
Policy, Bureau of Policy Development, Department of Health and Human 
Services, Health Care Financing Administration, C4-07-05, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4615

RIN: 0938-AH59
_______________________________________________________________________




1376.  INITIATIVE TO RECOGNIZE HEMODIALYSIS FACILITIES OF 
ACHIEVEMENT (HSQ-232-N)

Priority:  Other Significant

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

Legal Authority:  42 USC 1395rr

CFR Citation:  None

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: HSQ-232

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

RIN: 0938-AH71
_______________________________________________________________________




1377.  WAIVER OF STAFFING REQUIREMENTS FOR END STAGE RENAL 
DISEASE (ESRD) FACILITIES PARTICIPATING IN AN EXPERIMENT (HSQ-236-GNC)

Priority:  Other Significant

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

Legal Authority:  42 USC 1302; 42 USC 1320; 42 USC 1395x; 42 USC 1395y; 
42 USC 1395hh; 42 USC 1395kk; 42 USC 1395rr

CFR Citation:  42 CFR 405.2136; 42 CFR 405.2161; 42 CFR 405.2162; 42 
CFR 405.2163

Legal Deadline: None

Abstract: This general notice with comment period announces our 
intention to conduct a demonstration that would grant selected ESRD 
facilities a 2-year waiver of staffing requirements. The ESRD staffing 
requirements pertain to: the governing body and management, director of 
a facility, on-duty licensed health care professionals, and providing 
adequate laboratory, social, and dietetic services. Facilities would be 
given flexibility to deviate from specified regulation requirements, 
provided assurances are in place ensuring that quality of care 
standards are not being compromised.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/00/97

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: HSQ-236

Agency Contact: Julie Moyers, Health Insurance Specialist, Health 
Standards & Quality Bureau, Department of Health and Human Services, 
Health Care Financing Administration, S1-09-07, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6772

RIN: 0938-AH72
_______________________________________________________________________




1378.  HEALTH INSURANCE REFORM: PORTABILITY AND 
NONDISCRIMINATION IN THE GROUP INSURANCE MARKET; PORTABILITY IN THE 
INDIVIDUAL INSURANCE MARKET; REQUIREMENTS ON STATE FOR ALTERNATIVE 
MECHANISMS FOR REG

Regulatory Plan:  This entry is Seq. No. 38 in Part II of this issue of 
the Federal Register.

RIN: 0938-AH75

[[Page 62553]]

_______________________________________________________________________


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


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1379. PAYMENT FOR CLINICAL DIAGNOSTIC LABORATORY TESTS (BPD-309-F)

Priority:  Substantive, Nonsignificant

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

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

Legal Deadline: None

Abstract: This rule will incorporate provisions of the Deficit 
Reduction Act of 1984, COBRA '85, OBRA '86, OBRA '87, TMRA '88, OBRA 
'89, and OBRA '90 regarding payment and ``assignment'' for diagnostic 
clinical laboratory tests establishing in regulations the methods for 
implementing fee schedules. This rule will set forth the methods by 
which the fee schedules will be updated and will allow certain 
adjustments for exceptions to the fee schedule. It will also reflect a 
statutory revision mandated by OBRA '93.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/18/93                    58 FR 43156
NPRM Comment Period End         10/18/93
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-309

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

RIN: 0938-AB50
_______________________________________________________________________




1380. PARTICIPATION IN CHAMPUS AND CHAMPVA, HOSPITAL ADMISSIONS FOR 
VETERANS, DISCHARGE RIGHTS NOTICE, AND HOSPITAL RESPONSIBILITY FOR 
EMERGENCY CARE (BPD-393-F)

Priority:  Other Significant

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

CFR Citation:  42 CFR 488.18; 42 CFR 489.20; 42 CFR 489.24; 42 CFR 
489.25; 42 CFR 489.26; 42 CFR 489.27; 42 CFR 489.53; 42 CFR 1003

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-393

Agency Contact: Tzvi Hefter, Director, Division of Hospital Services, 
Department of Health and Human Services, Health Care Financing 
Administration, C5-08-27, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-1304

RIN: 0938-AC58
_______________________________________________________________________




1381. CRITERIA AND PROCEDURES FOR DEVELOPING MEDICAL SERVICES COVERAGE 
POLICY (BPD-432-N)

Priority:  Other Significant

Legal Authority:  42 USC 1395y

CFR Citation:  42 CFR 400.404; 42 CFR 405.201; 42 CFR 405.203; 42 CFR 
405.205; 42 CFR 405.207; 42 CFR 405.211

Legal Deadline: None

Abstract: This notice will announce generally applicable criteria and 
procedures for determining whether a service is ``reasonable and 
necessary'' under the Medicare program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/30/89                     54 FR 4302
NPRM Comment Period End         03/31/89
Notice                          00/00/00

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-432

Agency Contact: Ron Milhorn, Bureau of Policy Development, Department 
of Health and Human Services, Health Care Financing Administration, C4-
10-07, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-5663

RIN: 0938-AD07
_______________________________________________________________________




1382. PROHIBITION ON UNBUNDLING OF HOSPITAL OUTPATIENT SERVICES (BPD-
426-F)

Priority:  Other Significant

Legal Authority:  42 USC 1395y(a)(14); 42 USC 1395cc(a)(1)(H); 42 USC 
1395cc(g); 42 USC 1395x(w)(1)

CFR Citation:  42 CFR 409; 42 CFR 410; 42 CFR 411; 42 CFR 412; 42 CFR 
489; 42 CFR 1003

Legal Deadline: None

Abstract: This final rule, to be issued jointly by HCFA and the 
Department's Office of the Inspector General (OIG) will prohibit 
Medicare payment for nonphysician services furnished to a hospital 
outpatient by a provider or supplier other than the hospital, unless 
the services are furnished under an arrangement with the hospital. The 
hospital is obligated by its provider agreement to furnish the services 
directly or under an arrangement.

[[Page 62554]]

These regulations will also authorize the OIG to impose a civil money 
penalty, not to exceed $2,000, against any individual who knowingly and 
willfully presents, or causes to be presented, a bill or request for 
payment, for items or services furnished under Medicare, that is 
inconsistent with an arrangement under section 1866(a)(1)(H) of the 
Social Security Act or is in violation of the requirements for an 
arrangement. These regulations implement section 9343(c) of OBRA '86, 
section 4085(i)(17) of OBRA '87, and section 4157 of OBRA '90.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/05/88                    53 FR 29486
NPRM Comment Period End         10/04/88
Final Action                    00/00/00

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-426

Agency Contact: Carolyn Mullen, Office of Physician & Ambulatory Care 
Policy, Bureau of Policy Development, Department of Health and Human 
Services, Health Care Financing Administration, C4-11-16, 7500 Security 
Blvd., Baltimore, MD 21244
Phone: 410 786-4589

RIN: 0938-AD33
_______________________________________________________________________




1383. PROTECTION OF INCOME AND RESOURCES FOR COMMUNITY SPOUSES OF 
INSTITUTIONALIZED INDIVIDUALS (MB-023-P)

Priority:  Other Significant

Legal Authority:  42 USC 1396r-5; 42 USC 1302

CFR Citation:  42 CFR 435.650 to 674; 42 CFR 435.750 to 754

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: State, Local

Additional Information: MB-023

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

RIN: 0938-AE12
_______________________________________________________________________




1384. SURVEY REQUIREMENTS AND ALTERNATIVE SANCTIONS FOR HOME HEALTH 
AGENCIES (HSQ-169-F)

Priority:  Other Significant

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

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

Legal Deadline: None

Abstract: These rules will establish periodic, unannounced surveys of 
home health agencies (HHAs) and other survey requirements and also will 
specify sanctions that could be used when an HHA is out of compliance 
with Federal requirements (as an alternative or in addition to 
terminating an HHA's participation in the Medicare program).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/02/91                    56 FR 37054
NPRM Comment Period End         10/01/91
Final Action                    00/00/00

