[The Regulatory Plan and Unified Agenda of Federal Regulations]
[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

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)                          
  
  
_______________________________________________________________________
  

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

21 CFR Ch. I

42 CFR Chs. I-V

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

Unified Agenda of Regulations

AGENCY: Office of the Secretary, HHS.

ACTION: Publication of unified agenda of regulations.

_______________________________________________________________________

SUMMARY: The President's September 30, 1993, Executive order (12866) 
and the Regulatory Flexibility Act of 1980 require the Department to 
publish an agenda of significant regulations being developed and an 
indication of those regulatory actions that are being analyzed for 
their effect on small businesses. The Department published its last 
agenda on May 8, 1995.

DATES: Data, information, and views due date: December 5, 1995, for 
initial suggestions and any date thereafter for additional suggestions.

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

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

SUPPLEMENTARY INFORMATION:

Department of Health and Human Services' Regulatory Plan

    For this edition of the Department's regulatory agenda, the 
most important significant regulatory actions are included in The 
Regulatory Plan, which appears in Part II of this issue of the 
Federal Register. The Regulatory Plan entries are listed in the 
Table of Contents below and are denoted by a bracketed bold 
reference, which directs the reader to the appropriate Sequence 
Number in Part II.

Background

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

    The Executive order and the Administration's effort toward 
implementation have proven successful by providing real progress in 
reforming regulations. Building on those successes, in March of 
1995, the President announced plans for more immediate, 
comprehensive reform.

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

    As a result of the initiative discussed above, this semiannual 
unified agenda reflects our efforts to reinvent rules identified as 
needing reform. As we embark on this effort, we continue to invite 
comments on our unified agenda entries and suggestions for 
furthering the President's regulatory reinvention strategy.

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

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

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

    Administration on Aging: Jack McCarthy, Executive Secretariat, 
Room 4753, Wilbur H. Cohen Building, 330 Independence Avenue SW., 
Washington, DC 20201; phone 202-619-0441.

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

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

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

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

    Centers for Disease Control/Agency for Toxic Substances and 
Disease Registry: Galen Morris, 1600 Clifton Road NE., Building 1, 
Room 2050, Atlanta, Georgia 30333; phone 404-639-1548.

    Agency for Health Care Policy and Research: Peggy Washburn, 
6000 Executive Drive, Suite 603, Rockville, Maryland 20852; phone 
301-594-1457.

    Food and Drug Administration: Ed Dutra, Director, Regulatory 
Policy and Management Staff, (HF26), 5600 Fishers Lane, Room 12-A-
17, Rockville, Maryland 20857; phone 301-443-3480.

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

Claudia Cooley,

Executive Secretary to the Department.

                                  Office of the Secretary--Proposed Rule Stage                                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1192        Revisions to the Civil Money Penalty Provisions Relating to the Misuse of Certain                   
            Symbols and Emblems...................................................................    0991-AA81 
----------------------------------------------------------------------------------------------------------------


                                    Office of the Secretary--Final Rule Stage                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1193        Civil Money Penalties (CMPs) for Certain Hospital Physician Incentive Plans...........    0991-AA45 
1194        Uniform Administrative Requirements for Grants and Cooperative Agreements.............    0991-AA56 
1195        Clarification of the Initial OIG Safe Harbor Provisions and Establishment of                        
            Additional Safe Harbor Provisions Under the Anti-Kickback Statute.....................    0991-AA66 
1196        Safe Harbors for Protecting Health Plans..............................................    0991-AA69 
1197        Revisions to the PRO Sanctions Process................................................    0991-AA73 
----------------------------------------------------------------------------------------------------------------


                                   Office of the Secretary--Long-Term Actions                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1198        Civil Money Penalties (CMPs) for Certain Practices Relating to Medicare Supplemental                
            Policies..............................................................................    0991-AA53 
1199        Civil Money Penalties for Physician Ownership of and Referral to Certain Health Care                
            Entities..............................................................................    0991-AA65 
1200        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 
1201        Civil Money Penalties for False Information on Drug Manufacturer Price Surveys and                  
            Rebate Agreements.....................................................................    0991-AA80 
----------------------------------------------------------------------------------------------------------------


                                   Office of the Secretary--Completed Actions                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1202        Amendment to Grants Management Common Rule To Raise Threshold for Simplified Small                  
            Purchases.............................................................................    0991-AA77 
1203        Proposed Amendments to Nonprocurement Debarment and Suspension Common Rule To Achieve               
            Reciprocity With Procurement..........................................................    0991-AA78 
----------------------------------------------------------------------------------------------------------------


                   Substance Abuse and Mental Health Services Administration--Final Rule Stage                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1204        Protection and Advocacy for Individuals With Mental Illness...........................    0930-AA02 
1205        Block Grants for Prevention and Treatment of Substance Abuse (Tobacco Provisions) (Reg              
            Plan Seq. No. 26).....................................................................   0930-AA03  
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.          


                  Substance Abuse and Mental Health Services Administration--Long-Term Actions                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1206        Block Grants for Prevention and Treatment of Substance Abuse..........................    0930-AA01 
----------------------------------------------------------------------------------------------------------------


                  Substance Abuse and Mental Health Services Administration--Completed Actions                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1207        Confidentiality of Substance Abuse Patient Records....................................    0930-AA00 
----------------------------------------------------------------------------------------------------------------


                          Centers for Disease Control and Prevention--Completed Actions                         
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1208        Respiratory Protective Devices........................................................    0920-AA00 
1209        National Center for Health Statistics, Special Statistical Services; Grants for Health              
            Education/Risk Reduction; Vaccines Information and Education--Repeal..................    0920-AA01 
----------------------------------------------------------------------------------------------------------------


                                    Departmental Management--Final Rule Stage                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1210        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   
----------------------------------------------------------------------------------------------------------------
1211        Reinventing FDA Food Regulations......................................................    0910-AA58 
1212        Food Standards of Identity, Quality, and Fill of Container; Common or Usual Name                    
            Regulations: Request for Comments on Existing Regulations (Reg Plan Seq. No. 27)......   0910-AA67  
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.          


                                Food and Drug Administration--Proposed Rule Stage                               
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1213        Over-the-Counter (OTC) Drug Review....................................................    0910-AA01 
1214        Infant Formula: Good Manufacturing Practice, Quality Control Procedures, Quality                    
            Factors, Notification Requirements, and Records and Reports...........................    0910-AA04 
1215        Reporting of Errors and Accidents.....................................................    0910-AA12 
1216        Mammography Quality Standards Act of 1992 (Reg Plan Seq. No. 28)......................    0910-AA24 
1217        Effective Date of Requirement for Submission of Premarket Approval Applications.......    0910-AA31 
1218        Latex Condoms/Gloves: Expiration Date Labeling........................................    0910-AA32 
1219        Latex Warning.........................................................................    0910-AA34 
1220        Premarket Approval of Medical Devices; Supplemental Applications......................    0910-AA35 
1221        Hearing Aids; Professional and Patient Labeling; Conditions for Sale..................    0910-AA39 
1222        Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding               
            of Drugs; Proposed Amendment of Certain Requirements for Finished Pharmaceuticals.....    0910-AA45 
1223        Animal Drug Amendments of 1994, Extra-Label Use; Implementation.......................    0910-AA47 
1224        Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco               
            Products to Protect Children and Adolescents (Reg Plan Seq. No. 29)...................    0910-AA48 
1225        Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution....    0910-AA49 
1226        Habit Forming Drugs...................................................................    0910-AA50 
1227        Bioavailability and Bioequivalence Requirements.......................................    0910-AA51 
1228        Consolidation of Regulations..........................................................    0910-AA53 
1229        Revocation of Certain Regulations (Reg Plan Seq. No. 30)..............................    0910-AA54 
1230        Name of Selling Agent or Distributor..................................................    0910-AA56 
1231        Streamlining Procedures for Changes in Production of Biologics (Reg Plan Seq. No. 31).    0910-AA57 
1232        Dietary Supplement Regulations in Response to DSHEA...................................    0910-AA59 
1233        Protection of Human Subjects; Informed Consent (Reg Plan Seq. No. 32).................    0910-AA60 
1234        OTC Drug Labeling Review..............................................................    0910-AA63 
1235        Medical Device Exemptions From Premarket Notification (Reg Plan Seq. No. 33)..........    0910-AA65 
1236        Substances Approved for Use in the Preparation of Meat and Poultry Products...........   0910-AA66  
----------------------------------------------------------------------------------------------------------------
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   
----------------------------------------------------------------------------------------------------------------
1237        New Animal Drug Approval Process; Implementation of Title I of the Generic Animal Drug              
            and Patent Term Restoration Act.......................................................    0910-AA02 
1238        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 
1239        Lead in Foods.........................................................................    0910-AA06 
1240        Fees for Certification Services; Insulin and Color Additive Certification Programs....    0910-AA07 
1241        Prescription Drug Marketing Act of 1987; Policy Information, Guidance, and                          
            Clarifications........................................................................    0910-AA08 
1242        Implementation of the Safe Medical Devices Act of 1990................................    0910-AA09 
1243        Final Regulation to Establish Procedures for the Safe and Sanitary Processing and                   
            Importing of Fish and Fishery Products (Reg Plan Seq. No. 34).........................    0910-AA10 
1244        Bottled Water.........................................................................    0910-AA11 
1245        Medical Devices; Protective Restraints; Revocation of Exemptions From 510(k) Premarket              
            Notification Procedures and Current Good Manufacturing Practices Regulations..........    0910-AA17 
1246        Food Labeling Review..................................................................    0910-AA19 
1247        Disqualification of Clinical Investigators............................................    0910-AA21 
1248        Investigational Device Exemption; Intraocular Lenses..................................    0910-AA22 
1249        Dietary Supplement Label Review.......................................................    0910-AA23 
1250        Specific Requirements on Content and Format of Labeling for Human Prescription Drugs;               
            Addition of ``Geriatric Use'' Subsection in the Labeling..............................    0910-AA25 
1251        Tamper-Evident Packaging Requirements for Over-the-Counter Human Drug Products........    0910-AA26 
1252        Certification of Drugs Composed Wholly or Partly of Insulin; Fees for Certification of              
            Drugs Composed Wholly or Partly of Insulin............................................    0910-AA27 
1253        Electronic Signatures; Electronic Records.............................................    0910-AA29 
1254        Financial Disclosure by Clinical Investigators........................................    0910-AA30 
1255        Prescription Drug Product Labeling; Medication Guide (Reg Plan Seq. No. 35)...........    0910-AA37 
1256        Human Tissue Intended for Transplantation: Proposed Rule..............................    0910-AA40 
1257        Iron Containing Drugs and Supplements.................................................    0910-AA42 
1258        Public Information; Communications With State and Foreign Government Officials........   0910-AA46  
----------------------------------------------------------------------------------------------------------------
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   
----------------------------------------------------------------------------------------------------------------
1259        Policies Concerning Uses of Sulfiting Agents..........................................    0910-AA03 
1260        Review of Warnings, Use Instructions, and Precautionary Information Under Section 314               
            of the National Childhood Vaccine Injury Act of 1986..................................    0910-AA14 
1261        General Biological Product Standards; Alternative Procedures and Exceptions...........    0910-AA16 
1262        Medical Foods.........................................................................    0910-AA20 
1263        Adverse Experience Reporting Requirements for Human Drug and Licensed Biological                    
            Products..............................................................................    0910-AA28 
1264        Amalgam Ingredient Labeling...........................................................    0910-AA33 
1265        Classification of Computer Software Programs That Are Medical Devices.................    0910-AA41 
1266        Development of Hazard Analysis Critical Control Points for the Food Industry; Request               
            for Comments..........................................................................    0910-AA43 
1267        Drugs Used for Treatment of Narcotic Addicts..........................................    0910-AA52 
1268        Export Requirements for Drugs for Investigational Use in Other Countries..............    0910-AA61 
1269        Export Requirements for Medical Devices...............................................    0910-AA62 
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Completed Actions                                
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1270        Proposed Labeling for Drug Products Based on False or Fraudulent Data.................    0910-AA13 
1271        Recordkeeping and Reporting: Electronic Products......................................    0910-AA15 
1272        Threshold of Regulation Policy for Components of Food Contact Articles................    0910-AA18 
1273        Medical Devices; Restricted Devices...................................................    0910-AA36 
1274        Substances Prohibited for Use in Ruminant Feed........................................    0910-AA38 
1275        New Drug and Biological Product License Applications; Revisions to Existing                         
            Regulations...........................................................................    0910-AA44 
----------------------------------------------------------------------------------------------------------------


                        Health Resources and Services Administration--Proposed Rule Stage                       
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1276        National Vaccine Injury Compensation Program: Revisions and Additions to the Vaccine                
            Injury Table - II.....................................................................    0906-AA36 
----------------------------------------------------------------------------------------------------------------


                         Health Resources and Services Administration--Final Rule Stage                         
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1277        Organ Procurement and Transplantation Network Rules (Reg Plan Seq. No. 36)............    0906-AA32 
1278        Technical Amendments to the Health Professions, Nursing, and Allied Health Training                 
            Grant Programs Under 42 CFR Parts 57 and 58...........................................    0906-AA38 
1279        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   
----------------------------------------------------------------------------------------------------------------
1280        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   
----------------------------------------------------------------------------------------------------------------
1281        Grants for the Establishment of Departments of Family Medicine........................    0906-AA34 
1282        Federally Supported Health Centers Assistance Act of 1992.............................    0906-AA35 
1283        National Practitioner Data Bank for Adverse Information on Physicians, Dentists, and                
            Other Health Care Practitioners: Payment of Fees......................................    0906-AA37 
----------------------------------------------------------------------------------------------------------------


                               National Institutes of Health--Proposed Rule Stage                               
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1284        National Institutes of Health AIDS Research Loan Repayment Program....................    0925-AA02 
1285        National Institutes of Health Clinical Research Loan Repayment Program for Individuals              
            From Disadvantaged Backgrounds........................................................    0925-AA09 
1286        Undergraduate Scholarship Program Regarding Professions Needed by the NIH.............    0925-AA10 
1287        Traineeships (Termination Policies)...................................................    0925-AA11 
1288        Additional DHHS Protection for Pregnant Women and Human Fetuses Involved as Subjects                
            for Research, and Pertaining to Human In Vitro Fertilization..........................    0925-AA14 
----------------------------------------------------------------------------------------------------------------


                                 National Institutes of Health--Final Rule Stage                                
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1289        Grants for Research Projects..........................................................    0925-AA01 
1290        Hazardous Substances Basic Research and Training Grants...............................    0925-AA03 
1291        National Institutes of Health Construction Grants.....................................    0925-AA04 
1292        Training Grants.......................................................................    0925-AA05 
1293        National Institutes of Health Center Grants...........................................    0925-AA06 
1294        Grants for National Alcohol Research Centers..........................................    0925-AA08 
----------------------------------------------------------------------------------------------------------------


                                National Institutes of Health--Completed Actions                                
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1295        Responsibilities of Public Health Service-Funded Institutions for Promoting                         
            Objectivity in Research...............................................................    0925-AA07 
----------------------------------------------------------------------------------------------------------------


                           Office of Assistant Secretary for Health--Long-Term Actions                          
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1296        Standards of Compliance for Abortion-Related Services in Family Planning Service                    
            Projects..............................................................................    0937-AA00 
----------------------------------------------------------------------------------------------------------------


                               Health Care Financing Administration--Prerule Stage                              
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1297        Ambulance Services (BPD-813-P)........................................................    0938-AH13 
1298        Changes in Coverage and Payment Policies for Physician Assistant Services (BPD-829-P).    0938-AH26 
----------------------------------------------------------------------------------------------------------------


                            Health Care Financing Administration--Proposed Rule Stage                           
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1299        New Minimum Standards for Medicare Supplemental (Medigap) Policies (BPD-491-P)........    0938-AD82 
1300        ''Without Fault'' and Beneficiary Waiver of Recovery as It Applies to Medicare                      
            Overpayment Liability (BPD-719-P).....................................................    0938-AD95 
1301        Protection of Income and Resources for Community Spouses of Institutionalized                       
            Individuals (MB-023-P)................................................................    0938-AE12 
1302        Coverage of Physician Assistant, Nurse Practitioner, and Clinical Nurse Specialist                  
            Services (BPD-708-P)..................................................................    0938-AF00 
1303        Alternative Sanctions for Psychiatric Hospitals (HSQ-191-P)...........................    0938-AF32 
1304        Medicaid Payment for Covered Outpatient Drugs Under Rebate Agreements (MB-046-F)......    0938-AF42 
1305        Federally Qualified Health Center Services (Medicaid) (MB-043-P)......................    0938-AF90 
1306        Revisions to Rules on Health Care Prepayment Plans (OMC-016-P)........................    0938-AF97 
1307        Conditions of Participation for Rural Health Clinics (BPD-764-P)......................    0938-AG05 
1308        Medicare Appeals of Individual Claims (BPD-453-P).....................................    0938-AG18 
1309        Appointment of Representatives for Medicare Appeals (BPO-120-P).......................    0938-AG30 
1310        Enforcement Requirements for Renal Dialysis Facilities (HSQ-204-P)....................    0938-AG31 
1311        Disclosure of Confidential PRO Information for Research Purposes (HSQ-208-P)..........    0938-AG33 
1312        Effect of Change of Ownership on Provider and Supplier Penalties, Sanctions, and                    
            Overpayments (HSQ-215-P)..............................................................    0938-AG59 
1313        Medicare Program: Limitations on Medicare Coverage of Cataract Surgery (BPD-797-PN)...    0938-AG65 
1314        New Payment Methodology for Routine Extended Care Services Provider in a Swing Bed                  
            Hospital (BPD-805-P)..................................................................    0938-AG68 
1315        Salary Equivalency Guidelines for Physical Therapy, Respiratory Therapy, Speech                     
            Pathology, and Occupational Therapy (BPD-808-PN)......................................    0938-AG70 
1316        Medicaid: Optional Coverage of TB-Related Services for Individuals Infected with                    
            Tuberculosis (MB-082-P)...............................................................    0938-AG72 
1317        Physicians' Referrals to Health Care Entities With Which They Have Financial                        
            Relationships--Expanded to Designated Health Services (BPD-809-P).....................    0938-AG80 
1318        Home Health Agency (HHA) Conditions of Participation (BPD-819-P) (Reg Plan Seq. No.                 
            38)...................................................................................    0938-AG81 
1319        End-Stage Renal Disease (ESRD) Conditions of Coverage (BPD-818-P) (Reg Plan Seq. No.                
            39)...................................................................................    0938-AG82 
1320        Distinct Part Requirements for Nursing Homes and Prohibition of Financial Screening of              
            Applicants for Nursing Home Admission (BPD-815-P).....................................    0938-AG84 
1321        Medicaid: Nominal Copayments for Institutional Services for Medicaid Recipients (MB-                
            090-P)................................................................................    0938-AG90 
1322        Wage Index Used To Adjust Payment Rates for Hospice Services Under the Medicare                     
            Program (BPD-820-P)...................................................................    0938-AG93 
1323        Categorization and Certification Requirements for a New Subcategory of Moderate                     
            Complexity Testing (HSQ-222-P) (Reg Plan Seq. No. 40).................................    0938-AG98 
1324        CLIA Program: Categorization of Waived Tests (HSQ-225-P) (Reg Plan Seq. No. 41).......    0938-AG99 
1325        Medicaid Coverage of Personal Care Services (MB-071-P)................................    0938-AH00 
1326        Liability for Third Parties to Pay for Care and Services (MB-080-P)...................    0938-AH01 
1327        Medicare Program: Coverage of Certified Nurse-Midwife Services (BPD-496-P)............    0938-AH02 
1328        Medicare Program: Uniform Electronic Cost Reporting for Skilled Nursing Facilities and              
            Home Health Agencies (BPD-788-P)......................................................    0938-AH12 
1329        Adjustment in Payment Amounts for New Technology Intraocular Lenses (BPD-831-P).......    0938-AH15 
1330        Schedule of Limits for Skilled Nursing Facility Inpatient Routine Service Costs (BPD-               
            837-NC)...............................................................................    0938-AH18 
1331        Additional Supplier Standards (BPD-838-P).............................................    0938-AH19 
1332        Delegation of Civil Money Penalties (BPO-135-FC)......................................    0938-AH22 
1333        State Plan Amendment (SPA) Reconsideration Process (MB-096-P).........................    0938-AH24 
1334        Evidence of Lawful Permanent Residence (MB-097-P).....................................    0938-AH25 
1335        Hospice Care - Conditions of Participation (BPD-844-P)................................    0938-AH27 
1336        Limitations on Payment for Home Oxygen Therapy Based on Inherent Reasonableness                     
            Criteria (BPD-845-PN).................................................................    0938-AH28 
1337        Medicaid: Limitations on Aggregate Payments to Disproportionate Share Hospitals;                    
            Federal Fiscal Year 1997 (MB-098-N)...................................................    0938-AH30 
1338        Medicaid Eligibility Quality Control, Staffing and Training, and Utilization Control:               
            Removal of Obsolete and Restrictive Requirements (MB-099-P)...........................    0938-AH31 
1339        Changes to the Hospital Inpatient Prospective Payment System and Fiscal Year 1997                   
            Rates (BPD-847-P) (Reg Plan Seq. No. 42)..............................................   0938-AH34  
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.          


                             Health Care Financing Administration--Final Rule Stage                             
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1340        Deduction of Incurred Medical Expenses (Spenddown) (MB-020-F).........................    0938-AB07 
1341        Payment for Clinical Diagnostic Laboratory Tests (BPD-309-F)..........................    0938-AB50 
1342        Effective Dates for Provider Agreements and Supplier Approvals (HSQ-139-F)............    0938-AC88 
1343        Changes Concerning Suspension of Medicare Payments and Determinations of Allowable                  
            Interest Expense (BPO-118-FC).........................................................    0938-AC99 
1344        Prohibition on Unbundling of Hospital Outpatient Services (BPD-426-F).................    0938-AD33 
1345        Changes to Peer Review Organization Regulations (HSQ-135-F)...........................    0938-AD38 
1346        Revisions to the Freedom of Information Regulations (OPA-001-P).......................    0938-AD60 
1347        Omnibus Nursing Home Reform Requirements (BPD-488-F)..................................    0938-AD81 
1348        HMO Organizational Structure and Services (OMC-007-F).................................    0938-AE25 
1349        Hospital Standard for HIV Infectious Blood and Blood Products (BPD-633-F).............    0938-AE40 
1350        Medicare, Medicaid, and CLIA Programs: Regulations Implementing the Clinical                        
            Laboratory Improvement Amendments of 1988 (CLIA '88) (HSQ-226-F) (Reg Plan Seq. No.                 
            43)...................................................................................    0938-AE47 
1351        Conditions of Coverage for Organ Procurement Organizations (BPD-646-F)................    0938-AE48 
1352        Resident Assessment in Long-Term Care Facilities (HSQ-180-F)..........................    0938-AE61 
1353        Post-Contract Beneficiary Protections and Other Provisions (OMC-003-F)................    0938-AE63 
1354        Employer Contributions to HMOs (OMC-004-F)............................................    0938-AE64 
1355        Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Services (MB-28-F)....    0938-AE72 
1356        Payment for Nursing and Allied Health Science Education (BPD-685-F)...................    0938-AE79 
1357        Coverage of Screening Pap Smears (BPD-705-F)..........................................    0938-AE98 
1358        Medicare Coverage of Clinical Psychologist, Other Psychologist, and Clinical Social                 
            Worker Services--Medicare (BPD-706-F).................................................    0938-AE99 
1359        Case Management (MB-27-F).............................................................    0938-AF07 
1360        Payment for Federally Qualified Health Center (FQHC) Services (BPD-728-F).............    0938-AF14 
1361        Partial Hospitalization Services in Community Mental Health Centers (BPD-736-IFC).....    0938-AF53 
1362        Medicaid: Outstationed Intake Locations for Certain Low-Income Pregnant Women, Infants              
            and Children Under Age 19 (MB-052-F)..................................................    0938-AF69 
1363        Medicare and Medicaid Programs: Requirements for Physician Incentive Plans in Prepaid               
            Health Care Organizations (OMC-010-FC)................................................    0938-AF74 
1364        Part B Advance Payments to Physicians/Suppliers or Other Entities Furnishing Items or               
            Services Under Medicare Part B (BPO-105-F)............................................    0938-AF85 
1365        Retroactive Enrollment and Disenrollment in Risk Health Maintenance Organizations and               
            Competitive Medical Plans (OMC-015-F).................................................    0938-AF98 
1366        Payment for Preadmission Services (BPD-731-F).........................................    0938-AG00 
1367        Change in Provider Agreement Regulations Related to Federal Employee Health Benefits                
            (BPD-748-F)...........................................................................    0938-AG03 
1368        Intermediary and Carrier Functions (BPO-111-F)........................................    0938-AG06 
1369        Revised Medicaid Management Information Systems (MB-38-FN)............................    0938-AG10 
1370        End-Stage Renal Disease (ESRD) Payment Exception Requests and Organ Procurement Costs               
            (BPD-763-F)...........................................................................    0938-AG20 
1371        Medicare Program: Limitations on Medicare Coverage of Intermittent Positive Pressure                
            Breathing Machine Therapy (BPD-781-FN)................................................    0938-AG44 
1372        Telephone and Electronic Requests for Review of Part B Initial Claim Determinations                 
            (BPO-121-P)...........................................................................    0938-AG48 
1373        Schedule of Limits on Home Health Agency Costs Per Visit (BPD-793-N)..................    0938-AG54 
1374        Medicaid Program: Nurse-Midwife Services (MB-085-F)...................................    0938-AG73 
1375        Medicaid Program: Fees for Vaccine Administration Under Pediatric Immunization Program              
            (MB-084-FN)...........................................................................    0938-AG77 
1376        Revision of Medicare Hospital Conditions of Participation (BPD-745-P) (Reg Plan Seq.                
            No. 44)...............................................................................    0938-AG79 
1377        Medicare Program: Changes to the Inpatient Hospital Prospective Payment Systems and                 
            Fiscal Year 1996 Rates (BPD-825-FC)...................................................    0938-AG95 
1378        Medicare Program: Revisions to Payment Policies and Adjustments to the Relative Value               
            Units (RVUs) Under the Physician Fee Schedule for Calendar Year 1996 (BPD-827-FC) (Reg              
            Plan Seq. No. 45).....................................................................    0938-AG96 
1379        Medicare Program: Physician Fee Schedule Update for Calendar Year 1996 & Physician                  
            Volume Performance Standard Rates of Increase for Federal Fiscal Year 1996 (BPD-828-                
            FN)...................................................................................    0938-AH03 
1380        Part A Premium for 1996 for the Uninsured Aged and for Certain Disabled Individuals                 
            Who Have Exhausted Other Entitlement (OACT-051-N).....................................    0938-AH06 
1381        Medicare Program: Monthly Actuarial Rates and Monthly Supplementary Medical Insurance               
            Premium Rates Beginning January 1, 1996 (OACT-050-N)..................................    0938-AH07 
1382        Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance                   
            Amounts for 1996 (OACT-049-N).........................................................    0938-AH08 
1383        Limitations on Aggregate Payments to Disproportionate Share Hospitals: Federal Fiscal               
            Year 1995 (Medicaid Program) (MB-094-N)...............................................    0938-AH09 
1384        Reporting of Interest From Zero Coupon Bonds (BPD-647-F)..............................    0938-AH11 
1385        Update of the Reasonable Compensation Equivalent Limits for Services Furnished by                   
            Physicians (BPD-816-N)................................................................    0938-AH14 
1386        Criteria and Procedures for Extending Coverage to Certain Devices and Related Services              
            (BPD-841-FC) (Reg Plan Seq. No. 46)...................................................    0938-AH21 
1387        CLIA Program; Granting and Withdrawal of Authority to Private Nonprofit Accreditation               
            Organizations and of CLIA Exemption Under State Laboratory Programs; Technical                      
            Corrections...........................................................................    0938-AH32 
1388        Medicare Program; Special Enrollment Periods and Waiting Periods (BPD-752-FC).........   0938-AH33  
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.          


