[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

20 CFR Ch. III

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 April 25, 1994.

FOR FURTHER INFORMATION CONTACT: For further inquiries or comments 
related to specific regulations listed in the agenda, the public is 
encouraged to contact the appropriate responsible individual. Questions 
or comments on the overall agenda should be sent to: Ann White, 
Regulations Coordinator, Office of the Secretary, Department of Health 
and Human Services, 200 Independence Avenue SW., Washington, DC 20201; 
telephone: (202) 690-6824.

SUPPLEMENTARY INFORMATION:

Department of Health and Human Services Regulatory Plan

    For this edition of the Department of Health and Human 
Services' 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.

Health Care Financing Administration

    Please note that many of the Health Care Financing 
Administration entries use acronyms and public law citations that 
refer to popular titles of well-known laws. As an aid to readers, 
we offer the following cross-reference guide:

    COBRA '85--Consolidated Omnibus Budget Reconciliation Act of 
1985 (PL 99-272).

    OBRA '86--Omnibus Budget Reconciliation Act of 1986 (PL 99-
509).

    OBRA '87--Omnibus Budget Reconciliation Act of 1987 (PL 100-
93).

    MCAA '88--Medicare Catastrophic Coverage Act of 1988 (PL 100-
360).

    FSA '88--Family Support Act of 1988 (PL 100-485).

    CLIA '88--Clinical Laboratory Improvement Amendments of 1988 
(PL 100-578).

    TMRA '88--Technical and Miscellaneous Revenue Act of 1988 (PL 
100-647).

    OBRA '89--Omnibus Budget Reconciliation Act of 1989 (PL 101-
239).

    OBRA '90--Omnibus Budget Reconciliation Act of 1990 (PL 101-
508).

    OBRA '93--Omnibus Budget Reconciliation Act of 1993 (PL 103-
66).

Jacquelyn Y. White,

Deputy Executive Secretary to the Department.

                                  Office of the Secretary--Proposed Rule Stage                                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1339        Nondiscrimination Requirements (Including on the Basis of Sex or Religion) Applicable               
            to Block Grants and Standard Nondiscrimination Procedures Applicable to Certain Other               
            Programs..............................................................................    0991-AA02 
1340        Civil Money Penalties (CMPs) for Certain Hospital Physician Incentive Plans...........    0991-AA45 
1341        Civil Money Penalties (CMPs) for Certain Practices Relating to Medicare Supplemental                
            Policies..............................................................................    0991-AA53 
1342        Amendment to Grants Management Common Rule To Raise Threshold for Simplified Small                  
            Purchases.............................................................................    0991-AA77 
----------------------------------------------------------------------------------------------------------------


                                    Office of the Secretary--Final Rule Stage                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1343        Civil Money Penalties and Exclusions for Assistants at Cataract Surgery...............    0991-AA37 
1344        Block Grant Programs..................................................................    0991-AA55 
1345        Uniform Administrative Requirements for Grants and Cooperative Agreements.............    0991-AA56 
1346        Civil Money Penalties for Physician Ownership of and Referral to Certain Health Care                
            Entities..............................................................................    0991-AA65 
1347        Additional Safe Harbor Provisions Under the Anti-Kickback Statute.....................    0991-AA66 
1348        Safe Harbors for Protecting Health Plans..............................................    0991-AA69 
1349        Governmentwide Guidance for New Restrictions on Lobbying; Interim Final Guidance......    0991-AA70 
1350        Revisions to the PRO Sanctions Process................................................    0991-AA73 
1351        Clarification of the OIG Safe Harbor Anti-Kickback Provisions.........................    0991-AA74 
----------------------------------------------------------------------------------------------------------------


                                   Office of the Secretary--Completed Actions                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1352        Civil Money Penalties and Intermediate Sanctions for HMOs and Competitive Medical                   
            Plans.................................................................................    0991-AA44 
----------------------------------------------------------------------------------------------------------------


                                    Departmental Management--Final Rule Stage                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1353        Implementation of the Equal Access to Justice Act in Agency Proceedings...............    0990-AA02 
----------------------------------------------------------------------------------------------------------------


                               Social Security Administration--Proposed Rule Stage                              
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1354        Old-Age, Survivors, and Disability Insurance and Supplemental Security Income                       
            Programs; Adjustments in SSI Benefits on Account of Retroactive Benefits Under Title                
            II (061P).............................................................................    0960-AB38 
1355        Old-Age, Survivors, and Disability Insurance and Supplemental Security Income                       
            Programs; Evaluation Guides for Determining Substantial Gainful Activity (SGA) (147P).    0960-AB73 
1356        Old-Age, Survivors, and Disability Insurance Program; Nonpayment of Benefits to                     
            Prisoners, Vocational Rehabilitation Exception (166P).................................    0960-AC16 
1357        Old-Age, Survivors and Disability Insurance and Supplemental Security Income Programs;              
            Vocational Factors Regulations Restructuring and Clarification (207P).................    0960-AC61 
1358        Old-Age, Survivors, and Disability Insurance and Supplemental Security Income                       
            Programs; Interim Disability Benefits (215P)..........................................    0960-AC76 
1359        Old-Age, Survivors, and Disability Insurance and Supplemental Security Income                       
            Programs; Appeals Council Notice Requirements (235P)..................................    0960-AC93 
1360        Supplemental Security Income Program; Augmented Benefits (271P).......................    0960-AD07 
1361        Old-Age, Survivors, and Disability Insurance and Supplemental Security Income for the               
            Aged, Blind, and Disabled; Fees for Representation of Claimants (296P)................    0960-AD23 
1362        OASDI and SSI for the Aged, Blind and Disabled; Continuation of Benefits on Account of              
            Participation in a Non-State VR Program (299P)........................................    0960-AD26 
1363        Supplemental Security Income for the Aged, Blind, and Disabled; Exclusion From Income               
            and Resources of Victims' Compensation Payments and State Relocation Assistance (311F)    0960-AD36 
1364        Supplemental Security Income for the Aged, Blind, and Disabled; Reimbursement for VR                
            Services Furnished During Certain Months of Non-payment (315P)........................    0960-AD39 
1365        Code of Conduct for Administrative Law Judges and Administrative Appeals Judges of the              
            Social Security Administration (341P).................................................    0960-AD54 
1366        Election of Benefits Based on Age by Disabled Widow, Widower, and Surviving Divorced                
            Spouse Beneficiaries (343P)...........................................................    0960-AD56 
1367        Against Equity and Good Conscience (348P).............................................    0960-AD62 
1368        Old-Age, Survivors, and Disability Insurance Program; Revised Medical Criteria for                  
            Determination of Disability; Hemic and Lymphatic System, and Malignant Neoplastic                   
            Diseases (399P) (Reg Plan Seq. No. 33)................................................    0960-AD67 
1369        Procedures for Handling Earnings Reports (418F).......................................    0960-AD70 
1370        Conduct of Representatives Under Title II or Title XVI (431P).........................    0960-AD73 
1371        Statement of Earnings and Benefit Estimate (415P).....................................    0960-AD74 
1372        Fees for Federal Administration of State Supplementary Payments in the SSI Program                  
            (376P)................................................................................    0960-AD75 
1373        Who May Protect a Potential Claimant's Filing Date or Application for Supplemental                  
            Security Income Benefits (408P).......................................................    0960-AD76 
1374        Reliable Information Which is Currently Available for Determining Benefit Amounts in                
            the Supplemental Security Income Program (NEWMAN) (434P)..............................    0960-AD77 
1375        Revised Medical Criteria for Determination of Disability, Endocrine System and Obesity              
            and Related Criteria (436P) (Reg Plan Seq. No. 34)....................................    0960-AD78 
1376        Revised Medical Criteria for Determination of Disability, Growth Impairments (444P)                 
            (Reg Plan Seq. No. 35)................................................................    0960-AD80 
1377        Valuation of Certain In-Kind Support and Maintenance (ISM) Where There is a Cost-of-                
            Living Adjustment in SSI Benefits (454P)..............................................    0960-AD82 
1378        Relationship/Coverage Actions Note Initial Determinations/SSI Corrections (455P)......    0960-AD83 
1379        Prevention of Adverse Effects on Eligibility and Benefit Amount When Spouse or Parent               
            Absent Due to Active Military Service (462P)..........................................    0960-AD86 
1380        Extension of Time Period for Not Counting as Resources, Funds Received for Repair or                
            Replacement of Damaged or Destroyed Excluded Resources in the SSI Program (486P)......    0960-AD87 
1381        Federal OASDI and SSI for the Aged, Blind, and Disabled; Signature Requirements for                 
            State Agency Medical and Psychological Consultants in Disability Determinations (465P)    0960-AD88 
1382        Federal Old-Age, Survivors, and Disability Insurance and Supplemental Security Income,              
            Acceptable Medical Sources (469P).....................................................    0960-AD91 
1383        Old-Age, Survivors, and Disability Insurance Program; Contributions for Support (475P)    0960-AD92 
1384        Computation of SSI Benefits for the First Three Months of Payment (476P)..............    0960-AD93 
1385        Definition of ``Largest Benefit Amount'' for Purposes of Determining the Earnings                   
            Record on Which a Person Who Is Simultaneously Entitled to Child's Insurance Benefits               
            (481P)................................................................................   0960-AD95  
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.          


                                Social Security Administration--Final Rule Stage                                
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1386        Supplemental Security Income Program; Suspensions, Terminations, and Advance Notice of              
            Adverse Determinations (031F).........................................................    0960-AA22 
1387        Old-Age, Survivors, and Disability Insurance Program; Revised Medical Criteria for                  
            Determination of Disability; Musculoskeletal System (143F) (Reg Plan Seq. No. 36).....    0960-AB01 
1388        Old-Age, Survivors, and Disability Insurance and Supplemental Security Income Program;              
            Continued Payment of Benefits to Persons in Vocational Rehabilitation Programs (131F).    0960-AB05 
1389        Supplemental Security Income Program; Proceeds of a Loan, Payment of Pro Rata Share of              
            Household Operating Expenses (180F)...................................................    0960-AC42 
1390        Old-Age, Survivors, and Disability Insurance Program; Applicability of Government                   
            Pension to Certain Federal Employees (188F)...........................................    0960-AC46 
1391        Supplemental Security Income Program; Continuation of Full Benefit Standard for                     
            Certain Persons Temporarily Institutionalized (198F)..................................    0960-AC55 
1392        Old-Age, Survivors, and Disability Insurance Program; Medical Criteria for Evaluating               
            Mental Disorders for Adults (222F) (Reg Plan Seq. No. 37).............................    0960-AC74 
1393        Supplemental Security Income Program; Treatment of Augmented Veterans' Benefits (231F)    0960-AC82 
1394        Supplemental Security Income Program; Waiver of SSI Rule for Deeming to Children the                
            Income and Resources of Their Parents for Certain Disabled Children (252F)............    0960-AC96 
1395        SSI Program; Reduction in Time When Income and Resources of Separated Couples Must Be               
            Treated as Jointly Available for Purposes of SSI Eligibility and Benefits (254F)......    0960-AC98 
1396        Old-Age, Survivors, and Disability Insurance and Supplemental Security Income for the               
            Aged, Blind, and Disabled; Updating Nomenclature (264F)...............................    0960-AD11 
1397        Old-Age, Survivors, and Disability Insurance and Supplemental Security Income for the               
            Aged, Blind, and Disabled; Representative Payee Reforms (295F) (Reg Plan Seq. No. 38).    0960-AD22 
1398        Organization and Procedures; Procedures of the Office of Hearings and Appeals;                      
            Authority of Appeals Officers to Deny a Request for Appeals Council Review (334F).....    0960-AD45 
1399        OASDI and SSI; Testing Modifications to the Disability Determination Procedures (359F)              
            (Reg Plan Seq. No. 39)................................................................    0960-AD63 
1400        Reliable Information Which Is Currently Available for Determining Benefit Amounts in                
            the Supplemental Security Income Program (382F).......................................    0960-AD65 
1401        Compensation of Qualified Organizations Serving as Representative Payees Under Title                
            II and Title XVI (423F)...............................................................    0960-AD71 
1402        Federal OASDI and SSI; Computing Benefit Amounts, Disposing of Underpayments,                       
            Resolving Overpayments, and Payment Restriction (428F)................................    0960-AD72 
1403        Federal Old-Age, Survivors, and Disability Insurance; Evidence Required to Presume a                
            Person Is Dead (443F).................................................................    0960-AD79 
1404        Temporary Increase in Sponsorship Period for Aliens Under the SSI Program (457F)......    0960-AD84 
1405        Replacement of Lost, Damaged or Stolen Excluded Resources (Hurricane Andrew) (458I)...    0960-AD85 
1406        Technical Changes to Title XVI (466F).................................................    0960-AD89 
1407        Supplemental Security Income for the Aged, Blind or Disabled; Evidence of Lawful                    
            Admission for Permanent Residence in the United States (486F).........................   0960-AD90  
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.          