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Local, Federal

Additional Information: HSQ-169
TIMETABLE CONT: Pending completion of RIN 0938-AG81 (BPD-819)

Agency Contact: Wayne Smith, Ph.D., Director, Center for Hospital and 
Community Care, Health Standards and Quality Bureau, Department of 
Health and Human Services, Health Care Financing Administration, S2-11-
07, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-6762

RIN: 0938-AE39
_______________________________________________________________________




1385. CONDITIONS OF COVERAGE FOR ORGAN PROCUREMENT ORGANIZATIONS (BPD-
646-F)

Priority:  Other Significant

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

Legal Authority:  42 USC 1320b-8

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

Legal Deadline: None

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 qualification and performance criteria for 
OPOs; clarification of operational policy for certification and 
recertification of OPOs, competition for open areas, and, appeals of 
the Secretary's decisions. The rule with comment period contained 
provisions that were part of the Department's regulatory reinvention 
initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/21/91                    56 FR 28513
NPRM Comment Period End         08/21/91
Interim Final Rule With Comment 
Period                          09/08/94                    59 FR 46500
Effective Date                  10/11/94
Comment Period End              11/07/94
Final Rule With Comment Period  05/02/96                    61 FR 19722
Effective Date                  05/31/96
Comment Period End              07/01/96
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-646

Agency Contact: Claude Mone, Health Insurance Specialist, Department of 
Health and Human Services, Health Care Financing Administration, C5-05-

[[Page 62555]]

27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5666

RIN: 0938-AE48
_______________________________________________________________________




1386. EARLY AND PERIODIC SCREENING, DIAGNOSTIC, AND TREATMENT (EPSDT) 
SERVICES (MB-28-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396a(a)(43); 42 USC 1396d(r)

CFR Citation:  42 CFR 441.50; 42 CFR 440.40

Legal Deadline: None

Abstract: Section 1905(r) of the Social Security Act, added by section 
6403 of OBRA '89 defines the following EPSDT services: screening 
services, vision services, dental services and hearing services. EPSDT 
services also are defined to include such other necessary health care, 
diagnostic services, treatment, and other measures described in section 
1905(a) of the Act to correct or ameliorate defects, illnesses and 
conditions discovered by the screening services whether or not the 
services are covered under the State plan. Section 1902(a)(43) of the 
Act requires States to report to the Secretary certain information 
about EPSDT services provided under the plan during each fiscal year. 
This rule would set forth requirements to implement these statutory 
provisions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/01/93                    58 FR 51288
NPRM Comment Period End         11/30/93
Final Action                    00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: State, Local

Additional Information: MB-028

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

RIN: 0938-AE72
_______________________________________________________________________




1387. CHANGES TO THE LONG-TERM CARE FACILITY SURVEY PROCESS (HSQ-175-FC)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  PL 101-239, Sec 6901(a); 42 USC 1395i-3; 42 USC 
1395aa(d); 42 USC 1396r

CFR Citation:  42 CFR 442; 42 CFR 488

Legal Deadline: None

Abstract: This final rule with comment period will amend the Medicare 
and Medicaid regulations by removing obsolete long-term care survey 
forms, guidelines, and procedures used by State agencies when they 
evaluate a Medicare skilled nursing facility or a Medicaid nursing 
facility for compliance with Federal certification requirements. 
Effective October 1, 1990, the application of new Federal participation 
requirements for these facilities with an increased focus on actual or 
potential resident outcomes has made the survey forms and process in 
existing regulations outdated. Retention of the outdated items can 
cause confusion in connection with directions State survey agencies 
must follow in determining facility compliance.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule Effective 
Date                            10/19/94
Interim Final Rule Comment 
Period End                      11/18/94
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Additional Information: HSQ-175
TIMETABLE: This regulation may be published only with the concurrence 
of the U.S. District Court in the Smith v. Shalala suit.

Agency Contact: Helene Fredeking, Codirector, Center for Long Term 
Care, Health Standards and Quality Bureau, Department of Health and 
Human Services, Health Care Financing Administration, S2-21-27, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7304

RIN: 0938-AF02
_______________________________________________________________________




1388. CASE MANAGEMENT (MB-27-F)

Priority:  Other Significant

Legal Authority:  42 USC 1396d; 42 USC 1396n

CFR Citation:  42 CFR 431.51(c); 42 CFR 440.169; 42 CFR 440.250; 42 CFR 
441.10; 42 CFR 441.18; 42 CFR 447.327; 42 CFR 431.54

Legal Deadline: None

Abstract: This rule will place into our regulations provisions of COBRA 
'85, OBRA '86, TEFRA '86, OBRA '87 and TMRA '88 dealing with case 
management services. These regulations will provide for optimal 
Medicaid coverage of case management services furnished to specific 
groups in specific geographic areas or political subdivisions within a 
State.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/15/93                    58 FR 53481
NPRM Comment Period End         12/14/93
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: State, Local

Additional Information: MB-027

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

RIN: 0938-AF07
_______________________________________________________________________




1389. PRESUMPTIVE LIMITS ON PAYMENTS TO HMOS, CMPS, AND HCPPS (OMC-006-
F)

Priority:  Other Significant

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

CFR Citation:  42 CFR 417.532(a)(3); 42 CFR 417.802; 42 CFR 417.800(c)

Legal Deadline: None

Abstract: This rule establishes presumptive limits for Medicare cost 
payments to Health Maintenance Organizations and Competitive Medical 
Plans, and to Health Care Prepayment Plans (HCPPs) that furnish 
inpatient hospital care. It also revises the criteria that HCFA uses to 
determine reasonable costs for HCPPs that do not furnish inpatient 
hospital care.

[[Page 62556]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/22/94                     59 FR 8435
NPRM Comment Period End         04/25/94
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Additional Information: OMC-006

Agency Contact: A. G. D'Alberto, Office of Managed Care, Department of 
Health and Human Services, Health Care Financing Administration, S3-02-
01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1100

RIN: 0938-AF16
_______________________________________________________________________




1390. PART B ADVANCE PAYMENTS TO PHYSICIANS/SUPPLIERS OR OTHER ENTITIES 
FURNISHING ITEMS OR SERVICES UNDER MEDICARE PART B (BPO-105-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395u

CFR Citation:  42 CFR 421.214

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: BPO-105

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

RIN: 0938-AF85
_______________________________________________________________________




1391. INTERMEDIARY AND CARRIER FUNCTIONS (BPO-111-F)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1395h; 42 USC 1395u

CFR Citation:  42 CFR 421.100; 42 CFR 421.200

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPO-111

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

RIN: 0938-AG06
_______________________________________________________________________




1392. DISCLOSURE OF CONFIDENTIAL PRO INFORMATION FOR RESEARCH PURPOSES 
(HSQ-208-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1320c-9; 42 USC 1302

CFR Citation:  42 CFR 476.144

Legal Deadline: None

Abstract: This rule would allow Peer Review Organizations (PROs) to 
disclose confidential information to researchers without the consent of 
the individuals who would be identified. Currently, PROs can only 
disclose to the public nonconfidential aggregate data where no one is 
specifically identified. The statute, however, provides for limited 
disclosure in cases where there are circumstances to assure adequate 
protection of the rights established by regulation, and interest of 
patients, health care practitioners, or providers. HCFA is now 
emphasizing the sharing of PRO data for educational and research 
purposes as evidenced by the implementation of the Uniform Clinical 
Data Set and the Health Care Quality Improvement Initiative. This 
regulatory revision will make confidential PRO information accessible 
to researchers while still protecting the identities of beneficiaries 
and practitioners from unwarranted disclosure. PRO flexibility to share 
information with researchers is comparable with the revised 
requirements in the PRO's Fourth Scope of Work contract.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: State, Federal