                             Health Care Financing Administration--Long-Term Actions                            
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1389        Participation in CHAMPUS and CHAMPVA, Hospital Admissions for Veterans, Discharge                   
            Rights Notice, and Hospital Responsibility for Emergency Care (BPD-393-F).............    0938-AC58 
1390        Criteria and Procedures for Making Medical Services Coverage Decisions That Relate to               
            Health Care Technology (BPD-432-F)....................................................    0938-AD07 
1391        Medicare Coverage of Outpatient Occupational Therapy Services (BPD-425-P).............    0938-AD32 
1392        Medicare Secondary Payer for Disabled Individuals (BPD-482-FC)........................    0938-AD73 
1393        Fee Schedule for Payment of Clinical Psychologist Services (BPD-495-P)................    0938-AD84 
1394        Survey Requirements and Alternative Sanctions for Home Health Agencies (HSQ-169-F)....    0938-AE39 
1395        Fire Safety Standards for Hospitals, Long-Term Care Facilities, and Intermediate Care               
            Facilities for the Mentally Retarded (BPD-650-FC).....................................    0938-AE97 
1396        Changes to the Long-Term Care Facility Survey Process (HSQ-175-FC)....................    0938-AF02 
1397        OBRA '90 and Miscellaneous Managed Care Technical Amendments (OMC-018-FC).............    0938-AF15 
1398        Presumptive Limits on Payments to HMOs, CMPs, and HCPPs (OMC-006-F)...................    0938-AF16 
1399        Provider Reimbursement Determinations and Appeals Revisions (BPD-727-P)...............    0938-AF28 
1400        Referral to Child Support Enforcement Agencies of Medicaid Families (MB-051-F)........    0938-AF68 
1401        Assessing Interest Against Medicare Secondary Payer (MSP) Debts (BPO-108-P)...........    0938-AF87 
1402        General Criteria and Standards for Evaluating Performance of Contract Obligations (HSQ-             
            207-NC)...............................................................................    0938-AG32 
1403        Withdrawal of Coverage of Diagnostic Nocturnal Penile Tumescence Testing (Impotence                 
            Testing) (BPD-780-FN).................................................................    0938-AG43 
1404        Noncoverage of Electrostimulation of Salivary Glands for the Treatment of Xerostomia                
            (Dry Mouth) (BPD-782-FN)..............................................................    0938-AG45 
1405        Clinical Laboratory Improvement Amendment (CLIA) Fee Schedules (HSQ-219-FC)...........    0938-AG87 
1406        Mandatory Medigap Crossover Claims Transmittal Requirements (BPD-811-P)...............    0938-AG94 
1407        Definition of Skilled Nursing Facility (SNF) and Home Health Agency (HHA) for Coverage              
            of Durable Medical Equipment (DME) (BPD-834-P)........................................    0938-AH16 
1408        Medicare Coverage of Liver Transplantation (BPD-835-PN)...............................    0938-AH17 
1409        Provisions That Allow Rural Primary Care Hospitals (RPCHs) to Enter Into Swing-Bed                  
            Agreements (BPD-839-P)................................................................    0938-AH20 
1410        Transfer of Assets for Less Than Fair Market Value: Medicaid Program (MB-095-P).......    0938-AH23 
----------------------------------------------------------------------------------------------------------------


                             Health Care Financing Administration--Completed Actions                            
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1411        Clarifications of Medicare's Accrual Basis of Accounting Policy (BPD-366-F)...........    0938-AD01 
1412        Optional Payment System for Low Medicare Volume Skilled Nursing Facilities (BPD-409-F)    0938-AD02 
1413        Transfer of Resources for Less Than Fair Market Value (MB-10-P).......................    0938-AD18 
1414        Payment for Durable Medical Equipment and Orthotic and Prosthetic Devices (BPD-494-F).    0938-AD65 
1415        Uniform Electronic Cost Reporting System for Hospitals (BPD-689-F)....................    0938-AE80 
1416        Allowing Certifications and Recertifications by Nurse Practitioners and Clinical Nurse              
            Specialists for Certain Services (BPD-709-FC).........................................    0938-AF01 
1417        Medicaid Third Party Liability: Cost Effectiveness Waivers (MB-39-F)..................    0938-AF11 
1418        Required Coverage of Nurse Practitioner Services--Medicaid (MB-41-F)..................    0938-AF12 
1419        Physician Ownership of and Referrals to Health Care Facilities That Furnish Clinical                
            Laboratory Services and Financial Relationship Reporting Requirements (BPD-674-FC)....    0938-AF40 
1420        Medicare and Medicaid Programs; Advance Directives (BPD-718-F)........................    0938-AF50 
1421        Clarification of Resumption of Entitlement Rules for Medicare Patients with End-Stage               
            Renal Disease (BPD-738-F).............................................................    0938-AG19 
1422        Standards for Quality of Water Used in Dialysis and Revised Guidelines on Reuse of                  
            Hemodialyzer Filters for End-Stage Renal Disease Patients (BPD-766-F).................    0938-AG21 
1423        Community Supported Living Arrangements Services (MB-070-P)...........................    0938-AG35 
1424        Conditions for Payment for Physicians' Services in Teaching Settings (BPD-792-P)......    0938-AG53 
1425        Date for Filing Medicare Cost Reports (BPD-794-F).....................................    0938-AG55 
1426        Expansion of the Definition of Eye and Ear Specialty Hospitals (BPD-804-P)............    0938-AG67 
1427        Categorization of CLIA Tests and Personnel Modifications (HSQ-216-FC).................    0938-AG71 
1428        Criteria for Medicare Coverage of Lung Transplants (BPD-812-FN).......................    0938-AG83 
----------------------------------------------------------------------------------------------------------------


                          Administration for Children and Families--Proposed Rule Stage                         
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1429        Foster Care, Adoption Assistance, and Child Welfare Services..........................    0970-AA97 
1430        Block Grant Programs (Low Income Home Energy Assistance Program --LIHEAP)--FY 1995 and              
            FY 1996 Provisions....................................................................    0970-AB47 
1431        Administrative Flexibility Rule.......................................................    0970-AB49 
1432        Designation of Alternative Agency To Serve Indian Tribal Children.....................    0970-AB52 
1433        Construction of Head Start Facilities.................................................    0970-AB54 
1434        Quality Standards for Head Start Programs (Reg Plan Seq. No. 47)......................    0970-AB55 
1435        Head Start Fellowships Program........................................................    0970-AB56 
1436        Reporting Overdue Support Information to Consumer Reporting Agencies..................    0970-AB57 
1437        On-Site Foster Care Eligibility Reviews...............................................   0970-AB60  
----------------------------------------------------------------------------------------------------------------
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   
----------------------------------------------------------------------------------------------------------------
1438        Amendments to Developmental Disabilities Rules........................................    0970-AB11 
1439        Family Violence Prevention and Services...............................................    0970-AB18 
1440        Child Abuse and Neglect State Grant Program...........................................    0970-AB23 
1441        Standards for Safe Transportation.....................................................    0970-AB24 
1442        Standards for Purchase of Facilities..................................................    0970-AB31 
1443        National Voter Registration Act of 1993 Provisions Affecting Public Assistance                      
            Agencies..............................................................................    0970-AB32 
1444        Child Care--Revised Regulations.......................................................    0970-AB33 
1445        Family Preservation and Support.......................................................    0970-AB34 
1446        Administration of Native Americans 45 CFR Part 1336...................................    0970-AB37 
1447        Reduction of Reporting Requirements for the State Systems Advance Planning Document                 
            (APD) Process.........................................................................    0970-AB46 
1448        Income and Resource Disregards Related to Interests of Individual Indians in Trust or               
            Restricted Lands......................................................................    0970-AB59 
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Long-Term Actions                          
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1449        Income Eligibility Criteria for Indian Tribes.........................................    0970-AB53 
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Completed Actions                          
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1450        Block Grant Programs (Low-Income Home Energy Assistance Program --LIHEAP) FY 91 and FY              
            92 Provisions.........................................................................    0970-AB15 
1451        Block Grant Programs (Low-Income Home Energy Assistance Program--LIHEAP)--FY 93 and FY              
            94 Provisions.........................................................................    0970-AB16 
1452        Statewide Automated Child Welfare Information System..................................    0970-AB38 
1453        Refugee Resettlement Program: Miscellaneous, Comprehensive Changes....................    0970-AB42 
1454        Direct Payments to Indian Tribes and Tribal Organizations Under Title IV-B, Subpart 1.    0970-AB44 
1455        Repatriation - Advance Approval of Costs..............................................    0970-AB45 
1456        AFCARS Data Element on Foster Care Payments...........................................    0970-AB58 
1457        Removal of Keys Amendment Regulations.................................................    0970-AB61 
1458        Removal of Obsolete Family Assistance Regulation......................................    0970-AB62 
1459        Elimination of Obsolete Block Grant Rules.............................................    0970-AB63 
----------------------------------------------------------------------------------------------------------------


                                   Administration on Aging--Long-Term Actions                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                     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)
  
_______________________________________________________________________
  
1192. REVISIONS TO THE CIVIL MONEY PENALTY PROVISIONS RELATING TO 
THE MISUSE OF CERTAIN SYMBOLS AND EMBLEMS

Priority:  Substantive, Nonsignificant

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

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

CFR Citation:  42 CFR 1003

Legal Deadline: None

Abstract: This final rule will make a number of technical revisions to 
the civil money penalty authority relating to the misuse of certain 
symbols, emblems and names as a result of amendments to section 1140 of 
the Social Security Act. Among other revisions, this rule (1) 
eliminates the annual penalty cap, (2) includes the words and letters 
of the Department and Medicaid under the prohibition, and (3) redefines 
a violation with regard to bulk mailings and solicitations. In 
addition, this rule serves to remove references to Social Security and 
its programs from 42 CFR 1003. Sepearte rulemaking addressing 
violations of the SSA symbols, emblems and names are being developed in 
conjunction with this final rule.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            11/00/95

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0991-AA81
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Office of the Secretary (OS)
  
_______________________________________________________________________
  
1193. CIVIL MONEY PENALTIES (CMPS) FOR CERTAIN HOSPITAL PHYSICIAN 
INCENTIVE PLANS

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 1001; 42 CFR 1003

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/01/94                    59 FR 61571
NPRM Comment Period End         01/30/95
Final Action                    06/00/96

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

RIN: 0991-AA45
_______________________________________________________________________

1194. UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND 
COOPERATIVE AGREEMENTS

Priority:  Substantive, Nonsignificant

Legal Authority:  5 USC 301

CFR Citation:  45 CFR 74

Legal Deadline: None

Abstract: On 11/29/93 OMB revised circular A-110 which contains 
administrative requirements for grants to universities, hospitals, and 
nonprofit organizations. 45 CFR Part 74 is being revised to implement 
the circular.

Timetable:


Interim Final Rule 08/25/94 (59 FR 43754) Comment Period End 10/24/94 
Final Action 10/00/95

Small Entities Affected: None

Government Levels Affected: State, Local

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

RIN: 0991-AA56
_______________________________________________________________________

1195. 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                    03/00/96

Small Entities Affected: None

Government Levels Affected: None

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

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

RIN: 0991-AA66
_______________________________________________________________________

1196. SAFE HARBORS FOR PROTECTING HEALTH PLANS

Priority:  Other Significant

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

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

CFR Citation:  42 CFR 1001

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Rule With Comment Period  11/05/92                    57 FR 52723
Extension of Public Comment 
Period                          01/07/93                     58 FR 2989
Interim Final Rule              11/05/93                    57 FR 52723
Final Action                    12/00/95

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0991-AA69
_______________________________________________________________________

1197. REVISIONS TO THE PRO SANCTIONS PROCESS

Priority:  Substantive, Nonsignificant

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

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

CFR Citation:  42 CFR 1004

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            02/28/94                     59 FR 9452
NPRM Comment Period End         04/29/94
Final Action                    12/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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

RIN: 0991-AA73
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Long-Term Actions
Office of the Secretary (OS)
  
_______________________________________________________________________
  
1198. CIVIL MONEY PENALTIES (CMPS) FOR CERTAIN PRACTICES RELATING 
TO MEDICARE SUPPLEMENTAL POLICIES

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 1003

Legal Deadline: None

Abstract: This rule would authorize CMPs against any individual or 
entity who knowingly and willfully use 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
_______________________________________________________________________

1199. CIVIL MONEY PENALTIES FOR PHYSICIAN OWNERSHIP OF AND REFERRAL 
TO CERTAIN HEALTH CARE ENTITIES

Priority:  Substantive, Nonsignificant

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

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

CFR Citation:  42 CFR 1001; 42 CFR 1003

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0991-AA65
_______________________________________________________________________

1200. 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
_______________________________________________________________________

1201. CIVIL MONEY PENALTIES FOR FALSE INFORMATION ON DRUG 
MANUFACTURER PRICE SURVEYS AND REBATE AGREEMENTS

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 1003

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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

RIN: 0991-AA80
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Office of the Secretary (OS)
  
_______________________________________________________________________
  
1202. AMENDMENT TO GRANTS MANAGEMENT COMMON RULE TO RAISE THRESHOLD 
FOR SIMPLIFIED SMALL PURCHASES

Priority:  Substantive, Nonsignificant

CFR Citation:  45 CFR 92

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    04/19/95                    60 FR 19645
Final Action Effective          05/19/95

Small Entities Affected: None

Government Levels Affected: State, Local, Tribal

Agency Contact: Charles Gale
Phone: 202 690-6377

RIN: 0991-AA77
_______________________________________________________________________

1203. PROPOSED AMENDMENTS TO NONPROCUREMENT DEBARMENT AND 
SUSPENSION COMMON RULE TO ACHIEVE RECIPROCITY WITH PROCUREMENT

Priority:  Substantive, Nonsignificant

CFR Citation:  45 CFR 76

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    06/26/95                    60 FR 33037
Final Action Effective          08/25/95

Small Entities Affected: None

Government Levels Affected: None

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

Agency Contact: Neil Steyskal
Phone: 202 690-5729

RIN: 0991-AA78
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Substance Abuse and Mental Health Services Administration (SAMHSA)
  
_______________________________________________________________________
  
1204. PROTECTION AND ADVOCACY FOR INDIVIDUALS WITH MENTAL ILLNESS

Priority:  Substantive, Nonsignificant

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

CFR Citation:  45 CFR 51

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

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/14/94                    59 FR 64367
NPRM Comment Period End         02/13/95
Final Action                    04/00/96

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Local

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

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

RIN: 0930-AA02
_______________________________________________________________________

1205. BLOCK GRANTS FOR PREVENTION AND TREATMENT OF SUBSTANCE ABUSE 
(TOBACCO PROVISIONS)

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

RIN: 0930-AA03
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Long-Term Actions
Substance Abuse and Mental Health Services Administration (SAMHSA)
  
_______________________________________________________________________
  
1206. BLOCK GRANTS FOR PREVENTION AND TREATMENT OF SUBSTANCE ABUSE

Priority:  Other Significant

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

CFR Citation:  45 CFR 96

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

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Tribal

Additional Information: Previously reported under RIN 0905-AD98.
Alternate Contact: Sue Martone, DLEA, SAMHSA, PHS, 5600 Fishers Lane, 
Room 12C-15, Rockville, MD 20852; 301-443-4640

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

RIN: 0930-AA01
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Substance Abuse and Mental Health Services Administration (SAMHSA)
  
_______________________________________________________________________
  
1207. CONFIDENTIALITY OF SUBSTANCE ABUSE PATIENT RECORDS

Priority:  Other Significant

CFR Citation:  42 CFR 2

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    05/05/95                    60 FR 22296
Final Action Effective          06/05/95

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Tribal, Federal

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

RIN: 0930-AA00
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Centers for Disease Control and Prevention (CDC)
  
_______________________________________________________________________
  
1208. RESPIRATORY PROTECTIVE DEVICES

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:  30 CFR 11; 42 CFR 84

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    06/08/95                    60 FR 30336
Final Action Effective          07/10/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Richard Metzler
Phone: 304 284-5713

RIN: 0920-AA00
_______________________________________________________________________

1209. NATIONAL CENTER FOR HEALTH STATISTICS, SPECIAL STATISTICAL 
SERVICES; GRANTS FOR HEALTH EDUCATION/RISK REDUCTION; VACCINES 
INFORMATION AND EDUCATION--REPEAL

Priority:  Other

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

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

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    07/13/95                    60 FR 36072
Final Action Effective          07/13/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Gaylon Morris
Phone: 404 639-3243

RIN: 0920-AA01
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Departmental Management (HHSDM)
  
_______________________________________________________________________
  
1210. IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT IN AGENCY 
PROCEEDINGS

Priority:  Substantive, Nonsignificant

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

CFR Citation:  45 CFR 13

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            06/19/87                    52 FR 23311
NPRM Comment Period End         08/17/87
Final Action                    02/00/96
Final Action Effective          03/00/96

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0990-AA02
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)             Prerule Stage
Food and Drug Administration (FDA)
  
_______________________________________________________________________
  
1211.  REINVENTING FDA FOOD REGULATIONS

Priority:  Substantive, Nonsignificant

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

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

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

Legal Deadline: None

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

Timetable:

Additional categorical exclusions for environmental impact  NPRM 09/00/
96

Food Additives, Color Additives, and GRAS Petition Review  NPRM 03/00/
96

Food Standards and Other Regulations for Food  ANPRM 10/00/95

Notification Procedures for Independent GRAS Determinations  NPRM 02/
00/96

Small Entities Affected: Businesses

Government Levels Affected: State

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

RIN: 0910-AA58
_______________________________________________________________________

1212.  FOOD STANDARDS OF IDENTITY, QUALITY, AND FILL OF 
CONTAINER; COMMON OR USUAL NAME REGULATIONS: REQUEST FOR COMMENTS ON 
EXISTING REGULATIONS

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

RIN: 0910-AA67
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Food and Drug Administration (FDA)
  
_______________________________________________________________________
  
1213. 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)

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) 11/00/95

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) 11/00/95

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

Antidiarrheal Products  ANPRM 03/21/75 (40 FR 12924)  NPRM 04/30/86 (51 
FR 16138)  Final Action 12/00/95

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

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

Antiflatulent Drug Products  NPRM 11/12/73 (38 FR 31260)  Final Action 
06/04/74 (39 FR 19877)  NPRM (Amendment) 01/29/88 (53 FR 2716)  Final 
Action (Amendment) 12/00/95

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Cough/Cold (Combination) Products  ANPRM 09/09/76 (41 FR 38312)  NPRM 
08/12/88 (53 FR 30522)  NPRM (Amendment)(DPH Combinations) 02/23/95 (60 
FR 10286)  Final Action Theophylline 07/27/95 (60 FR 38636)  Final 
Action 03/00/96

Cough/Cold (Diphenhydramine) Products  Final Action/Enforcement Policy 
12/00/95

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)  NPRM (Phenylpropanolamine) 
03/00/96

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Internal Analgesic Products  ANPRM 07/08/77 (42 FR 35346)  NPRM 11/16/
88 (53 FR 46204)  NPRM (Amendment) (Overindulgence) 12/24/91 (56 FR 
66762)  NPRM (Amdt.)(Sodium Bicarbonate) 02/02/94 (59 FR 5068)  NPRM 
(Amendment)(Alcohol Warning) 12/00/95  Final Action (Cardio/
Cerebrvasclar) 02/00/96  NPRM (Labeling-revised indications) 03/00/
96  NPRM (Prof. Labeling)(Acute MI) 03/00/96

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

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

Labeling of Drug Products for OTC Use  NPRM 04/05/93 (58 FR 
17553)  Final Action 01/28/94 (59 FR 3998)  NPRM (Do not mix drugs) 08/
03/94 (59 FR 39499)  NPRM (Amendment) (Do not mix drugs) 10/04/95 (60 
FR 52058)  NPRM (Unless a doctor tells you) 11/00/95  NPRM (Format/
Examples) 02/00/96  NPRM (Calcium/Magnesium/Potassium) 03/00/96

Laxative Products  ANPRM 03/21/75 (40 FR 12902)  NPRM 01/15/85 (50 FR 
2124)  NPRM (Amendment) 10/01/86 (51 FR 35136)  NPRM (Amendment) 09/02/
93 (58 FR 46589)  Final Action 03/00/96

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

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

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

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

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

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

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

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

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

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

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

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

Otic Products (Dry Water-Clogged Ears)  NPRM (Amendment) 02/00/96

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

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

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

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

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

Phenylpropanolamine Products (Labeling)  NPRM 01/00/96

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

Poison Treatment Products  NPRM 01/15/85 (50 FR 2244)  Final Action 03/
00/96

Quinine for Malaria  NPRM 04/19/95 (60 FR 19650)

Reporting of Adverse Reactions  NPRM 12/00/95

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

Skin Protectant Products  ANPRM 08/04/78 (43 FR 34628)  NPRM 02/15/83 
(48 FR 6820)  NPRM (Amendment) (Astringent) 04/03/89 (54 FR 
13490)  NPRM (Amendment) (Poison Ivy) 10/03/89 (54 FR 40808)  NPRM 
(Amendment) (Fvr Blister/Ext) 01/31/90 (55 FR 3362)  NPRM (Amendment) 
(Diaper Rash) 06/20/90 (55 FR 25204)  Final Action (Astringent) 10/21/
93 (58 FR 54466)  Final Action (Witch Hazel) 06/03/94 (59 FR 
28767)  Final Action (Poison Ivy) 03/00/96  Final Action 03/00/96

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

Sodium Labeling  NPRM 04/25/91 (56 FR 19222)  Final Action 12/00/95

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

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

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

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

Sunscreen Products  ANPRM 08/25/78 (43 FR 38206)  NPRM 05/12/93 (58 FR 
28194)  NPRM (Amendment) 06/08/94 (59 FR 29706)

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

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

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

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

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

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

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

Weight Control Products  ANPRM 02/26/82 (47 FR 8466)  NPRM 10/30/90 (55 
FR 45788)  Final Action 08/08/91 (56 FR 37792)  NPRM (Amendment) 01/00/
96

Small Entities Affected: None

Government Levels Affected: None

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

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

RIN: 0910-AA01
_______________________________________________________________________

1214. INFANT FORMULA: GOOD MANUFACTURING PRACTICE, QUALITY CONTROL 
PROCEDURES, QUALITY FACTORS, NOTIFICATION REQUIREMENTS, AND RECORDS AND 
REPORTS

Priority:  Other Significant

Legal Authority:  21 USC 350a

CFR Citation:  21 CFR 107; 21 CFR 106

Legal Deadline: None

Abstract: The agency published on December 24, 1991, a final rule 
implementing certain aspects of the Infant Formula Act of 1986. The 
rule establishes infant formula record and record retention 
requirements. The agency is preparing a proposed rule that will 
establish current good manufacturing practice regulations, quality 
control procedures, quality factors, notification requirements, and 
reports for the production of infant formulas.