                                Social Security Administration--Completed Actions                               
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1408        Supplemental Security Income Program; What Is Not Income (121F).......................    0960-AB09 
1409        Supplemental Security Income Program; Continuation of Benefits and Special Eligibility              
            for Certain Severely Impaired Recipients Who Work (171F)..............................    0960-AC22 
1410        Old-Age, Survivors, and Disability Insurance and Supplemental Security Income                       
            Programs; Deemed Application Date Based on Misinformation (267F)......................    0960-AD05 
1411        Supplemental Security Income Program; Financial Institution Accounts in the SSI                     
            Program (278F)........................................................................    0960-AD10 
1412        Supplemental Security Income for the Aged, Blind, and Disabled; Treatment of Certain                
            Royalties and Honoraria (310F)........................................................    0960-AD35 
1413        Supplemental Security Income Program; Treatment of Promissory Notes in Home                         
            Replacement Situations (182F).........................................................    0960-AD61 
1414        Appeal Rights Following State-Initiated Mass Change in Federally Administered State                 
            Supplementary Payments Resulting in Reduction, Suspension, or Termination of State                  
            Supplementary Payments (383F).........................................................    0960-AD66 
1415        Eligibility for Children of Armed Forces Personnel Residing Outside the United States               
            Other Than in Foreign Countries (452F)................................................    0960-AD81 
1416        Federal Old-Age, Survivors and Disability Insurance; Determining Disability and                     
            Blindness; Extension of Expiration Date for the Listing of Impairments, Mental                      
            Disorders in Adults (477F)............................................................    0960-AD94 
----------------------------------------------------------------------------------------------------------------


            Public Health Service--Office of Assistant Secretary for Health (OASH)--Final Rule Stage            
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1417        Public Health Service Policies on Research Misconduct.................................    0905-AE02 
1418        Standards of Compliance for Abortion-Related Services in Family Planning Service                    
            Projects..............................................................................    0905-AE03 
----------------------------------------------------------------------------------------------------------------


            Public Health Service--Office of Assistant Secretary for Health (OASH)--Completed Actions           
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1419        Privacy Act; Exempt System............................................................    0905-AD31 
----------------------------------------------------------------------------------------------------------------


 Public Health Service--Substance Abuse and Mental Health Services Administration (SAMHSA)--Proposed Rule Stage 
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1420        Confidentiality of Substance Abuse Patient Records....................................    0905-AD97 
1421        Protection and Advocacy for Individuals With Mental Illness...........................    0905-AD99 
1422        Community Mental Health Services Block Grants.........................................    0905-AE24 
----------------------------------------------------------------------------------------------------------------


   Public Health Service--Substance Abuse and Mental Health Services Administration (SAMHSA)--Final Rule Stage  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1423        Block Grants for Prevention and Treatment of Substance Abuse..........................    0905-AD98 
1424        Block Grants for Prevention and Treatment of Substance Abuse (Tobacco Provisions) (Reg              
            Plan Seq. No. 45).....................................................................   0905-AE05  
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.          


            Public Health Service--Centers for Disease Control and Prevention (CDC)--Final Rule Stage           
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1425        Respiratory Protective Devices (Reg Plan Seq. No. 46).................................    0905-AB58 
1426        Interstate Shipment of Biological Material That Contains or May Contain Infectious                  
            Substances............................................................................    0905-AC89 
1427        Medical Examination of Aliens.........................................................   0905-AD29  
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.          


                    Public Health Service--Food and Drug Administration (FDA)--Prerule Stage                    
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1428        Medical Foods.........................................................................    0905-AD91 
1429        Sunglasses; Labeling; Ultraviolet Radiation...........................................    0905-AE35 
1430        Investigational Device Exemption: Cost Recovery.......................................    0905-AE36 
1431        Development of Hazard Analysis Critical Control Points for the Food Industry; Request               
            for Comments (Reg Plan Seq. No. 40)...................................................   0905-AE60  
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.          


                 Public Health Service--Food and Drug Administration (FDA)--Proposed Rule Stage                 
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1432        Over-the-Counter (OTC) Drug Review....................................................    0905-AA06 
1433        New Animal Drug Approval Process; Implementation of Title I of the Generic Animal Drug              
            and Patent Term Restoration Act.......................................................    0905-AA96 
1434        Infant Formula Act....................................................................    0905-AC46 
1435        Reporting of Errors and Accidents Relating to Blood Safety and Withdrawal of                        
            Previously Proposed Rule..............................................................    0905-AD67 
1436        Proposed Labeling for Drug Products Based on False or Fraudulent Data.................    0905-AD71 
1437        Review of Warnings, Use Instructions, and Precautionary Information Under Section 314               
            of the National Childhood Vaccine Injury Act of 1986..................................    0905-AD72 
1438        Performance Standard for the Infant Apnea Monitor.....................................    0905-AD83 
1439        Mammography Quality Standards Act of 1992 (Reg Plan Seq. No. 41)......................    0905-AE19 
1440        Certification of Drugs Composed Wholly or Partly of Insulin; Fees for Certification of              
            Drugs Composed Wholly or Partly of Insulin............................................    0905-AE28 
1441        Adverse Experience Reporting Requirements for Human Drug and Licensed Biological                    
            Products..............................................................................    0905-AE29 
1442        Electronic Signatures.................................................................    0905-AE31 
1443        Financial Disclosure by Clinical Investigators........................................    0905-AE32 
1444        Effective Date of Requirement for Submission of Premarket Approval Applications.......    0905-AE34 
1445        Latex Condoms/Gloves: Expiration Date Labeling........................................    0905-AE37 
1446        Amalgam Ingredient Labeling...........................................................    0905-AE39 
1447        Latex Warning.........................................................................    0905-AE40 
1448        Premarket Approval of Medical Devices; Supplemental Applications......................    0905-AE41 
1449        Medical Devices; Restricted Devices...................................................    0905-AE42 
1450        Prescription Drug Product Labeling; Medication Guide (Reg Plan Seq. No. 42)...........    0905-AE43 
1451        Hearing Aids; Professional and Patient Labeling; Conditions for Sale..................    0905-AE46 
1452        Human Tissue Intended for Transplantation: Proposed Rule..............................    0905-AE49 
1453        Foods Derived from New Plant Varieties; Premarket Notification (Reg Plan Seq. No. 43).    0905-AE50 
1454        Classification of Computer Software Programs That Are Medical Devices.................    0905-AE58 
1455        Iron Containing Drugs and Supplements.................................................    0905-AE59 
1456        New Drug and Biological Product License Applications; Regulations Implementing the                  
            Prescription Drug User Fee Act of 1992 and Clarifying Existing Regulations............    0905-AE61 
1457        Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding               
            of Drugs; Proposed Amendment of Certain Requirements for Finished Pharmaceuticals.....   0905-AE63  
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.          


                   Public Health Service--Food and Drug Administration (FDA)--Final Rule Stage                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1458        Policies Concerning Uses of Sulfiting Agents..........................................    0905-AB52 
1459        Abbreviated New Drug Application Regulations (Title I of the ``Drug Price Competition               
            and Patent Term Restoration Act of 1984'')............................................    0905-AB63 
1460        Current Good Manufacturing Practice for Blood and Blood Components; Notification of                 
            Consignees Receiving Blood and Blood Components at Increased Risk for Transmitting HIV              
            Infection.............................................................................    0905-AC90 
1461        Lead in Foods.........................................................................    0905-AC91 
1462        Expediting Approval for Drugs Intended To Treat Life-Threatening and Severely                       
            Debilitating Illnesses................................................................    0905-AC94 
1463        Fees for Certification Services; Insulin and Color Additive Certification Programs....    0905-AD34 
1464        Prescription Drug Marketing Act of 1987; Policy Information, Guidance, and                          
            Clarifications........................................................................    0905-AD44 
1465        Implementation of the Safe Medical Devices Act of 1990................................    0905-AD59 
1466        Mandatory HACCP Seafood Inspection Program............................................    0905-AD60 
1467        Bottled Water.........................................................................    0905-AD65 
1468        Specific Requirements on Content and Format of Labeling for Human Prescription Drugs;               
            Revision of ``Pediatric Use'' Subsection in the Labeling..............................    0905-AD76 
1469        Recordkeeping and Reporting: Electronic Products......................................    0905-AD78 
1470        General Biological Product Standards; Alternative Procedures and Exceptions...........    0905-AD82 
1471        Medical Devices; Protective Restraints; Revocation of Exemptions From 510(k) Premarket              
            Notification Procedures and Current Good Manufacturing Practices Regulations..........    0905-AD84 
1472        Threshold of Regulation Policy for Components of Food Contact Articles................    0905-AD86 
1473        Food Labeling Review..................................................................    0905-AD89 
1474        Levo-Alpha-Methadol (LAAM) in Maintenance; Joint Proposed Revision of Conditions for                
            Use...................................................................................    0905-AD92 
1475        Temporomandibular Joint Implant Classification........................................    0905-AD93 
1476        Disqualification of Clinical Investigators............................................    0905-AD94 
1477        Investigational Device Exemption; Intraocular Lenses..................................    0905-AD95 
1478        Dietary Supplement Label Review.......................................................    0905-AD96 
1479        Adverse Experience Reporting Required for Licensed Biological Products................    0905-AE18 
1480        Specific Requirements on Content and Format of Labeling for Human Prescription Drugs;               
            Addition of ``Geriatric Use'' Subsection in the Labeling..............................    0905-AE26 
1481        Tamper-Evident Packaging Requirements for Over-The-Counter Human Drug Products........    0905-AE27 
1482        Substances Prohibited for Use in Ruminant Feed........................................    0905-AE45 
----------------------------------------------------------------------------------------------------------------


                  Public Health Service--Food and Drug Administration (FDA)--Completed Actions                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1483        Implementation of Title I of the Generic Animal Drug and Patent Term Restoration Act..    0905-AD15 
----------------------------------------------------------------------------------------------------------------


         Public Health Service--Health Resources and Services Administration (HRSA)--Proposed Rule Stage        
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1484        National Health Service Corps Loan Repayment Program; Grants for State Loan Repayment               
            Programs..............................................................................    0905-AC65 
1485        Organ Procurement and Transplantation Network Rules (Reg Plan Seq. No. 44)............    0905-AD26 
1486        Health Education Assistance Loan (HEAL) Program: Lenders'/ Holders' Performance                     
            Standards.............................................................................    0905-AD87 
1487        National Vaccine Injury Compensation Program: Revisions and Additions to the Vaccine                
            Injury Table - II.....................................................................   0905-AE52  
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.          