Additional Information: HSQ-208

Agency Contact: Mike Rappaport, Director, Division of Systems 
Management, Health Standards and Quality Bureau, Department of Health 
and Human Services, Health Care Financing Administration, S1-09-26, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6759

RIN: 0938-AG33

[[Page 62557]]

_______________________________________________________________________




1393. NONCOVERAGE OF ELECTROSTIMULATION OF SALIVARY GLANDS FOR THE 
TREATMENT OF XEROSTOMIA (DRY MOUTH) (BPD-782-FN)

Priority:  Substantive, Nonsignificant

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

CFR Citation:  None

Legal Deadline: None

Abstract: This notice announces the Medicare program's intent to 
exclude from coverage electrostimulation of the salivary glands in the 
treatment of xerostomia secondary to Sjogren's Syndrome. Public Health 
Service (PHS) studies show that there is insufficient data to establish 
the clinical utility of electrostimulation to evaluate its long-term 
effectiveness, or to identify those xerostomia patients who would 
benefit from this procedure. Also, PHS reports that electrostimulation 
is not widely accepted as a treatment for xerostomia secondary to 
Sjogren's Syndrome.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Notice                 05/23/94                    59 FR 26653
Comment Period End              07/22/94
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-782

Agency Contact: Francina Spencer, Office of Chronic Care & Insurance 
Policy, Bureau of Policy Development, Department of Health and Human 
Services, Health Care Financing Administration, C4-04-05, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4614

RIN: 0938-AG45
_______________________________________________________________________




1394. DISTINCT PART REQUIREMENTS FOR NURSING HOMES AND PROHIBITION OF 
FINANCIAL SCREENING OF APPLICANTS FOR NURSING HOME ADMISSION (BPD-815-P)

Priority:  Other Significant

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

CFR Citation:  42 CFR 409; 42 CFR 483; 42 CFR 413

Legal Deadline: None

Abstract: In this proposed rule we would define ``distinct part'' by 
specifying that a distinct part is a physically identifiable unit of an 
institution (that is, an entire ward wing, floor, or building) 
including all beds in the unit. In conjunction with this change we 
propose an alternative approach for calculating Medicare payments to a 
skilled nursing facility (SNF). This new ``distinct costing'' procedure 
would enable a participating SNF to establish a distinct costing area 
within the SNF for its relatively high intensity residents so that it 
can isolate and fully capture the routine cost of their care without 
resorting to the use of arbitrary certification boundaries to achieve 
this result. This proposed rule would also prohibit nursing homes from 
financially screening private pay applicants for admission. Instead, 
nursing homes would be permitted to charge up to a 2-month deposit 
before admission to ensure that sufficient funds are available to pay 
for care to which the individual may be entitled.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-815

Agency Contact: William Ullman, Health Insurance Specialist, Bureau of 
Policy Development, Department of Health and Human Services, Health 
Care Financing Administration, C4-13-15, 7500 Security Blvd, Baltimore, 
MD 21244
Phone: 401 786-5667

RIN: 0938-AG84
_______________________________________________________________________




1395. CATEGORIZATION AND CERTIFICATION REQUIREMENTS FOR A NEW 
SUBCATEGORY OF MODERATE COMPLEXITY TESTING (HSQ-222-F)

Priority:  Other Significant

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

Legal Authority:  42 USC 263a

CFR Citation:  42 CFR 493.2; 42 CFR 493.3; 42 CFR 493.5; 42 CFR 493.18; 
42 CFR 493.20; 42 CFR 493.21; 42 CFR 493.25; 42 CFR 493.43; 42 CFR 
493.45; 42 CFR 493.48; 42 CFR 493.49; 42 CFR 493.51; 42 CFR 493.53; 42 
CFR 493.638

Legal Deadline: None

Abstract: As part of the CLIA program (see RIN 0938-AE47), this rule 
will develop criteria for simple and easy-to-use test systems that have 
demonstrated accuracy and precision through scientific studies. It will 
waive the routine 2-year survey of users of accurate and precise 
technology (APT) tests, conducting surveys only if there are 
indications of problems or complaints. A small number of surveys will 
be conducted to validate the criteria for determining APT and to assure 
quality. This regulation is part of the Administration's Reinventing 
Government and Regulatory Reform Initiatives.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/15/95                    60 FR 47982
NPRM Comment Period End         11/14/95
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Additional Information: HSQ-222

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

RIN: 0938-AG98
_______________________________________________________________________




1396. MEDICARE COVERAGE OF LIVER TRANSPLANTATION (BPD-835-PN)

Priority:  Other Significant

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

CFR Citation:  None

Legal Deadline: None

Abstract: This proposed notice would announce changes in Medicare's 
national coverage policy for liver transplantations. Currently, 
Medicare coverage for liver transplantation in adults is limited to 
seven diagnoses. This notice proposes to expand the diagnoses for which 
Medicare would cover a liver transplant to include all end stage liver 
disease except malignancies, hepatitis B, and hemochromatosis. We are 
also proposing a change in the criteria for

[[Page 62558]]

approval of a facility to perform liver transplants.

Timetable: Next Action Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-835

Agency Contact: Lana Price, Director, Division of End Stage Renal 
Disease, Bureau of Policy Development, Department of Health and Human 
Services, Health Care Financing Administration, C5-05-27, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4533

RIN: 0938-AH17
_______________________________________________________________________




1397. LIMITS ON ACTUAL CHARGES OF NONPARTICIPATING PHYSICIANS (BPD-862-
P)

Priority:  Other Significant

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

Legal Authority:  42 USC 1302; 42 USC 1395hh; 42 USC 1395rr(b)(1)

CFR Citation:  42 CFR 414.48

Legal Deadline: None

Abstract: This proposed rule would reflect provisions of OBRA '93 as to 
the suppliers subject to the charge limits, and provisions of SSA '94 
as to administrative procedures for enforcing the charge limits. This 
rulemaking is part of the reinventing Government effort. It will revise 
text in the CFR to reduce burden or duplication, or streamline 
requirements. It will give beneficiaries the opportunity to make 
informed consumer decisions regarding the choice of Medicare Part B 
services.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Additional Information: BPD-862

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

RIN: 0938-AH50
_______________________________________________________________________




1398. LIMITATIONS ON LIABILITY (BPD-859-FC)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1302 and 1395hh; 42 USC 1395pp

CFR Citation:  42 CFR 411.404

Legal Deadline: None

Abstract: This proposed rule would implement section 1879 of the Social 
Security Act, which limits beneficiary liability for certain durable 
medical equipment. This rulemaking is part of the Reinventing 
Government effort. Toward this end, we are working with industry 
representatives to develop guidelines that will streamline requirements 
and reduce burden and duplication. It will give beneficiaries the 
opportunity to make informed consumer decisions regarding certain 
medical equipment and supplies.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule With Comment Period  00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: BPD-859

Agency Contact: Denis Garrison, Division of Beneficiary and Insurance 
Issues, Department of Health and Human Services, Health Care Financing 
Administration, C4-06-21, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5643

RIN: 0938-AH51
_______________________________________________________________________




1399. MEDICARE SECONDARY PAYER CLARIFICATIONS AND AMENDMENTS (BPD-865-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 411

Legal Deadline: None

Abstract: This regulation would incorporate in regulations, policies 
with respect to liability insurance issues, such as structured 
liability settlements, future medical expenses, provider malpractice, 
wrongful death, and Federal tort claims policy. It would also clarify 
the rules dealing with group health plan bankruptcies, religious 
orders, and foreign group health plans, and make numerous other 
changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: BPD-865

Agency Contact: Herb Pollock, Health Insurance Specialist, Department 
of Health and Human Services, Health Care Financing Administration, C4-
08-27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4474

RIN: 0938-AH52
_______________________________________________________________________




1400.  MEDICARE PROGRAM; SCHEDULE OF LIMITS ON HHA COSTS PER 
VISIT FOR COST REPORTING PERIODS BEGINNING ON OR AFTER JULY 1, 1996 
(BPD-867-NC)

Priority:  Other Significant

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

CFR Citation:  None

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

Abstract: This notice sets forth a revised schedule of limits on Home 
health agency costs that may be paid under the Medicare program. These 
limits replace the per-visit limits that were set forth in our February 
14, 1995 notice with comment period. This notice also responds to 
comments on the February 14, 1995 notice. This notice does not provide 
for a permanent extension of the provision of the Omnibus Budget 
Reconciliation Act of 1993 (OBRA '93) that there be no changes in the 
Home Health Agency cost limits for cost reporting periods beginning on 
or after July 1, 1994 and before July 1, 1996.