Timetable:

Current Good Mfg. Practices; Qual Control Proc  NPRM 05/00/96  NPRM 
(Comment Period End) 08/00/96

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

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AC46.

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

RIN: 0910-AA04
_______________________________________________________________________

1215. REPORTING OF ERRORS AND ACCIDENTS

Priority:  Substantive, Nonsignificant

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

CFR Citation:  21 CFR 600; 21 CFR 606

Legal Deadline: None

Abstract: All licensed manufacturers are required to notify FDA 
promptly of errors or accidents in the manufacture of products that may 
affect the safety, purity, or potency of any distributed biological 
product (21 CFR 600.14). The reporting of certain errors or accidents 
occurring in the manufacture of blood and blood components is necessary 
so that FDA can respond where the public health may be endangered and 
provide added assurance as to the continued safety, identity, quality, 
purported quality, and purity of blood and blood components. FDA has 
determined that errors and accidents that are detected and corrected 
before a finished unit is removed from the unprocessed inventory and 
made available for release and distribution do not affect the safety of 
the blood supply and need not be reported to the Agency. The proposed 
rule would require licensed establishments, unlicensed establishments, 
and transfusion services to report and keep records. The cost to 
licensed establishments would be minimal. Since they already are 
required to report, licensed establishments would only have to make 
some changes in standard operating procedures. Unlicensed 
establishments are already required to keep records and conduct 
investigations. Under the proposed rule they would have to establish 
reporting procedures and report to FDA. The transfusion services would 
have to assure their recordkeeping and investigation procedures are 
sufficient and establish reporting procedures. Reporting by transfusion 
services is expected to be minimal.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD67.

Agency Contact: Jean M. Olson, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Center for Biologics 
Evaluation and Research (HFM-630), 1401 Rockville Pike, Suite 200N, 
Rockville, MD 20852-1448
Phone: 301 594-3074

RIN: 0910-AA12
_______________________________________________________________________

1216. MAMMOGRAPHY QUALITY STANDARDS ACT OF 1992

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

RIN: 0910-AA24
_______________________________________________________________________

1217. EFFECTIVE DATE OF REQUIREMENT FOR SUBMISSION OF PREMARKET 
APPROVAL APPLICATIONS

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 360e

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

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

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE34.

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

RIN: 0910-AA31
_______________________________________________________________________

1218. LATEX CONDOMS/GLOVES: EXPIRATION DATE LABELING

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 351; 21 USC 352

CFR Citation:  21 CFR 801

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/00/95

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE37.

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

RIN: 0910-AA32
_______________________________________________________________________

1219. LATEX WARNING

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 352

CFR Citation:  21 CFR 801

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            01/00/96

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE40.

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

RIN: 0910-AA34
_______________________________________________________________________

1220. PREMARKET APPROVAL OF MEDICAL DEVICES; SUPPLEMENTAL 
APPLICATIONS

Priority:  Substantive, Nonsignificant

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

Legal Authority:  21 USC 360e

CFR Citation:  21 CFR 814.39

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/00/95

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE41.

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

RIN: 0910-AA35
_______________________________________________________________________

1221. HEARING AIDS; PROFESSIONAL AND PATIENT LABELING; CONDITIONS 
FOR SALE

Priority:  Other Significant

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

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

CFR Citation:  21 CFR 801.420; 21 CFR 801.421

Legal Deadline: None

Abstract: FDA is considering revising its present regulation governing 
the labeling and conditions for sale of hearing aids. The present rule 
requires an examination by a physician before purchase of a hearing 
aid, but permits an informed adult to waive that requirement. There is 
some evidence that this waiver provision is being misused. FDA is 
reconsidering which types of health professionals are competent to 
perform hearing evaluations. FDA is also considering revisions to its 
professional and patient labeling to require updated information.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

ANPRM                           11/10/93                    58 FR 59695
ANPRM Comment Period End        01/10/94
NPRM                            12/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: Previously reported under RIN 0905-AE46.

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

RIN: 0910-AA39
_______________________________________________________________________

1222. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, 
PROCESSING, PACKING, OR HOLDING OF DRUGS; PROPOSED AMENDMENT OF CERTAIN 
REQUIREMENTS FOR FINISHED PHARMACEUTICALS

Priority:  Substantive, Nonsignificant

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

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

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/00/95

Small Entities Affected: None

Government Levels Affected: Federal

Additional Information: Previously reported under RIN 0905-AE63.

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

RIN: 0910-AA45
_______________________________________________________________________

1223. ANIMAL DRUG AMENDMENTS OF 1994, EXTRA-LABEL USE; 
IMPLEMENTATION

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 103-396

CFR Citation:  None

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

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/00/95
Final Action                    10/00/96

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE66.

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

RIN: 0910-AA47
_______________________________________________________________________

1224.  REGULATIONS RESTRICTING THE SALE AND DISTRIBUTION OF 
CIGARETTES AND SMOKELESS TOBACCO PRODUCTS TO PROTECT CHILDREN AND 
ADOLESCENTS

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

RIN: 0910-AA48
_______________________________________________________________________

1225.  REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF 
DRUGS IN COMMERCIAL DISTRIBUTION

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; 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: Revises and clarifies these regulations to reduce burden to 
manufacturers, packers, distributors, and to consolidate and streamline 
the requirements.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            06/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Howard Muller, Regulatory Counsel, Division of 
Regulatory Affairs, Department of Health and Human Services, Food and 
Drug Administration, Center for Drug Evaluation and Research (HFD-362), 
7500 Standish Place Rockville, MD 20855
Phone: 301 594-1049
Fax: 301 827-0901

RIN: 0910-AA49
_______________________________________________________________________

1226.  HABIT FORMING DRUGS

Priority:  Substantive, Nonsignificant

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

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

CFR Citation:  21 CFR 329

Legal Deadline: None

Abstract: Revise and clarify these regulations and to be consistent 
with the Drug Enforcement Administration regulation and the Controlled 
Substances Act; to streamline requirements.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            06/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Division of 
Regulatory Affairs, Department of Health and Human Services, Food and 
Drug Administration, Center for Drug Evaluation and Research (HFD-362), 
7500 Standish Place, Rockville, MD 20855
Phone: 301 594-1049
Fax: 301 827-0901

RIN: 0910-AA50
_______________________________________________________________________

1227.  BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

Priority:  Substantive, Nonsignificant

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

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

CFR Citation:  21 CFR 320

Legal Deadline: None

Abstract: Revisions and clarification of these requirements to 
eliminate duplication and inconsistencies and streamline requirements.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            02/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Erica L. Keys, Regulatory Counsel, Division of 
Regulatory Affairs, Department of Health and Human Services, Food and 
Drug Administration, Center for Drug Evaluation and Research (HFD-362), 
7500 Standish Place Rockville, MD 20855
Phone: 301 594-1046
Fax: 301 827-0901

RIN: 0910-AA51
_______________________________________________________________________

1228.  CONSOLIDATION OF REGULATIONS

Priority:  Other

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

Legal Authority:  21 USC 371

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

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            02/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Mary E. Catchings, Regulatory Counsel, Division of 
Regulatory Affairs, Department of Health and Human Services, Food and 
Drug Administration, Center for Drug Evaluation and Research (HFD-366), 
7500 Standish Place Rockville, MD 20855
Phone: 301 594-2041
Fax: 301 827-0901

RIN: 0910-AA53
_______________________________________________________________________

1229.  REVOCATION OF CERTAIN REGULATIONS

Regulatory Plan:  This entry is Seq. No. 30 in Part II of this issue of 
the Federal Register.

RIN: 0910-AA54
_______________________________________________________________________

1230.  NAME OF SELLING AGENT OR DISTRIBUTOR

Priority:  Other Significant

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

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

CFR Citation:  21 CFR 610

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Jean M. Olson and Tracey Forfa, Regulatory Counsel, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Biologics Evaluation and Research (HFM-630), 1401 Rockville 
Pike, Suite 200N, Rockville, MD 20852-1448
Phone: 301 594-3074

RIN: 0910-AA56
_______________________________________________________________________

1231.  STREAMLINING PROCEDURES FOR CHANGES IN PRODUCTION OF 
BIOLOGICS

Regulatory Plan:  This entry is Seq. No. 31 in Part II of this issue of 
the Federal Register.

RIN: 0910-AA57
_______________________________________________________________________

1232.  DIETARY SUPPLEMENT REGULATIONS IN RESPONSE TO DSHEA

Priority:  Routine and Frequent

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

CFR Citation:  21 CFR 101

Legal Deadline: None

Abstract: On January 4, 1994, FDA published final rules relative to 
nutrition labeling, nutrient content claims and health claims for 
dietary supplements. The Dietary Supplement Health and Education Act 
(DSHEA) was enacted on October 25, 1995, modifying the provisions for 
labeling of dietary supplements. FDA is initiating rulemaking to modify 
its regulations for dietary supplements accordingly. One proposal would 
modify the nutrition labeling and ingredient declaration requirements. 
A second proposal would modify the provisions for nutrient content 
claims and health claims for the disclaimer to accompany statements of 
nutritional support. A third proposal would define the terms high 
potency and antioxident.

Timetable:

High Potency and Antioxident terms; Dietary Supplements  NPRM 12/00/95

Nutrition Content and Health Claims; Dietary Supplements  NPRM 12/00/95

Nutrition Labeling and Ingredient Labeling; Dietary Supplements  NPRM 
12/00/95

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

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

RIN: 0910-AA59
_______________________________________________________________________

1233.  PROTECTION OF HUMAN SUBJECTS; INFORMED CONSENT

Regulatory Plan:  This entry is Seq. No. 32 in Part II of this issue of 
the Federal Register.

RIN: 0910-AA60
_______________________________________________________________________

1234.  OTC DRUG LABELING REVIEW

Priority:  Substantive, Nonsignificant

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 200

Legal Deadline: None

Abstract: As part of the Food and Drug Administration's ongoing process 
to improve the labeling of over-the counter (OTC) drug products, the 
agency will seek public comment on a standardized uniform format for 
OTC labeling. This action is intended to improve the communication of 
important information about OTC products to consumers.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            03/00/96

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Ilisa B. G. Bernstein, Department of Health and Human 
Services, Food and Drug Administration, Office of Policy (HF-23) 5600 
Fishers Lane, Rm. 15-74 Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 443-6906

RIN: 0910-AA63
_______________________________________________________________________

1235.  MEDICAL DEVICE EXEMPTIONS FROM PREMARKET 
NOTIFICATION

Regulatory Plan:  This entry is Seq. No. 33 in Part II of this issue of 
the Federal Register.

RIN: 0910-AA65
_______________________________________________________________________

1236.  SUBSTANCES APPROVED FOR USE IN THE PREPARATION OF 
MEAT AND POULTRY PRODUCTS

Priority:  Other Significant

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

Legal Authority:  21 USC 321; 21 USC 342; 21 USC 348; 21 USC 355 to 
357; 21 USC 360; 21 USC 360b to 360f; 21 USC 360h to 360j; 21 USC 361; 
21 USC 371; 21 USC 379e; 21 USC 381; 42 USC 216; 42 USC 262

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

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            11/00/95

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: Federal

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

RIN: 0910-AA66
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Food and Drug Administration (FDA)
  
_______________________________________________________________________
  
1237. NEW ANIMAL DRUG APPROVAL PROCESS; IMPLEMENTATION OF TITLE I 
OF THE GENERIC ANIMAL DRUG AND PATENT TERM RESTORATION ACT

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 08/
00/96

Reporting Requirements for Marketed Animal Drugs  NPRM 12/17/91 (56 FR 
65581)  Final Action 02/00/96

Small Entities Affected: Businesses

Government Levels Affected: None

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

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

RIN: 0910-AA02
_______________________________________________________________________

1238. CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD 
COMPONENTS; NOTIFICATION OF CONSIGNEES RECEIVING BLOOD AND BLOOD 
COMPONENTS AT INCREASED RISK FOR TRANSMITTING HIV INFECTION

Priority:  Substantive, Nonsignificant

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

CFR Citation:  21 CFR 606; 21 CFR 610

Legal Deadline: None

Abstract: The agency currently requires that all blood and blood 
components intended for transfusion or for the manufacture of any 
product be tested for antibody to human immunodeficiency virus (HIV). 
In instances when the blood of a donor is found to contain antibodies 
to HIV, some blood centers have initiated a program of voluntary 
``look-back'' to determine the suitability of previous donations and to 
notify consignees of blood and blood components obtained from the 
donor's prior donations. Consignees may withdraw or destroy such blood 
and blood products, and may trace and notify recipients. A well-
conducted look-back program can provide an effective mechanism for 
quarantine of products and for identifying, testing, and counseling 
recipients of transfusions determined to be at increased risk of HIV 
infection--those who receive blood from a donor later found to be 
infected with HIV. The agency is publishing a final rule to establish a 
mandatory look-back program. The final rule will require blood 
collection facilities to develop a procedure to identify and quarantine 
products from prior collections and to notify consignees promptly 
whenever a blood donor who has previously donated blood or source 
plasma is found to be positive for the antibody to HIV; and to keep 
appropriate records when such notification has been made. In addition, 
the final rule will require hospital transfusion services to notify 
recipients of blood products at increased risk for transmitting HIV and 
to keep appropriate records of the notification process. The purpose of 
the rulemaking is to ensure the notification of consignees and blood 
transfusion recipients and that prompt and appropriate action is taken.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            06/30/93                    58 FR 34962
Final Action                    12/00/95

Small Entities Affected: Businesses, Organizations

Government Levels Affected: Undetermined

Additional Information: Previously reported under RIN 0905-AC90.

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

RIN: 0910-AA05
_______________________________________________________________________

1239. LEAD IN FOODS

Priority:  Substantive, Nonsignificant

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

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

Legal Deadline: None

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

Timetable:

Lead From Ceramic Pitchers  NPRM 06/01/89 (54 FR 23485)  NPRM Comment 
Period End 07/31/89  Withdrawal of NPRM 00/00/00

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

Prohibit Use of Tin-Coated Lead Foil Capsules on Wine Bottles  NPRM 11/
25/92 (57 FR 55485)  Final Action 12/00/95

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AC91.

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

RIN: 0910-AA06
_______________________________________________________________________

1240. 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 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. 
The fees are intended to recover the full costs of operation of FDA's 
insulin certification program, including the unfunded liability of the 
Civil Service Retirement Fund and appropriate overhead costs of the 
Public Health Service and Department of Health and Human Services. FDA 
is publishing a new interim rule lowering the fees, to reflect lower 
costs involved in administering the insulin certification program.
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. The 
change in fees will allow FDA to continue to maintain an adequate color 
certification program as required by the Federal Food, Drug, and 
Cosmetic Act.
On February 13, 1995, FDA received comments from only one interested 
party, the International Association of Color Manufacturers (IACM). 
Those comments, which stated IACM's opposition to an automatic annual 
escalator provision in the interim rule, will be incorporated into a 
final rule. The final rule is expected to be published in the Federal 
Register by early 1996. FDA expects to eliminate the automatic annual 
escalator provision in response to IACM's concerns.

Timetable:

Color Additives  Interim Final Rule 11/29/94 (59 FR 60898)  Final 
Action 11/00/95

Insulin  Interim Final Rule 10/04/91 (56 FR 50248)  Interim Final Rule 
11/00/95

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD34.

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
_______________________________________________________________________

1241. PRESCRIPTION DRUG MARKETING ACT OF 1987; POLICY INFORMATION, 
GUIDANCE, AND CLARIFICATIONS

Priority:  Substantive, Nonsignificant

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

CFR Citation:  21 CFR 203

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            03/14/94                    59 FR 11842
NPRM Comment Period End         08/01/94
Final Action                    12/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: Previously reported under RIN 0905-AD44.

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

RIN: 0910-AA08
_______________________________________________________________________

1242. IMPLEMENTATION OF THE SAFE MEDICAL DEVICES ACT OF 1990

Priority:  Other Significant

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

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

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

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Action                    00/00/00
Assignment of Agency Component for Review of Premarket Applctns  Notice 
(Public Hearing) 07/12/91 (56 FR 31951)  Final Action 11/21/91 (56 FR 
31951)

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

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

CGMPs for Medical Devices  ANPRM (Revisions;Request for Cmnts) 06/15/90 
(55 FR 24544)  ANPRM (Suggested Changes;Availblty) 11/30/90 (55 FR 
49644)  ANPRM (Extension of Comment Period) 02/14/91 (56 FR 
5965)  Notice (Open Public Advsy Cmte Mtg) 04/17/91 (56 FR 15626)  NPRM 
11/23/93 (58 FR 61952)  NPRM 07/24/95 (60 FR 37856)  Final Action 03/
00/96

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

Medical Device Recall Authority  NPRM 06/14/94 (59 FR 30656)  NPRM 
(Correction) 06/23/94 (59 FR 32489)  Final Action 12/00/95

Medical Device Reporting  Notice (Public Conf ;Rqst for Info) 03/28/91 
(56 FR 12934)  NPRM 11/26/91 (56 FR 60024)  Final Rule (Distributor 
Reporting) 09/01/93 (58 FR 46514)  Final Action 11/00/95

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

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

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

Reports of Removals and Corrections of Medical Devices  NPRM 06/04/94 
(59 FR 13828)  Final Action 12/00/95

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

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

Temporary Suspension of a Premarket Approval Application  NPRM 10/12/93 
(58 FR 52729)  Final Action 12/00/95

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD59.

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

RIN: 0910-AA09
_______________________________________________________________________

1243. FINAL REGULATION TO ESTABLISH PROCEDURES FOR THE SAFE AND 
SANITARY PROCESSING AND IMPORTING OF FISH AND FISHERY PRODUCTS

Regulatory Plan:  This entry is Seq. No. 34 in Part II of this issue of 
the Federal Register.

RIN: 0910-AA10
_______________________________________________________________________

1244. BOTTLED WATER

Priority:  Routine and Frequent

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

CFR Citation:  21 CFR 103; 21 CFR 165

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

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

Timetable:

Beverages; Bottled Water  NPRM 01/05/93 (58 FR 393)  Final Action 11/
00/95

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

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

Quality Standards for 24 Contaminants  NPRM 08/04/93 (58 FR 
41612)  Final Action 02/00/96

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

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD65.

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

RIN: 0910-AA11
_______________________________________________________________________

1245. MEDICAL DEVICES; PROTECTIVE RESTRAINTS; REVOCATION OF 
EXEMPTIONS FROM 510(K) PREMARKET NOTIFICATION PROCEDURES AND CURRENT GOOD 
MANUFACTURING PRACTICES REGULATIONS

Priority:  Substantive, Nonsignificant

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

CFR Citation:  21 CFR 880.6760; 21 CFR 890.3910

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            06/19/92                    57 FR 27397
NPRM Comment Period End         08/18/92
Final Action                    12/00/95

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Additional Information: Previously reported under RIN 0905-AD84.

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

RIN: 0910-AA17
_______________________________________________________________________

1246. FOOD LABELING REVIEW

Priority:  Routine and Frequent

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

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

Legal Deadline: None

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

Timetable:

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

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

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

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

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

Reference Daily Intakes  NPRM 01/04/94 (59 FR 427)  Final Action 02/00/
96

Small Business Exemption, Nutrition Labeling  NPRM 03/14/94 (59 FR 
11872)  Final Action 11/00/95

Voluntary Guidelines for Nutrition Labeling Produce  NPRM 07/18/94 (59 
FR 36379)  Final Action 01/00/96

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Additional Information: Previously reported under RIN 0905-AD89.

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

RIN: 0910-AA19
_______________________________________________________________________

1247. 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                    12/00/95

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD94.

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

RIN: 0910-AA21
_______________________________________________________________________

1248. INVESTIGATIONAL DEVICE EXEMPTION; INTRAOCULAR LENSES

Priority:  Other

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

Legal Authority:  21 USC 360j(g)

CFR Citation:  21 CFR 813; 21 CFR 812

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            10/06/93                    58 FR 52142
Final Action                    12/00/95

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD95.

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

RIN: 0910-AA22
_______________________________________________________________________

1249. DIETARY SUPPLEMENT LABEL REVIEW

Priority:  Routine and Frequent

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

CFR Citation:  21 CFR 101

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

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

Timetable:

Health Claims and Label Statements; Dietary Supplements  NPRM Folic 
Acid and Neural Tube Def 10/14/93 (58 FR 53254)  Final Action 01/04/94 
(59 FR 433)  Final Action Effective 07/01/94  Final Action 03/00/96

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

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

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

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

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

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Additional Information: Previously reported under RIN 0905-AD96.

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

RIN: 0910-AA23
_______________________________________________________________________

1250. SPECIFIC REQUIREMENTS ON CONTENT AND FORMAT OF LABELING FOR 
HUMAN PRESCRIPTION DRUGS; ADDITION OF ``GERIATRIC USE'' SUBSECTION IN THE 
LABELING

Priority:  Substantive, Nonsignificant

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

CFR Citation:  21 CFR 201

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE26.

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

RIN: 0910-AA25
_______________________________________________________________________

1251. TAMPER-EVIDENT PACKAGING REQUIREMENTS FOR OVER-THE-COUNTER 
HUMAN DRUG PRODUCTS

Priority:  Substantive, Nonsignificant

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

CFR Citation:  21 CFR 211

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            01/18/94                     59 FR 2542
NPRM Comment Period End         03/21/94
Final Action                    01/00/96

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE27.

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

RIN: 0910-AA26
_______________________________________________________________________

1252. CERTIFICATION OF DRUGS COMPOSED WHOLLY OR PARTLY OF INSULIN; 
FEES FOR CERTIFICATION OF DRUGS COMPOSED WHOLLY OR PARTLY OF INSULIN

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 356; 21 USC 371

CFR Citation:  21 CFR 429.55

Legal Deadline: None

Abstract: The Food and Drug Administration intends to issue an interim 
rule, with opportunity for public comment, to revise the fee schedule 
for insulin certification services to reflect lower agency costs for 
the program.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Interim Final Rule              10/00/95
NPRM                            11/00/95

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE28.

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

RIN: 0910-AA27
_______________________________________________________________________

1253. ELECTRONIC SIGNATURES; ELECTRONIC RECORDS

Priority:  Other Significant

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

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

CFR Citation:  21 CFR 11

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: Federal

Additional Information: Previously reported under RIN 0905-AE31.

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

RIN: 0910-AA29
_______________________________________________________________________

1254. FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS

Priority:  Other Significant

Legal Authority:  42 USC 262; 21 USC 321; 21 USC 331; 21 USC 351; 21 
USC 352; 21 USC 353; 21 USC 355; 21 USC 356; 21 USC 357; 21 USC 360; 21 
USC 371; 21 USC 372; 21 USC 373; 21 USC 374; 21 USC 375; ...

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

Legal Deadline: None

Abstract: This final regulation addresses the problem of certain 
financial arrangements and interests of clinical investigators that 
have the potential to bias the outcome of clinical trials. The problem 
is significant because clinical research data provide the basis for 
FDA's evaluation of drugs, biologics and devices for marketing. The 
regulation requires the sponsor of a product that is the subject of a 
marketing application to submit either a statement certifying that the 
clinical investigator is not a party to any problematic financial 
interests and arrangements or a statement disclosing problematic 
interests and arrangements to which the investigator is a party. This 
information would enable FDA to subject the relevant clinical research 
data to an appropriate level of scrutiny to test its reliability. 
Alternatives are to prohibit investigators from holding certain 
financial interests altogether or to require divestiture by the 
investigator of a prohibited interest. The estimated costs to industry 
associated with preparation, submission, and retention of the 
information required by this 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                    04/00/96

Small Entities Affected: None

Government Levels Affected: None

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

1255. PRESCRIPTION DRUG PRODUCT LABELING; MEDICATION GUIDE

Regulatory Plan:  This entry is Seq. No. 35 in Part II of this issue of 
the Federal Register.