          Public Health Service--Health Resources and Services Administration (HRSA)--Final Rule Stage          
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1488        National Vaccine Injury Compensation Program (VICP): Revisions to the Vaccine Injury                
            Table.................................................................................    0905-AD64 
1489        Grants for Faculty Training Projects in Geriatric Medicine and Dentistry..............    0905-AE13 
1490        Grants for the Establishment of Departments of Family Medicine........................    0905-AE17 
1491        Medical Facility Construction and Modernization Requirements for Provision of Services              
            to Persons Unable to Pay (Nursing Homes)..............................................    0905-AE33 
1492        National Practitioner Data Bank for Adverse Information on Physicians and Other Health              
            Care Practitioners: Amendment to Data Bank Regulations To Comply With Court Order.....    0905-AE38 
1493        Federally Supported Health Centers Assistance Act of 1992.............................    0905-AE48 
1494        National Practitioner Data Bank for Adverse Information on Physicians, Dentists, and                
            Other Health Care Practitioners: Debt Collection Methods..............................    0905-AE53 
1495        Technical Amendments to the Health Professions, Nursing, and Allied Health Training                 
            Grant Programs Under 42 CFR Parts 57 and 58...........................................    0905-AE54 
----------------------------------------------------------------------------------------------------------------


          Public Health Service--Health Resources and Services Administration (HRSA)--Completed Actions         
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1496        Maternal and Child Health (MCH) Project Grants........................................    0905-AD88 
1497        Medical Facility Construction and Modernization; Requirements for Provision of                      
            Services to Persons Unable To Pay (Charitable Facilities).............................    0905-AE06 
1498        Grants for Nurse Practitioner and Nurse-Midwifery Programs............................    0905-AE11 
----------------------------------------------------------------------------------------------------------------


                     Public Health Service--Indian Health Service (IHS)--Proposed Rule Stage                    
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1499        Indian Health Service Loan Repayment Program Regulations..............................    0905-AC96 
1500        Indian Health Service Catastrophic Health Emergency Fund Program......................    0905-AC97 
1501        Revision of Urban Indian Health Regulations...........................................    0905-AD20 
1502        Acquisition Under the Buy Indian Act..................................................    0905-AE09 
----------------------------------------------------------------------------------------------------------------


                      Public Health Service--Indian Health Service (IHS)--Final Rule Stage                      
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1503        Revision of Indian Self-Determination Regulations (Reg Plan Seq. No. 47)..............    0905-AC98 
1504        Review of the Determination of an Indian Tribe's Resource Deficiency Level............   0905-AD21  
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.          


                 Public Health Service--National Institutes of Health (NIH)--Proposed Rule Stage                
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1505        Grants for Research Projects..........................................................    0905-AC02 
1506        National Institutes of Health AIDS Research Loan Repayment Program....................    0905-AD18 
1507        Hazardous Substances Basic Research and Training Grants...............................    0905-AD46 
1508        National Institutes of Health Construction Grants.....................................    0905-AD49 
1509        Standards for Bone Marrow Registries and Centers......................................    0905-AD51 
1510        Training Grants.......................................................................    0905-AD56 
1511        National Institutes of Health Center Grants...........................................    0905-AE00 
1512        Grants for National Alcohol Research Centers..........................................    0905-AE08 
1513        National Institutes of Health Clinical Research Loan Repayment Program for Individuals              
            from Disadvantaged Backgrounds........................................................    0905-AE56 
1514        Undergraduate Scholarship Program Regarding Professions Needed by the NIH.............    0905-AE57 
1515        Traineeships (Termination Policies)...................................................    0905-AE62 
----------------------------------------------------------------------------------------------------------------


                  Public Health Service--National Institutes of Health (NIH)--Final Rule Stage                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1516        Traineeships..........................................................................    0905-AD28 
1517        National Institute of Environmental Health Sciences Hazardous Waste Worker Training...    0905-AD69 
1518        Responsibilities of Public Health Service-Funded Institutions for Promoting                         
            Objectivity in Research (Reg Plan Seq. No. 48)........................................    0905-AE01 
1519        National Heart, Lung, and Blood Institute Grants for Prevention and Control Projects..    0905-AE25 
1520        National Library of Medicine Grants...................................................   0905-AE55  
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.          


                  Public Health Service--National Institutes of Health (NIH)--Completed Actions                 
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1521        Health and Human Services Policy for Protection of Human Subjects.....................    0905-AE47 
----------------------------------------------------------------------------------------------------------------


           Public Health Service--Agency for Health Care Policy and Research (AHCPR)--Final Rule Stage          
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1522        Health Services Research, Evaluation, Demonstration, and Dissemination Projects; Peer               
            Review of Grants and Contracts........................................................    0905-AD30 
----------------------------------------------------------------------------------------------------------------