[[Page 62559]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice Effective Date           07/01/96
Notice With Comment Period      07/01/96                    61 FR 34344
Comment Period End              08/30/96
Final Action                    00/00/00

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: Federal

Additional Information: BPD-867

Agency Contact: Michael Bussacca, Office of Chronic Care & Insurance 
Policy, Bureau of Policy Development, Department of Health and Human 
Services, Health Care Financing Administration, C4-06-28, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4602

RIN: 0938-AH54
_______________________________________________________________________




1401.  DESIGNATION OF INDEPENDENT RURAL PRIMARY CARE HOSPITALS 
(RPCHS) (BPD-784-N)

Priority:  Info./Admin./Other

Legal Authority:  42 USC 1395i-4; 42 USC 1395cc; 42 USC 1395ww

CFR Citation:  None

Legal Deadline: None

Abstract: This notice will announce the availability of Rural Primary 
Care Hospital (RPCH) status to facilities located in areas of the 
United States outside the States of California, Colorado, South Dakota, 
Kansas, West Virginia, New York, and North Carolina. Facilities wishing 
to be designated as RPCHs must apply to the Health Care Financing 
Administration (HCFA) for this status. Application materials may be 
obtained upon request in writing to HCFA. Based on the applications 
received, HCFA may designate up to 15 facilities as independent RPCHs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: BPD-784

Agency Contact: Thomas Hoyer, Office of Chronic Care & Insurance 
Policy, Bureau of Policy Development, Department of Health and Human 
Services, Health Care Financing Administration, C4-02-17, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-5661

RIN: 0938-AH60
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1402. REVISIONS TO THE CONFIDENTIALITY AND DISCLOSURE REGULATION (OPA-
001-P)

Priority:  Substantive, Nonsignificant

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

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Publication Not 
Expected During This Semiannual 
Period                          11/06/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Melody Hardy
Phone: 410 786-5358

RIN: 0938-AD60
_______________________________________________________________________




1403. NEW MINIMUM STANDARDS FOR MEDICARE SUPPLEMENTAL (MEDIGAP) POLICIES 
(BPD-491-P)

Priority:  Substantive, Nonsignificant

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

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Publication Not 
Expected During This Semiannual 
Period                          11/06/96

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Julie Walton
Phone: 410 786-4622

RIN: 0938-AD82
_______________________________________________________________________




1404. HMO ORGANIZATIONAL STRUCTURE AND SERVICES (OMC-007-F)

Priority:  Other Significant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Publication Not 
Expected During This Semiannual 
Period                          10/18/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Maureen Miller
Phone: 410 786-1097

RIN: 0938-AE25
_______________________________________________________________________




1405. HOSPITAL STANDARD FOR HIV INFECTIOUS BLOOD AND BLOOD PRODUCTS 
(BPD-633-F)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 482.27

[[Page 62560]]

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/09/96                    61 FR 47423
Final Action Effective          11/08/96

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Janet Samen
Phone: 410 786-9161

RIN: 0938-AE40
_______________________________________________________________________




1406. EMPLOYER CONTRIBUTIONS TO HMOS (OMC-004-F)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 417

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/31/96                    61 FR 27282

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Marty Abeln
Phone: 410 786-1096

RIN: 0938-AE64
_______________________________________________________________________




1407. PARTIAL HOSPITALIZATION SERVICES IN COMMUNITY MENTAL HEALTH 
CENTERS (BPD-736-F)

Priority:  Substantive, Nonsignificant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Replaced by BPD-871-
P (RIN 0938-AH58)               07/01/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Janet Samen
Phone: 410 786-9161

RIN: 0938-AF53
_______________________________________________________________________




1408. MEDICARE PROGRAM: LIMITATIONS ON MEDICARE COVERAGE OF CATARACT 
SURGERY (BPD-797-FN)

Priority:  Other Significant

CFR Citation:  None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn by Agency Based on 
Public Comments                 11/04/96

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: Karen McVearry
Phone: 410 786-4643

RIN: 0938-AG65
_______________________________________________________________________




1409. NEW PAYMENT METHODOLOGY FOR ROUTINE EXTENDED CARE SERVICES 
PROVIDER IN A SWING BED HOSPITAL (BPD-805-F)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 413.53; 42 CFR 413.114

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/03/96                    61 FR 51611
Final Action Effective          11/04/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: John Daviser
Phone: 410 786-0008

RIN: 0938-AG68
_______________________________________________________________________




1410. REPORTING OF INTEREST FROM ZERO COUPON BONDS (BPD-647-F)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 413.153

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/16/96                    61 FR 37011

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Ann Pash
Phone: 410 786-4615

RIN: 0938-AH11
_______________________________________________________________________




1411. SCHEDULE OF LIMITS FOR SKILLED NURSING FACILITY INPATIENT ROUTINE 
SERVICE COSTS (BPD-837-NC)

Priority:  Other Significant

CFR Citation:  42 CFR 413

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Implemented through 
instructions / manuals.         07/01/96

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Robert Kuhl
Phone: 410 786-4597

RIN: 0938-AH18
_______________________________________________________________________




1412. MEDICAID: LIMITATIONS ON AGGREGATE PAYMENTS TO DISPROPORTIONATE 
SHARE HOSPITALS; FEDERAL FISCAL YEAR 1996 (PRELIMINARY) (MB-098-N)

Priority:  Other Significant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/09/96                    61 FR 21195

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Richard Strauss
Phone: 410 786-2019

RIN: 0938-AH30
_______________________________________________________________________




1413. MEDICAID ELIGIBILITY QUALITY CONTROL, STAFFING AND TRAINING, AND 
UTILIZATION CONTROL: REMOVAL OF OBSOLETE AND RESTRICTIVE REQUIREMENTS 
(MB-099-F)

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 431.861; 42 CFR 431.862; 42 CFR 431.863; 42 CFR 
431.864; 42 CFR 431.865; 42 CFR 433.8; 42 CFR 433.201 to 217; 42 CFR 
456; 42 CFR 440.1; 42 CFR 441.153; 42 CFR 441.155; 42 CFR 447.10; 42 
CFR 447.300; 42 CFR 447.342

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/24/96                    61 FR 38395

Small Entities Affected: Businesses, Organizations

Government Levels Affected: State, Local

Agency Contact: Robert Weaver
Phone: 410 786-5914

RIN: 0938-AH31

[[Page 62561]]

_______________________________________________________________________




1414. MEDICARE PROGRAM; SPECIAL ENROLLMENT PERIODS AND WAITING PERIODS 
(BPD-752-FC)

Priority:  Substantive, Nonsignificant

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

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/02/96                    61 FR 40343

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Margaret Jefferson
Phone: 410 786-4482

RIN: 0938-AH33
_______________________________________________________________________




1415. CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEM AND 
FISCAL YEAR 1997 RATES (BPD-847-F)

Priority:  Economically Significant. Major under 5 USC 801.