RIN: 0910-AA37
_______________________________________________________________________

1256. HUMAN TISSUE INTENDED FOR TRANSPLANTATION: PROPOSED RULE

Priority:  Other Significant

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

CFR Citation:  21 CFR 1270

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Interim Rule; Opport. for 
Comment                         12/14/93                    58 FR 65514
Interim Rule; Comment Period End03/14/94
Final Action                    01/00/96
NPRM                            04/00/96
NPRM Comment Period End         07/00/96

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Additional Information: Previously reported under RIN 0905-AE49.

Agency Contact: Paula 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
_______________________________________________________________________

1257. IRON CONTAINING DRUGS AND SUPPLEMENTS

Priority:  Substantive, Nonsignificant

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

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

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE59.

Agency Contact: Linda Kahl, Acting Director, Division of Programs and 
Enforcement Policy, Department of Health and Human Services, Food and 
Drug Administration, Center for Food Safety and Applied Nutrition (HFS-
455), 200 C Street SW., Washington, DC 20204
Phone: 202 205-5365

RIN: 0910-AA42
_______________________________________________________________________

1258. PUBLIC INFORMATION; COMMUNICATIONS WITH STATE AND FOREIGN 
GOVERNMENT OFFICIALS

Priority:  Other

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

CFR Citation:  21 CFR 20

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: State, Local, Federal

Additional Information: Previously reported under RIN 0905-AE65.
42 USC 300u-300u-5 42 USC 300aa-1

Agency Contact: Linda Horton, Director, International Policy Staff, 
Department of Health and Human Services, Food and Drug Administration, 
Office of Policy (HF-23), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-3344
Fax: 301 443-6906
Email: [email protected]

RIN: 0910-AA46
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Long-Term Actions
Food and Drug Administration (FDA)
  
_______________________________________________________________________
  
1259. POLICIES CONCERNING USES OF SULFITING AGENTS

Priority:  Other Significant

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

CFR Citation:  21 CFR 182.3616; 21 CFR 182.3637; 21 CFR 182.3739; 21 
CFR 182.3766; 21 CFR 182.3798; 21 CFR 182.3862; 21 CFR 100; 21 CFR 
130.9

Legal Deadline: None

Abstract: Acceptable evidence and information exist to show that a 
subgroup of asthmatics is at moderate to severe risk for a severe 
reaction upon exposure to sulfites. The agency's primary tool for 
handling a situation where population subgroups may be at increased 
risk from a food ingredient that is safe for most people is to use 
labeling to inform those persons who need or want to avoid the 
ingredient. The agency issued a final rule, effective January 7, 1987, 
that requires that when a sulfiting agent is present in a finished food 
at 10 parts per million or greater, the sulfiting agent must be 
declared on the label. In addition, FDA issued a final rule, effective 
August 8, 1986, prohibiting the use of sulfiting agents on raw fruits 
and vegetables intended to be served or sold raw to consumers (e.g., in 
salad bars). On December 10, 1987, FDA announced its tentative 
conclusion that there is no longer a basis to find that the use of 
sulfiting agents on ``fresh'' potatoes served or sold unpackaged to 
consumers is GRAS. On December 19, 1988, FDA proposed to affirm, with 
specific limitations, that certain other uses of sulfiting agents are 
GRAS and to establish labeling requirements for sulfiting agents in 
standardized foods.
On March 15, 1990 (55 FR 9826), FDA issued a final rule prohibiting the 
use of sulfiting agents on ``fresh'' potatoes (55 FR 9826) and 
requested data and information concerning the use of sulfiting agents 
on frozen potatoes (55 FR 9834).
On August 3, 1990, the United States District Court for the Middle 
District of Pennsylvania declared the final rule concerning fresh 
potatoes to be ``null and void'' based on perceived procedural defects 
in the rulemaking proceeding. The Government appealed the district 
court's decision. On May 22, 1991, the U.S. Court of Appeals for the 
Third Circuit en banc split equally. Therefore, the decision of the 
district court invalidating on procedural grounds FDA's final rule 
revoking the GRAS status of the use of sulfiting agents on fresh 
potatoes.
FDA's reproposed rule will include the GRAS status of sulfiting agents 
on both minimally processed (formerly fresh) and frozen potatoes was 
left in place.

Timetable:

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

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

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

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

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

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

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: Previously reported under RIN 0905-AB52.

Agency Contact: JoAnn Ziyad, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Food Safety and Applied Nutrition (HFS-207), 200 C Street SW., 
Washington, DC 20204
Phone: 202 254-3116

RIN: 0910-AA03
_______________________________________________________________________

1260. REVIEW OF WARNINGS, USE INSTRUCTIONS, AND PRECAUTIONARY 
INFORMATION UNDER SECTION 314 OF THE NATIONAL CHILDHOOD VACCINE INJURY 
ACT OF 1986

Priority:  Other Significant

Legal Authority:  PL 99-660, sec 314

CFR Citation:  None

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

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: State

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

Agency Contact: Tracey Forfa, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Center for Biologics 
Evaluation and Research (HFM-630), 1401 Rockville Pike, Suite 200N, 
Rockville, MD 20852-1448
Phone: 301 594-3074

RIN: 0910-AA14
_______________________________________________________________________

1261. GENERAL BIOLOGICAL PRODUCT STANDARDS; ALTERNATIVE PROCEDURES 
AND EXCEPTIONS

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 262

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

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Action                    12/00/96

Small Entities Affected: None

Government Levels Affected: Undetermined

Additional Information: Previously reported under RIN 0905-AD82.

Agency Contact: Stephen Ripley, 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-AA16
_______________________________________________________________________

1262. 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                           00/00/00

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Additional Information: Previously reported under RIN 0905-AD91.

Agency Contact: Robert Moore, Regulatory Branch, Division of Programs 
and Enforcement Policy, Office of Spec Nut., Department of Health and 
Human Services, Food and Drug Administration, Center for Food Safety 
and Applied Nutrition (HFS-456), 200 C Street SW., Washington, DC 20204
Phone: 202 205-5372

RIN: 0910-AA20
_______________________________________________________________________

1263. ADVERSE EXPERIENCE REPORTING REQUIREMENTS FOR HUMAN DRUG AND 
LICENSED BIOLOGICAL PRODUCTS

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 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 single unified form (FDA 
Form 3500A) and require the use of this new reporting form. The new 
form was announced as part of FDA's MedWatch program. The 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 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

Additional Information: Previously reported under RIN 0905-AE29.

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

RIN: 0910-AA28
_______________________________________________________________________

1264. AMALGAM INGREDIENT LABELING

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 352

CFR Citation:  21 CFR 801

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE39.

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

RIN: 0910-AA33
_______________________________________________________________________

1265. CLASSIFICATION OF COMPUTER SOFTWARE PROGRAMS THAT ARE MEDICAL 
DEVICES

Priority:  Other Significant

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

CFR Citation:  None

Legal Deadline: None

Abstract: FDA is announcing its intention to classify stand-alone 
computer software products that fit the definition of a medical device 
under the Federal Food, Drug, and Cosmetic Act. The Agency anticipates 
classifying these devices by using a risk-based approach as required 
under the Medical Device Amendments to the act. Under this approach low 
risk medical software devices would be subject only to the adulteration 
and misbranding provisions of the act. Moderate risk devices would 
additionally be subject to the registration, listing, and good 
manufacturing practice requirements for adverse events and complaints. 
High risk devices would be the only products to require premarket 
submissions. 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
_______________________________________________________________________

1266. 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
_______________________________________________________________________

1267.  DRUGS USED FOR TREATMENT OF NARCOTIC ADDICTS

Priority:  Substantive, Nonsignificant

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

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

CFR Citation:  21 CFR 291

Legal Deadline: None

Abstract: Revise these regulations to reduce burden, to streamline 
requirements, to consolidate various sections.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            01/00/97

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Division of 
Regulatory Affairs, Department of Health and Human Services, Food and 
Drug Administration, Center for Drug Evaluation and Research (HFD-362), 
7500 Standish Place Rockville, MD 20855
Phone: 301 594-1049
Fax: 301 827-0901

RIN: 0910-AA52
_______________________________________________________________________

1268.  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 considering whether to amend its regulations on 
investigational new drugs to streamline requirements for exports of 
unapproved drugs for investigational use in other countries. FDA is 
considering whether to exempt, or reduce requirements for exports of 
such drugs to highly developed countries such as Australia, Canada, 
Japan, and countries that are members of the European Union or the 
European Free Trade Area. The proposal carries out the President's and 
Vice President's ``National Performance Review'' for drugs and devices 
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
_______________________________________________________________________

1269.  EXPORT REQUIREMENTS FOR MEDICAL DEVICES

Priority:  Substantive, Nonsignificant

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

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

CFR Citation:  21 CFR 812.18

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            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
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Food and Drug Administration (FDA)
  
_______________________________________________________________________
  
1270. PROPOSED LABELING FOR DRUG PRODUCTS BASED ON FALSE OR 
FRAUDULENT DATA

Priority:  Substantive, Nonsignificant

CFR Citation:  21 CFR 201

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn                       08/14/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Howard Muller
Phone: 301 594-1049

RIN: 0910-AA13
_______________________________________________________________________

1271. RECORDKEEPING AND REPORTING: ELECTRONIC PRODUCTS

Priority:  Substantive, Nonsignificant

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

CFR Citation:  21 CFR 1000; 21 CFR 1002

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    09/19/95                    60 FR 48374

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0910-AA15
_______________________________________________________________________

1272. THRESHOLD OF REGULATION POLICY FOR COMPONENTS OF FOOD CONTACT 
ARTICLES

Priority:  Substantive, Nonsignificant

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

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    07/17/95                    60 FR 36582
Final Action Effective          08/16/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Edward J. Machuga
Phone: 202 418-3085

RIN: 0910-AA18
_______________________________________________________________________

1273. MEDICAL DEVICES; RESTRICTED DEVICES

Priority:  Other Significant

CFR Citation:  21 CFR 801; 21 CFR 899

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn                       08/16/95

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0910-AA36
_______________________________________________________________________

1274. SUBSTANCES PROHIBITED FOR USE IN RUMINANT FEED

Priority:  Substantive, Nonsignificant

CFR Citation:  21 CFR 589.2000

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn - No action planned in 
the next 12 months.             08/08/95

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: John P. Honstead
Phone: 301 594-1728

RIN: 0910-AA38
_______________________________________________________________________

1275. NEW DRUG AND BIOLOGICAL PRODUCT LICENSE APPLICATIONS; 
REVISIONS TO EXISTING REGULATIONS

Priority:  Other Significant

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

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn                       08/14/95

Small Entities Affected: None

Government Levels Affected: State, Federal

Agency Contact: Thomas Hassall
Phone: 301 594-6740

RIN: 0910-AA44
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Resources and Services Administration (HRSA)
  
_______________________________________________________________________
  
1276. NATIONAL VACCINE INJURY COMPENSATION PROGRAM: REVISIONS AND 
ADDITIONS TO THE VACCINE INJURY TABLE - II

Priority:  Other Significant

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

CFR Citation:  42 CFR 100

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            11/00/95

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
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Resources and Services Administration (HRSA)
  
_______________________________________________________________________
  
1277. ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK RULES

Regulatory Plan:  This entry is Seq. No. 36 in Part II of this issue of 
the Federal Register.

RIN: 0906-AA32
_______________________________________________________________________

1278. TECHNICAL AMENDMENTS TO THE HEALTH PROFESSIONS, NURSING, AND 
ALLIED HEALTH TRAINING GRANT PROGRAMS UNDER 42 CFR PARTS 57 AND 58

Priority:  Other

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

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

CFR Citation:  42 CFR 57; 42 CFR 58

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Action                    12/00/95

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE54.

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

RIN: 0906-AA38
_______________________________________________________________________

1279.  REMOVAL OF OBSOLETE REGULATIONS OF THE TITLE VII 
GRANT FOR THE CONSTRUCTION OF TEACHING FACILITIES FOR HEALTH PROFESSIONS 
PERSONNEL

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 292 et seq

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

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Action                    04/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Charlotte Pascoe, Chief, Division of Acilities 
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)
  
_______________________________________________________________________
  
1280. 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)
  
_______________________________________________________________________
  
1281. GRANTS FOR THE ESTABLISHMENT OF DEPARTMENTS OF FAMILY 
MEDICINE

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 57, subpart R

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action Correction Notice - 
7/31/95, 60 FR 38970            05/30/95                    60 FR 28065

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Enrique Fernandez, M.D., M.Ed.
Phone: 301 443-6190

RIN: 0906-AA34
_______________________________________________________________________

1282. FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE ACT OF 1992

Priority:  Other Significant

CFR Citation:  42 CFR 6

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    05/08/95                    60 FR 22530

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Libby Merrill, Legislative Analyst
Phone: 301 594-4060

RIN: 0906-AA35
_______________________________________________________________________

1283. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON 
PHYSICIANS, DENTISTS, AND OTHER HEALTH CARE PRACTITIONERS: PAYMENT OF 
FEES

Priority:  Other

CFR Citation:  45 CFR 60

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    05/26/95                    60 FR 27898

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0906-AA37
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
National Institutes of Health (NIH)
  
_______________________________________________________________________
  
1284. 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                            10/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: Previously reported under RIN 0905-AD18.

Agency Contact: Marc Horowitz, Director, NIH AIDS Research Loan 
Repayment Program, Department of Health and Human Services, National 
Institutes of Health, Office of AIDS Research, 9000 Rockville Pike, 
Bethesda, MD 20892
Phone: 301 496-0357
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA02
_______________________________________________________________________

1285. 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                            11/00/95

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE56.

Agency Contact: Marc Horowitz, Dir., Clinical Research Loan Repayment 
Prog., Individuals from Disadvantaged Backgrounds, Department of Health 
and Human Services, National Institutes of Health, Office of AIDS 
Research, 9000 Rockville Pike, Bethesda, MD 20892
Phone: 301 402-0852
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA09
_______________________________________________________________________

1286. UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING PROFESSIONS 
NEEDED BY THE NIH

Priority:  Other

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

CFR Citation:  42 CFR 68b

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            03/00/96

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE57.

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

RIN: 0925-AA10
_______________________________________________________________________

1287. TRAINEESHIPS (TERMINATION POLICIES)

Priority:  Other

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

CFR Citation:  42 CFR 63

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/00/95

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, 9000 
Rockville Pike, Bldg 31, Rm 1B25, Center DR MSC 2075, Bethesda, MD 
20892-2075
Phone: 301 496-4606

RIN: 0925-AA11
_______________________________________________________________________

1288.  ADDITIONAL DHHS PROTECTION FOR PREGNANT WOMEN AND 
HUMAN FETUSES INVOLVED AS SUBJECTS FOR RESEARCH, AND PERTAINING TO HUMAN 
IN VITRO FERTILIZATION

Priority:  Other

Legal Authority:  5 USC 301; 42 USC 289

CFR Citation:  45 CFR 46, supart 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                            12/00/95

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
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
National Institutes of Health (NIH)
  
_______________________________________________________________________
  
1289. GRANTS FOR RESEARCH PROJECTS

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 216

CFR Citation:  42 CFR 52

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            08/02/94                    59 FR 39312
NPRM Comment Period End         10/03/94
Final Action                    12/00/95

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AC02.

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

RIN: 0925-AA01
_______________________________________________________________________

1290. HAZARDOUS SUBSTANCES BASIC RESEARCH AND TRAINING GRANTS

Priority:  Other

Legal Authority:  42 USC 9660; 42 USC 216

CFR Citation:  42 CFR 65a

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            03/07/95                    60 FR 12525
NPRM Comment Period End         05/08/95                    60 FR 12525
Final Action                    10/00/95

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD46.

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

RIN: 0925-AA03
_______________________________________________________________________

1291. NATIONAL INSTITUTES OF HEALTH CONSTRUCTION GRANTS

Priority:  Other

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

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

CFR Citation:  42 CFR 52b

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            07/06/95                    60 FR 35266
NPRM Comment Period End         09/05/95                    60 FR 35266
Final Action                    03/00/96

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD49.

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 9000 
Rockville Pike, Bldg. 31, Rm 1B25, Center DR MSC 2075, Bethesda, MD 
20892-2075
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA04
_______________________________________________________________________

1292. TRAINING GRANTS

Priority:  Other

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

Legal Authority:  42 USC 216; 42 USC 242l(b)(3); 42 USC 284(b)(1)(C); 
42 USC 287c(b); 42 USC 300cc-15(a)(1); 42 USC 300cc-41(a)(3)(C); 42 USC 
7403(h)(2)

CFR Citation:  42 CFR 63a

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            01/24/95                     60 FR 4742
NPRM Comment Period End         03/27/95                     60 FR 4742
Final Action                    12/00/95

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD56.

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 9000 
Rockville Pike, Bldg. 31, Rm 1B25, Center DR MSC 2075, Bethesda, MD 
20892-2075
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA05
_______________________________________________________________________

1293. NATIONAL INSTITUTES OF HEALTH CENTER GRANTS

Priority:  Other

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

Legal Authority:  42 USC 216; 42 USC 285a-3; 42 USC 285b-4; 42 USC 
285c-5; 42 USC 285d-6; 42 USC 285e-2; 42 USC 285e-3; 42 USC 285f-1; 42 
USC 285g-5; 42 USC 285g-7; 42 USC 285m-3; 42 USC 285o-2; 42 USC 300cc-
16; 42 USC 285a-6(c)(1)(E); 42 USC 285c-8

CFR Citation:  42 CFR 52a

Legal Deadline: None

Abstract: NIH Center Grants regulations will be amended to show their 
applicability to the Drug Abuse Research Centers Program authorized by 
PHS Act, section 464N, as added by section 123 of the ADAMHA 
Reorganization Act, P.L. 102-321, and several new centers authorized 
under the NIH Revitalization Act of 1993. Additionally, in accordance 
with the President's Reinventing Government effort, NIH is merging the 
regulations governing Grants for National Alcohol Research Centers 
codified at 42 CFR Part 54a with the Center Grants regulations and 
removing 42 CFR Part 54a from the CFR.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            02/17/95                     60 FR 9560
NPRM Comment Period End         04/18/95                     60 FR 9560
Final Action                    12/00/95

Small Entities Affected: None

Government Levels Affected: None

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

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 9000 
Rockville Pike, Bldg 31, Rm 1B25, Center DR MSC 2075, Bethesda, MD 
20892-2075
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA06
_______________________________________________________________________

1294. GRANTS FOR NATIONAL ALCOHOL RESEARCH CENTERS

Priority:  Other

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

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

CFR Citation:  42 CFR 54a

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            08/19/94                    59 FR 42793
NPRM Comment Period End         10/18/94                    59 FR 42793
Final Action                    12/00/95

Small Entities Affected: None

Government Levels Affected: None

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

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, Bldg. 31, Rm. 
3B-11, 9000 Rockville Pike, Bethesda, MD 20892
Phone: 301 496-2832
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA08
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
National Institutes of Health (NIH)
  
_______________________________________________________________________
  
1295. RESPONSIBILITIES OF PUBLIC HEALTH SERVICE-FUNDED INSTITUTIONS 
FOR PROMOTING OBJECTIVITY IN RESEARCH

Priority:  Other Significant

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

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    07/11/95                    60 FR 35810
Final Action Effective          10/01/95

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Dr. George J. Galasso
Phone: 301 496-5356

RIN: 0925-AA07
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Long-Term Actions
Office of Assistant Secretary for Health (OASH)
  
_______________________________________________________________________
  
1296. STANDARDS OF COMPLIANCE FOR ABORTION-RELATED SERVICES IN 
FAMILY PLANNING SERVICE PROJECTS

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 300a-4

CFR Citation:  42 CFR 59

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: State

Additional Information: Previously reported under RIN 0905-AE03.

Agency Contact: Felicia Stewart, M.D., Deputy Assistant Secretary for 
Population Affairs, Department of Health and Human Services, Office of 
Assistant Secretary for Health, East-West Towers, Suite 200, West 
Bldg., 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 594-4000

RIN: 0937-AA00
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)             Prerule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
  
1297.  AMBULANCE SERVICES (BPD-813-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 1861(s)(7)

CFR Citation:  42 CFR 410.40

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

ANPRM                           12/00/95

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0938-AH13
_______________________________________________________________________

1298.  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 the Omnibus Budget Reconciliation Act 
of 1989. It would provide consistent qualification requirements for 
physician assistants.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

ANPRM                           04/00/96

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Pat Moore, Bureau of Policy Development, Department of 
Health and Human Services, Health Care Financing Administration, C4-02-
26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-8090

RIN: 0938-AH26
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
  
1299. NEW MINIMUM STANDARDS FOR MEDICARE SUPPLEMENTAL (MEDIGAP) 
POLICIES (BPD-491-P)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1395ss

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

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            04/00/96

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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

RIN: 0938-AD82
_______________________________________________________________________

1300. ``WITHOUT FAULT'' AND BENEFICIARY WAIVER OF RECOVERY AS IT 
APPLIES TO MEDICARE OVERPAYMENT LIABILITY (BPD-719-P)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1395gg

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

Legal Deadline: None

Abstract: This rule would amend the Medicare regulations to clarify our 
interpretation of ``without fault'' as it applies to physician, 
provider, supplier and beneficiary liability for overpayments. This 
definition would result in greater uniformity of determinations by 
carriers and intermediaries. Additionally, this proposed 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                            02/00/96

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0938-AD95
_______________________________________________________________________

1301. PROTECTION OF INCOME AND RESOURCES FOR COMMUNITY SPOUSES OF 
INSTITUTIONALIZED INDIVIDUALS (MB-023-P)

Priority:  Other Significant

Legal Authority:  42 USC 1396r-5

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

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            08/00/96

Small Entities Affected: Undetermined

Government Levels Affected: State, Local

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

RIN: 0938-AE12
_______________________________________________________________________

1302. COVERAGE OF PHYSICIAN ASSISTANT, NURSE PRACTITIONER, AND 
CLINICAL NURSE SPECIALIST SERVICES (BPD-708-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302; 42 USC 1395x(s)(2)(K); 42 USC 1396(d)(1)

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

Legal Deadline: None

Abstract: This proposed rule concerns the coverage of payment for 
services performed by nurse practitioners and clinical nurse 
specialists and services furnished as an incident to those services. It 
would conform Medicare regulations to the provisions in section 6114 of 
OBRA '89, section 4155 of OBRA '90, and section 147(e) of SSA '94. In 
addition, under the authority of sections 1861(aa) and 1905(l) of the 
Social Security Act, it would revise our existing definition of ``nurse 
practitioner'' for purposes of the conditions rural health clinics must 
meet to qualify for payment under Medicare and Medicaid and that 
Federally qualified health clinics must meet to qualify for payment 
under Medicare.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            01/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Roberta Epps, Office of Physician & Ambulatory Care 
Policy, Department of Health and Human Services, Health Care Financing 
Administration, C4-02-26, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4503

RIN: 0938-AF00
_______________________________________________________________________

1303. ALTERNATIVE SANCTIONS FOR PSYCHIATRIC HOSPITALS (HSQ-191-P)

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 488

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            11/00/95

Small Entities Affected: Undetermined

Government Levels Affected: State, Federal

Agency Contact: Pam Vocke, Director, Division of Program Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, Room 2-D-2, ME, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-7089

RIN: 0938-AF32
_______________________________________________________________________

1304. 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)

CFR Citation:  42 CFR 447; 42 CFR 441

Legal Deadline: None

Abstract: This rule will incorporate section 4401 of OBRA '90 to add 
specific requirements for Medicaid payment for covered outpatient 
drugs. The requirements concern: denial of Federal financial 
participation unless rebate agreements and drug use review are in 
effect; prohibiting some State plan drug access limitations for drugs 
covered under a rebate agreement; and the content of the rebate 
agreements. The drug rebate agreement was previously published in the 
Federal Register on February 21, 1991 (56 FR 7049). This rule will also 
reflect statutory revisions mandated by the Veteran's Health Care Act 
of 1992 and OBRA '93. The revision of the drug rebate dispute 
resolution process is part of the Department's regulatory reinvention 
initiative.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            09/19/95                    60 FR 48442
NPRM Comment Period End         11/20/95                    60 FR 48442
Interim Final Rule              03/01/96
Final Action                    00/00/00