                            Health Care Financing Administration--Proposed Rule Stage                           
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1523        Hospice Services (MB-7-P).............................................................    0938-AC52 
1524        Transfer of Resources for Less Than Fair Market Value (MB-10-P).......................    0938-AD18 
1525        Medicare Coverage of Outpatient Occupational Therapy Services (BPD-425-P).............    0938-AD32 
1526        Revisions to the Freedom of Information Regulations (OPA-1-P).........................    0938-AD60 
1527        New Minimum Standards for Medicare Supplemental (Medigap) Policies (BPD-491-P)........    0938-AD82 
1528        Fee Schedule for Payment of Clinical Psychologist Services (BPD-495-P)................    0938-AD84 
1529        Clarification of ``Without Fault'' as It Applies to Physician Provider and Supplier                 
            Liability (BPD-719-P).................................................................    0938-AD95 
1530        Protection of Income and Resources for Community Spouse (MB-23-P).....................    0938-AE12 
1531        Physician Certification and Plan of Care Requirements and Inspection of Care Reviews                
            (HSQ-178-P)...........................................................................    0938-AE17 
1532        Medicaid Payment of Medicare Cost Sharing for Qualified Medicare Beneficiaries and                  
            Qualified Disabled and Working Individuals and Specified Low-Income Medicare                        
            Beneficiaries (MB-031-P)..............................................................    0938-AE38 
1533        Coverage of Physician Assistant, Nurse Practitioner, and Clinical Nurse Specialist                  
            Services (BPD-708-P)..................................................................    0938-AF00 
1534        Provider Reimbursement Determinations and Appeals Revisions (BPD-727-P)...............    0938-AF28 
1535        Alternative Sanctions for Psychiatric Hospitals (HSQ-191-P)...........................    0938-AF32 
1536        Medicaid Payment for Obstetrical and Pediatric Services--Adequate Payment Level                     
            Provision (MB-036-P)..................................................................    0938-AF62 
1537        Clarification of Coverage of Inpatient Psychiatric Services (MB-060-P)................    0938-AF73 
1538        Federally Qualified Health Center Services (Medicaid) (MB-043-P)......................    0938-AF90 
1539        Minimum Physician Qualifications for Certain Services (MB-059-P)......................    0938-AF92 
1540        Revisions to Rules on Health Care Prepayment Plans (OMC-016-P)........................    0938-AF97 
1541        Conditions of Participation for Rural Health Clinics (BPD-764-P)......................    0938-AG05 
1542        Income and Eligibility Verification System (MB-66-P)..................................    0938-AG12 
1543        Medicare Appeals of Individual Claims (BPD-453-P).....................................    0938-AG18 
1544        End-Stage Renal Disease (ESRD) Payment Exception Requests and Organ Procurement Costs               
            (BPD-763-P)...........................................................................    0938-AG20 
1545        Appointment of Representatives for Appeal (BPO-120-P).................................    0938-AG30 
1546        Enforcement Requirements for Renal Dialysis Facilities (HSQ-204-P)....................    0938-AG31 
1547        Disclosure of Confidential PRO Information for Research Purposes (HSQ-208-P)..........    0938-AG33 
1548        Community Supported Living Arrangements Services (MB-070-P)...........................    0938-AG35 
1549        Telephone Requests for Review of Initial Determinations (BPO-121-P)...................    0938-AG48 
1550        Conditions for Payment for Physicians' Services in Teaching Settings (BPD-792-P)......    0938-AG53 
1551        New Look Behind for Intermediate Care Facilities for the Mentally Retarded (ICFs/MR)                
            (HSQ-214-P)...........................................................................    0938-AG58 
1552        Effect of Change of Ownership on Provider and Supplier Penalties, Sanctions, and                    
            Overpayments (HSQ-215-P)..............................................................    0938-AG59 
1553        Institutional Plan Amendment Findings (MB-078-P) (Reg Plan Seq. No. 49)...............    0938-AG60 
1554        Medicare Program: Limitations on Medicare Coverage of Cataract Surgery (BPD-797-PN)...    0938-AG65 
1555        Effects of Generally Accepted Accounting Principles (GAAP) on Reasonable Costs                      
            Determinations (BPD-800-P)............................................................    0938-AG66 
1556        Expansion of the Definition of Eye and Ear Specialty Hospitals (BPD-804-P)............    0938-AG67 
1557        Salary Equivalency Guidelines for Physical and Respiratory Therapy Services Furnished               
            Under Arrangements (BPD-808-PN).......................................................    0938-AG70 
1558        Medicaid: Optional Coverage of TB-Related Services for Individuals Infected with                    
            Tuberculosis (MB-082-P)...............................................................    0938-AG72 
1559        Proposed Payments to Disproportionate Share Hospitals for FY 1995 (MB-089-N)..........    0938-AG75 
1560        Revision of Medicare Hospital Conditions of Participation (BPD-745-P) (Reg Plan Seq.                
            No. 50)...............................................................................    0938-AG79 
1561        Physicians' Referrals to Health Care Entities With Which They Have Financial                        
            Relationships--Expanded to Designated Health Services (BPD-809-P) (Reg Plan Seq. No.                
            51)...................................................................................    0938-AG80 
1562        Home Health Agency (HHA) Conditions of Participation (BPD-819-P) (Reg Plan Seq. No.                 
            52)...................................................................................    0938-AG81 
1563        End Stage Renal Disease (ESRD) Conditions of Coverage (BPD-818-P) (Reg Plan Seq. No.                
            53)...................................................................................    0938-AG82 
1564        Distinct Parts and Costing for Skilled Nursing Facilities and Nursing Facilities (BPD-              
            815-P)................................................................................    0938-AG84 
1565        Extension of Certain Effective Dates for Clinical Laboratory Requirements and                       
            Personnel Requirements for Cytologists (HSQ-217-FC)...................................    0938-AG86 
1566        Clinical Laboratory Improvement Amendment (CLIA) Fee Schedules (HSQ-219-FC)...........    0938-AG87 
1567        Approval of the American Society for Histocompatibility and Immunogenetics for the                  
            Specialty of Histocompatibility (HSQ-220-N)...........................................    0938-AG88 
1568        Medicaid: Coverage of Rehabilitation Services (MB-076-P)..............................    0938-AG89 
1569        Medicaid: Nominal Copayments for Institutional Services for Medicaid Recipients (MB-                
            090-FC)...............................................................................    0938-AG90 
1570        Wage Index Used To Adjust Payment Rates for Hospice Services Under the Medicare                     
            Program (BPD-820-N)...................................................................   0938-AG93  
----------------------------------------------------------------------------------------------------------------
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   
----------------------------------------------------------------------------------------------------------------
1571        Payment for Clinical Diagnostic Laboratory Services (BPD-309-F).......................    0938-AB50 
1572        Home and Community-Based Services and Respiratory Care for Ventilator-Dependent                     
            Individuals (MB-8-FC).................................................................    0938-AC55 
1573        Participation in CHAMPUS and CHAMPVA, Hospital Admissions for Veterans, Discharge                   
            Rights Notice, and Hospital Responsibility for Emergency Care (BPD-393-FC)............    0938-AC58 
1574        Denial of Payment for Substandard Quality Care (HSQ-132-F)............................    0938-AC84 
1575        Revised Effective Date of Medicare/Medicaid Provider Agreement and Supplier                         
            Participation (HSQ-139-F).............................................................    0938-AC88 
1576        Changes Concerning Suspension of Medicare Payments and Determinations of Allowable                  
            Interest Expense (BPO-118-FC).........................................................    0938-AC99 
1577        Changes Concerning the Definition of Accrual Basis of Accounting (BPD-366-FC).........    0938-AD01 
1578        Optional Payment System for Low Medicare Volume Skilled Nursing Facilities (BPD-409-F)    0938-AD02 
1579        Criteria and Procedures for Making Medical Services Coverage Decisions That Relate to               
            Health Care Technology (BPD-432-F)....................................................    0938-AD07 
1580        Revisions to Conditions of Participation for Hospitals and Conditions for Coverage of               
            Suppliers of End-Stage Renal Disease Services (BPD-421-F).............................    0938-AD11 
1581        Medicaid Eligibility of Poverty Level Groups and Extended Coverage of Services (MB-13-              
            F)....................................................................................    0938-AD17 
1582        Prohibition on Unbundling of Hospital Outpatient Services (BPD-426-F) (Reg Plan Seq.                
            No. 54)...............................................................................    0938-AD33 
1583        Changes to Peer Review Organization Regulations (HSQ-135-F)...........................    0938-AD38 
1584        Payment for Durable Medical Equipment and Orthotic and Prosthetic Devices (BPD-494-F).    0938-AD65 
1585        Medicare Secondary Payer for Disabled Individuals (BPD-482-FC)........................    0938-AD73 
1586        Medicare Coverage of Home Health Services, Medicare Conditions of Participation and                 
            Home Health Aide Supervision (BPD-469-F)..............................................    0938-AD78 
1587        Appeals for Enrollees of Prepaid Health Care Plans (OMC-008-F)........................    0938-AD79 
1588        Omnibus Nursing Home Reform Requirements (BPD-488-FC).................................    0938-AD81 
1589        Survey and Certification of Skilled Nursing Facilities and Nursing Facilities and                   
            Enforcement Procedures (HSQ-156-F) (Reg Plan Seq. No. 55).............................    0938-AD94 
1590        HMO Organizational Structure and Services (OMC-007-F).................................    0938-AE25 
1591        ''Confined to the Home'' Requirements for Home Health Services (BPD-626-F)............    0938-AE34 
1592        Survey Requirements and Alternative Sanctions for Home Health Agencies (HSQ-169-F)....    0938-AE39 
1593        Hospital Standard for HIV Infectious Blood (BPD-633-F)................................    0938-AE40 
1594        Medicare, Medicaid, and CLIA Programs: Regulations Implementing the Clinical                        
            Laboratory Improvement Amendments of 1988 (CLIA '88) (HSQ-202-F) (Reg Plan Seq. No.                 
            56)...................................................................................    0938-AE47 
1595        Conditions of Coverage for Organ Procurement Organizations (BPD-646-FC)...............    0938-AE48 
1596        Preadmission Screening and Annual Resident Review (BPD-661-F).........................    0938-AE49 
1597        Extended Medicaid Eligibility for Certain Individuals (MB-026-F)......................    0938-AE51 
1598        Resident Assessment in Long-Term Care Facilities (HSQ-180-F)..........................    0938-AE61 
1599        Post-Contract Beneficiary Protections and Other Provisions (OMC-003-F)................    0938-AE63 
1600        Conforming Provisions for 1988 HMO Amendments (OMC-004-F).............................    0938-AE64 
1601        Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Services (MB-28-F)                  
            (Reg Plan Seq. No. 57)................................................................    0938-AE72 
1602        Payment for Nursing and Allied Health Science Education (BPD-685-F)...................    0938-AE79 
1603        Uniform Electronic Cost Reporting System for Hospitals (BPD-689-F)....................    0938-AE80 
1604        Medicare Coverage of Prescription Drugs Used in Immunosuppressive Therapy (BPD-424-F).    0938-AE94 
1605        Fire Safety Standards for Hospitals, Long-Term Care Facilities, and Intermediate Care               
            Facilities for the Mentally Retarded (BPD-650-F)......................................    0938-AE97 
1606        Coverage of Screening Pap Smears (BPD-705-F)..........................................    0938-AE98 
1607        Medicare Coverage of Clinical Psychologist, Other Psychologist, and Clinical Social                 
            Worker Services--Medicare (BPD-706-F).................................................    0938-AE99 
1608        Allowing Certifications and Recertifications by Nurse Practitioners and Clinical Nurse              
            Specialists for Certain Services (BPD-709-F)..........................................    0938-AF01 
1609        Changes to the Long-Term Care Facility Survey Process (HSQ-175-FC)....................    0938-AF02 
1610        Case Management (MB-27-F).............................................................    0938-AF07 
1611        Medicaid Third Party Liability: Cost Effectiveness Waivers (MB-39-F)..................    0938-AF11 
1612        Required Coverage of Nurse Practitioner Services--Medicaid (MB-41-F)..................    0938-AF12 
1613        Payment for Federally Qualified Health Center (FQHC) Services (BPD-728-F).............    0938-AF14 
1614        OBRA '90 and Miscellaneous Managed Care Technical Amendments (OMC-018-FC).............    0938-AF15 
1615        Criteria for the Determination of Reasonable Costs for Medicare --Contracting Prepaid               
            Health Plans (OMC-006-F)..............................................................    0938-AF16 
1616        Physician Ownership of and Referrals to Health Care Facilities That Furnish Clinical                
            Laboratory Services and Financial Relationship Reporting Requirements (BPD-674-FC)                  
            (Reg Plan Seq. No. 58)................................................................    0938-AF40 
1617        Medicaid Payment for Covered Outpatient Drugs Under Rebate Agreements (MB-046-IFC)....    0938-AF42 
1618        Medicare and Medicaid Programs; Advance Directives (BPD-718-F)........................    0938-AF50 
1619        Partial Hospitalization Services in Community Mental Health Centers (BPD-736-F).......    0938-AF53 
1620        Requirements for Enrollment of Medicaid Recipients Under Cost Effective Employer Based              
            Group Health Plans (MB-047-F).........................................................    0938-AF64 
1621        Referral to Child Support Enforcement Agencies of Medicaid Families With an Absent                  
            Parent (MB-051-F).....................................................................    0938-AF68 
1622        Medicaid: Outstationed Intake Locations for Certain Low-Income Pregnant Women, Infants              
            and Children (MB-052-IFC).............................................................    0938-AF69 
1623        Optional Spenddown (MB-055-IFC).......................................................    0938-AF72 
1624        Medicare and Medicaid Programs: Requirements for Physician Incentive Plans in Prepaid               
            Health Care Organizations (OMC-010-F) (Reg Plan Seq. No. 59)..........................    0938-AF74 
1625        National Coverage Decisions: Rules for Risk Contracting HMOs and CMPs (OMC-019-F).....    0938-AF76 
1626        Part B Advance Payments to Physicians/Suppliers or Other Entities Furnishing Items or               
            Services Under Medicare Part B (BPO-105-F)............................................    0938-AF85 
1627        Application of Interest Charges to Medicare Secondary Payer Recoveries (BPO-108-GN)...    0938-AF87 
1628        Retroactive Enrollment (OMC-015-F)....................................................    0938-AF98 
1629        Payment for Preadmission Services (BPD-731-F).........................................    0938-AG00 
1630        Change in Provider Agreement Regulations Related to Federal Employee Health Benefits                
            (BPD-748-F)...........................................................................    0938-AG03 
1631        Payment for Extracorporeal Shock Wave Lithotripsy Services Furnished by Ambulatory                  
            Surgical Centers (BPD-762-FN).........................................................    0938-AG04 
1632        Intermediary and Carrier Functions (BPO-111-N)........................................    0938-AG06 
1633        Revised Medicaid Management Information Systems (MB-38-FN)............................    0938-AG10 
1634        Revisions to the Definition of End-Stage Renal Disease and Resumption of Entitlement                
            (BPD-738-F)...........................................................................    0938-AG19 
1635        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 
1636        Medicare Program: Proposed Additions to and Deletions From the Current List of Covered              
            Surgical Procedures for Ambulatory Surgical Centers (BPD-776-FN)......................    0938-AG27 
1637        Medicare Program: Special Payment Limits for Home Blood Glucose Monitors (BPD-778-FN).    0938-AG28 
1638        General Evaluation Criteria and Standards for Evaluating Performance of Contract (HSQ-              
            207-GNC)..............................................................................    0938-AG32 
1639        Withdrawal of Coverage of Diagnostic Nocturnal Penile Tumescence Testing (Impotence                 
            Testing) (BPD-780-FN).................................................................    0938-AG43 
1640        Medicare Program: Limitations on Medicare Coverage of Intermittent Positive Pressure                
            Breathing Machine Therapy (BPD-781-FN)................................................    0938-AG44 
1641        Noncoverage of Electrostimulation of Salivary Glands for the Treatment of Xerostomia                
            (Dry Mouth) (BPD-782-FN)..............................................................    0938-AG45 
1642        Part A Premium for 1995 for the Uninsured Aged and for Certain Disabled Individuals                 
            Who Have Exhausted Other Entitlement (OACT-046-N).....................................    0938-AG49 
1643        Medicare Program: Monthly Actuarial Rates and Monthly Supplementary Medical Insurance               
            Premium Rates Beginning January 1, 1995 (OACT-047-N)..................................    0938-AG50 
1644        Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance                   
            Amounts for 1995 (OACT-048-N).........................................................    0938-AG51 
1645        Revisions to Geographic Practice Cost Indices, Payment Policies and Adjustments to the              
            Relative Value Units Under the Physician Fee Schedule for CY 1995 (BPD-789-FC) (Reg                 
            Plan Seq. No. 60).....................................................................    0938-AG52 
1646        Reductions in Payments for HHA Services (BPD-793-NC)..................................    0938-AG54 
1647        Date for Filing Medicare Cost Reports (BPD-794-F).....................................    0938-AG55 
1648        Freedom of Choice Waiver; Conforming Changes (OMC-021-F)..............................    0938-AG63 
1649        Payment to Swing Bed Hospitals (BPD-805-FC)...........................................    0938-AG68 
1650        Physician Performance Standard Rates of Increase for FY 1995 and Physician Fee                      
            Schedule Update for CY 1995 (BPD-807-FNC).............................................    0938-AG69 
1651        Categorization of CLIA Tests and Personnel Modifications (HSQ-216-FC).................    0938-AG71 
1652        Medicaid Program: Nurse-Midwife Services (MB-085-P)...................................    0938-AG73 
1653        Medicaid Program: Fees for Vaccine Administration Under Pediatric Immunization Program              
            (MB-084-NC) (Reg Plan Seq. No. 61)....................................................    0938-AG77 
1654        Criteria for Medicare Coverage of Lung Transplants (BPD-812-NC).......................    0938-AG83 
1655        Information, Counseling, and Assistance Grants Programs: Medicare Program (OBS-001-FC)    0938-AG91 
1656        Qualified Health Maintenance Organizations: Technical Amendments (OMC-009-FC).........   0938-AG92  
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.          


                             Health Care Financing Administration--Completed Actions                            
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1657        Medicaid Eligibility and Coverage Requirements (MB-001-F).............................    0938-AA58 
1658        Deduction of Incurred Medical Expenses (Spenddown) (MB-020-F).........................    0938-AB07 
1659        Home and Community-Based Services for the Elderly (MB-019-F)..........................    0938-AD55 
1660        Payment Adjustments for Hospitals That Serve a Disproportionate Number of Low-Income                
            Patients (MB-017-IFC).................................................................    0938-AE35 
1661        Utilization and Quality Control Peer Review Organizations (PRO): Confidential                       
            Information (HSQ-190-P)...............................................................    0938-AF03 
1662        Day Habilitation and Related Services (MB-37-P).......................................    0938-AF10 
1663        Medicare Coverage of Screening Mammography (BPD-724-F)................................    0938-AF26 
1664        Medicare, Medicaid, and CLIA Programs: Inspection and Certification Procedures for                  
            Laboratories (HSQ-193-P)..............................................................    0938-AF33 
1665        Medicaid Drug Use Review Program and Electronic Claims Management System for                        
            Outpatient Drug Claims (MB-050-F).....................................................    0938-AF67 
1666        Intermediary and Carrier Checks That Are Lost, Stolen, Defaced, Mutilated, Destroyed,               
            or Paid on Forged Endorsements (BPO-114-FC)...........................................    0938-AG16 
1667        Changes in Physician Attestation Requirements (BPD-769-F).............................    0938-AG34 
1668        Medicare Program: Changes to the Inpatient Hospital Prospective Payment Systems and                 
            Fiscal Year 1995 Rates (BPD-802-F)....................................................    0938-AG46 
1669        Reductions in Payments for SNF Services (BPD-795-NC)..................................    0938-AG56 
1670        Limitations on Revisions to Final Administrative Cost Proposals (BPO-122-P)...........    0938-AG57 
1671        Required Laboratory Procedures for Rural Health Clinics (BPD-783-F)...................    0938-AG62 
1672        Self-Implementing Coverage and Payment Provisions: 1993 Legislation (BPD-791-F).......    0938-AG64 
1673        Final Limitations on Aggregate Payments to Disproportionate Share Hospitals: Federal                
            Fiscal Year 1994 (MB-088-N)...........................................................    0938-AG74 
1674        Small Business Innovation Research Grants for FY 95 (ORD-068-N).......................    0938-AG76 
1675        Medicare and Medicaid Programs; Medicare-Medicaid Coverage Data Bank Requirements:                  
            Preliminary Guidance (BPO-125-N)......................................................    0938-AG78 
----------------------------------------------------------------------------------------------------------------