CFR Citation:  42 CFR 412; 42 CFR 413

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/30/96                    61 FR 46166
Final Action Effective          10/01/96                    61 FR 51217

Small Entities Affected: Businesses, Organizations

Government Levels Affected: State, Federal

Agency Contact: Charles Booth
Phone: 410 786-4487

RIN: 0938-AH34
_______________________________________________________________________




1416. MEDICARE PROGRAM: FIVE-YEAR REVIEW OF WORK RELATIVE VALUE UNITS 
UNDER THE PHYSICIAN FEE SCHEDULE (BPD-846-FN)

Priority:  Other Significant

CFR Citation:  None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Merged With RIN 0938-AH40 (BPD-
852)                            08/01/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Terrence Kay
Phone: 410 786-4497

RIN: 0938-AH38
_______________________________________________________________________




1417. MEDICARE PROGRAM: MONTHLY ACTUARIAL RATES AND MONTHLY 
SUPPLEMENTARY MEDICAL INSURANCE PREMIUM RATES BEGINNING JANUARY 1, 1997 
(OACT-052-N)

Priority:  Other Significant

CFR Citation:  None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Notice                    10/23/96                    61 FR 55002

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Carter Warfield, Director
Phone: 410 786-6396

RIN: 0938-AH42
_______________________________________________________________________




1418. MEDICAID: LIMITATIONS ON AGGREGATE PAYMENTS TO DISPROPORTIONATE 
SHARE HOSPITALS; FEDERAL FISCAL YEAR 1996 (FINAL) (MB-100-N)

Priority:  Other Significant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/23/96                    61 FR 49781

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Richard Strauss
Phone: 410 786-2019

RIN: 0938-AH44
_______________________________________________________________________




1419. PART A PREMIUM FOR 1997 FOR THE UNINSURED AGED FOR CERTAIN 
DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER ENTITLEMENT (OACT-053-N)

Priority:  Other Significant

CFR Citation:  None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Notice                    11/04/96                    61 FR 56691

Small Entities Affected: None

Government Levels Affected: Undetermined

Agency Contact: John Wandishin
Phone: 410 786-6389

RIN: 0938-AH45
_______________________________________________________________________




1420. INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED CARE 
SERVICES COINSURANCE AMOUNTS FOR 1997 (OACT-054-N)

Priority:  Other Significant

CFR Citation:  None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Notice                    11/04/96                    61 FR 56690

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: John Wandishin
Phone: 410 786-6389

RIN: 0938-AH46
_______________________________________________________________________




1421. PRIVACY AND SECURITY ENFORCEMENT FOR THE MEDICARE TRANSACTION 
SYSTEM (BPO-142-P)

Priority:  Other Significant

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

CFR Citation:  42 CFR 401; 42 CFR 420

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

To Be Merged With Broader 
Rulemaking Under PL 104-191.    09/16/96

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Gerald Waters
Phone: 410 786-5894

RIN: 0938-AH47
_______________________________________________________________________




1422.  SCHEDULE OF PROSPECTIVELY DETERMINED PAYMENT RATES FOR 
SKILLED NURSING FACILITY INPATIENT ROUTINE SERVICE COSTS (BPD-842)

Priority:  Substantive, Nonsignificant

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

[[Page 62562]]

CFR Citation:  42 CFR 413.1; 42 CFR 413.24; 42 CFR 413.300 to 413.321

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

Abstract: This final notice with comment period sets forth the schedule 
of payment rates for low Medicare volume skilled nursing facilities for 
prospective payments for routine service costs for Federal fiscal year 
1997 (cost reporting periods beginning on or after October 1, 1996 and 
before October 1, 1997).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/03/96                    61 FR 46466
Final Action Effective          10/01/96

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-842

Agency Contact: Joseph Menning, Health Insurance Specialist, Bureau of 
Policy Development, Department of Health and Human Services, Health 
Care Financing Administration, C4-13-17, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-4594

RIN: 0938-AH56
_______________________________________________________________________




1423.  CRITERIA FOR A RURAL HOSPITAL TO BE DESIGNATED AS AS 
ESSENTIAL ACCESS COMMUNITY HOSPITAL (EACH) (BPD-856-F)

Priority:  Other Significant

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 412.109

Legal Deadline: None

Abstract: This final rule revises the criteria that a rural hospital 
must meet to be designated as an Essential Access Community Hospital 
(EACH). The revised criteria permit HCFA to designate a hospital as an 
EACH if the hospital cannot be designated as an EACH by the State only 
because it has fewer than 75 beds and is located 35 miles or less from 
another hospital. Hospitals in rural areas that are designated as EACHs 
by HCFA are treated, for payment purposes, as sole community hospitals. 
The revised criteria are designated to facilitate development of 
network affiliations between rural EACHs and small rural facilities, 
known as Rural Primary Care Hospitals known as (RPCHs). The revisions 
affect hospitals located in rural areas of the States of California, 
Colorado, Kansas, South Dakota, New York, West Virginia, and North 
Carolina, or in an adjacent State.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule Effective 
Date                            05/13/96
Interim Final Rule With Comment 
Period                          05/13/96                    61 FR 21969
Interim Final Rule Comment 
Period End                      07/12/96
Withdrawn - No Comments on 
Interim Rule; No Further Action 
Required                        10/21/96

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local

Additional Information: BPD-856

Agency Contact: George Morey, Health Insurance Specialist, Bureau of 
Policy Development, Department of Health and Human Services, Health 
Care Financing Administration, C5-08-07, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-4653

RIN: 0938-AH57
_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




1424. FOSTER CARE, ADOPTION ASSISTANCE, AND CHILD WELFARE SERVICES

Priority:  Other Significant

Legal Authority:  42 USC 627; 42 USC 671; 42 USC 1320a-1a

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

Legal Deadline:  NPRM, Statutory, July 1, 1995.

Abstract: This NPRM will propose requirements that implement the 
statutory provisions of the Social Security Act Amendments of 1994 on 
review of State programs under Parts B and E of the Social Security Act 
for conformity with State Plan requirements.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/97

Small Entities Affected: None

Government Levels Affected: State

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

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

RIN: 0970-AA97
_______________________________________________________________________




1425. 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

[[Page 62563]]

will be included, concerning the following issues: (1) Consideration of 
different weighting of factors under the allocation formula for the 
leveraging incentive program; (2) Hearing requirements for audit 
disallowances; and (3) Allotments for territories.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/97

Small Entities Affected: None

Government Levels Affected: State, Tribal

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

RIN: 0970-AB47
_______________________________________________________________________




1426. DESIGNATION OF ALTERNATIVE AGENCY TO SERVE INDIAN TRIBAL CHILDREN

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 9801 et seq

CFR Citation:  45 CFR 1302

Legal Deadline: None

Abstract: This NPRM will specify a process by which an Indian tribe may 
identify and establish an alternative agency to provide Head Start 
Services if the agency previously serving the tribe is terminated.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/97

Small Entities Affected: Organizations

Government Levels Affected: Tribal

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start Bureau, Department of Health and Human Services, Administration 
for Children and Families, P.O. Box 1182, Washington, DC 20013
Phone: 202 205-8569

RIN: 0970-AB52
_______________________________________________________________________




1427. CONSTRUCTION OF HEAD START FACILITIES

Priority:  Other Significant

Legal Authority:  42 USC 9801 et seq

CFR Citation:  45 CFR 1309

Legal Deadline: None

Abstract: This NPRM will establish procedures to be used by Head Start 
agencies in requesting to use Head Start grant funds to construct or 
renovate a Head Start facility.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/97