Small Entities Affected: Businesses

Government Levels Affected: State

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

RIN: 0938-AF42
_______________________________________________________________________

1305. FEDERALLY QUALIFIED HEALTH CENTER SERVICES (MEDICAID) (MB-
043-P)

Priority:  Other Significant

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

CFR Citation:  42 CFR 440; 42 CFR 447

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            04/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: David Worgo, Office of Medical Services, Department of 
Health and Human Services, Health Care Financing Administration, C4-15-
18, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5919

RIN: 0938-AF90
_______________________________________________________________________

1306. 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                            03/00/96

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Tim Love, Health Insurance Specialist, 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: 410 786-1094

RIN: 0938-AF97
_______________________________________________________________________

1307. CONDITIONS OF PARTICIPATION FOR RURAL HEALTH CLINICS (BPD-
764-P)

Priority:  Other Significant

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

Legal Authority:  42 USC 1395l(a); 42 USC 1395l(b); 42 USC 1395l(d); 42 
USC 1395x(aa); 42 USC 1395oo(j); 42 USC 1395ww(a)(4); 42 USC 
1396a(a)(13)(E)

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

Legal Deadline: None

Abstract: This rule would update our regulations to incorporate several 
health care coverage and payment provisions contained in Public Laws 
100-203, 101-239, and 101-508 (the OBRAs '87, '89, and '90) and would 
propose administrative changes that clarify policy related to sharing 
space between rural health centers and other entities, such as 
physician offices, the replacement of the provider-based cost basis 
system with the all-inclusive rate payment system, and the allowance of 
separate payment under Part B for more complex laboratory services. 
This rule is part of HCFA's regulatory reform initiative.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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

RIN: 0938-AG05
_______________________________________________________________________

1308. MEDICARE APPEALS OF INDIVIDUAL CLAIMS (BPD-453-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395ff

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

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            03/00/96

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0938-AG18
_______________________________________________________________________

1309. APPOINTMENT OF REPRESENTATIVES FOR MEDICARE APPEALS (BPO-120-
P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395ff; 42 USC 405(a); 42 USC 406; 42 USC 
1395ii

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

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            01/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Betsy Horn, Bureau of Program Operations, Department of 
Health and Human Services, Health Care Financing Administration, S-1-
05-15, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0973

RIN: 0938-AG30
_______________________________________________________________________

1310. ENFORCEMENT REQUIREMENTS FOR RENAL DIALYSIS FACILITIES (HSQ-
204-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 1395rr(h)

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

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            04/00/96

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Debbie Schoenemann, Office of Survey & Certification, 
Department of Health and Human Services, Health Care Financing 
Administration, S-2-19-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6771

RIN: 0938-AG31
_______________________________________________________________________

1311. DISCLOSURE OF CONFIDENTIAL PRO INFORMATION FOR RESEARCH 
PURPOSES (HSQ-208-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1320c-9

CFR Citation:  42 CFR 476.144

Legal Deadline: None

Abstract: This rule would allow Peer Review Organizations (PROs) to 
disclose confidential information to researchers without the consent of 
the individuals who would be identified. Currently, PROs can only 
disclose to the public nonconfidential aggregate data where no one is 
specifically identified. The statute, however, provides for limited 
disclosure in case there are circumstances the Secretary shall by 
regulations provide to assure adequate protection of the rights and 
interest of patients, health care practitioners, or providers. HCFA is 
now emphasizing the sharing of PRO data for educational and research 
purposes as evidenced by the implementation of the Uniform Clinical 
Data Set and the Health Care Quality Improvement Initiative. This 
regulatory revision will make confidential PRO information accessible 
to researchers while still protecting the identities of beneficiaries 
and practitioners from unwarranted disclosure. PRO flexibility to share 
information with researchers is comparable with the revised 
requirements in the PRO's Fourth Scope of Work contract.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            04/00/96

Small Entities Affected: None

Government Levels Affected: State, Federal

Agency Contact: Mike Rappaport, Director, Division of Systems 
Management, Health Standards Quality Bureau, Department of Health and 
Human Services, Health Care Financing Administration, S-1-09-26, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6759

RIN: 0938-AG33
_______________________________________________________________________

1312. EFFECT OF CHANGE OF OWNERSHIP ON PROVIDER AND SUPPLIER 
PENALTIES, SANCTIONS, AND OVERPAYMENTS (HSQ-215-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395hh

CFR Citation:  42 CFR 405.1803; 42 CFR 405.1811; 42 CFR 405.1835; 42 
CFR 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 regulations on provider agreements to 
clarify the effect a change of ownership has on penalties and sanctions 
incurred by Medicare providers. It would state that all Medicare 
penalties and sanctions are automatically assigned to a new owner. It 
would also extend the same principle to suppliers; i.e., we would 
require the new owner of a supplier to be liable for any Medicare 
overpayments, penalties, and sanctions incurred by or imposed the 
previous owner.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            02/00/96

Small Entities Affected: None

Government Levels Affected: Undetermined

Agency Contact: Irene Gibson, Deputy Director, Office of Survey & 
Certification, Department of Health and Human Services, Health Care 
Financing Administration, S-2-14-17, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-6768

RIN: 0938-AG59
_______________________________________________________________________

1313. MEDICARE PROGRAM: LIMITATIONS ON MEDICARE COVERAGE OF 
CATARACT SURGERY (BPD-797-PN)

Priority:  Other Significant

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

CFR Citation:  None

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: Karen McVearry, Technology & Special Analysis Staff, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-10-07, 7500 Security Boulevard, Baltimore, MD 21297
Phone: 410 786-4643

RIN: 0938-AG65
_______________________________________________________________________

1314. NEW PAYMENT METHODOLOGY FOR ROUTINE EXTENDED CARE SERVICES 
PROVIDER IN A SWING BED HOSPITAL (BPD-805-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395tt

CFR Citation:  42 CFR 413.53; 42 CFR 413.114

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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

RIN: 0938-AG68
_______________________________________________________________________

1315. SALARY EQUIVALENCY GUIDELINES FOR PHYSICAL THERAPY, 
RESPIRATORY THERAPY, SPEECH PATHOLOGY, AND OCCUPATIONAL THERAPY (BPD-808-
PN)

Priority:  Other Significant

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

CFR Citation:  42 CFR 413.106

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Proposed Notice                 04/00/96

Small Entities Affected: Undetermined

Government Levels Affected: None

Agency Contact: Jacqueline Gordon, Health Insurance Specialist, 
Division of Home Care and Therapy, Department of Health and Human 
Services, Health Care Financing Administration, C4-07-14, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4517

RIN: 0938-AG70
_______________________________________________________________________

1316. MEDICAID: OPTIONAL COVERAGE OF TB-RELATED SERVICES FOR 
INDIVIDUALS INFECTED WITH TUBERCULOSIS (MB-082-P)

Priority:  Other Significant

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

CFR Citation:  42 CFR 435.219; 42 CFR 435.201; 42 CFR 440.250; 42 CFR 
436.201; 42 CFR 436.219; 42 CFR 440.164

Legal Deadline: None

Abstract: This rule would amend the existing Medicaid regulations to 
provide for optional Medicaid coverage of low-income individuals 
infected with tuberculosis (TB). These individuals would be eligible 
only for specified TB-related services.
The rule would incorporate and interpret provisions of section 13603 of 
OBRA '93.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            04/00/96

Small Entities Affected: None

Government Levels Affected: State, Local

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

RIN: 0938-AG72
_______________________________________________________________________

1317. 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                            01/00/96

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Betty Burrier, Office of Chronic Care Insurance Policy, 
Bureau of Policy Development, Department of Health and Human Services, 
Health Care Financing Administration, C4-11-23, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-0191

RIN: 0938-AG80
_______________________________________________________________________

1318. HOME HEALTH AGENCY (HHA) CONDITIONS OF PARTICIPATION (BPD-
819-P)

Regulatory Plan:  This entry is Seq. No. 38 in Part II of this issue of 
the Federal Register.

RIN: 0938-AG81
_______________________________________________________________________

1319. END-STAGE RENAL DISEASE (ESRD) CONDITIONS OF COVERAGE (BPD-
818-P)

Regulatory Plan:  This entry is Seq. No. 39 in Part II of this issue of 
the Federal Register.

RIN: 0938-AG82
_______________________________________________________________________

1320. DISTINCT PART REQUIREMENTS FOR NURSING HOMES AND PROHIBITION 
OF FINANCIAL SCREENING OF APPLICANTS FOR NURSING HOME ADMISSION (BPD-815-
P)

Priority:  Other Significant

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

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

CFR Citation:  42 CFR 409; 42 CFR 483; 42 CFR 413

Legal Deadline: None

Abstract: In this proposed rule we would define ``distinct part'' by 
specifying that a distinct part is a physically identifiable unit of an 
institution (that is, an entire ward wing, floor, or building) 
including all beds in the unit. In conjunction with this change we also 
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                            12/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: William Ullman, Health Insurance Specialist, Bureau of 
Policy Development, Department of Health and Human Services, Health 
Care Financing Administration, C4-13-15, 7500 Security Blvd, Baltimore, 
MD 21244
Phone: 401 786-5667

RIN: 0938-AG84
_______________________________________________________________________

1321. MEDICAID: NOMINAL COPAYMENTS FOR INSTITUTIONAL SERVICES FOR 
MEDICAID RECIPIENTS (MB-090-P)

Priority:  Other Significant

Legal Authority:  42 USC 1396a(a)(14); 42 USC 1396o

CFR Citation:  42 CFR 447.54; 42 CFR 447.55

Legal Deadline: None

Abstract: This final rule with comment period redefines the nominal 
maximum deductible, coinsurance, or copayment charge that a State may 
impose on certain Medicaid recipients for each admission for inpatient 
hospital services. This revision of the copayment amount will help 
prevent undue hardships on Medicaid recipients who have low or no 
income by limiting the impact of rising health care costs.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            04/00/96

Small Entities Affected: None

Government Levels Affected: State

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

RIN: 0938-AG90
_______________________________________________________________________

1322. WAGE INDEX USED TO ADJUST PAYMENT RATES FOR HOSPICE SERVICES 
UNDER THE MEDICARE PROGRAM (BPD-820-P)

Priority:  Other Significant

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

Legal Authority:  42 USC 1395f(i); 5 USC 561 to 590

CFR Citation:  42 CFR 418

Legal Deadline: None

Abstract: The Medicare hospice benefit has been in effect since 1983. 
This proposed rule would update the wage index used to adjust payment 
rates to reflect local differences in area wage levels. We are 
undertaking development of this proposed rule through a ``negotiated 
rulemaking'' proceeding under the Negotiated Rulemaking Act of 1990. 
This proposed rule is part of the Department's regulatory reinvention 
initiative.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Notice of Intent                10/14/94                    59 FR 52129
NPRM                            05/00/96

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Janice Flaherty, Director, Division of Home Care & 
Therapy, Department of Health and Human Services, Health Care Financing 
Administration, C4-05-27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4637

RIN: 0938-AG93
_______________________________________________________________________

1323. CATEGORIZATION AND CERTIFICATION REQUIREMENTS FOR A NEW 
SUBCATEGORY OF MODERATE COMPLEXITY TESTING (HSQ-222-P)

Regulatory Plan:  This entry is Seq. No. 40 in Part II of this issue of 
the Federal Register.

RIN: 0938-AG98
_______________________________________________________________________

1324. CLIA PROGRAM: CATEGORIZATION OF WAIVED TESTS (HSQ-225-P)

Regulatory Plan:  This entry is Seq. No. 41 in Part II of this issue of 
the Federal Register.

RIN: 0938-AG99
_______________________________________________________________________

1325. MEDICAID COVERAGE OF PERSONAL CARE SERVICES (MB-071-P)

Priority:  Other Significant

Legal Authority:  42 USC 1396d(a)(24)

CFR Citation:  42 CFR 440.70; 42 CFR 440.167; 42 CFR 440.170

Legal Deadline: None

Abstract: This rule would revise the Medicaid regulations to 
incorporate the provisions of OBRA '93 relating to coverage of personal 
care services. Personal care services furnished to an individual who is 
not an inpatient or resident of a hospital, nursing facility, 
intermediate care facility for the mentally retarded or an institution 
for mental disease is an optional Medicaid benefit, effective October 
1, 1994. The services may be furnished both in the home and in other 
locations.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            11/00/95

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Mary Jean Duckett, 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: 410 786-3294

RIN: 0938-AH00
_______________________________________________________________________

1326. LIABILITY FOR THIRD PARTIES TO PAY FOR CARE AND SERVICES (MB-
080-P)

Priority:  Other Significant

Legal Authority:  42 USC 1396a(a)(25)(A); 42 USC 1396b(o)

CFR Citation:  42 CFR 433.135 to 152

Legal Deadline: None

Abstract: This rule would amend the regulations governing third party 
liability as required by OBRA '93. It would add ERISA plans, service 
benefit plans and health maintenance organizations to the definition of 
liable third parties. It would require States to prohibit any health 
insurer from taking into account when enrolling or making payments, 
that an individual is eligible for or receiving Medicaid. It would also 
require States to enact a law under which the State is deemed to have 
acquired a recipient's right to payment by a third party.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            04/00/96

Small Entities Affected: Undetermined

Government Levels Affected: State, Federal

Agency Contact: Robert Nakielny, Health Insurance Specialist, Medicaid 
Bureau, Department of Health and Human Services, Health Care Financing 
Administration, C4-21-01, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4466

RIN: 0938-AH01
_______________________________________________________________________

1327. MEDICARE PROGRAM: COVERAGE OF CERTIFIED NURSE-MIDWIFE 
SERVICES (BPD-496-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 13951; 42 USC 1395x(s); 42 USC 1395x(gg)

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

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Roberta Epps, Office of Physician & Ambulatory Care 
Policy, Department of Health and Human Services, Health Care Financing 
Administration, C4-02-26, 7500 Security Blvd., Baltimore, MD 21244
Phone: 419 786-4503

RIN: 0938-AH02
_______________________________________________________________________

1328.  MEDICARE PROGRAM: UNIFORM ELECTRONIC COST REPORTING 
FOR SKILLED NURSING FACILITIES AND HOME HEALTH AGENCIES (BPD-788-P)

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 proposed rule would add the requirement that, for cost 
reporting periods beginning on or after October 1, 1995 all skilled 
nursing facilities and home health agencies must submit cost reports 
currently required under Medicare regulations in a uniform electronic 
format. This proposed rule would 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                            11/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Thomas Talbott, Auditor, Bureau of Policy Development, 
Department of Health and Human Services, Health Care Financing 
Administration, C5-03-03, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4592

RIN: 0938-AH12
_______________________________________________________________________

1329.  ADJUSTMENT IN PAYMENT AMOUNTS FOR NEW TECHNOLOGY 
INTRAOCULAR LENSES (BPD-831-P)

Priority:  Substantive, Nonsignificant

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 in regulations a process under 
which interested parties may request a review of the appropriateness of 
the current payment amount for IOLs furnished by Medicare participating 
ASCs. This rule is part of HCFA's regulatory reform initiative.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Cathaleen Ahern, Office of Physician & Ambulatory Care 
Policy, 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
_______________________________________________________________________

1330.  SCHEDULE OF LIMITS FOR SKILLED NURSING FACILITY 
INPATIENT ROUTINE SERVICE COSTS (BPD-837-NC)

Priority:  Other Significant

Legal Authority:  42 USC 1395f(b); 42 USC 1395x(v)(1); 42 USC 1395yy

CFR Citation:  42 CFR 413

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

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            10/00/95

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0938-AH18
_______________________________________________________________________

1331.  ADDITIONAL SUPPLIER STANDARDS (BPD-838-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 1395f; 42 USC 1395g(c); 42 USC 1395n; 42 USC 
1495u(b)and(p); 42 USC 1395cc(d); 42 USC 1395gg(e)and(f)

CFR Citation:  42 CFR 424.57

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

Abstract: This rule would establish additional standards for entities 
seeking to qualify as Medicare suppliers for purposes of submitting 
claims for medical equipment and supplies. This rule is part of HCFA's 
regulatory reform initiative.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            03/00/96

Small Entities Affected: Businesses

Government Levels Affected: None

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
_______________________________________________________________________

1332.  DELEGATION OF CIVIL MONEY PENALTIES (BPO-135-FC)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 405(a); 42 USC 1302; 42 USC 1395x(aa); 42 USC 
1395cc; 42 USC 1395ff(c); 42 USC 1395hh; 42 USC 1395ii

CFR Citation:  None

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

                                     
NPRM                            05/00/96
                                     

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Joel Cohen, Bureau of Program Operations, Department of 
Health and Human Services, Health Care Financing Administration, S-03-
14-17, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3345

RIN: 0938-AH22
_______________________________________________________________________

1333.  STATE PLAN AMENDMENT (SPA) RECONSIDERATION PROCESS 
(MB-096-P)

Priority:  Other

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

Legal Authority:  42 USC 1396a(a)

CFR Citation:  42 CFR 430.18; 42 CFR 430.60

Legal Deadline: None

Abstract: This proposed rule would revise and streamline the State Plan 
Amendment (SPA) reconsideration process. Currently, when a State 
requests reconsideration of a denied SPA, a hearing is held in all 
cases, even when the only dispute is over the interpretation of the 
statute. Under the proposed regulation, the State and HCFA could avoid 
the cost and delay of the hearing process by agreeing that the only 
issue is interpretation of the statute and permit the State to take the 
issue directly to court. The reconsidered decision would than be made 
without a hearing. This rule is part of the Department's regulatory 
reinvention initiative.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            03/00/96

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Robert Tomlinson, Office of Beneficiary Services, 
Medicaid Bureau, Department of Health and Human Services, Health Care 
Financing Administration, C4-23-07, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4463

RIN: 0938-AH24
_______________________________________________________________________

1334.  EVIDENCE OF LAWFUL PERMANENT RESIDENCE (MB-097-P)

Priority:  Other

Legal Authority:  42 USC 1396b(v)

CFR Citation:  42 CFR 435.406; 42 CFR 435.408

Legal Deadline: None

Abstract: This proposed rule would revise HCFA regulations concerning 
documents which are required to determine proof of satisfactory 
immigration status for Medicaid eligibility. It would specify that 
lawful permanent residence be verified by whatever document is 
currently in use by the Immigration and Naturalization Services (INS) 
for that purpose. Currently, HCFA does not specify in regulations the 
current documents used by INS for determining proof of lawful permanent 
residence. HCFA needs to publish companion regulations to conform to 
final SSA regulations for the supplemental security income (SSI) 
program to ensure consistency among INS, HCFA, and SSA.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            04/00/96

Small Entities Affected: None

Government Levels Affected: State, Local

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-AH25
_______________________________________________________________________

1335.  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 held 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                            09/30/96

Small Entities Affected: Businesses

Government Levels Affected: State, Local

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

RIN: 0938-AH27
_______________________________________________________________________

1336.  LIMITATIONS ON PAYMENT FOR HOME OXYGEN THERAPY BASED 
ON INHERENT REASONABLENESS CRITERIA (BPD-845-PN)

Priority:  Economically Significant

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

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

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            10/00/95
Proposed Notice                 10/00/95

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: William J. Long, Health Insurance Specialist, 
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
_______________________________________________________________________

1337.  MEDICAID: LIMITATIONS ON AGGREGATE PAYMENTS TO 
DISPROPORTIONATE SHARE HOSPITALS; FEDERAL FISCAL YEAR 1997 (MB-098-N)

Priority:  Other Significant

Legal Authority:  42 USC 1395r-4

CFR Citation:  42 CFR 447.297; 42 CFR 447.298

Legal Deadline:  Other, Statutory, October 1995.

Abstract: This notice announces the preliminary Federal fiscal year 
1997 national target and individual State allotments for Medicaid 
payment made to hospitals that serve a disproportionate number of 
Medicaid recipients and low-income patients with special needs.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/00/95

Small Entities Affected: Businesses

Government Levels Affected: State

Agency Contact: Richard Strauss, Health Insurance Specialist, Medicaid 
Bureau, Department of Health and Human Services, Health Care Financing 
Administration, Room C-4-18-26, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-2019

RIN: 0938-AH30
_______________________________________________________________________

1338.  MEDICAID ELIGIBILITY QUALITY CONTROL, STAFFING AND 
TRAINING, AND UTILIZATION CONTROL: REMOVAL OF OBSOLETE AND RESTRICTIVE 
REQUIREMENTS (MB-099-P)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1302; 42 USC 1396a(a)(4); 42 USC 1396a(a)(26); 
42 USC 1396b(g) and (i); 42 USC 1396b(u); 42 USC 1396d(a)(16); 42 USC 
1396d(h)

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

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            06/00/96

Small Entities Affected: Businesses, Organizations

Government Levels Affected: State, Local

Agency Contact: William Hickman, Medicaid Bureau, Department of Health 
and Human Services, Health Care Financing Administration, Room C-4-24-
27A, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3235

RIN: 0938-AH31
_______________________________________________________________________

1339.  CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE 
PAYMENT SYSTEM AND FISCAL YEAR 1997 RATES (BPD-847-P)

Regulatory Plan:  This entry is Seq. No. 42 in Part II of this issue of 
the Federal Register.