                          Administration for Children and Families--Proposed Rule Stage                         
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1676        Foster Care, Adoption Assistance, and Child Welfare Services..........................    0970-AA97 
1677        Amendments to Developmental Disabilities Rules........................................    0970-AB11 
1678        Standards for Safe Transportation.....................................................    0970-AB24 
1679        Title IV-E Training...................................................................    0970-AB25 
1680        Standards for Purchase of Facilities..................................................    0970-AB31 
1681        National Voter Registration Act of 1993 Provisions Affecting Public Assistance                      
            Agencies..............................................................................    0970-AB32 
1682        Family Preservation and Support.......................................................    0970-AB34 
1683        Notice of Proposed Rulemaking for the Administration of Native Americans 45 CFR Part                
            1336..................................................................................    0970-AB37 
1684        Interstate Case Closure...............................................................    0970-AB41 
1685        Direct Payments to Indian Tribes and Tribal Organizations under Title IV-B, Subpart 1.    0970-AB44 
1686        Repatriation - Advance Approval of Costs..............................................    0970-AB45 
1687        Reduction of Reporting Requirements for the State Systems Advance Planning Document                 
            (APD) Process.........................................................................    0970-AB46 
1688        Block Grant Programs (Low Income Home Energy Assistance Program --LIHEAP)--FY 1995 and              
            FY 1996 Provisions....................................................................    0970-AB47 
1689        Automobile Resource Limit (Reg Plan Seq. No. 62)......................................    0970-AB48 
1690        Administrative Flexibility Rule.......................................................    0970-AB49 
1691        Head Start Initiative on Families With Infants and Toddlers (Reg Plan Seq. No. 63)....    0970-AB50 
1692        Flexibility in the Utilization of Information Obtained through the Income Eligibility               
            Verification System...................................................................    0970-AB51 
1693        Designation of Alternative Agency to Serve Indian Tribal Children.....................    0970-AB52 
1694        Income Eligibility Criteria for Indian Tribes.........................................    0970-AB53 
1695        Construction of Head Start Facilities.................................................    0970-AB54 
1696        Quality Standards for Head Start Programs.............................................    0970-AB55 
1697        Head Start Fellowships Program........................................................   0970-AB56  
----------------------------------------------------------------------------------------------------------------
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   
----------------------------------------------------------------------------------------------------------------
1698        Aid to Families With Dependent Children Program; Extension of Medicaid Eligibility                  
            When Support Collections Result in Termination of AFDC Eligibility....................    0970-AA07 
1699        Block Grant Programs (Low-Income Home Energy Assistance Program --LIHEAP) FY 91 and FY              
            92 Provisions.........................................................................    0970-AB15 
1700        Block Grant Programs (Low-Income Home Energy Assistance Program--LIHEAP)--FY 93 and FY              
            94 Provisions.........................................................................    0970-AB16 
1701        Family Violence Prevention and Services...............................................    0970-AB18 
1702        Child Abuse and Neglect State Grant Program...........................................    0970-AB23 
1703        State Legalization Impact Assistance Grant............................................    0970-AB28 
1704        Child Care--Revised Regulations.......................................................    0970-AB33 
1705        Statewide Automated Child Welfare Information System..................................    0970-AB38 
1706        Child Support Enforcement Program: Paternity Establishment and Revision of Child                    
            Support Enforcement Program and Audit Regulations.....................................    0970-AB40 
1707        Refugee Resettlement Program: Miscellaneous Changes...................................    0970-AB42 
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Completed Actions                          
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1708        Revisions of Child Support Enforcement Program and Audit Regulations..................    0970-AA74 
1709        Head Start Performance Standards for Infants, Toddlers, and Pregnant Women............    0970-AB04 
1710        Technical Changes to the AFDC Program as Required by OBRA 90..........................    0970-AB14 
1711        Automatic Data Processing Equipment and Services; Conditions for Federal Financial                  
            Participation and General Administration - Public Assistance Programs.................    0970-AB39 
----------------------------------------------------------------------------------------------------------------


                                  Administration on Aging--Proposed Rule Stage                                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1712        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)
  
_______________________________________________________________________
  
1339. NONDISCRIMINATION REQUIREMENTS (INCLUDING ON THE BASIS OF SEX OR 
RELIGION) APPLICABLE TO BLOCK GRANTS AND STANDARD NONDISCRIMINATION 
PROCEDURES APPLICABLE TO CERTAIN OTHER PROGRAMS

Legal Authority:  42 USC 9906; 42 USC 300x-7; 42 USC 708; 42 USC 8625; 
42 USC 9821; 42 USC 9849; 42 USC 1397; 42 USC 300w-7

CFR Citation:  45 CFR 94

Legal Deadline: None

Abstract: To implement the nondiscrimination requirements applicable to 
block grants authorized by the Omnibus Budget Reconciliation Act of 
1981, P.L. 97-35, as amended by the Omnibus Budget Reconciliation Act 
of 1990, P.L. 101-508.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            01/21/86                     51 FR 2806
NPRM Comment Period End         03/24/86
Second NPRM                     11/00/94

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local

Agency Contact: Marcella Haynes, Director, Policy & Special Projects 
Staff, Office for Civil Rights, Department of Health and Human 
Services, Office of the Secretary, 330 Independence Ave., SW., Rm. 
5034, Washington, DC 20201, 202 619-0671

RIN: 0991-AA02
_______________________________________________________________________

1340. CIVIL MONEY PENALTIES (CMPS) FOR CERTAIN HOSPITAL PHYSICIAN 
INCENTIVE PLANS

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 proposed rule would 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                            10/00/94
NPRM Comment Period End         12/00/94

Small Entities Affected: Undetermined

Government Levels Affected: None

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

RIN: 0991-AA45
_______________________________________________________________________

1341. CIVIL MONEY PENALTIES (CMPS) FOR CERTAIN PRACTICES RELATING TO 
MEDICARE SUPPLEMENTAL POLICIES

Legal Authority:  PL 100-360, Sec 428(b); PL 101-508, Sec 4351; PL 101-
508, Sec 4353(a); PL 101-508, Sec 4354; PL 101-508, Sec 4355(a); PL 
101-508, Sec 4357

CFR Citation:  42 CFR 1003

Legal Deadline: None

Abstract: This proposed rule would authorize the imposition of CMPs 
against individuals or entities who knowingly and willfully use 
misleading and 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 meet Medigap policy loss-ratio requirements, failure to 
comply with policy simplification standards, and failure to obtain 
Secretarial certification of Medigap policies in States with non-
approved regulatory programs.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Businesses

Government Levels Affected: State

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

RIN: 0991-AA53
_______________________________________________________________________

1342.  AMENDMENT TO GRANTS MANAGEMENT COMMON RULE TO RAISE 
THRESHOLD FOR SIMPLIFIED SMALL PURCHASES

Legal Authority:  5 USC 301

CFR Citation:  45 CFR 92

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            10/00/94
NPRM Comment Period End         12/00/94
Final Action                    05/00/95
Final Action Effective          05/00/95

Small Entities Affected: None

Government Levels Affected: State, Local, Tribal

Additional Information: OMB Circular A-102

Agency Contact: Charles Gale, Director, Division of Grants Policy and 
Oversight, Department of Health and Human Services, Office of the 
Secretary, Room 517-D, 200 Independence Avenue SW., Washington, DC 
20301, 202 690-6377

RIN: 0991-AA77
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Office of the Secretary (OS)
  
_______________________________________________________________________
  
1343. CIVIL MONEY PENALTIES AND EXCLUSIONS FOR ASSISTANTS AT CATARACT 
SURGERY

Legal Authority:  PL 99-272, Sec 9307; PL 99-514, Sec 1895(b)(16)

CFR Citation:  42 CFR 1001; 42 CFR 1003

Legal Deadline: None

Abstract: These final regulations provide for the imposition of civil 
money penalties and exclusions against physicians billing the Medicare 
program or program beneficiaries for services of an assistant at 
surgery for cataract operations where prior approval has not been 
granted. This rule specifically responds to various comments raised as 
a result of the interim final, and makes a number of technical 
corrections to those final regulations.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Interim Final Rule              04/10/87                    52 FR 11649
Final Action                    12/00/94

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0991-AA37
_______________________________________________________________________

1344. BLOCK GRANT PROGRAMS

Legal Authority:  PL 100-485; PL 100-607; PL 100-690

CFR Citation:  45 CFR 96

Legal Deadline: None

Abstract: Recent legislation modified technical, administrative and 
reporting requirements for several of the Department's block grants. 
This notice would propose regulatory changes to reflect these statutory 
changes and to clarify certain other block grant regulatory provisions.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            07/17/92                    57 FR 31682


Next Action Undetermined

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Terrance Tychan, Department of Health and Human 
Services, Office of the Secretary, 200 Independence Avenue SW., 
Washington, DC 20201, 202 690-6901

RIN: 0991-AA55
_______________________________________________________________________

1345. UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND COOPERATIVE 
AGREEMENTS

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:

45 CFR 74  Interim Final Rule 08/25/94 (59 FR 43754)  Comment Period 
End 10/24/94  Final Action 05/00/95

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, 202 690-6377

RIN: 0991-AA56
_______________________________________________________________________

1346. CIVIL MONEY PENALTIES FOR PHYSICIAN OWNERSHIP OF AND REFERRAL TO 
CERTAIN HEALTH CARE ENTITIES

Legal Authority:  PL 101-239, Sec 6204; PL 101-508, Sec 4207(e); PL 
101-508, Sec 4207(m)(2); PL 103-66, Sec 13562

CFR Citation:  42 CFR 1003

Legal Deadline:  Final, Statutory, October 1, 1991.

Abstract: This rule will implement new civil money penalty authorities 
regarding prohibited physician ownership and referral arrangements as 
set forth in Section 1877 of the Social Security Act.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            10/20/93                    58 FR 54096
NPRM Comment Period End         12/20/93
Final Action                    11/00/94

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: This rulemaking is being developed in 
conjunction with RIN 0938-AF40 and will be amended in accordance with 
OBRA 1993 and the inclusion of designated health services.

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

RIN: 0991-AA65
_______________________________________________________________________

1347. ADDITIONAL SAFE HARBOR PROVISIONS UNDER THE ANTI-KICKBACK STATUTE

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

CFR Citation:  42 CFR 1001

Legal Deadline: None

Abstract: This final rule will set forth additional ``safe harbor'' 
provisions, as authorized by section 14 of PL 100-93. The final rule 
delineates business and payment practices relating to the Medicare and 
State health care programs that will be immunized from either criminal 
or civil prosecution in accordance with the Medicare/Medicaid anti-
kickback statute.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            09/21/93                    58 FR 49008
NPRM Comment Period End         11/22/93
Final Action                    01/00/95

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, 
202 619-3270

RIN: 0991-AA66
_______________________________________________________________________

1348. SAFE HARBORS FOR PROTECTING HEALTH PLANS

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                    12/00/94

Small Entities Affected: None

Government Levels Affected: None

Additional Information: The OIG is currently assessing the public 
comments received and will be issuing a revised final rule.