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: Local, Tribal

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start Bureau, Department of Health and Human Services, Administration 
for Children and Families, P.O. Box 1182, Washington, DC 20013
Phone: 202 205-8569

RIN: 0970-AB54
_______________________________________________________________________




1428. ON-SITE FOSTER CARE ELIGIBILITY REVIEWS

Priority:  Other Significant

Legal Authority:  42 USC 1302

CFR Citation:  45 CFR 1356; 42 CFR 672

Legal Deadline: None

Abstract: This NPRM will propose requirements that govern on-site 
eligibility reviews that the Administration for Children and Families 
conducts to assure State agencies' compliance with the statutory 
requirements under Title IV-E of the Social Security Act for 
eligibility of foster care providers and eligibility of the children in 
foster care.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/97

Small Entities Affected: None

Government Levels Affected: State

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

RIN: 0970-AB60
_______________________________________________________________________




1429.  DATA COLLECTION AND REPORTING UNDER THE TEMPORARY 
ASSISTANCE FOR NEEDY FAMILIES BLOCK GRANT

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 104-193

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: ACF will propose regulations to define data elements and 
specify data collection, verification, and other provisions to meet the 
requirements of the Temporary Assistance for Needy Families Block 
Grant.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/97

Small Entities Affected: None

Government Levels Affected: State, Local, Tribal

Agency Contact: Howard Rolston, Director, Office of Planning, Research, 
and Evaluation, Department of Health and Human Services, Administration 
for Children and Families, 370 L'Enfant Promenade, SW., 7th Floor West, 
Washington, DC 20447
Phone: 202 401-9220
Fax: 202 205-3598

RIN: 0970-AB64
_______________________________________________________________________




1430.  METHODOLOGY FOR DETERMINING CHILD POVERTY RATES

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 104-193

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: This NPRM will propose a Methodology to be used by States to 
determine their child poverty rates, Section 413(i) of the Social 
Security Act, as amended, requires that the Secretary establish this 
methodology by regulation and mentions three specific factors which 
might be used. States must begin reporting their rules within 90 days 
of enactment.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/96

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Don Oellerich, Director, Division of Data and

[[Page 62564]]

Technical, Analysis OASPE, Department of Health and Human Services, 
Administration for Children and Families, Room 404E, 200 Independence 
Avenue SW., Washington, DC 20201
Phone: 202 690-6805

RIN: 0970-AB65
_______________________________________________________________________




1431.  BONUS TO REWARD HIGH PERFORMANCE STATES UNDER THE 
TEMPORARY ASSISTANCE FOR NEEDY FAMILIES BLOCK GRANT

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 104-193

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: ACF, in consultation with the National Governor's Association 
and the American Public Welfare Association, will propose a formula for 
measuring state performance under the Temporary Assistance for Needy 
Families Block Grant as the basis for payment of a bonus to high 
performing states.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/97

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Howard Rolston, Director, Office of Planning, Research 
and Evaluation, Department of Health and Human Services, Administration 
for Children and Families, Adminstration for Children and Families, 370 
L'Enfant Promenade SW., 7th Floor, West, Washington, DC 20447
Phone: 202 401-9220
Fax: 202 205-3598

RIN: 0970-AB66
_______________________________________________________________________




1432.  STATE DIRECTORY OF NEW HIRES

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 104-193

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: This regulation specifies the information on wages and 
employment compensation paid by individuals that the State Directory of 
New Hires on a quarterly basis provides to the National Directory of 
New Hires.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/96

Small Entities Affected: None

Government Levels Affected: State, Federal

Agency Contact: Donna Bonar, Director, DPO, Department of Health and 
Human Services, Administration for Children and Families, OCSE, DHHS, 
370 L'Enfant Promenade SW., Mail Stop: OCSE/DPO, Washington, DC 20447
Phone: 202 401-9271
Fax: 202 401-5559

RIN: 0970-AB67
_______________________________________________________________________




1433.  STATE CASE REGISTRY AND EXPANSION OF FPLS

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 104-193

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: This regulation specifies what constitutes the minimum amount 
of information on child support cases recorded in the State Case 
Registry that is necessary to operate the Federal Case Registry. It 
also specifies the necessary information to identify the individuals 
who owe or are owed support and the State or States which have the 
case.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/97

Small Entities Affected: Undetermined

Government Levels Affected: State, Federal

Agency Contact: Donna Bonar, Director, DPO, Department of Health and 
Human Services, Administration for Children and Families, OCSE, DHHS, 
370 L'Enfant Promenade SW., Mail Stop: OCSE/DPO, Washington, DC 20447
Phone: 202 401-9271
Fax: 202 401-5559

RIN: 0970-AB68
_______________________________________________________________________




1434.  STATE LAW CONCERNING PATERNITY ESTABLISHMENT

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 104-193

CFR Citation:  45 CFR 303.5

Legal Deadline: None

Abstract: This regulation covers voluntary paternity establishment 
services offered by hospital and birth record agencies and specifies 
the types of other entities that may offer voluntary paternity 
establishment services. The provision of such services must include a 
requirement that such an entity use the same notice provision, 
materials, training, and evaluation as the ones used by the voluntary 
paternity establishment programs of hospitals and birth record 
agencies.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/96

Small Entities Affected: None

Government Levels Affected: State, Local

Agency Contact: Elizabeth C. Matheson, Director, Division of Policy and 
Planning, Department of Health and Human Services, Administration for 
Children and Families, OCSE, DHHS, 370 L'Enfant Promenade SW., Mail 
Stop: OCSE/DPP, Washington, DC 20447
Phone: 202 401-9386
Fax: 202 401-5559

RIN: 0970-AB69
_______________________________________________________________________




1435.  AUTOMATED DATA PROCESSING REQUIREMENTS

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 104-193

CFR Citation:  45 CFR 307

Legal Deadline:  Final, Statutory, October 1, 1998.

Abstract: This regulation, which should be finalized not later than two 
years after date of enactment of the Act, sets a deadline of October 1, 
2000 for implementation of new requirements except that the deadline 
shall be extended by one day for each day that the Secretary misses the 
two-year deadline.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/97

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Ronald Logan, Computer Specialist, Department of Health 
and Human Services, Administration for Children and Families, DHHS Room 
326F, 200

[[Page 62565]]

Independence Avenue SW., Washington, DC 20201
Phone: 202 401-6502

RIN: 0970-AB70
_______________________________________________________________________




1436.  AUTOMATED DATA PROCESSING FUNDING LIMITATION

Priority:  Other Significant

Legal Authority:  PL 104-193

CFR Citation:  45 CFR 307

Legal Deadline: None

Abstract: This regulation sets the limitation for the total amount 
payable of federal funding to a state for fiscal years 1996 through 
2001.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/96

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Helen Morgan Smith, Electronic Benefits Transfer 
Specialist, Department of Health and Human Services, Administration for 
Children and Families, OPS/OSS/OD, Room 326F, DHHS/HHH, 200 
Independence Avenue SW., Washington, DC 20201
Phone: 202 690-6639
Fax: 202 401-6400

RIN: 0970-AB71
_______________________________________________________________________




1437.  GRANTS TO STATES FOR ACCESS AND VISITATION PROGRAMS

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 104-193

CFR Citation:  45 CFR 300

Legal Deadline: None

Abstract: This regulation specifies the monitoring, evaluating, and 
reporting of State grants designed to support and facilitate absent 
parents' access to and visitation of their children.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/97