RIN: 0938-AH34
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
  
1340. 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 final rule permits States flexibility to revise the 
process by which incurred medical expenses are considered to reduce an 
individual's or a family's income in order for the individual or family 
to become Medicaid eligible. Only States that cover the medically 
needy, and States that use more restrictive criteria to determine 
eligibility of the aged, blind, and disabled than the criteria used to 
determine eligibility for Supplemental Security Income (SSI) benefits, 
have a spenddown.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            09/02/83                    48 FR 39959
NPRM Comment Period End         11/16/83                    48 FR 39959
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                    03/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Roy Trudel, Health Insurance Specialist, Medicaid 
Bureau, Department of Health and Human Services, Health Care Financing 
Administration, C4-25-02, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3417

RIN: 0938-AB07
_______________________________________________________________________

1341. PAYMENT FOR CLINICAL DIAGNOSTIC LABORATORY TESTS (BPD-309-F)

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 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 DEFRA, COBRA, OBRA 
'86, OBRA '87, the Technical and Miscellaneous Revenue Act of 1988, 
OBRA '89, and OBRA '90 regarding payment and ``assignment'' for 
diagnostic clinical laboratory tests establishing in regulations the 
methods for implementing fee schedules. This rule would set forth the 
methods by which the fee schedules would be updated and would allow 
certain adjustments for exceptions to the fee schedule. It will also 
reflect a statutory revision mandated by OBRA '93.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            08/18/93                    58 FR 43156
NPRM Comment Period End         10/18/93                    58 FR 43156
Final Action                    06/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Charles Spalding, Director, Division of Ambulatory Care 
Services, Department of Health and Human Services, Health Care 
Financing Administration, C-4-05-24, 7500 Security Blvd., Baltimore, MD 
21244
Phone: 410 786-4496

RIN: 0938-AB50
_______________________________________________________________________

1342. 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 establishes uniform criteria for determining the 
effective dates of Medicare and Medicaid provider agreements and of the 
approval of Medicare suppliers when the provider or supplier is subject 
to survey as a basis for determining participation in those programs.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            10/08/92                    57 FR 46362
NPRM Comment Period End         12/07/92
Final Action                    06/00/96

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Agency Contact: Irene Givson, Deputy Director, Office of Survey and 
Certification, Department of Health and Human Services, Health Care 
Financing Administration, S-02-14-17, 7500 Security Blvd., Baltimore, 
MD 21244
Phone: 410 786-6768

RIN: 0938-AC88
_______________________________________________________________________

1343. CHANGES CONCERNING SUSPENSION OF MEDICARE PAYMENTS AND 
DETERMINATIONS OF ALLOWABLE INTEREST EXPENSE (BPO-118-FC)

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 405.370 to 405.377; 42 CFR 413.5; 42 CFR 413.153

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Sam Guida, Director, Div. of Acct. Mgmnt. & 
Collections, Division of Payment and Reporting Policy, Department of 
Health and Human Services, Health Care Financing Administration, S-2-
08-28, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-7495

RIN: 0938-AC99
_______________________________________________________________________

1344. PROHIBITION ON UNBUNDLING OF HOSPITAL OUTPATIENT SERVICES 
(BPD-426-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395y(a)(14); 42 USC 1395cc(a)(1)(H); 42 USC 
1395cc(g); 42 USC 1395x(w)(1)

CFR Citation:  42 CFR 409; 42 CFR 410; 42 CFR 411; 42 CFR 412; 42 CFR 
489; 42 CFR 1003

Legal Deadline: None

Abstract: This final rule, issued jointly by HCFA and the OIG, 
prohibits Medicare payment for nonphysician services furnished to a 
hospital outpatient by a provider or supplier other than the hospital, 
unless the services are furnished under an arrangement with the 
hospital. The hospital is obligated by its provider agreement to 
furnish the services directly or under an arrangement. These 
regulations also authorize the OIG to impose a civil money penalty, not 
to exceed $2,000, against any individual who knowingly and willfully 
presents, or causes to be presented, a bill or request for payment, for 
items or services furnished under Medicare, that is inconsistent with 
an arrangement under section 1866(a)(1)(H) of the Social Security Act 
or is in violation of the requirements for an arrangement. These 
regulations implement section 9343(c) of OBRA '86, section 4085(i)(17) 
of OBRA '87, and section 4157 of OBRA '90.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            08/05/88                    53 FR 29486
NPRM Comment Period End         10/04/88                    53 FR 29486
Final Action                    04/00/96

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Carolyn Mullen, Office of Physician & Ambulatory Care 
Policy, Department of Health and Human Services, Health Care Financing 
Administration, C-4-11-16, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4589

RIN: 0938-AD33
_______________________________________________________________________

1345. 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                     53 FR 8654
Final Action                    12/00/95

Small Entities Affected: None

Government Levels Affected: Undetermined

Agency Contact: Harvey Brook, Deputy Director, Office of Quality 
Improvement Programs, Department of Health and Human Services, Health 
Care Financing Administration, S-1-09-26, 7500 Security Blvd., 
Baltimore, MD 21244
Phone: 410 786-6853

RIN: 0938-AD38
_______________________________________________________________________

1346. REVISIONS TO THE FREEDOM OF INFORMATION REGULATIONS (OPA-001-
P)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  5 USC 552(b)(4); EO 12600; PL 99-570, Sec 1801; PL 
99-570, Sec 1802; PL 99-570, Sec 1803; PL 99-570, Sec 1804

CFR Citation:  42 CFR 401.101 to 401.102; 42 CFR 401,110; 42 CFR 
401.120 to 401.123; 42 CFR 401.124 to 401.125; 42 CFR 401.105 to 
401.108; 42 CFR 401.115 to 401.116

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Action                    01/00/96

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0938-AD60
_______________________________________________________________________

1347. OMNIBUS NURSING HOME REFORM REQUIREMENTS (BPD-488-F)

Priority:  Other Significant

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

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

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

Legal Deadline: None

Abstract: This final rule responds to public comments on the February 
5, 1992, proposed rule that 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                     57 FR 4516
Final Action                    04/00/96

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Bill Ullman, Health Insurance Specialist, Bureau of 
Policy Development, Department of Health and Human Services, Health 
Care Financing Administration, C4-11-06, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-5667

RIN: 0938-AD81
_______________________________________________________________________

1348. HMO ORGANIZATIONAL STRUCTURE AND SERVICES (OMC-007-F)

Priority:  Other Significant

Legal Authority:  42 USC 1395mm

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

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Maureen Miller, Office of Managed Care, Department of 
Health and Human Services, Health Care Financing Administration, S-3-
02-01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1097

RIN: 0938-AE25
_______________________________________________________________________

1349. HOSPITAL STANDARD FOR HIV INFECTIOUS BLOOD AND BLOOD PRODUCTS 
(BPD-633-F)

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 482

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            06/30/93                    58 FR 34977
NPRM Comment Period End         08/30/93                    58 FR 34977
Final Action                    11/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Janet Samen, Office of Chronic Care & Insurance Policy, 
Bureau of Policy Development, Department of Health and Human Services, 
Health Care Financing Administration, C5-13-07, 7500 Security Blvd., 
Baltimore, MD 21244
Phone: 410 786-5244

RIN: 0938-AE40
_______________________________________________________________________

1350. MEDICARE, MEDICAID, AND CLIA PROGRAMS: REGULATIONS 
IMPLEMENTING THE CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 (CLIA 
'88) (HSQ-226-F)

Regulatory Plan:  This entry is Seq. No. 43 in Part II of this issue of 
the Federal Register.

RIN: 0938-AE47
_______________________________________________________________________

1351. 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 1395x

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

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

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            06/21/91                    56 FR 28513
NPRM Comment Period End         08/21/91                    56 FR 28513
Interim Final Rule With Comment 
Period                          09/08/94                    59 FR 46500
Effective Date                  10/11/94
Comment Period End              11/07/94
Final Action                    12/00/95

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0938-AE48
_______________________________________________________________________

1352. RESIDENT ASSESSMENT IN LONG-TERM CARE FACILITIES (HSQ-180-F)

Priority:  Substantive, Nonsignificant

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

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

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

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/28/92                    57 FR 61614
NPRM Comment Period End         02/26/93                    57 FR 61614
Final Action                    04/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Sue Nonemaker, Health Standards Quality Bureau, 
Department of Health and Human Services, Health Care Financing 
Administration, S-2-19-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6825

RIN: 0938-AE61
_______________________________________________________________________

1353. POST-CONTRACT BENEFICIARY PROTECTIONS AND OTHER PROVISIONS 
(OMC-003-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395mm

CFR Citation:  42 CFR 417

Legal Deadline: None

Abstract: This rule will provide Medicare beneficiaries with certain 
coverage for pre-existing conditions under supplemental insurance after 
non-renewal or termination of a Medicare health maintenance 
organization (HMO) or competitive medical plan (CMP) contract; provide 
a 30-day open enrollment period for individuals who would otherwise 
lose prepaid Medicare coverage as a result of termination, non-renewal 
or reduction in service area of a risk contract; accelerate the 
deadline for risk contracting HMOs and CMPs to submit adjusted 
community rate proposals; require all HMOs and CMPs to furnish a copy 
of an executed enrollment application form to Medicare applicants, and 
require HCPPs to comply with HMO/CMP beneficiary application 
procedures.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            03/11/94                    59 FR 11230
NPRM Comment Period End         05/09/94
Final Action                    01/00/96

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0938-AE63
_______________________________________________________________________

1354. EMPLOYER CONTRIBUTIONS TO HMOS (OMC-004-F)

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 417

Legal Deadline: None

Abstract: This rule would conform existing regulations to sections 5(b) 
and 7 of the Health Maintenance Organization (HMO) Amendments of 1988 
(PL 100-517). It would prohibit employers from financially 
discriminating against HMO enrollees in setting the contributions the 
employers make to employees' health plans.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            07/05/91                    56 FR 30723
Comment Period End              09/03/91                    56 FR 30723
Final Action                    11/00/95

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0938-AE64
_______________________________________________________________________

1355. 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 6403 of OBRA '89 defines in new section 1905(r) of 
the Social Security Act the following EPSDT services: screening 
services, vision services, dental services and hearing services. It 
also extends EPSDT services to include such other necessary health 
care, diagnostic services, treatment, and other measures described in 
section 1905(a) of the Act to correct or ameliorate defects and 
illnesses and conditions discovered by the screening services whether 
or not the services are covered under the State plan. Section 6403 also 
amended section 1902(a)(43) of the Act to require States to report to 
the Secretary certain information about EPSDT services provided under 
the plan during each fiscal year. This rule would set forth 
requirements to implement these statutory provisions.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            10/01/93                    58 FR 51288
NPRM Comment Period End         11/30/93                    58 FR 51288
Final Action                    04/00/96

Small Entities Affected: Undetermined

Government Levels Affected: State, Local

Agency Contact: Robert Wardwell, Director, Office of Medical and 
Remedial Care Services, 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
_______________________________________________________________________

1356. PAYMENT FOR NURSING AND ALLIED HEALTH SCIENCE EDUCATION (BPD-
685-F)

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 413

Legal Deadline:  NPRM, Statutory, July 1, 1990.

Abstract: This rule will set forth our policy for the payment of the 
costs of approved nursing and allied health science programs, an action 
directed by section 6205(b)(2) of OBRA '89. For the most part, the 
provisions set forth in this rule restate or clarify our current 
policies governing these costs, which have been previously set forth in 
the provider reimbursement manual and other documents, but have never 
been included in the regulations. In addition, we are amending the list 
of approved programs and clarify payment rules for certified registered 
nurse anesthetist programs. This rule will also implement section 4004 
of OBRA '90 which provides that, effective with cost reporting periods 
beginning on or after October 1, 1990, under certain conditions, costs 
incurred by a hospital or educational institution related to the 
hospital for clinical training are treated as pass-through costs and 
paid on the basis of reasonable cost even though the hospital does not 
operate the education programs.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            09/22/92                    57 FR 43659
NPRM Comment Period End         11/23/92                    57 FR 43659
Final Action                    12/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Tzvi Hefter, Director, Division of Hospital Services, 
Department of Health and Human Services, Health Care Financing 
Administration, C5-08-27, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-1850

RIN: 0938-AE79
_______________________________________________________________________

1357. COVERAGE OF SCREENING PAP SMEARS (BPD-705-F)

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 410.10; 42 CFR 410.15; 42 CFR 410.56

Legal Deadline: None

Abstract: This rule will establish regulations under section 6115 of 
OBRA '89 to govern Medicare Part B coverage of screening pap smears and 
related medically necessary services (including a physician's 
interpretation of the test results) provided to a woman for the early 
detection of cervical cancer.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            11/26/93                    58 FR 62312
NPRM Comment Period End         01/24/94                    58 FR 62312
Final Action                    04/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Joyce Eng, Office of Physician Ambulatory Care Policy, 
Bureau of Policy Development, Department of Health and Human Services, 
Health Care Financing Administration, C-4-02-26, 7500 Security Blvd., 
Baltimore, MD 21244
Phone: 410 786-4619

RIN: 0938-AE98
_______________________________________________________________________

1358. MEDICARE COVERAGE OF CLINICAL PSYCHOLOGIST, OTHER 
PSYCHOLOGIST, AND CLINICAL SOCIAL WORKER SERVICES--MEDICARE (BPD-706-F)

Priority:  Substantive, Nonsignificant

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

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

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/29/93                    58 FR 68829
NPRM Comment Period End         02/28/94                    58 FR 68829
Final Action                    03/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Regina Walker, Office of Chronic Care & Insurance 
Policy, Bureau of Policy Development, Department of Health and Human 
Services, Health Care Financing Administration, C-4-08-16, 7500 
Security Blvd., Baltimore, MD 21244
Phone: 410 786-6735

RIN: 0938-AE99
_______________________________________________________________________

1359. CASE MANAGEMENT (MB-27-F)

Priority:  Other Significant

Legal Authority:  42 USC 1396d; 42 USC 1396n

CFR Citation:  42 CFR 431.51(c); 42 CFR 440.169; 42 CFR 440.250; 42 CFR 
441.10; 42 CFR 441.18; 42 CFR 447.327; 42 CFR 431.54

Legal Deadline: None

Abstract: This rule will place into our regulations provisions of COBRA 
'85, OBRA '86, TEFRA '86, TMRA '88 and OBRA '87 dealing with case 
management services. These regulations will provide for optimal 
Medicaid coverage of case management services furnished to specific 
groups in specific geographic areas or political subdivisions within a 
State.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            10/15/93                    58 FR 53481
NPRM Comment Period End         12/14/93
Final Action                    03/00/96

Small Entities Affected: None

Government Levels Affected: State, Local

Agency Contact: Robert Wardwell, Director, Office of Medical and 
Remedial Care Services, 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
_______________________________________________________________________

1360. PAYMENT FOR FEDERALLY QUALIFIED HEALTH CENTER (FQHC) SERVICES 
(BPD-728-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395x(aa); 42 USC 13951

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

Legal Deadline: None

Abstract: This final rule will respond to comments received as a result 
of our publication of a final rule with comment period (57 FR 24961) 
which established a new category of facility known as an FQHC, the 
services of which are covered under the Medicare program. Those 
regulations also established requirements for coverage and payment of 
FQHC services under Medicare. They implemented section 4161(a) of PL 
101-508 and section 13556 of PL 103-66. This final rule will clarify or 
change policy, as appropriate, based on our evaluation of public 
comments.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Effective Date                  06/12/92                    57 FR 24961
Final Rule with Comment Period  06/12/92                    57 FR 24961
Comment Period End              08/11/92
Final Action                    01/00/96

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Bernadette Schumaker, Acting Director, Office of 
Physician and Ambulatory Care Policy, Department of Health and Human 
Services, Health Care Financing Administration, C4-11-16, 7500 Security 
Blvd., Baltimore, MD 21244
Phone: 410 786-0309

RIN: 0938-AF14
_______________________________________________________________________

1361. PARTIAL HOSPITALIZATION SERVICES IN COMMUNITY MENTAL HEALTH 
CENTERS (BPD-736-IFC)

Priority:  Substantive, Nonsignificant

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

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

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Interim Final Rule              02/11/94                     59 FR 6570
Effective Date                  03/13/94                     59 FR 6570
Comment Period End              04/12/94
Final Action                    03/00/96

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0938-AF53
_______________________________________________________________________

1362. 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 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 Aid to Families with Dependent 
Children (AFDC) applications. The statutory requirement also provides 
that the application form for these individuals must not be the AFDC 
application form.
The rule is based on section 1902(a)(55) of the Social Security Act as 
added by section 4602 of OBRA '90, PL 101-508.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Interim Final Rule With Comment 
Period                          08/23/94                    59 FR 48805
Interim Final Rule              09/23/94                    59 FR 48805
Comment Period End              11/22/94                    59 FR 48805
Effective Date                  11/24/94
Final Action                    03/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Robert Tomlinson, Health Insurance Specialist, 
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
_______________________________________________________________________

1363. MEDICARE AND MEDICAID PROGRAMS: REQUIREMENTS FOR PHYSICIAN 
INCENTIVE PLANS IN PREPAID HEALTH CARE ORGANIZATIONS (OMC-010-FC)

Priority:  Other Significant

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

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

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/14/92                    57 FR 59024
Comment Period End              04/13/93                     58 FR 8568
Final Action                    12/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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

RIN: 0938-AF74
_______________________________________________________________________

1364. 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 would amend Medicare regulations to provide advance 
payment to physicians, suppliers, or entities that furnish items or 
services under Medicare Part B. These payments could be made only when 
claims processing is so delayed that interest payments alone are 
insufficient to adequately compensate the provider, in light of cash 
flow needs. This change is intended to result in more efficient and 
economical administration of the Medicare program.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            07/18/94                    59 FR 36415
NPRM Comment Period End         09/16/94                    59 FR 36415
Final Action                    12/00/95

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Bob Shaw, Bureau of Program Operations, Department of 
Health and Human Services, Health Care Financing Administration, S-2-
01-23, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7671

RIN: 0938-AF85
_______________________________________________________________________

1365. RETROACTIVE ENROLLMENT AND DISENROLLMENT IN RISK HEALTH 
MAINTENANCE ORGANIZATIONS AND COMPETITIVE MEDICAL PLANS (OMC-015-F)

Priority:  Other Significant

Legal Authority:  42 USC 1395mm

CFR Citation:  42 CFR 417.448; 42 CFR 417.450; 42 CFR 417.456; 42 CFR 
417.460; 42 CFR 417.461; 42 CFR 417.462; 42 CFR 417.464; 42 CFR 417.584

Legal Deadline: None

Abstract: This rule will allow retroactive enrollment of up to 90 days 
for individuals enrolling with an eligible organization (which has a 
risk-sharing contract under section 1876 of the Social Security Act) 
under a health benefit plan operated, sponsored, or contributed to, by 
the individual's employer or former employer (or the employer or former 
employer of the individual's spouse). The regulation implements section 
4204(e) of OBRA '90. In addition, the rule will permit the Secretary to 
authorize retroactive disenrollment in specific cases.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/27/93                    58 FR 68366
Comment Period End              02/25/94                    58 FR 68366
Final Action                    05/00/96

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0938-AF98
_______________________________________________________________________

1366. 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. In addition, this 
final rule responds to comments received on the interim final rule with 
comment period. 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                    03/00/96

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0938-AG00
_______________________________________________________________________

1367. 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 rule will amend current Medicare regulations to require 
that payment for inpatient hospital services furnished to retired 
Federal workers age 65 and older who are enrolled in a Federal Employee 
Health Benefits (FEHB) plan but who are not covered under Medicare Part 
A (Hospital Insurance) must accept as payment in full an amount that 
approximates as closely as possible the inpatient hospital Medicare 
prospective payment rate. The rule will also amend current Medicare 
regulations to authorize HCFA to consider termination or nonrenewal of 
a hospital's Medicare provider agreement for knowingly and willfully 
failing to accept, on a repeated basis, the Medicare rate as payment in 
full from an FEHB plan. This rule will implement section 7002(f) of 
OBRA '90, enacted November 5, 1990. This rule is part of the 
Department's regulatory initiative.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            02/10/94                     59 FR 6228
NPRM Comment Period End         04/11/94                     59 FR 6228
Final Action                    02/00/96

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

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

RIN: 0938-AG03
_______________________________________________________________________

1368. INTERMEDIARY AND CARRIER FUNCTIONS (BPO-111-F)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1395h; 42 USC 1395u

CFR Citation:  42 CFR 421.100; 42 CFR 421.200

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            02/22/94                     59 FR 8446
NPRM Comment Period End         04/25/94                     59 FR 8446
Notice to Reopen Comment Period 07/17/94                    59 FR 35664
Comment Period End              10/11/94
Final Action                    02/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Alan Bromberg, Bureau of Program Operations, Department 
of Health and Human Services, Health Care Financing Administration, S-
2-01-23, 2300 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7441

RIN: 0938-AG06
_______________________________________________________________________

1369. REVISED MEDICAID MANAGEMENT INFORMATION SYSTEMS (MB-38-FN)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396b(r)

CFR Citation:  42 CFR 433.1; 42 CFR 431.17; 42 CFR 447.10; 42 CFR 
447.45; 42 CFR 74.20; 42 CFR 74.21

Legal Deadline: None

Abstract: This notice sets forth revised general functional 
requirements for the Medicaid Management Information System (MMIS). The 
MMIS consists of software and hardware used to process Medicaid claims 
and to retrieve and produce utilization and management information 
about services that are required by the Medicaid agency or Federal 
Government for administrative or audit purposes. The revised 
requirements allow States more flexibility to exercise variations in 
the implementation.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Proposed Notice                 11/22/93                    58 FR 61692
Comment Period End              01/21/94
Final Action                    12/00/95
Final Action                    01/00/96

Small Entities Affected: None

Government Levels Affected: State

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

RIN: 0938-AG10
_______________________________________________________________________

1370. 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: These regulations specify the criteria HCFA will use to 
determine if a facility furnishing dialysis services to patients with 
end-stage renal disease qualifies for a higher payment under an 
exception to the prospectively determined payment rate; and the 
procedures used to evaluate ESRD payment exceptions requests. The rule 
also revised 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                    59 FR 44097
Final Action                    12/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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

RIN: 0938-AG20
_______________________________________________________________________

1371. 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 severally impaired. 
Based on a Public Health Service recommendation, we propose to place 
limitations on Medicare coverage of IPPB machine therapy.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Proposed Notice                 06/29/94                    59 FR 33520
Comment Period End              08/29/94
Final Action                    04/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Francine Spencer, Office of Chronic Care & Insurance 
Policy, 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
_______________________________________________________________________

1372. TELEPHONE AND ELECTRONIC REQUESTS FOR REVIEW OF PART B 
INITIAL CLAIM DETERMINATIONS (BPO-121-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 1395hh; 42 USC 1395ff

CFR Citation:  42 CFR 405.807

Legal Deadline: None

Abstract: Current Medicare regulations allow a Medicare beneficiary to 
appeal, in writing, decisions to deny payment for a claim under 
supplementary medical insurance. This rule would allow a beneficiary to 
appeal an initial payment determination either in writing or by 
telephone. This rule is part of HCFA's regulatory reform initiative.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            07/10/95                    60 FR 35544
Final Action                    01/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Rosalind Little, Bureau of Program Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, S-01-05-18, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-6972

RIN: 0938-AG48
_______________________________________________________________________

1373. SCHEDULE OF LIMITS ON HOME HEALTH AGENCY COSTS PER VISIT 
(BPD-793-N)

Priority:  Other Significant

Legal Authority:  42 USC 1395f(b); 42 USC 1395x(v)(1)(A); 42 USC 
1395x(v)(1)(L); 42 USC 1395hh; PL 103-66, Sec 13564(a); 42 USC 
1395cc(a)

CFR Citation:  None

Legal Deadline: None

Abstract: This notice responds to public comments on the February 14, 
1995 notice with comment period (60 FR 8389) that set forth a revised 
schedule of limits on home health agency costs that may be paid under 
the Medicare program for cost reporting periods beginning on or after 
July 1, 1993. The revised limits replaced the per-visit limits that 
were set forth in our July 8, 1993 notice with comment period (58 FR 
36748). The February 14 notice also provided, in accordance with the 
provisions of OBRA '93, that there will 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.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Other Provisions Effective      07/01/93                     60 FR 8389
Notice With Comment Period      02/14/95                     60 FR 8389
Comment Period End              04/17/95
Final Action                    03/00/96

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Michael Bussacca, Health Insurance Specialist, Bureau 
of Policy Development, Department of Health and Human Services, Health 
Care Financing Administration, C4-05-27, 7500 Security Boulevard, 
Baltimore, MD 21207
Phone: 410 786-4602

RIN: 0938-AG54
_______________________________________________________________________

1374. MEDICAID PROGRAM: NURSE-MIDWIFE SERVICES (MB-085-F)

Priority:  Other Significant

Legal Authority:  PL 103-66, Sec 13605

CFR Citation:  42 CFR 440

Legal Deadline: None

Abstract: This rule would expand coverage of nurse-midwife services 
under the Medicaid program by including coverage for those services the 
nurse-midwives perform outside the maternity cycle as allowed by State 
law and regulation. The provisions of this rule conform the regulations 
to the legislative provisions of OBRA '93.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            07/18/94                    59 FR 36419
NPRM Comment Period End         09/16/94                    59 FR 36419
Final Action                    01/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Linda Sizelove, Office of Medical Services, Medicaid 
Bureau, Department of Health and Human Services, Health Care Financing 
Administration, C4-24-02, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3255

RIN: 0938-AG73
_______________________________________________________________________

1375. MEDICAID PROGRAM: FEES FOR VACCINE ADMINISTRATION UNDER 
PEDIATRIC IMMUNIZATION PROGRAM (MB-084-FN)

Priority:  Other Significant

Legal Authority:  PL 103-66, sec 13631; 42 USC 1396a(a)(62); 42 USC 
1396s

CFR Citation:  None

Legal Deadline: None

Abstract: This notice establishes a regional maximum fee that a 
Medicaid provider may charge for the administration of qualified 
pediatric vaccines under the Medicaid Pediatric Immunization Program. 
It also specifies the methodology used to develop this maximum fee and 
allows a State to pay a rate lower than the maximum fee if the State 
can ensure federally vaccine-eligible children adequate access to the 
vaccines at the lower rate. This notice implements section 
1928(c)(2)(C)(ii) of the Social Security Act, as added by section 13631 
of OBRA '93.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Effective Date                  10/01/94                    59 FR 50235
Notice With Comment Period      10/03/94                    59 FR 50235
Comment Period End              12/12/94
Final Action                    04/00/96

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State

Agency Contact: Marge Sciulli, Health Insurance Specialist, Medicaid 
Bureau, Department of Health and Human Services, Health Care Financing 
Administration, C4-21-26, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-0691

RIN: 0938-AG77
_______________________________________________________________________

1376. REVISION OF MEDICARE HOSPITAL CONDITIONS OF PARTICIPATION 
(BPD-745-P)

Regulatory Plan:  This entry is Seq. No. 44 in Part II of this issue of 
the Federal Register.

RIN: 0938-AG79
_______________________________________________________________________

1377. MEDICARE PROGRAM: CHANGES TO THE INPATIENT HOSPITAL 
PROSPECTIVE PAYMENT SYSTEMS AND FISCAL YEAR 1996 RATES (BPD-825-FC)

Priority:  Other Significant

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

Legal Authority:  42 USC 1395ww

CFR Citation:  42 CFR 412; 42 CFR 413

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

Abstract: This rule would make revisions to the inpatient hospital 
prospective payment systems for operating costs and capital-related 
costs. It also would include changes in the methods amounts and factors 
used to determine the prospective payment rates applicable to 
discharges occurring during FY 1996. In addition, the rule would set 
forth the rate of increase limits for hospitals and hospital units 
excluded from the prospective payment systems. Finally, this rule would 
eliminate the requirement for physicians to sign an ``attestation 
form'' for each Medicare patient discharged from a hospital. This rule 
includes provisions that are part of HCFA's regulatory reform 
initiative and the Department's regulatory reinvention initiative.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            06/02/95                    60 FR 29202
NPRM Comment Period End         08/01/95                    60 FR 29202
Final Rule With Comment Period  09/01/95                    60 FR 45778
Effective Date                  10/01/95
Comment Period End              11/01/95
Final Action                    00/00/00

Small Entities Affected: Businesses, Organizations

Government Levels Affected: State, Federal

Agency Contact: Nancy Edwards, Director, Division of Prospective 
Payment Systems, Department of Health and Human Services, Health Care 
Financing Administration, C5-07-22, 7500 Security Blvd., Baltimore, MD 
21244
Phone: 410 786-4531

RIN: 0938-AG95
_______________________________________________________________________

1378. MEDICARE PROGRAM: REVISIONS TO PAYMENT POLICIES AND 
ADJUSTMENTS TO THE RELATIVE VALUE UNITS (RVUS) UNDER THE PHYSICIAN FEE 
SCHEDULE FOR CALENDAR YEAR 1996 (BPD-827-FC)

Regulatory Plan:  This entry is Seq. No. 45 in Part II of this issue of 
the Federal Register.