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

RIN: 0991-AA69
_______________________________________________________________________

1349. GOVERNMENTWIDE GUIDANCE FOR NEW RESTRICTIONS ON LOBBYING; INTERIM 
FINAL GUIDANCE

Legal Authority:  31 USC 1352

CFR Citation:  45 CFR 93

Legal Deadline: None

Abstract: This interim final rule is in response to section 319 of P.L. 
101-121. Section 319 generally prohibits recipients of Federal 
contracts, grants, and loans from using appropriated funds for lobbying 
the Executive or Legislative Branches of the Federal Government in 
connection with a specific contract, grant, or loan. Section 319 also 
requires that each person who requests or receives a Federal contract, 
grant, cooperative agreement, loan or a Federal commitment to insure or 
guarantee a loan, must disclose lobbying activities.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Interim Final Rule              02/26/90                     55 FR 6736


Next Action Undetermined

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, 202 690-6574

RIN: 0991-AA70
_______________________________________________________________________

1350. REVISIONS TO THE PRO SANCTIONS PROCESS

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                    01/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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

RIN: 0991-AA73
_______________________________________________________________________

1351. CLARIFICATION OF THE OIG SAFE HARBOR ANTI-KICKBACK PROVISIONS

Legal Authority:  PL 100-93, sec 14

CFR Citation:  42 CFR 1001

Legal Deadline: None

Abstract: This rule will clarify various aspects of the original set of 
safe harbor provisions that were published on July 29, 1991 (56 FR 
35952) and that are currently set forth in 42 CFR 1001.952(a)-(k). This 
clarifying rule will modify the final safe harbor provisions to give 
greater clarity to their original intent.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            07/21/94                    59 FR 37202
NPRM Comment Period End         09/21/94
Final Action                    03/00/95

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 the 
Inspector General, OMP, 330 Independence Avenue SW., Washington, DC 
20201, 202 619-3270

RIN: 0991-AA74
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Office of the Secretary (OS)
  
_______________________________________________________________________
  
1352. CIVIL MONEY PENALTIES AND INTERMEDIATE SANCTIONS FOR HMOS AND 
COMPETITIVE MEDICAL PLANS

CFR Citation:  42 CFR 1003; 42 CFR 417; 42 CFR 431; 42 CFR 434

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    07/15/94                    59 FR 36072
Final Action Effective          09/13/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Joel Jay Schaer, 202 619-3270

RIN: 0991-AA44

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
 
Departmental Management (HHSDM)
  
_______________________________________________________________________
  
1353. IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT IN AGENCY 
PROCEEDINGS

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                    01/00/95
Final Action Effective          01/00/95

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0990-AA02

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
 
Social Security Administration (SSA)
  
_______________________________________________________________________
  
1354. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL 
SECURITY INCOME PROGRAMS; ADJUSTMENTS IN SSI BENEFITS ON ACCOUNT OF 
RETROACTIVE BENEFITS UNDER TITLE II (061P)

Legal Authority:  42 USC 405; 42 USC 1320a-6; 42 USC 1302; 42 USC 1383; 
PL 98-369, Sec 2615; 42 USC 1383b; 42 USC 1327

CFR Citation:  20 CFR 404.408b; 20 CFR 416.1123; 20 CFR 416.1402(m); 20 
CFR 416.1123a; 20 CFR 404.902

Legal Deadline: None

Abstract: Sec. 2615 of Pub. L. 98-369 amended sec. 1127 of the Social 
Security Act to eliminate windfalls that permitted some people who were 
paid Old-Age, Survivors and Disability Insurance (OASDI) and 
Supplemental Security Income (SSI) benefits retroactively to receive 
more in total benefits for the same period than if they had been paid 
the benefits when regularly due. The two main changes are: (1) SSI 
benefits will be reduced where retroactive OASDI benefits have been 
paid before the SSI benefits. Under prior law, reductions could be made 
only in retroactive OASDI benefits and only when the retroactive SSI 
had been paid first. (2) OASDI or SSI benefits payable upon 
reinstatement following a period of suspension or termination will be 
reduced by the amount of SSI benefits that would not have been paid if 
the OASDI benefits had been paid when regularly due. We will amend our 
regulations to conform to the statutory changes. Any costs/savings are 
associated with the legislation being implemented and not with the 
regulations themselves.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jack Schanberger, Legal Assistant, Department of Health 
and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Boulevard, Baltimore, Maryland 21235, 410 
965-8471

RIN: 0960-AB38
_______________________________________________________________________

1355. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL 
SECURITY INCOME PROGRAMS; EVALUATION GUIDES FOR DETERMINING SUBSTANTIAL 
GAINFUL ACTIVITY (SGA) (147P)

Legal Authority:  PL 98-460, Sec 10; PL 99-643; PL 100-203; PL 101-508

CFR Citation:  20 CFR 404; 20 CFR 416

Legal Deadline: None

Abstract: These proposed changes will clarify how the Social Security 
Administration evaluates a person's work activity. These regulations 
also will increase the monthly earnings amount that constitutes 
services for trial work period purposes and change the rules to allow 
the value of any subsidy or impairment-related work expenses to be 
deducted in determining that monthly earnings amount. These regulations 
also reflect statutory changes with respect to the trial work period 
and the re-entitlement period.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Cassandra Bond, Legal Assistant, Department of Health 
and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1794

RIN: 0960-AB73
_______________________________________________________________________

1356. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE PROGRAM; NONPAYMENT OF 
BENEFITS TO PRISONERS, VOCATIONAL REHABILITATION EXCEPTION (166P)

Legal Authority:  42 USC 402(x)(1); 42 USC 405

CFR Citation:  20 CFR 404.468; 20 CFR 404.469 (New)

Legal Deadline: None

Abstract: Existing regulations at 20 CFR 404.468(d) provide a 
vocational rehabilitation exception to the nonpayment of benefits to 
prisoners provision described at 20 CFR 404.468(a). Under the 
exception, the nonpayment provision does not apply if a prisoner who is 
entitled to benefits on the basis of disability is actively and 
satisfactorily participating in a rehabilitation program which has been 
specifically approved for the individual by a court of law. In 
addition, the Secretary must determine that the program is expected to 
result in the individual being able to do substantial gainful activity 
upon release and within a reasonable time. No benefits will be paid to 
the prisoner for any month prior to the approval of the program. The 
proposed regulations would set out more definitive criteria for 
applying the exception and would define terms, such as ``rehabilitation 
program,'' ``court of law,'' and ``reasonable time,'' for purposes of 
applying the exception.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Duane Heaton, Legal Assistant, Department of Health and 
Human Services, Social Security Administration, Office of Regulations, 
6401 Security Blvd., Baltimore, MD 21235, 410 965-8470

RIN: 0960-AC16
_______________________________________________________________________

1357. OLD-AGE, SURVIVORS AND DISABILITY INSURANCE AND SUPPLEMENTAL 
SECURITY INCOME PROGRAMS; VOCATIONAL FACTORS REGULATIONS RESTRUCTURING 
AND CLARIFICATION (207P)

Legal Authority:  42 USC 405; 42 USC 421; 42 USC 423; 42 USC 1302; 42 
USC 1382c; 42 USC 1383

CFR Citation:  20 CFR 404.1520; 20 CFR 404.1550 to 404.1567; 20 CFR 
416.920; 20 CFR 416.950 to 416.967

Legal Deadline: None

Abstract: Based upon adjudicative experience, we are proposing 
clarifications and a restructuring of the disability vocational 
evaluation regulations.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Harry J. Short, Legal Assistant, Department of Health 
and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Blvd., Baltimore, MD 21235, 410 965-6243

RIN: 0960-AC61
_______________________________________________________________________

1358. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL 
SECURITY INCOME PROGRAMS; INTERIM DISABILITY BENEFITS (215P)

Legal Authority:  42 USC 423(h); 42 USC 1383(a); PL 100-647, Sec 8001

CFR Citation:  20 CFR 404; 20 CFR 416

Legal Deadline: None

Abstract: These regulations implement a section of Pub. L. 100-647 that 
authorizes interim benefit payments whenever an Administrative Law 
Judge (ALJ) decides that a claimant is entitled to benefits based on 
disability or blindness and the Secretary has not issued his final 
decision within 110 days after the date of the ALJ's determination.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Lawrence V. Dudar, Legal Assistant, Department of 
Health and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1759

RIN: 0960-AC76
_______________________________________________________________________

1359. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL 
SECURITY INCOME PROGRAMS; APPEALS COUNCIL NOTICE REQUIREMENTS (235P)

Legal Authority:  42 USC 401(g); 42 USC 405(a); 42 USC 405(b); 42 USC 
405(d) to 405(h); 42 USC 421(d); 42 USC 1302; 42 USC 1383; 42 USC 1383b

CFR Citation:  20 CFR 404.973; 20 CFR 416.1473

Legal Deadline: None

Abstract: These proposed regulations amend the existing regulations to 
clarify the requirements that the Appeals Council (AC) notify the 
parties of its reasons for reviewing a case and the issues to be 
decided. The proposed regulations clarify the AC's procedures with 
regard to providing the notice required by the regulations and do not 
represent any change in policy. These regulations are intended to 
remove any ambiguities in the current regulations concerning the 
circumstances and the manner in which the AC provides notice to the 
parties.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Harry J. Short, Legal Assistant, Department of Health 
and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-6243

RIN: 0960-AC93
_______________________________________________________________________

1360. SUPPLEMENTAL SECURITY INCOME PROGRAM; AUGMENTED BENEFITS (271P)

Legal Authority:  42 USC 1382a

CFR Citation:  20 CFR 416.1121; 20 CFR 416.1122

Legal Deadline: None

Abstract: These proposed regulations will state how benefits from other 
programs that have been augmented to provide for dependents are treated 
under the Supplemental Security Income program. Our current regulations 
only explain the treatment of the primary beneficiary's portion of an 
augmented Department of Veterans Affairs benefit.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Duane Heaton, Legal Assistant, Department of Health and 
Human Services, Social Security Administration, Office of Regulations, 
6401 Security Boulevard, Baltimore, MD 21235, 410 965-8470

RIN: 0960-AD07
_______________________________________________________________________

1361. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL 
SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED; FEES FOR 
REPRESENTATION OF CLAIMANTS (296P)

Legal Authority:  PL 101-508, Sec 5106

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: We propose to amend the regulations to reflect section 
5106(a) of Pub. L. 101-508 which modifies the manner in which past-due 
benefits are calculated and the process by which SSA approves fees 
charged by persons representing claimants before the Agency.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Lawrence V. Dudar, Legal Assistant, Department of 
Health and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1759

RIN: 0960-AD23
_______________________________________________________________________

1362. OASDI AND SSI FOR THE AGED, BLIND AND DISABLED; CONTINUATION OF 
BENEFITS ON ACCOUNT OF PARTICIPATION IN A NON-STATE VR PROGRAM (299P)

Legal Authority:  PL 101-508, Sec 5113

CFR Citation:  20 CFR 404.316; 20 CFR 404.337; 20 CFR 404.352; 20 CFR 
404.902; 20 CFR 404.1586; 20 CFR 404.1596; 20 CFR 404.1597; 20 CFR 
416.1321; 20 CFR 416.1338; 20 CFR 416.1402

Legal Deadline: None

Abstract: These regulations will implement section 5113 of Pub. L. 101-
508, which amends sections 225(b) and 1631(a)(6) of the Act to extend 
eligibility for continuation of benefits under these sections to 
persons who are participating in a non-State VR program. Prior to these 
amendments, the law only provided for continuation of benefits when a 
person was participating in a State VR Program. These regulatory 
changes will bring our regulations into conformity with the amendments 
to the law.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jack Schanberger, Legal Assistant, Department of Health 
and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-8471

RIN: 0960-AD26
_______________________________________________________________________

1363. SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED; 
EXCLUSION FROM INCOME AND RESOURCES OF VICTIMS' COMPENSATION PAYMENTS AND 
STATE RELOCATION ASSISTANCE (311F)

Legal Authority:  PL 101-508, sec 5031; PL 101-508, sec 5035; PL 103-
66, sec 13732

CFR Citation:  20 CFR 416.1124; 20 CFR 416.1161(a); 20 CFR 416.1204(a); 
20 CFR 416.1210; 20 CFR 416.1229 (New); 20 CFR 416.1239 (New)

Legal Deadline: None

Abstract: These regulations will provide for the exclusion from income 
and from resources (for nine months) in the Supplemental Security 
Income Program payments received by a person from a State established 
fund to aid victims of crime and payments received as State or local 
government relocation assistance.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            08/26/94                    59 FR 44093
NPRM Comment Period End         10/25/94
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Additional Information: RIN 0960-AD37 has been merged with this action.