Small Entities Affected: None

Government Levels Affected: State, Local, Federal

Agency Contact: Elizabeth C. Matheson, Director, Division of Policy and 
Planning, Department of Health and Human Services, Administration for 
Children and Families, OCSE/DHHS, 370 L'Enfant Promenade SW., Mail 
Stop: OCSE/DPP, Washington, DC 20447
Phone: 202 401-9386
Fax: 202 401-5559

RIN: 0970-AB72
_______________________________________________________________________




1438.  CHILD SUPPORT ENFORCEMENT FOR INDIAN TRIBES

Priority:  Other Significant

Legal Authority:  PL 104-193

CFR Citation:  45 CFR 300

Legal Deadline: None

Abstract: Any state that has Indian country may enter into a 
cooperative agreement for the provision of child support enforcement 
service(s) with an Indian Tribe if the tribe demonstrate that it has an 
established tribal court system with several specific characteristics. 
The Secretary of DHHS may make direct payments to Indian tribes that 
have approved child support enforcement plans.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/97

Small Entities Affected: None

Government Levels Affected: State, Tribal

Agency Contact: Elizabeth C. Matheson, Director, Division of Policy and 
Planning, Department of Health and Human Services, Administration for 
Children and Families, OCSE/DHHS, 370 L'Enfant Promenade, S.W, Mail 
Stop: OCSE/DPP, Washington, DC 20447
Phone: 202 401-9386
Fax: 202 401-5559

RIN: 0970-AB73
_______________________________________________________________________




1439.  CHILD CARE PROPOSED RULE

Priority:  Other Significant

Legal Authority:  42 USC 601 to 617; 42 USC 9858

CFR Citation:  45 CFR 98.14; 45 CFR 98.33; 45 CFR 98.43; 45 CFR 98.50; 
45 CFR 98.51; 45 CFR 98.52; 45 CFR 98.53; 45 CFR 98.60; 45 CFR 98.61; 
45 CFR 98.62; 45 CFR 98.63; 45 CFR 98.64; 45 CFR 98.66; 45 CFR 98.81; 
45 CFR 98.83; ...

Legal Deadline: None

Abstract: The Administration for Children and Families, will amend 
existing regulations which govern the administration of the Child Care 
and Development Block Grant program. The purpose of this regulatory 
package will be to implement the legislative changes contained in the 
Personal Responsibility and Work Opportunity Reconciliation Act of 
1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/96

Small Entities Affected: None

Government Levels Affected: State, Tribal

Agency Contact: Joan Lombardi, Director, Child Care Bureau, Department 
of Health and Human Services, Administration for Children and Families, 
P.O. Box 1182, Washington, DC 20013
Phone: 202 401-6947

RIN: 0970-AB74
_______________________________________________________________________




1440.  TANF PROGRAM AND FINANCIAL REQUIREMENTS

Priority:  Other Significant

Legal Authority:  PL 104-193

CFR Citation:  45 CFR 200

Legal Deadline: None

Abstract: This regulatory action provides for state plan submissions 
determination of completeness, financial management and reporting, and 
individual development accounts.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/96

Small Entities Affected: None

Government Levels Affected: State, Local, Federal

Agency Contact: Mack Storrs, Director, Division of Self Sufficiency 
Programs, Department of Health and Human Services, Administration for 
Children and Families, Office of Family Assistance, 370 L'Enfant 
Promenade SW., Washington, DC 20447
Phone: 202 401-9289
Fax: 202 205-5887
Email: MS[email protected]

RIN: 0970-AB75

[[Page 62566]]

_______________________________________________________________________




1441.  TANF AUDITS/PENALTIES AND CORRECTIVE ACTIONS

Regulatory Plan:  This entry is Seq. No. 39 in Part II of this issue of 
the Federal Register.

RIN: 0970-AB76
_______________________________________________________________________




1442.  TANF WORK REQUIREMENTS

Regulatory Plan:  This entry is Seq. No. 40 in Part II of this issue of 
the Federal Register.

RIN: 0970-AB77
_______________________________________________________________________




1443.  TRIBAL PROGRAM REQUIREMENTS

Priority:  Other Significant

Legal Authority:  PL 104-193

CFR Citation:  45 CFR 250

Legal Deadline: None

Abstract: This regulatory action provides for tribal plans funding 
disagreements, program criteria for Alaskan tribes, and 
individualization of tribal programs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/97

Small Entities Affected: None

Government Levels Affected: State, Tribal, Federal

Agency Contact: Mack Storrs, Director, Division of Self-Sufficiency 
Program, Department of Health and Human Services, Administration for 
Children and Families, Office of Family Assistance, 370 L'Enfant 
Promenade SW., Washington, DC 20447
Phone: 202 401-9289
Fax: 202 205-5887
Email: MS[email protected]

RIN: 0970-AB78
_______________________________________________________________________




1444.  ILLEGITIMACY RATE REDUCTION BONUS

Priority:  Other Significant

Legal Authority:  PL 104-193

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: This regulation specifies the requirements for grants that 
each eligible State is entitled to receive from the Secretary for each 
bonus year for which the State demonstrates a net decrease in out-of-
wedlock births. The regulation specifies the amount of grant, defines 
``eligible State,'' and gives the appropriate years for the grant.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/97

Small Entities Affected: Undetermined

Government Levels Affected: State

Agency Contact: Kelleen Kaye, Office of the Assistant Secretary for 
Planning and Evaluation, Department of Health and Human Services, 
Administration for Children and Families, 200 Independence Avenue SW., 
Washington, DC 20201
Phone: 202 401-6634

RIN: 0970-AB79
_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




1445. STANDARDS FOR SAFE TRANSPORTATION

Priority:  Other Significant

Legal Authority:  42 USC 9801 et seq

CFR Citation:  45 CFR 1310

Legal Deadline: None

Abstract: This rule establishes Head Start Performance Standards for 
the safe transportation of Head Start children, including vehicle 
requirements, driver qualifications and training and safety rules for 
children and staff while en route and loading and unloading of 
vehicles.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/15/95                    60 FR 31612
NPRM Comment Period End         08/14/95
Final Action                    09/00/97

Small Entities Affected: Organizations

Government Levels Affected: None

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start Bureau, Department of Health and Human Services, Administration 
for Children and Families, P.O. Box 1182, Washington, DC 20013
Phone: 202 205-8569

RIN: 0970-AB24
_______________________________________________________________________




1446. STANDARDS FOR PURCHASE OF FACILITIES

Priority:  Other Significant

Legal Authority:  42 USC 9801 et seq

CFR Citation:  45 CFR 1309

Legal Deadline: None

Abstract: This regulation establishes standards for the purchase of 
facilities as required by the Head Start Improvement Act of 1992.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/01/94                    59 FR 61575
NPRM Comment Period End         01/31/95
Final Action                    04/00/97

Small Entities Affected: Organizations

Government Levels Affected: None

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start Bureau, Department of Health and Human Services, Administration 
for Children and Families, P.O. Box 1182, Washington, DC 20013
Phone: 202 205-8569

RIN: 0970-AB31
_______________________________________________________________________




1447. NATIONAL VOTER REGISTRATION ACT OF 1993 PROVISIONS AFFECTING 
PUBLIC ASSISTANCE AGENCIES

Priority:  Other Significant

Legal Authority:  PL 103-31

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

Legal Deadline: None

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

[[Page 62567]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State, Local

Agency Contact: Mack Storrs, Director, Division of AFDC Program, 
Department of Health and Human Services, Administration for Children 
and Families, 370 L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 401-9289

RIN: 0970-AB32
_______________________________________________________________________




1448. FAMILY PRESERVATION AND SUPPORT

Priority:  Other Significant

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

Legal Authority:  42 USC 430 to 435

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/04/94                    59 FR 50646
Final Action                    11/00/96