RIN: 0938-AG96
_______________________________________________________________________

1379. MEDICARE PROGRAM: PHYSICIAN FEE SCHEDULE UPDATE FOR CALENDAR 
YEAR 1996 & PHYSICIAN VOLUME PERFORMANCE STANDARD RATES OF INCREASE FOR 
FEDERAL FISCAL YEAR 1996 (BPD-828-FN)

Priority:  Other Significant

Legal Authority:  42 USC 1395w-4

CFR Citation:  None

Legal Deadline:  Other, Statutory, October 31, 1995.
Annual update required.

Abstract: This notice announces the calendar year 1996 updates to the 
Medicare physician fee schedule and the federal fiscal year 1996 
performance standard rates of increase for expenditures and volume of 
physicians' services under the Medicare Supplementary Medical Insurance 
(Part B) program as required by sections 1848(d) and (f) of the Social 
Security Act.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Action                    10/00/95

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0938-AH03
_______________________________________________________________________

1380. PART A PREMIUM FOR 1996 FOR THE UNINSURED AGED AND FOR 
CERTAIN DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER ENTITLEMENT (OACT-
051-N)

Priority:  Substantive, Nonsignificant

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

CFR Citation:  None

Legal Deadline:  Other, Statutory, September 30, 1995.
Other deadline is for publication of Notice.

Abstract: This notice announces the hospital insurance premium for 
calendar year 1996 under the Medicare's hospital insurance program 
(Part A) for the uninsured aged and for certain disabled individuals 
who have exhausted other entitlement. The uninsured aged are those 
individuals who are not insured under the Social Security or Railroad 
Retirement Acts and do not otherwise meet the requirements for 
entitlement to Medicare Part A. The disabled beneficiaries are those 
who lose monthly Social Security cash payments because they returned to 
work even though their disability continues. Section 1818(d) of the 
Social Security Act specifies the method to be used to determine this 
amount.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Notice                          10/16/95                    60 FR 53631

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: John Wandishin, Director, Division of Hospital 
Insurance, Department of Health and Human Services, Health Care 
Financing Administration, N-3-26-00, 7500 Security Blvd., Baltimore, MD 
21244
Phone: 410 786-6389

RIN: 0938-AH06
_______________________________________________________________________

1381. MEDICARE PROGRAM: MONTHLY ACTUARIAL RATES AND MONTHLY 
SUPPLEMENTARY MEDICAL INSURANCE PREMIUM RATES BEGINNING JANUARY 1, 1996 
(OACT-050-N)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395r

CFR Citation:  None

Legal Deadline:  Other, Statutory, September 1995.
Other deadline is for publication of Notice.

Abstract: This notice announces the monthly actuarial rates for aged 
(age 65 and over) and disabled (under age 65) enrollees, in the 
Medicare Supplementary Insurance (SMI) program for the 12 months 
beginning January 1, 1996. It also announces the monthly SMI premium 
rate to be paid by all enrollees during the 12 months beginning January 
1, 1996.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Notice                          10/16/95                    60 FR 53626

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Carter Warfield, Director, Division of Supplementary 
Medical Insurance, Department of Health and Human Services, Health Care 
Financing Administration, N-3-26-00, 7500 Security Blvd., Baltimore, MD 
21244
Phone: 410 786-6396

RIN: 0938-AH07
_______________________________________________________________________

1382. INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED CARE 
SERVICES COINSURANCE AMOUNTS FOR 1996 (OACT-049-N)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395e

CFR Citation:  None

Legal Deadline:  Other, Statutory, September 15, 1995.
Other deadline is for publication of Notice.

Abstract: This notice announces the inpatient hospital deductible and 
the hospital and extended care services coinsurance amounts for 
services furnished in calendar year 1996 under Medicare's hospital 
insurance program (Medicare Part A). The Medicare statute specifies the 
formulae to be used to determine these amounts.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Notice                          10/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: John Wandishin, Director, Division of Hospital 
Insurance, Department of Health and Human Services, Health Care 
Financing Administration, N-3-36-24, 7500 Security Blvd., Baltimore, MD 
21244
Phone: 410 786-6389

RIN: 0938-AH08
_______________________________________________________________________

1383.  LIMITATIONS ON AGGREGATE PAYMENTS TO 
DISPROPORTIONATE SHARE HOSPITALS: FEDERAL FISCAL YEAR 1995 (MEDICAID 
PROGRAM) (MB-094-N)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396r-4(f)

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

Legal Deadline: None

Abstract: This notice announces the final Federal fiscal year (FFY) 
1995 national target and individual State allotments for Medicaid 
payment adjustments made to hospitals that serve a disproportionate 
number of Medicaid recipients and low-income patients with special 
needs.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Action                    11/00/95

Small Entities Affected: None

Government Levels Affected: State, Federal

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

RIN: 0938-AH09
_______________________________________________________________________

1384.  REPORTING OF INTEREST FROM ZERO COUPON BONDS (BPD-
647-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395x(v)

CFR Citation:  42 CFR 413.153

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/13/93                    58 FR 65150
Final Action                    01/00/96

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0938-AH11
_______________________________________________________________________

1385.  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 for 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                    01/00/96

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0938-AH14
_______________________________________________________________________

1386.  CRITERIA AND PROCEDURES FOR EXTENDING COVERAGE TO 
CERTAIN DEVICES AND RELATED SERVICES (BPD-841-FC)

Regulatory Plan:  This entry is Seq. No. 46 in Part II of this issue of 
the Federal Register.

RIN: 0938-AH21
_______________________________________________________________________

1387.  CLIA PROGRAM; GRANTING AND WITHDRAWAL OF AUTHORITY 
TO PRIVATE NONPROFIT ACCREDITATION ORGANIZATIONS AND OF CLIA EXEMPTION 
UNDER STATE LABORATORY PROGRAMS; TECHNICAL CORRECTIONS

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 263a

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

Legal Deadline: None

Abstract: This rule clarifies that a state may obtain approval from 
HCFA for exemption of its licensed laboratories from CLIA requirements 
given if it does not license all laboratories in the state. We are also 
making technical revisions and corrections to the final rule published 
July 31, 1992, that include data format requirements, laboratory 
performance information to be sent to us by accreditation organizations 
and CLIA-exempt states and the right of a state to appeal termination 
of its exemption for failure to pay required law.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Rule With Comment Period  11/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Josephine Simmons, Chief, Laboratory Performance 
Branch, HSQB, HCFA, HHS, Department of Health and Human Services, 
Health Care Financing Administration, 7500 Security Blvd, Room 52-19-
26, Baltimore, MD 21244
Phone: 410 786-3409

RIN: 0938-AH32
_______________________________________________________________________

1388.  MEDICARE PROGRAM; SPECIAL ENROLLMENT PERIODS AND 
WAITING PERIODS (BPD-752-FC)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1302; 42 USC 1395

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

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Rule with Comment Period  12/00/95

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0938-AH33
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Long-Term Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
  
1389. PARTICIPATION IN CHAMPUS AND CHAMPVA, HOSPITAL ADMISSIONS FOR 
VETERANS, DISCHARGE RIGHTS NOTICE, AND HOSPITAL RESPONSIBILITY FOR 
EMERGENCY CARE (BPD-393-F)

Priority:  Other Significant

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

CFR Citation:  42 CFR 488.18; 42 CFR 489.20; 42 CFR 489.24; 42 CFR 
489.25; 42 CFR 489.26; 42 CFR 489.27; 42 CFR 489.53; 42 CFR 1003

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Tzvi Hefter, Director, Division of Hospital Service, 
Department of Health and Human Services, Health Care Financing 
Administration, C5-08-27, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-1304

RIN: 0938-AC58
_______________________________________________________________________

1390. CRITERIA AND PROCEDURES FOR MAKING MEDICAL SERVICES COVERAGE 
DECISIONS THAT RELATE TO HEALTH CARE TECHNOLOGY (BPD-432-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395y

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

Legal Deadline: None

Abstract: The final rule establishes in regulations generally 
applicable criteria and procedures for determining whether a service is 
``reasonable and necessary'' under the Medicare program; it sets forth 
the coverage decisionmaking process; and it summarizes and provides an 
analysis of the public comments that we received in response to the 
January 30, 1989 proposed rule (54 FR 4302). The objective of the 
criteria and procedures set forth in this rule is to ensure that 
Federal funds are expended only for medical services that are 
appropriate to meet an individual's medical needs.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            01/30/89                     54 FR 4302
NPRM Comment Period End         03/31/89                     54 FR 4302
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: David Higbee, Technology & Special Analysis Staff, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-10-07, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4643

RIN: 0938-AD07
_______________________________________________________________________

1391. 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                            00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Sheridan Gladhill, Bureau of Policy Development, 
Department of Health and Human Services, Health Care Financing 
Administration, C-4-05-27, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-1782

RIN: 0938-AD32
_______________________________________________________________________

1392. MEDICARE SECONDARY PAYER FOR DISABLED INDIVIDUALS (BPD-482-
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 1395y(b)

CFR Citation:  42 CFR 411

Legal Deadline: None

Abstract: This rule implements the Medicare secondary payer (MSP) 
provision for disabled individuals who are covered under large group 
health plans (LGHPs). Under this provision LGHPs may not take into 
account that such individuals are entitled to Medicare. The rule 
contains procedures under which a plan can appeal a determination of 
nonconformance which could lead to a tax penalty. It reflects statutory 
revisions mandated by OBRA '86, OBRA '89, and OBRA '93, some of which 
also affect the MSP provisions for persons who are entitled on the 
basis of age or end-stage renal disease. This rule is part of HCFA's 
regulatory reform initiative.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            03/08/90                     55 FR 8491
NPRM Comment Period End         05/08/90                     55 FR 8491
Final Rule With Comment         08/31/95                    60 FR 45344
Effective Date                  09/29/95
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Herbert Pollock, Office of Chronic Care & Insurance 
Policy, Bureau of Policy Development, Department of Health and Human 
Services, Health Care Financing Administration, C-4-08-14, 7500 
Security Blvd., Baltimore, MD 21244
Phone: 410 786-4474

RIN: 0938-AD73
_______________________________________________________________________

1393. FEE SCHEDULE FOR PAYMENT OF CLINICAL PSYCHOLOGIST SERVICES 
(BPD-495-P)

Priority:  Other Significant

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

CFR Citation:  42 CFR 414

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Elisa Tunanidas, Office of Physician & Ambulatory Care 
Policy, Department of Health and Human Services, Health Care Financing 
Administration, C4-02-26, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4505

RIN: 0938-AD84
_______________________________________________________________________

1394. SURVEY REQUIREMENTS AND ALTERNATIVE SANCTIONS FOR HOME HEALTH 
AGENCIES (HSQ-169-F)

Priority:  Other Significant

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

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

Legal Deadline: None

Abstract: These rules will establish periodic, unannounced surveys of 
home health agencies (HHAs) and other survey requirements and also will 
specify a number of sanctions that could be used, when an HHA is out of 
compliance with Federal requirements, as an alternative or in addition 
to terminating an HHA's participation in the Medicare program.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            08/02/91                    56 FR 37054
NPRM Comment Period End         10/01/91                    56 FR 37054
Final Action                    00/00/00

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Local, Federal

Agency Contact: Pam Vocke, Director, Division of Program Operations, 
Office of Survey and Certification, Department of Health and Human 
Services, Health Care Financing Administration, S-2-19-26, 6300 
Security Blvd., Baltimore, MD 21244
Phone: 410 786-3487

RIN: 0938-AE39
_______________________________________________________________________

1395. 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 1395x; 42 USC 1396d

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

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0938-AE97
_______________________________________________________________________

1396. 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 amends 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 could 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 Rule With Comment Period  00/00/00

Small Entities Affected: None

Government Levels Affected: None

Additional Information: 
TIMETABLE: Pending court ruling.

Agency Contact: Pam Vocke, Director, Division of Program Operations, 
Office of Survey and Certification, Department of Health and Human 
Services, Health Care Financing Administration, S-2-19-26, 6300 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3487

RIN: 0938-AF02
_______________________________________________________________________

1397. OBRA '90 AND MISCELLANEOUS MANAGED CARE TECHNICAL AMENDMENTS 
(OMC-018-FC)

Priority:  Substantive, Nonsignificant

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

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

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jane McClard, Health Insurance Specialist, Office of 
Managed Care, Department of Health and Human Services, Health Care 
Financing Administration, S-03-02-01, 7500 Security Blvd., Baltimore, 
MD 21244
Phone: 410 786-4460

RIN: 0938-AF15
_______________________________________________________________________

1398. PRESUMPTIVE LIMITS ON PAYMENTS TO HMOS, CMPS, AND HCPPS (OMC-
006-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 1395mm(h); 42 USC 1395x(v)(1)(A)

CFR Citation:  42 CFR 417.532(a)(3); 42 CFR 417.802; 42 CFR 417.800(c)

Legal Deadline: None

Abstract: This rule will establish presumptive limits for Medicare 
payments to Health Maintenance Organizations and Competitive Medical 
Plans, and to Health Care Prepayment Plans (HCPPs) that furnishes 
inpatient hospital care. It will also revise the criteria that HCFA 
uses to determine reasonable costs for HCPPs that do not furnish 
inpatient hospital care. This rule is part of HCFA's regulatory reform 
initiative.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            02/22/94                     59 FR 8435
NPRM Comment Period End         04/25/94                     59 FR 8435
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: A. G. D'Alberto, Office of Managed Care, Department of 
Health and Human Services, Health Care Financing Administration, S-3-
02-01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7610

RIN: 0938-AF16
_______________________________________________________________________

1399. PROVIDER REIMBURSEMENT DETERMINATIONS AND APPEALS REVISIONS 
(BPD-727-P)

Priority:  Other

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

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

CFR Citation:  42 CFR 405.1801; 42 CFR 405.1889

Legal Deadline: None

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

Timetable: Next Action Undetermined

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0938-AF28
_______________________________________________________________________

1400. REFERRAL TO CHILD SUPPORT ENFORCEMENT AGENCIES OF MEDICAID 
FAMILIES (MB-051-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396k

CFR Citation:  42 CFR 433.160; 42 CFR 433.135; 42 CFR 433.137; 42 CFR 
433.151

Legal Deadline: None

Abstract: This rule will require State Medicaid agencies to refer 
Medicaid families with an absent parent to child support enforcement 
(CSE) agencies. Section 9142 of OBRA '87 required CSE agencies to 
provide all CSE services to such Medicaid families who have assigned to 
the State their rights to medical support. The purpose of these rules 
is to require States to make this referral to State CSE agencies to 
ensure that those recipients requiring CSE services receive them.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            09/22/93                    58 FR 49272
NPRM Comment Period End         11/22/93                    58 FR 49272
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Randy Graydon, Director, Division of Benenficiary 
Services, Department of Health and Human Services, Health Care 
Financing Administration, C4-22-27, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4451

RIN: 0938-AF68
_______________________________________________________________________

1401. ASSESSING INTEREST AGAINST MEDICARE SECONDARY PAYER (MSP) 
DEBTS (BPO-108-P)

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 411.40; 42 CFR 405.376

Legal Deadline: None

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

Timetable: Next Action Undetermined

Small Entities Affected: None

Government Levels Affected: None

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

Agency Contact: John Albert, Health Insurance Spcialist, Bureau of 
Program Operations, Department of Health and Human Services, Health 
Care Financing Administration, S-03-02-26, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-7457

RIN: 0938-AF87
_______________________________________________________________________

1402. 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 1320-2

CFR Citation:  42 CFR 462

Legal Deadline: None

Abstract: This notice provides general criteria and standards that will 
be used to evaluate the effective and efficient performance of 
Utilization and Quality Control Peer Review Organizations (PROs) for 
new contracts entered into on or after April 1, 1993, by the 53 PROs.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Notice With Comment Period      00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Kathleen Kelso, Health Standards & Quality Bureau, 
Department of Health and Human Services, Health Care Financing 
Administration, S-1-09-27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7214

RIN: 0938-AG32
_______________________________________________________________________

1403. WITHDRAWAL OF COVERAGE OF DIAGNOSTIC NOCTURNAL PENILE 
TUMESCENCE TESTING (IMPOTENCE TESTING) (BPD-780-FN)

Priority:  Substantive, Nonsignificant

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

CFR Citation:  None

Legal Deadline: None

Abstract: This notice announces the Medicare program's intent to 
withdraw coverage for diagnostic nocturnal penile tumescence (NPT) 
testing in the sleep disorder clinic and to exclude coverage for 
nocturnal penile tumescence testing by plethysmography and other 
monitoring devices in all settings. Public Health Service studies show 
that NPT testing is not a reliable index for evaluating impotence. 
Therefore, it does not meet HCFA's criteria for effectiveness.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Proposed Notice                 01/04/94                      59 FR 308
Comment Period End              03/07/94                      59 FR 309
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Bob Ulikowski, Office of Physician & Ambulatory Care 
Policy, Department of Health and Human Services, Health Care Financing 
Administration, C4-10-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5721

RIN: 0938-AG43
_______________________________________________________________________

1404. NONCOVERAGE OF ELECTROSTIMULATION OF SALIVARY GLANDS FOR THE 
TREATMENT OF XEROSTOMIA (DRY MOUTH) (BPD-782-FN)

Priority:  Substantive, Nonsignificant

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

CFR Citation:  None

Legal Deadline: None

Abstract: This notice announces the Medicare program's intent to 
exclude from coverage electrostimulation of the salivary glands in the 
treatment of xerostomia secondary to Sjogren's Syndrome. Public Health 
Service (PHS) studies show that there is insufficient data to establish 
the clinical utility of electrostimulation to evaluate its long-term 
effectiveness, or to identify those xerostomia patients who would 
benefit from this procedure. Also, PHS reports that electrostimulation 
is not widely accepted as a treatment for xerostomia secondary to 
Sjogren's Syndrome.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Proposed Notice                 05/23/94                    59 FR 26653
Comment Period End              07/22/94
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Francina Spencer, Office of Chronic Care & Insurance 
Policy, Department of Health and Human Services, Health Care Financing 
Administration, C4-040-05, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4614

RIN: 0938-AG45
_______________________________________________________________________

1405. CLINICAL LABORATORY IMPROVEMENT AMENDMENT (CLIA) FEE 
SCHEDULES (HSQ-219-FC)

Priority:  Other Significant

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

Legal Authority:  42 USC 263a(m)

CFR Citation:  42 CFR 493.638; 42 CFR 493.649

Legal Deadline: None

Abstract: The preamble to this final rule with comment period announces 
updated fees that laboratories must pay as required by CLIA '88. Fee 
increases are necessary to meet the costs of program administration, 
which are to be borne by the laboratories. In addition, technical 
conforming changes are made to the regulations to ensure consistent and 
complete references. This rule is part of HCFA's regulatory reform 
initiative.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Ed Mortimore, Survey & Certification, Department of 
Health and Human Services, Health Care Financing Administration, S-2-
18-14, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-3509

RIN: 0938-AG87
_______________________________________________________________________

1406. MANDATORY MEDIGAP CROSSOVER CLAIMS TRANSMITTAL REQUIREMENTS 
(BPD-811-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395ss

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

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: None

Agency Contact: Thomas Hoyer, Director, Office of Chronic Care & 
Insurance Policy, Department of Health and Human Services, Health Care 
Financing Administration, C4-02-16, 7500 Security Bldg., Baltimore, MD 
21244
Phone: 410 786-5661

RIN: 0938-AG94
_______________________________________________________________________

1407.  DEFINITION OF SKILLED NURSING FACILITY (SNF) AND 
HOME HEALTH AGENCY (HHA) FOR COVERAGE OF DURABLE MEDICAL EQUIPMENT (DME) 
(BPD-834-P)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1495x(n)

CFR Citation:  42 CFR 409; 42 CFR 410

Legal Deadline: None

Abstract: This proposed rule would define skilled nursing facilities 
(SNF) (under Medicare and Medicaid) for purposes of Medicare coverage 
of DME and home health. 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 NFs are section 1819(a) facilities and this would not be 
considered a home for DME and home health coverage. This rule would 
identify non- Medicare nursing homes as skilled facilities based upon 
the receipt of skilled care by a proportion of their resident 
population that is at least comparable to the proportion typically 
found in participating Medicare SNFs. This proposed rule is part of the 
Department's regulatory reinvention initiative.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            09/00/96


  

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Thomas Hoyer, Director, Office of Chronic Care and 
Insurance Policy, Department of Health and Human Services, Health Care 
Financing Administration, C4-02-16, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4605

RIN: 0938-AH16
_______________________________________________________________________

1408.  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 notice announces proposed changes in Medicare's national 
coverage policy for liver transplantations. Currently, Medicare 
coverage for liver transplantation in adults is limited to seven 
diagnosis. This notice proposes to expand the diagnoses for which 
Medicare would cover a liver transplant to include all end stage liver 
disease except malignancies, hepatitis B, and hemochromatosis. We are 
also proposing a change in the criteria for approval of a facility to 
perform liver transplants.