Agency Contact: Harry J. Short, Legal Assistant, Department of Health 
and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1753

RIN: 0960-AD36
_______________________________________________________________________

1364. SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED; 
REIMBURSEMENT FOR VR SERVICES FURNISHED DURING CERTAIN MONTHS OF NON-
PAYMENT (315P)

Legal Authority:  PL 101-508, Sec 5037

CFR Citation:  20 CFR 416.1321; 20 CFR 416.1331; 20 CFR 416.1338; 20 
CFR 416.1402; 20 CFR 416.2201

Legal Deadline: None

Abstract: These regulations reflect section 5037 of Pub. L. 101-508, 
which amends section 1615 of the Act, to provide for reimbursement for 
VR services furnished during certain months of nonpayment of 
Supplemental Security Income benefits. Prior to these amendments there 
was no provision in the law for such reimbursement.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jack Schanberger, Legal Assistant, Department of Health 
and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-8471

RIN: 0960-AD39
_______________________________________________________________________

1365. CODE OF CONDUCT FOR ADMINISTRATIVE LAW JUDGES AND ADMINISTRATIVE 
APPEALS JUDGES OF THE SOCIAL SECURITY ADMINISTRATION (341P)

Legal Authority:  EO 12674 as modified by EO 12731;; 42 USC 405

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: These regulations would establish a Code of Conduct for OHA 
Administrative Law Judges and Administrative Appeals Judges.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jack Schanberger, Legal Assistant, Office of 
Regulations, Department of Health and Human Services, Social Security 
Administration, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-
8471

RIN: 0960-AD54
_______________________________________________________________________

1366. ELECTION OF BENEFITS BASED ON AGE BY DISABLED WIDOW, WIDOWER, AND 
SURVIVING DIVORCED SPOUSE BENEFICIARIES (343P)

Legal Authority:  42 USC 405

CFR Citation:  20 CFR 404.335; 20 CFR 404.336; 20 CFR 404.337

Legal Deadline: None

Abstract: We propose to amend our regulations to permit the election of 
benefits based on age by widows, widowers and surviving divorced 
spouses (hereinafter, collectively widows) who are at least age 60 and 
who are already entitled to widow's benefits based on disability. This 
proposal would allow the widow to choose which of the two types of 
widow's benefits is more advantageous. The estimated increase in 
benefit payments is less than $500,000 per year for fiscal years 1992-
1995.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Cassandra Bond, Legal Assistant, Office of Regulations, 
Department of Health and Human Services, Social Security 
Administration, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-
1794

RIN: 0960-AD56
_______________________________________________________________________

1367. AGAINST EQUITY AND GOOD CONSCIENCE (348P)

Legal Authority:  30 USC 923; 42 USC 404; 42 USC 1383

CFR Citation:  20 CFR 404.509; 20 CFR 410.561d; 20 CFR 416.554

Legal Deadline: None

Abstract: These proposed regulations amend the existing regulations to 
change how we determine when recovery of an overpayment would be 
against equity and good conscience. Currently, regulations permit 
determinations that recovery of an overpayment would be against equity 
and good conscience under three specific conditions. The proposed 
regulations will provide for the ``against equity and good conscience'' 
determination to be based on an examination and consideration of a 
variety of factors such as cause and result of overpayment and fairness 
as they affect both the beneficiary and the Social Security 
Administration.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Duane Heaton, Legal Assistant, Office of Regulations, 
Department of Health and Human Services, Social Security 
Administration, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-
8470

RIN: 0960-AD62
_______________________________________________________________________

1368. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE PROGRAM; REVISED 
MEDICAL CRITERIA FOR DETERMINATION OF DISABILITY; HEMIC AND LYMPHATIC 
SYSTEM, AND MALIGNANT NEOPLASTIC DISEASES (399P)

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

RIN: 0960-AD67
_______________________________________________________________________

1369. PROCEDURES FOR HANDLING EARNINGS REPORTS (418F)

Legal Authority:  42 USC 405(a); 42 USC 1302(a); 42 USC 1320b-1

CFR Citation:  20 CFR 422.115; 20 CFR 422.120

Legal Deadline: None

Abstract: These regulations will update our current regulations to 
reflect the procedures we use for handling employers' wage reports that 
lack a correct social security number. Additionally, the regulations 
will include our requirements for employers to file corrections of 
erroneous wage reports. The regulations will also include a description 
of our process for providing pension plan information under the 
Employee Retirement Income Security Act of 1974. There are no 
significant costs.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            08/30/94                    59 FR 44674
NPRM Comment Period End         10/31/94
Final Action                    00/00/00

Small Entities Affected: Businesses

Government Levels Affected: Local, Federal

Agency Contact: Jack Schanberger, Legal Assistant, Department of Health 
and Human Services, Social Security Administration, 6401 Security 
Boulevard, Baltimore, MD 21235, 410 965-8471

RIN: 0960-AD70
_______________________________________________________________________

1370. CONDUCT OF REPRESENTATIVES UNDER TITLE II OR TITLE XVI (431P)

Legal Authority:  42 USC 405(a); 42 USC 406; 42 USC 1302(a); 42 USC 
1383(d)(1); 42 USC 1383(d)(2)

CFR Citation:  20 CFR 404.1700ff; 20 CFR 416.1500ff

Legal Deadline: None

Abstract: These regulations explain who may serve as a representative, 
how claimants appoint and discharge representatives, the necessary 
qualifications which representatives must possess, and rules of conduct 
and standards of responsibility that a representative must follow.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: Undetermined

Agency Contact: Harry J. Short, Legal Assistant, Department of Health 
and Human Services, Social Security Administration, 6401 Security 
Boulevard, Baltimore, MD 21235, 410 965-6243

RIN: 0960-AD73
_______________________________________________________________________

1371. STATEMENT OF EARNINGS AND BENEFIT ESTIMATE (415P)

Legal Authority:  42 USC 405; 42 USC 1302; 42 USC 1320b-13

CFR Citation:  20 CFR 404.811; 20 CFR 404.812 (New); 20 CFR 422.125

Legal Deadline: None

Abstract: Section 1143(c) of the Social Security Act requires that by 
not later than September 30, 1995, we must furnish a social security 
account statement to each eligible individual who has attained age 60 
by October 1, 1994, is not receiving social security benefits, and for 
whom we can determine a current mailing address. During fiscal year 
1995 through 1999, we must furnish such a statement to eligible 
individuals attaining age 60 in the fiscal year they turn age 60. 
Similarly, beginning no later than October 1, 1999, we must provide 
such a statement annually to eligible individuals age 25 or over. In 
these regulations, we provide who will be sent a statement, who will 
not be sent a statement, how we will determine addresses, and the 
contents of the statements. We have not yet compiled all the costs. 
These regulations will benefit the public by implementing section 
1143(c) which will help individuals verify that we have entered their 
correct earnings into our records and by showing the benefits to which 
such individuals may become entitled.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            11/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jack Schanberger, Legal Assistant, Department of Health 
and Human Services, Social Security Administration, 6401 Security 
Boulevard, Baltimore, MD 21235, 410 965-8471

RIN: 0960-AD74
_______________________________________________________________________

1372. FEES FOR FEDERAL ADMINISTRATION OF STATE SUPPLEMENTARY PAYMENTS IN 
THE SSI PROGRAM (376P)

Legal Authority:  42 USC 1302; 42 USC 1382(e); 42 USC 1383; PL 93-66, 
sec 212

CFR Citation:  20 CFR 416.2010; 20 CFR 416.2090

Legal Deadline: None

Abstract: Section 13731 of Pub. L. 103-66 (the Omnibus Budget 
Reconciliation Act of 1993) enacted August 10, 1993, requires the 
Secretary to assess each State an administration fee for processing the 
State's mandatory and optional supplementary payments. The fee will be 
charged for all State supplementary payments issued on or after October 
1, 1993. Also, the Secretary may charge a State an additional services 
fee if, at the request of the State, the Secretary provides services 
beyond the level customarily provided in the administration of such 
payments.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Henry D. Lerner, Legal Assistant, Department of Health 
and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1762

RIN: 0960-AD75
_______________________________________________________________________

1373. WHO MAY PROTECT A POTENTIAL CLAIMANT'S FILING DATE OR APPLICATION 
FOR SUPPLEMENTAL SECURITY INCOME BENEFITS (408P)

Legal Authority:  42 USC 1302; 42 USC 1382; 42 USC 1383(a); 42 USC 
1383(d); 42 USC 1383(e)

CFR Citation:  20 CFR 416.315ff

Legal Deadline: None

Abstract: These proposed regulations would make protecting a filing 
date easier and protect potential claimants from losing SSI benefits if 
an application is filed.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Lawrence V. Dudar, Legal Assistant, Department of 
Health and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1759

RIN: 0960-AD76
_______________________________________________________________________

1374. RELIABLE INFORMATION WHICH IS CURRENTLY AVAILABLE FOR DETERMINING 
BENEFIT AMOUNTS IN THE SUPPLEMENTAL SECURITY INCOME PROGRAM (NEWMAN) 
(434P)

Legal Authority:  42 USC 1302; 42 USC 1382(a) to 1382(c); 42 USC 1383

CFR Citation:  20 CFR 416.420

Legal Deadline: None

Abstract: The Social Security Act (the Act) provides that if the 
Secretary of Health and Human Services (the Secretary) determines that 
reliable information is currently available concerning the income of an 
individual, the Secretary may use that information to determine an 
individual's current month's supplemental security income (SSI) benefit 
amount. This method of determining SSI benefit amounts is an exception 
to the use of income from a prior month, known as retrospective monthly 
accounting (RMA). The Secretary has determined that no reliable 
information exists which is currently available for determining SSI 
benefit amounts for a current month using any method other than RMA. 
These rules are applicable only in California pursuant to a court order 
issued in Newman v. Shalala.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Henry D. Lerner, Legal Assistant, Department of Health 
and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1762

RIN: 0960-AD77
_______________________________________________________________________

1375. REVISED MEDICAL CRITERIA FOR DETERMINATION OF DISABILITY, ENDOCRINE 
SYSTEM AND OBESITY AND RELATED CRITERIA (436P)

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

RIN: 0960-AD78
_______________________________________________________________________

1376. REVISED MEDICAL CRITERIA FOR DETERMINATION OF DISABILITY, GROWTH 
IMPAIRMENTS (444P)

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

RIN: 0960-AD80
_______________________________________________________________________

1377. VALUATION OF CERTAIN IN-KIND SUPPORT AND MAINTENANCE (ISM) WHERE 
THERE IS A COST-OF-LIVING ADJUSTMENT IN SSI BENEFITS (454P)

Legal Authority:  PL 103-66, sec 13735

CFR Citation:  20 CFR 416.420; 20 CFR 416.1130(a)

Legal Deadline: None

Abstract: These proposed regulation would reflect the amendment to 
section 1611(c) of the Act, effective January 1, 1995, that the current 
Federal benefit rate be used in determining the value of certain in-
kind support and maintenance for the first 2 months after there is a 
cost-of-living adjustment in SSI benefits.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            02/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Lawrence V. Dudar, Legal Assistant, Department of 
Health and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1759

RIN: 0960-AD82
_______________________________________________________________________

1378. RELATIONSHIP/COVERAGE ACTIONS NOTE INITIAL DETERMINATIONS/SSI 
CORRECTIONS (455P)

Legal Authority:  42 USC 402; 42 USC 403(a); 42 USC 403(b); 42 USC 
405(a); 42 USC 405(b); 42 USC 416; 42 USC 423; 42 USC 428(a); 42 USC 
428(b); 42 USC 428(c); 42 USC 428(d); 42 USC 428(e); 42 USC 1302; 42 
USC 401(j); 42 USC 405(a)

CFR Citation:  20 CFR 404.331; 20 CFR 404.332; 20 CFR 404.341; 20 CFR 
404.357; 20 CFR 404.361; 20 CFR 404.366; 20 CFR 404.903; 20 CFR 
416.1180

Legal Deadline: None

Abstract: This regulation will make technical changes to several 
sections. Most of the changes correct problems with wording which 
occurred during the 1980 recodification. One change corrects an obvious 
clerical error in the wording of section 416.1180. Another change 
expands section 404.903 to clarify that extending social security or 
medical coverage in accordance with section 218 of the Act is a matter 
between the individual and the State and is not subject to SSA's 
administrative review process.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: Undetermined

Agency Contact: Lois Berg, Paralegal Specialist, Department of Health 
and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1713

RIN: 0960-AD83
_______________________________________________________________________

1379. PREVENTION OF ADVERSE EFFECTS ON ELIGIBILITY AND BENEFIT AMOUNT 
WHEN SPOUSE OR PARENT ABSENT DUE TO ACTIVE MILITARY SERVICE (462P)

Legal Authority:  PL 103-66, sec 13733

CFR Citation:  20 CFR 416.1160ff

Legal Deadline: None

Abstract: These proposed regulations reflect the provisions of section 
13733 of Pub. L. 103-66 which allows us to consider, absent evidence to 
the contrary, an ineligible parent or spouse who is absent from a 
deeming household due solely to an active duty military assignment, to 
be living in the same household as the eligible individual for deeming 
purposes. This will prevent possible adverse SSI effects which could 
otherwise result when a military deemor is absent from the household.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Lawrence V. Dudar, Legal Assistant, Department of 
Health and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1759

RIN: 0960-AD86
_______________________________________________________________________

1380.  EXTENSION OF TIME PERIOD FOR NOT COUNTING AS RESOURCES, 
FUNDS RECEIVED FOR REPAIR OR REPLACEMENT OF DAMAGED OR DESTROYED EXCLUDED 
RESOURCES IN THE SSI PROGRAM (486P)