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State, Tribal

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

RIN: 0970-AB34
_______________________________________________________________________




1449. INCOME ELIGIBILITY CRITERIA FOR INDIAN TRIBES

Priority:  Substantive, Nonsignificant

Legal Authority:  45 USC 9801 et seq

CFR Citation:  45 CFR 1305

Legal Deadline: None

Abstract: This Final Rule will revise the income eligibility criteria 
used in enrolling Head Start children and families to allow Indian 
tribes, in certain situations, to enroll more children whose families 
do not meet Head Start's income criteria than would otherwise be 
possible.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/25/95                    60 FR 54648
NPRM Comment Period End         12/26/95
Final Action                    03/00/97

Small Entities Affected: Organizations

Government Levels Affected: Tribal

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start Bureau, Department of Health and Human Services, Administration 
for Children and Families, P.O. Box 1182, Washington, DC 20013
Phone: 202 205-8569

RIN: 0970-AB53
_______________________________________________________________________




1450. HEAD START FELLOWSHIP PROGRAM

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 9801 et seq

CFR Citation:  45 CFR 1311

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/15/96                    61 FR 24467
NPRM Comment Period End         07/15/96
Final Action                    03/00/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start Bureau, Department of Health and Human Services, Administration 
for Children and Families, P.O. Box 1182, Washington, DC 20013
Phone: 202 205-8569

RIN: 0970-AB56
_______________________________________________________________________




1451. EXTENSION OF DEADLINE FOR CERTIFIED STATEWIDE SYSTEMS AND 
REVISIONS FOR THE PRESIDENT'S REFORM INITIATIVE

Priority:  Substantive, Nonsignificant

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

Legal Authority:  PL 104-35

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

Legal Deadline: None

Abstract: This rule implements PL 104-35, enacted October 12, 1995, 
which revises section 454(24) of the Social Security Act. This rule 
also includes technical changes to other child support regulations to 
support the President's Regulatory Reinvention Initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State, Local

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

RIN: 0970-AB57

[[Page 62568]]

_______________________________________________________________________




1452. INCOME AND RESOURCE DISREGARDS RELATED TO INTERESTS OF INDIVIDUAL 
INDIANS IN TRUST OR RESTRICTED LANDS

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 103-66

CFR Citation:  45 CFR 233

Legal Deadline: None

Abstract: These rules incorporate statutory disregards in the AFDC 
program and the Adult Assistance programs in Guam, Puerto Rico and the 
Virgin Islands. The first provides that up to $2,000 per year of income 
derived from interests of individual Indians in trust or restricted 
lands shall not be considered in determining assistance. The second is 
a provision requiring that interests of individual Indians in trust or 
restricted lands shall not be considered a resource in determining 
eligibility for assistance.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/25/94                    59 FR 51536
Final Action                    06/00/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Mack A. Storrs, Director, Division of AFDC Program, 
Office of Family Assistance, Department of Health and Human Services, 
Administration for Children and Families, 370 L'Enfant Promenade SW., 
Washington, DC 20447
Phone: 202 401-9289

RIN: 0970-AB59
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Administration for Children and Families (ACF)



_______________________________________________________________________




1453. AMENDMENTS TO DEVELOPMENTAL DISABILITIES RULES

Priority:  Substantive, Nonsignificant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/30/96                    61 FR 51142

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Elsbeth Wyett
Phone: 202 690-6590

RIN: 0970-AB11
_______________________________________________________________________




1454. CHILD ABUSE AND NEGLECT STATE GRANT PROGRAM

Priority:  Substantive, Nonsignificant

CFR Citation:  45 CFR 1340

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn Due to PL 104-235     10/03/96

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Emily Cooke
Phone: 202 205-8586

RIN: 0970-AB23
_______________________________________________________________________




1455. CHILD CARE--REVISED REGULATIONS

Priority:  Other Significant

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

CFR Citation:  45 CFR 98; 45 CFR 255; 45 CFR 256; 45 CFR 257

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn Due to Recent Welfare 
Reform Law (PL 104-193)         08/22/96

Small Entities Affected: None

Government Levels Affected: Undetermined

Agency Contact: Joan Lombardi
Phone: 202 401-6947

RIN: 0970-AB33
_______________________________________________________________________




1456. ADMINISTRATION FOR NATIVE AMERICANS (ANA) 45 CFR PART 1336

Priority:  Substantive, Nonsignificant

CFR Citation:  45 CFR 1336

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/19/96                    61 FR 42817
Final Action Effective          09/18/96

Small Entities Affected: Organizations

Government Levels Affected: Tribal

Agency Contact: R. Denise Rodriguez, J.D.
Phone: 202 690-6265

RIN: 0970-AB37
_______________________________________________________________________




1457. REDUCTION OF REPORTING REQUIREMENTS FOR THE STATE SYSTEMS ADVANCE 
PLANNING DOCUMENT (APD) PROCESS

Priority:  Other Significant

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

CFR Citation:  45 CFR 95.600

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/31/96                    61 FR 39894
Final Action Effective          07/31/96

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: Bill Davis
Phone: 202 401-6404

RIN: 0970-AB46
_______________________________________________________________________




1458. ADMINISTRATIVE FLEXIBILITY RULE

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

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

[[Page 62569]]

CFR Citation:  45 CFR 205.31

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

PL 104-193 makes this rule 
obsolete                        08/22/96

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Mack Storrs
Phone: 202 401-9289

RIN: 0970-AB49
_______________________________________________________________________




1459. QUALITY STANDARDS FOR EARLY HEAD START AND HEAD START PROGRAMS

Priority:  Other Significant

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

CFR Citation:  45 CFR 1301; 45 CFR 1302; 45 CFR 1305; 45 CFR 1306; 45 
CFR 1308; 45 CFR 1304

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/05/96                    61 FR 57187

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: Local, Tribal

Agency Contact: Douglas Klafehn
Phone: 202 205-8569

RIN: 0970-AB55
_______________________________________________________________________


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


Administration on Aging (AOA)



_______________________________________________________________________




1460. GRANTS FOR STATE AND COMMUNITY PROGRAMS ON AGING, INTRASTATE 
FUNDING FORMULAS; TRAINING, RESEARCH AND DISCRETIONARY PROGRAMS; 
VULNERABLE ELDER RIGHTS; AND GRANTS TO INDIANS & NATIVE HAWAIIANS

Priority:  Substantive, Nonsignificant

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

Legal Authority:  PL 102-375

CFR Citation:  45 CFR 1321; 45 CFR 1324; 45 CFR 1326; 45 CFR 1327; 45 
CFR 1328

Legal Deadline: None
Unknown until law is reauthorized.

Abstract: The Administration on Aging (AoA) anticipates revising 
current rules to reflect the changes resulting from the pending 
reauthorization of the Older Americans Act which incorporates greater 
flexibility for the States. PURPOSE: The purpose of these revisions is 
to implement the newly enacted law in the development and provision of 
community-based services.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM - OAA Amendments in FY '97 08/00/97

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Tribal

Additional Information: The Administration on Aging, in consultation 
with the Office of Management and Budget, has determined that it is no 
longer necessary to pursue final action on rules earlier proposed to 
implement the 1992 amendments to the Older Americans Act. The 
provisions of the Act remain in force and need no further regulations 
to implement them. AoA anticipates promulgating rules in the latter 
part of 1997 to implement the provisions to the next reauthorization of 
the Older Americans Act, if necessary.

Agency Contact: Edwin Walker, Director, Office of Program Operations, 
and Development, Department of Health and Human Services, 
Administration on Aging, 330 Independence Avenue SW., Room 4733, Cohen 
Bldg., Washington, DC 20201
Phone: 202 619-0011

RIN: 0985-AA00
[FR Doc. 96-26268 Filed 11-27-96; 8:45 am]
BILLING CODE 4150-04-F