Timetable: Next Action Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Lana Price, Director, Division of End Stage Renal 
Disease, Bureau of Policy Development, Department of Health and Human 
Services, Health Care Financing Administration, C5-05-27, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4533

RIN: 0938-AH17
_______________________________________________________________________

1409.  PROVISIONS THAT ALLOW RURAL PRIMARY CARE HOSPITALS 
(RPCHS) TO ENTER INTO SWING-BED AGREEMENTS (BPD-839-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395i-4

CFR Citation:  42 CFR 485.645

Legal Deadline: None

Abstract: This proposed rule would revise the provisions under which 
Rural Primary Care Hospitals (RPCHs) are allowed to enter into swing-
bed agreements. These changes are being made to conform the regulations 
to changes made by section 102(c) of Public Law 103-432. Changes are 
also being made to ensure consistent treatment of similar facilities, 
and to protect the health and safety of patients in RPCH swing beds.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            04/00/96


Next Action Undetermined

Small Entities Affected: Undetermined

Government Levels Affected: None

Agency Contact: George Morey, Office of Hospital Policy, Department of 
Health and Human Services, Health Care Financing Administration, C5-08-
27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4653

RIN: 0938-AH20
_______________________________________________________________________

1410.  TRANSFER OF ASSETS FOR LESS THAN FAIR MARKET VALUE: 
MEDICAID PROGRAM (MB-095-P)

Priority:  Other Significant

Legal Authority:  42 USC 1396p(c)

CFR Citation:  42 CFR 435; 42 CFR 436

Legal Deadline: None

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

Timetable: Next Action Undetermined

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Roy Trudel, Division of Eligibility Policy, Medicaid 
Bureau, Department of Health and Human Services, Health Care Financing 
Administration, C4-25-02, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3417

RIN: 0938-AH23
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
  
1411. CLARIFICATIONS OF MEDICARE'S ACCRUAL BASIS OF ACCOUNTING 
POLICY (BPD-366-F)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 413.24; 42 CFR 413.100

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    06/27/95                    60 FR 33126
Final Action Effective          07/27/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: John Eppinger
Phone: 410 786-4518

RIN: 0938-AD01
_______________________________________________________________________

1412. OPTIONAL PAYMENT SYSTEM FOR LOW MEDICARE VOLUME SKILLED 
NURSING FACILITIES (BPD-409-F)

Priority:  Substantive, Nonsignificant

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

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    07/21/95                    60 FR 37590
Final Action Effective          08/21/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Bob Kuhl
Phone: 410 786-4597

RIN: 0938-AD02
_______________________________________________________________________

1413. TRANSFER OF RESOURCES FOR LESS THAN FAIR MARKET VALUE (MB-10-
P)

Priority:  Other Significant

CFR Citation:  42 CFR 435; 42 CFR 436

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn New regulation (MB-
095-P) under development.       01/12/95

Small Entities Affected: None

Government Levels Affected: State, Local

Agency Contact: Roy Trudel
Phone: 410 786-3417

RIN: 0938-AD18
_______________________________________________________________________

1414. PAYMENT FOR DURABLE MEDICAL EQUIPMENT AND ORTHOTIC AND 
PROSTHETIC DEVICES (BPD-494-F)

Priority:  Substantive, Nonsignificant

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

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    07/10/95                    60 FR 35402

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: William Long
Phone: 410 786-5655

RIN: 0938-AD65
_______________________________________________________________________

1415. UNIFORM ELECTRONIC COST REPORTING SYSTEM FOR HOSPITALS (BPD-
689-F)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 413.24

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    06/27/95                    60 FR 33123
Final Action Effective          07/27/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Thomas Talbott
Phone: 410 786-4592

RIN: 0938-AE80
_______________________________________________________________________

1416. ALLOWING CERTIFICATIONS AND RECERTIFICATIONS BY NURSE 
PRACTITIONERS AND CLINICAL NURSE SPECIALISTS FOR CERTAIN SERVICES (BPD-
709-FC)

Priority:  Other Significant

CFR Citation:  42 CFR 424

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    07/26/95                    60 FR 38266

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Roberta Epps
Phone: 410 786-4503

RIN: 0938-AF01
_______________________________________________________________________

1417. MEDICAID THIRD PARTY LIABILITY: COST EFFECTIVENESS WAIVERS 
(MB-39-F)

Priority:  Substantive, Nonsignificant

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

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    07/10/95                    60 FR 35498
Final Action Effective          09/08/95

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Richard Friedman
Phone: 410 786-3292

RIN: 0938-AF11
_______________________________________________________________________

1418. REQUIRED COVERAGE OF NURSE PRACTITIONER SERVICES--MEDICAID 
(MB-41-F)

Priority:  Other Significant

CFR Citation:  42 CFR 440

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    04/21/95                    60 FR 19856
Final Action Effective          05/22/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Robert Wardwell
Phone: 410 786-5659

RIN: 0938-AF12
_______________________________________________________________________

1419. PHYSICIAN OWNERSHIP OF AND REFERRALS TO HEALTH CARE 
FACILITIES THAT FURNISH CLINICAL LABORATORY SERVICES AND FINANCIAL 
RELATIONSHIP REPORTING REQUIREMENTS (BPD-674-FC)

Priority:  Other Significant

CFR Citation:  42 CFR 411

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    08/14/95                    60 FR 41914

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Betty Burrier
Phone: 410 786-0191

RIN: 0938-AF40
_______________________________________________________________________

1420. MEDICARE AND MEDICAID PROGRAMS; ADVANCE DIRECTIVES (BPD-718-
F)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 417.436; 42 CFR 417.801; 42 CFR 431.20; 42 CFR 
431.107; 42 CFR 434.28; 42 CFR 483.10; 42 CFR 484.10; 42 CFR 489.10; 42 
CFR 489.100; 42 CFR 489.104; 42 CFR 498.3; 42 CFR 417.472; 42 CFR 
489.102

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    06/27/95                    60 FR 33262

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Thomas Hoyer
Phone: 410 786-5661

RIN: 0938-AF50
_______________________________________________________________________

1421. CLARIFICATION OF RESUMPTION OF ENTITLEMENT RULES FOR MEDICARE 
PATIENTS WITH END-STAGE RENAL DISEASE (BPD-738-F)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 406.13

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    05/08/95                    60 FR 22533
Final Action Effective          06/07/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Paul Olenick
Phone: 410 786-4472

RIN: 0938-AG19
_______________________________________________________________________

1422. STANDARDS FOR QUALITY OF WATER USED IN DIALYSIS AND REVISED 
GUIDELINES ON REUSE OF HEMODIALYZER FILTERS FOR END-STAGE RENAL DISEASE 
PATIENTS (BPD-766-F)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 405.2140; 42 CFR 405.2150

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    09/18/95                    60 FR 48039

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jackie Sheridan
Phone: 410 786-4635

RIN: 0938-AG21
_______________________________________________________________________

1423. COMMUNITY SUPPORTED LIVING ARRANGEMENTS SERVICES (MB-070-P)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 435.3; 42 CFR 435.260; 42 CFR 440.1; 42 CFR 
440.190; 42 CFR 441.400; 42 CFR 441.402; 42 CFR 441.404; 42 CFR 
441.406; 42 CFR 441.408; 42 CFR 441.410; 42 CFR 441.412; 42 CFR 441.414

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn - Funding ceased to 
exist after 9/30/95             03/20/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Mary Jean Duckett
Phone: 410 786-3294

RIN: 0938-AG35
_______________________________________________________________________

1424. CONDITIONS FOR PAYMENT FOR PHYSICIANS' SERVICES IN TEACHING 
SETTINGS (BPD-792-P)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 405; 42 CFR 415; 42 CFR 400

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Combined With RIN 0938-AG96     08/15/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: William Morse
Phone: 410 786-4520

RIN: 0938-AG53
_______________________________________________________________________

1425. DATE FOR FILING MEDICARE COST REPORTS (BPD-794-F)

Priority:  Other

CFR Citation:  42 CFR 405.376; 42 CFR 413.24

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    06/27/95                    60 FR 33137

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Katie Walker
Phone: 410 786-7278

RIN: 0938-AG55
_______________________________________________________________________

1426. EXPANSION OF THE DEFINITION OF EYE AND EAR SPECIALTY 
HOSPITALS (BPD-804-P)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 413

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn - Sunset date of 
legislation has been reached.   08/16/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Carolyn Mullen
Phone: 410 786-4589

RIN: 0938-AG67
_______________________________________________________________________

1427. CATEGORIZATION OF CLIA TESTS AND PERSONNEL MODIFICATIONS 
(HSQ-216-FC)

Priority:  Other Significant

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

CFR Citation:  42 CFR 493.2; 42 CFR 493.3; 42 CFR 493.5; 42 CFR 493.45; 
42 CFR 493.9; 42 CFR 493.47; 42 CFR 493.18; 42 CFR 493.19; 42 CFR 
493.20; 42 CFR 493.49; 42 CFR 493.25; 42 CFR 493.35; 42 CFR 493.37; 42 
CFR 493.39; 42 CFR 493.43; ...

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    04/24/95                    60 FR 20035

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Judith Yost
Phone: 410 786-3531

RIN: 0938-AG71
_______________________________________________________________________

1428. CRITERIA FOR MEDICARE COVERAGE OF LUNG TRANSPLANTS (BPD-812-
FN)

Priority:  Other Significant

CFR Citation:  None

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn - Public comments 
received did not require 
revisions.                      08/10/95

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Claude Mone
Phone: 410 786-5666

RIN: 0938-AG83
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Administration for Children and Families (ACF)
  
_______________________________________________________________________
  
1429. FOSTER CARE, ADOPTION ASSISTANCE, AND CHILD WELFARE SERVICES

Priority:  Other Significant

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

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

Legal Deadline:  NPRM, Statutory, July 1, 1995.

Abstract: This NPRM will propose requirements that implement the 
statutory provisions of the Social Security Act Amendments of 1994 on 
review of State programs under Parts B and E of the Social Security Act 
for conformity with State Plan requirements.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            04/00/96

Small Entities Affected: None

Government Levels Affected: State

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

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

RIN: 0970-AA97
_______________________________________________________________________

1430. BLOCK GRANT PROGRAMS (LOW INCOME HOME ENERGY ASSISTANCE 
PROGRAM --LIHEAP)--FY 1995 AND FY 1996 PROVISIONS

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 8621

CFR Citation:  45 CFR 96

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            02/00/96

Small Entities Affected: None

Government Levels Affected: State, Tribal

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

RIN: 0970-AB47
_______________________________________________________________________

1431. ADMINISTRATIVE FLEXIBILITY RULE

Priority:  Other Significant

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

Legal Authority:  42 USC 1302

CFR Citation:  45 CFR 205.31

Legal Deadline: None

Abstract: This proposed rule adds a new section 205.31 which will 
provide a simple administrative process for requesting waivers of 
certain AFDC regulatory provisions. Such waivers will give States more 
flexibility to devise procedures for the effective and efficient 
administration of their AFDC programs. The major provisions for which 
waivers will be granted are: (1) the requirements for prospective 
budgeting of income; (2) the time period for calculating the total 
amount of overpayment and the determination of when the initial 
overpayment begins; and (3) other provisions on various disregards and 
self-employment business expenses.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            04/00/96

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Mack Storrs, Director, Division of AFDC Program, 
Department of Health and Human Services, Administration for Children 
and Families, 370 L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 401-9289

RIN: 0970-AB49
_______________________________________________________________________

1432. DESIGNATION OF ALTERNATIVE AGENCY TO SERVE INDIAN TRIBAL 
CHILDREN

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 9801

CFR Citation:  45 CFR 1302

Legal Deadline: None

Abstract: This NPRM will specify a process by which an Indian tribe may 
identify and establish an alternative agency to provide Head Start 
Services if the agency previously serving the tribe is terminated.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            02/00/96

Small Entities Affected: Organizations

Government Levels Affected: Tribal

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start Bureau, Department of Health and Human Services, Administration 
for Children and Families, P.O. Box 1182, Washington, DC 20013
Phone: 202 205-8569

RIN: 0970-AB52
_______________________________________________________________________

1433. CONSTRUCTION OF HEAD START FACILITIES

Priority:  Other Significant

Legal Authority:  42 USC 9801

CFR Citation:  45 CFR 1309

Legal Deadline: None

Abstract: This NPRM will establish procedures to be used by Head Start 
agencies in requesting to use Head Start grant funds to construct or 
renovate a Head Start facility.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            01/00/96

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: Local, Tribal

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start, Bureau, Department of Health and Human Services, Administration 
for Children and Families, P.O. Box 1182, Washington, DC 20013
Phone: 202 205-8569

RIN: 0970-AB54
_______________________________________________________________________

1434. QUALITY STANDARDS FOR HEAD START PROGRAMS

Regulatory Plan:  This entry is Seq. No. 47 in Part II of this issue of 
the Federal Register.

RIN: 0970-AB55
_______________________________________________________________________

1435. HEAD START FELLOWSHIPS PROGRAM

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 9801

CFR Citation:  45 CFR 1311

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start Bureau, Department of Health and Human Services, Administration 
for Children and Families, P.O. Box 1182, Washington, DC 20013
Phone: 202 205-8569

RIN: 0970-AB56
_______________________________________________________________________

1436. REPORTING OVERDUE SUPPORT INFORMATION TO CONSUMER REPORTING 
AGENCIES

Priority:  Substantive, Nonsignificant

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

Legal Authority:  PL 103-432

CFR Citation:  45 CFR 302; 45 CFR 303

Legal Deadline: None

Abstract: This rule contains provisions regarding required State laws 
for reporting information concerning unpaid child support obligations 
to consumer reporting agencies. These provisions implement the 
requirements of section 212 of the Social Security Act Amendments of 
1994, which amend title IV-D of the Social Security Act. These 
provisions require States to adopt procedures for periodic reporting of 
information to consumer reporting agencies. This regulatory package 
will also include technical changes to other child support regulations 
to support the President's Regulatory reinvention initiative.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/00/95
Interim Final Rule              10/00/96

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State, Local

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

RIN: 0970-AB57
_______________________________________________________________________

1437.  ON-SITE FOSTER CARE ELIGIBILITY REVIEWS

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302

CFR Citation:  45 CFR 1356

Legal Deadline: None

Abstract: This NPRM will propose requirements that govern on-site 
eligibility reviews that the Administration for Children and Families 
conducts to assure State agencies' compliance with the statutory 
requirements under Title IV-E of the Social Security Act for 
eligibility of foster care providers and eligibility of the children in 
foster care.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            04/00/96

Small Entities Affected: None

Government Levels Affected: State

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

RIN: 0970-AB60
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Administration for Children and Families (ACF)
  
_______________________________________________________________________
  
1438. AMENDMENTS TO DEVELOPMENTAL DISABILITIES RULES

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 6000 et seq

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

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

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: State

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

Agency Contact: John Doyle, Director, Administration and Planning 
Staff, Administration on Developmental Disabilities, Department of 
Health and Human Services, Administration for Children and Families, 
200 Independence Avenue SW., Room 315D, Washington, DC 20201
Phone: 202 690-5504

RIN: 0970-AB11
_______________________________________________________________________

1439. FAMILY VIOLENCE PREVENTION AND SERVICES

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 10407

CFR Citation:  45 CFR 1370

Legal Deadline:  NPRM, Statutory, August 26, 1992. Final, Statutory, 
September 25, 1992.

Abstract: Would implement the requirements under the Family Violence 
Prevention and Services Act which provides various grants related to 
domestic violence.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/10/93                    58 FR 64920
Final Action                    12/00/95

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Local

Agency Contact: Margaret Washnitzer, Director, Division of State 
Assistance, Office of Community Services, Department of Health and 
Human Services, Administration for Children and Families, 370 L'Enfant 
Promenade SW., Washington, DC 20447
Phone: 202 401-2333

RIN: 0970-AB18
_______________________________________________________________________

1440. CHILD ABUSE AND NEGLECT STATE GRANT PROGRAM

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 5101

CFR Citation:  45 CFR 1340

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            05/18/94                    59 FR 26046
Final Action                    02/00/96

Small Entities Affected: None

Government Levels Affected: State

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

RIN: 0970-AB23
_______________________________________________________________________

1441. STANDARDS FOR SAFE TRANSPORTATION

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 9801 et seq

CFR Citation:  45 CFR 1310

Legal Deadline: None

Abstract: This rule establishes Head Start Performance Standards for 
the safe transportation of Head Start children, including vehicle 
requirements, driver qualifications and training and safety rules for 
children and staff while enroute and loading and unloading of vehicles.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            06/15/95                    60 FR 31612
Final Action                    06/00/96

Small Entities Affected: Organizations

Government Levels Affected: None

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start Bureau, Department of Health and Human Services, Administration 
for Children and Families, P.O. Box 1182, Washington, DC 20013
Phone: 202 205-8569

RIN: 0970-AB24
_______________________________________________________________________

1442. 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 established standards for the purchase of 
facilities as required by the Head Start Improvement Act of 1992.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/01/94                    59 FR 61575
Final Action                    01/00/96

Small Entities Affected: Organizations

Government Levels Affected: None

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start Bureau, Department of Health and Human Services, Administration 
for Children and Families, P.O. Box 1182, Washington, DC 20013
Phone: 202 205-8569

RIN: 0970-AB31
_______________________________________________________________________

1443. NATIONAL VOTER REGISTRATION ACT OF 1993 PROVISIONS AFFECTING 
PUBLIC ASSISTANCE AGENCIES

Priority:  Other Significant

Legal Authority:  PL 103-31

CFR Citation:  45 CFR 205.50 (a)(4); 45 CFR 206.10; 42 CFR 431.307 (a); 
42 CFR 431.307 (b)

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            11/22/94                    59 FR 60109
Final Action                    12/00/95

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
_______________________________________________________________________

1444. CHILD CARE--REVISED REGULATIONS

Priority:  Other Significant

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

Legal Authority:  42 USC 1302

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

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            05/11/94                    59 FR 24510
Final Action                    02/00/96

Small Entities Affected: None

Government Levels Affected: Undetermined

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

RIN: 0970-AB33
_______________________________________________________________________

1445. 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                    01/00/96

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
_______________________________________________________________________

1446. ADMINISTRATION OF NATIVE AMERICANS 45 CFR PART 1336

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 2991

CFR Citation:  45 CFR 1336

Legal Deadline: None

Abstract: This regulation amends 45 CFR part 1336 to implement 
legislative requirements. It will incorporate an appeals procedure 
affording applicants the opportunity to appeal based on organizational 
ineligibility or activities deemed ineligible, when determined by the 
ANA Commissioner. Native American organizations are expected to welcome 
these changes which provide for an appeal of appeals decisions and 
comport with amendments to the statute.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            04/21/95                    60 FR 19994
Final Action                    11/00/95

Small Entities Affected: Organizations

Government Levels Affected: Tribal

Agency Contact: Sharon McCully, Director, Planning and Support, 
Department of Health and Human Services, Administration for Children 
and Families, 200 Independence Ave SW., Washington, DC 20201
Phone: 020 690-5780

RIN: 0970-AB37
_______________________________________________________________________

1447. REDUCTION OF REPORTING REQUIREMENTS FOR THE STATE SYSTEMS 
ADVANCE PLANNING DOCUMENT (APD) PROCESS

Priority:  Other Significant

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

Legal Authority:  42 USC 1302

CFR Citation:  45 CFR 95.600

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            07/21/95                     60 FR 7858
Final Action                    07/00/96

Small Entities Affected: Undetermined

Government Levels Affected: None

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

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

RIN: 0970-AB46
_______________________________________________________________________

1448. 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                    02/00/96

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Mack A. Storrs, Director, Division of AFDC Program, 
Office of Family Assistance, Department of Health and Human Services, 
Administration for Children and Families, 370 L'Enfant Promenade SW., 
Washington, DC 20447
Phone: 202 401-9289

RIN: 0970-AB59
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Long-Term Actions
Administration for Children and Families (ACF)
  
_______________________________________________________________________
  
1449. INCOME ELIGIBILITY CRITERIA FOR INDIAN TRIBES

Priority:  Substantive, Nonsignificant

Legal Authority:  45 USC 9801

CFR Citation:  45 CFR 1305

Legal Deadline: None

Abstract: This NPRM will revise the income eligibility criteria used in 
enrolling Head Start children and families to allow Indian tribes, in 
certain situations, to enroll more children whose families do not meet 
Head Start's income criteria than would otherwise be possible.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/00/96

Small Entities Affected: Organizations

Government Levels Affected: Tribal

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start Bureau, Department of Health and Human Services, Administration 
for Children and Families, P.O. Box 1182, Washington, DC 20013
Phone: 202 205-8569

RIN: 0970-AB53
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Administration for Children and Families (ACF)
  
_______________________________________________________________________
  
1450. BLOCK GRANT PROGRAMS (LOW-INCOME HOME ENERGY ASSISTANCE 
PROGRAM --LIHEAP) FY 91 AND FY 92 PROVISIONS

Priority:  Substantive, Nonsignificant

CFR Citation:  45 CFR 96

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    05/01/95                    60 FR 21322

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Janet M. Fox
Phone: 202 401-9351

RIN: 0970-AB15
_______________________________________________________________________

1451. BLOCK GRANT PROGRAMS (LOW-INCOME HOME ENERGY ASSISTANCE 
PROGRAM--LIHEAP)--FY 93 AND FY 94 PROVISIONS

Priority:  Substantive, Nonsignificant

CFR Citation:  45 CFR 96

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn - Responsibility is 
transferred to ASPE.            10/01/95

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Janet M. Fox
Phone: 202 401-9351

RIN: 0970-AB16
_______________________________________________________________________

1452. STATEWIDE AUTOMATED CHILD WELFARE INFORMATION SYSTEM

Priority:  Substantive, Nonsignificant

CFR Citation:  45 CFR 1355; 45 CFR 1356

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    05/19/95                    60 FR 26829

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Naomi B. Marr
Phone: 202 401-6960

RIN: 0970-AB38
_______________________________________________________________________

1453. REFUGEE RESETTLEMENT PROGRAM: MISCELLANEOUS, COMPREHENSIVE 
CHANGES

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 400

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    06/28/95                    60 FR 33617

Small Entities Affected: None

Government Levels Affected: State, Local

Agency Contact: Toyo A. Biddle
Phone: 202 401-9250

RIN: 0970-AB42
_______________________________________________________________________

1454. DIRECT PAYMENTS TO INDIAN TRIBES AND TRIBAL ORGANIZATIONS 
UNDER TITLE IV-B, SUBPART 1

Priority:  Substantive, Nonsignificant

CFR Citation:  45 CFR 1357.40

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    06/22/95                    60 FR 28735

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State, Tribal

Agency Contact: Michael Ambrose
Phone: 202 205-8618

RIN: 0970-AB44
_______________________________________________________________________

1455. REPATRIATION - ADVANCE APPROVAL OF COSTS

Priority:  Substantive, Nonsignificant

CFR Citation:  45 CFR 212

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    04/21/95                    60 FR 19862

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: David B. Smith
Phone: 202 401-9255

RIN: 0970-AB45
_______________________________________________________________________

1456. AFCARS DATA ELEMENT ON FOSTER CARE PAYMENTS

Priority:  Substantive, Nonsignificant

CFR Citation:  45 CFR 1355

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    08/09/95                    60 FR 40505

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Daniel H. Lewis
Phone: 202 205-8619

RIN: 0970-AB58
_______________________________________________________________________

1457.  REMOVAL OF KEYS AMENDMENT REGULATIONS

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:  42 USC 1302

CFR Citation:  45 CFR 1397

Legal Deadline: None

Abstract: Effective March 31, 1995, the Social Security Administration 
has responsibility for the Key Amendments as part of the independent 
agency legislations. We are eliminating these Deppartmental rules so 
that Social Security can proceed with their own regulations and 
guidance.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Action                    05/16/95                    60 FR 26000

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Madeline Mocko, Director, Office of Legislation and 
Budget, Department of Health and Human Services, Administration for 
Children and Families, 370 L'enfant Promenade SW., WWashington, DC 
20447
Phone: 202 401-9223

RIN: 0970-AB61
_______________________________________________________________________

1458.  REMOVAL OF OBSOLETE FAMILY ASSISTANCE REGULATION

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

CFR Citation:  45 CFR 205; 45 CFR 224; 45 CFR 233; 45 CFR 238; 45 CFR 
239; 45 CFR 240; 45 CFR 282

Legal Deadline: None

Abstract: This notice removes several obsolete provisions from the Code 
of Federal Regulations. Most involve work program activities which were 
superseded when State welfare agencies began their JOBS programs in 
1989 and 1990.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Action                    05/17/95                    60 FR 26373

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Maneline Mocko, Director, Office of Legislation and 
Budget, Department of Health and Human Services, Administration for 
Children and Families, 370 L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 401-9223

RIN: 0970-AB62
_______________________________________________________________________

1459.  ELIMINATION OF OBSOLETE BLOCK GRANT RULES

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 9912

CFR Citation:  45 CFR 1010; 45 CFR 1050; 45 CFR 1060; 45 CFR 1061; 45 
CFR 1064; 45 CFR 1067; 45 CFR 1068; 45 CFR 1069; 45 CFR 1070; 45 CFR 
1076

Legal Deadline: None

Abstract: This final rule removes a number of obsolete provisions from 
the Code of Federal Regulations. These provisions concern program 
activities under the former Community Services Administration (CSA) 
which were superseded by Community Services Block Grant Act, enacted as 
part of the Omnibus Budget Reconciliation Act of 1981.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Action                    05/17/95                    60 FR 26374

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Madeline Mocko, Director, Office of Legislation and 
Budget, Department of Health and Human Services, Administration for 
Children and Families, 370 L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 401-9223

RIN: 0970-AB63
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Long-Term Actions
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, sec 202(a)(10); PL 102-375, sec 
202(a)(14); PL 102-375, sec 305(a); PL 102-375, sec 305(a)(1); PL 102-
375, sec 305(a)(2)(c); PL 102-375, sec 305(a)(2); PL 102-375, sec 
305(a)(2)(D); PL 102-375, sec 305(a)(1)(E); PL 102-375, sec 
305(a)(2)(E); PL 102-375, secs 305(d)(1) to 305(d)(4); PL 102-375, sec 
305(a)(A)(i); PL 102-375, sec 306(a)(6)(O)(i); PL 102-375, sec 
306(a)(13); PL 102-375, sec 307(a)(1); PL 102-375, sec 307(a)(C)(i)

CFR Citation:  45 CFR 1321; 45 CFR 1324; 45 CFR 1326; 45 CFR 1327; 45 
CFR 1328

Legal Deadline: None
Unknown until law is reauthorized.

Abstract: The Administration on Aging (AoA) anticipates revising 
current rules to reflect the changes resulting from the pending 
reauthorization of the Older Americans Act which incorporates greater 
flexibility for the States. PURPOSE: The purpose of these revisions are 
to implement the newly enacted law. in the development and provision of 
community-based services.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Elder Rights Protection  NPRM 11/15/94 (59 FR 59056)  NPRM Comment 
Period End 01/17/95 (59 FR 59056)

Intrastate Funding Formulas  NPRM 10/17/94 (59 FR 12728)  Final Action 
08/01/95

OAA Amdendments in FY '96  NPRM 08/01/96


Next Action Undetermined

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Tribal

Agency Contact: Edwin Walker, Director, Office of Program Development 
and Operations, Department of Health and Human Services, Administration 
on Aging, 330 Independence Avenue SW., Room 4733, Cohen Bldg., 
Washington, DC 20201
Phone: 202 619-0011

RIN: 0985-AA00
[FR Doc. 95-26777 Filed 11-24-95; 8:45 am]
BILLING CODE 4150-04-F