Legal Authority:  42 USC 1302; 42 USC 1383

CFR Citation:  20 CFR 416.1232

Legal Deadline: None

Abstract: In the past several years, portions of the United States have 
experienced natural disasters that have had unprecedented effects on 
supplemental security income (SSI) recipients. In August 1992, 
Hurricane Andrew devastated south Florida causing damage estimated in 
excess of $18 billion. Because of the extent of the devastation, many 
SSI recipients in the area were unable to use insurance payments to 
repair or replace their damaged property within the timeframes provided 
by regulations at that time. With the expiration of existing 
timeframes, the payments would have counted as a resource for SSI 
purposes. On March 17, 1994, the Social Security Administration (SSA) 
published interim-final regulations which provided victims of Hurricane 
Andrew with an additional 12-month time period if needed in which to 
repair or replace their property. We are proposing regulations which 
provide SSA with the flexibility to consider these types of occurrences 
and provide individuals with additional time to repair or replace 
damaged or destroyed excluded resources when certain criteria are met.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM Comment Period End         00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Henry D. Lerner, Legal Assistant, Department of Health 
and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1762

RIN: 0960-AD87
_______________________________________________________________________

1381.  FEDERAL OASDI AND SSI FOR THE AGED, BLIND, AND DISABLED; 
SIGNATURE REQUIREMENTS FOR STATE AGENCY MEDICAL AND PSYCHOLOGICAL 
CONSULTANTS IN DISABILITY DETERMINATIONS (465P)

Legal Authority:  42 USC 405(a); 42 USC 421; 42 USC 1302; 42 USC 1382c; 
42 USC 1383; 42 USC 1383b

CFR Citation:  20 CFR 404.1615; 20 CFR 416.1015

Legal Deadline: None

Abstract: We propose to revise sections 404.1615 and 416.1015 of the 
current regulations regarding the certifications required on disability 
determination forms. Current regulations require that, unless the 
disability determination is made by a State agency disability hearing 
officer, disability hearing officer, disability determinations will be 
made by a team consisting of a State agency medical or psychological 
consultant and a State agency disability examiner, even when the 
determination is made on technical, nonmedical grounds. We propose to 
remove the requirement that a medical or psychological consultant make 
the determination jointly with the disability examiner when there is no 
medical evidence to be evaluated.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            01/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Harry J. Short, Legal Assistant, Department of Health 
and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Boulevard, 410 965-6243

RIN: 0960-AD88
_______________________________________________________________________

1382.  FEDERAL OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND 
SUPPLEMENTAL SECURITY INCOME, ACCEPTABLE MEDICAL SOURCES (469P)

Legal Authority:  42 USC 1302; 42 USC 1383; 42 USC 405

CFR Citation:  20 CFR 404.1513; 20 CFR 416.913

Legal Deadline: None

Abstract: We propose to add speech and language pathologists to the 
list of acceptable medical sources in our current regulations. These 
sources will assist us in establishing the existence of speech and 
language impairments. We also propose to make other changes in our 
regulations to clarify what we mean by an acceptable medical source.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            04/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Richard M. Bresnick, Legal Assistant, Department of 
Health and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1758

RIN: 0960-AD91
_______________________________________________________________________

1383.  OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE PROGRAM; 
CONTRIBUTIONS FOR SUPPORT (475P)

Legal Authority:  42 USC 402(d)(3); 42 USC 416(b)(3); 42 USC 405(a); 42 
USC 1302

CFR Citation:  20 CFR 404.366

Legal Deadline: None

Abstract: To provide more uniformity in our decision making, we are 
amending our rules on the contributions for support that must be 
provided by the insured to certain categories of claimants for child's 
benefits.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jack Schanberger, Legal Assistant, Department of Health 
and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-8471

RIN: 0960-AD92
_______________________________________________________________________

1384.  COMPUTATION OF SSI BENEFITS FOR THE FIRST THREE MONTHS OF 
PAYMENT (476P)

Legal Authority:  42 USC 1302; 42 USC 1383

CFR Citation:  20 CFR 416.320

Legal Deadline: None

Abstract: SSI eligibility and payment are calculated by taking into 
account income received by the applicant/recipient. Two calculations 
must be made for each month. The first is the eligibility computation 
and is based on the current (payment) month's income. The second is the 
eligibility computation, which, under retrospective monthly accounting, 
is based (usually) on the income of a prior month called the budget 
month. Generally the budget month is 2 months prior to the payment 
month. The transitional computation for the first 3 months of ssi 
payment is an exception to the general rule described above. While the 
eligibility computation continues to apply to the current month's 
income, the budget month on which each of the first 3 months' payments 
are based is the first month of eligibility. This policy was intended 
to facilitate the transition into 2 month retrospective accounting 
cycle and to avoid penalizing the recipient for income received prior 
to initial SSI eligibility. However, the policy also has the effect of 
counting income which is only received in one month more than one time. 
In Jones v. Shalala the Ninth Circuit Court of Appeals ruled

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Henry D. Lerner, Legal Assistant, Department of Health 
and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1762

RIN: 0960-AD93
_______________________________________________________________________

1385.  DEFINITION OF ``LARGEST BENEFIT AMOUNT'' FOR PURPOSES OF 
DETERMINING THE EARNINGS RECORD ON WHICH A PERSON WHO IS SIMULTANEOUSLY 
ENTITLED TO CHILD'S INSURANCE BENEFITS (481P)

Legal Authority:  42 USC 402(d); 42 USC 402(k); 42 USC 1302; 42 USC 
405(a)

CFR Citation:  20 CFR 404.304; 20 CFR 404.353b; 20 CFR 404.407d

Legal Deadline: None

Abstract: Section 202(k)(2)(A) of the Act (42 U.S.C. 402(k)(2)(A)) 
contains the statutory requirements for determining the earnings record 
on which SSA will pay a person, who is simultaneously entitled to 
child's insurance benefits on the earnings records of more than one 
worker. Generally, the child's benefits will be paid on the earnings 
record that yields the highest primary insurance amount (PIA). However, 
under certain circumstances, the child's benefits will be paid on the 
earnings record that yields a lower PIA if that record produces the 
``largest benefit'' to which the child could be entitled under section 
202(d) without the application of the reduction under the ``family 
maximum'' provisions. In implementing section 202(k)(2)(A), SSA has 
determined the ``largest benefit'' under section 202(k)(2)(A) by 
comparing the original benefit amount (i.e., 50 percent of the PIA of a 
living worker and 75 percent of the PIA of a deceased worker) 
calculated on the dependent and/or survivor claim of the child on the 
earnings record of each worker without applying any reductions or 
deductions. The United States District Court for the Northern District 
of Alabama in Agee v. Sullivan rejected

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Lois Berg, Paralegal Specialist, Department of Health 
and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1713

RIN: 0960-AD95
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
  
1386. SUPPLEMENTAL SECURITY INCOME PROGRAM; SUSPENSIONS, TERMINATIONS, 
AND ADVANCE NOTICE OF ADVERSE DETERMINATIONS (031F)

Legal Authority:  42 USC 1382; 42 USC 1382a; 42 USC 1382b; 42 USC 
1382c; 42 USC 1382d; 42 USC 1383; PL 99-643, sec 3; PL 99-643, sec 4; 
PL 100-203, sec 9103; PL 100-203, sec 9112; PL 100-203, sec 9115; PL 
101-239, sec 8009; PL 101-508, sec 5038; PL 101-508, sec 5105

CFR Citation:  20 CFR 416B; 20 CFR 416G; 20 CFR 416M

Legal Deadline: None

Abstract: This regulation reorganizes, revises, and clarifies the rules 
on stopping, reducing, suspending, and terminating an SSI beneficiary's 
SSI benefits. This regulation's purpose is to make these rules easier 
to read and understand. These rules also reflect the following 
statutory enactments: (1) section 3 of Pub. L. 99-643, (2) section 4 of 
Pub. L. 99-643, (3) section 9103 of Pub. L. 100-203, (4) section 9112 
of Pub. L. 100-203, (5) section 9115 of Pub. L. 100-203, (6) section 
8009 of Pub. L. 101-239, (7) section 5038 of Pub. L. 101-508, and (8) 
section 5105 of Pub. L. 101-508.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Notice of Decision to Develop 
Regs                            06/19/79                    44 FR 35241
NPRM                            05/08/86                    51 FR 17057
NPRM Comment Period End         07/07/86
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Lawrence V. Dudar, Legal Assistant, Department of 
Health and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1759

RIN: 0960-AA22
_______________________________________________________________________

1387. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE PROGRAM; REVISED 
MEDICAL CRITERIA FOR DETERMINATION OF DISABILITY; MUSCULOSKELETAL SYSTEM 
(143F)

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

RIN: 0960-AB01
_______________________________________________________________________

1388. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL 
SECURITY INCOME PROGRAM; CONTINUED PAYMENT OF BENEFITS TO PERSONS IN 
VOCATIONAL REHABILITATION PROGRAMS (131F)

Legal Authority:  42 USC 405; 42 USC 425; 42 USC 1302; 42 USC 1383

CFR Citation:  20 CFR 404.316; 20 CFR 404.337; 20 CFR 404.352; 20 CFR 
404.902; 20 CFR 404.1586; 20 CFR 404.1596; 20 CFR 404.1597; 20 CFR 
416.1321; 20 CFR 416.1338; 20 CFR 416.1331; 20 CFR 416.1402

Legal Deadline: None

Abstract: These changes permit the continued payment of disability 
benefits to persons who medically recover while participating in a 
vocational rehabilitation (VR) program, without regard to whether the 
person was expected at the onset of the VR program to medically recover 
before the scheduled completion date of the program and without regard 
to whether the person has any residual functional limitation. These 
changes bring the regulations into conformity with certain court 
decisions.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Interim Final Rule              05/14/86                    51 FR 17616
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jack Schanberger, Legal Assistant, Department of Health 
and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Blvd., Baltimore, MD 21235, 410 965-8471

RIN: 0960-AB05
_______________________________________________________________________

1389. SUPPLEMENTAL SECURITY INCOME PROGRAM; PROCEEDS OF A LOAN, PAYMENT 
OF PRO RATA SHARE OF HOUSEHOLD OPERATING EXPENSES (180F)

Legal Authority:  42 USC 1302

CFR Citation:  20 CFR 416.1103; 20 CFR 416.1133

Legal Deadline: None

Abstract: Money borrowed (a loan) is not income for SSI purposes and 
therefore has no effect on a person's SSI benefits. These regulations 
will state that only cash transactions may be considered loans. These 
regulations will also provide that the one-third reduction rule which 
applies when a person who lives in another's household and receives in-
kind support and maintenance will not apply if the SSI recipient pays 
his or her pro rata share in cash and no later than the month under 
consideration. No additional costs or savings are anticipated.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            08/20/90                    55 FR 33922
NPRM Comment Period End         10/19/90
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Duane Heaton, Legal Assistant, Department of Health and 
Human Services, Social Security Administration, Office of Regulations, 
6401 Security Blvd., Baltimore, MD 21235, 410 965-8470

RIN: 0960-AC42
_______________________________________________________________________

1390. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE PROGRAM; APPLICABILITY 
OF GOVERNMENT PENSION TO CERTAIN FEDERAL EMPLOYEES (188F)

Legal Authority:  42 USC 402(b); 42 USC 402(c); 42 USC 402(e); 42 USC 
402(f); 42 USC 402(g); PL 100-203, Sec 9007; PL 100-647, Sec 8014

CFR Citation:  20 CFR 404.408a

Legal Deadline: None

Abstract: This final rule would reflect provisions of the Omnibus 
Budget Reconciliation Act of 1987 (PL 100-203, sec 9007) on the 
Government pension offset and provisions of the Technical and 
Miscellaneous Revenue Act of 1988 (PL 100-647), which also contained 
new rules on the government pension offset.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/12/89                    54 FR 51036
NPRM Comment Period End         02/12/90
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jack Schanberger, Legal Assistant, Department of Health 
and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Blvd., Baltimore, MD 21235, 410 965-8471

RIN: 0960-AC46
_______________________________________________________________________

1391. SUPPLEMENTAL SECURITY INCOME PROGRAM; CONTINUATION OF FULL BENEFIT 
STANDARD FOR CERTAIN PERSONS TEMPORARILY INSTITUTIONALIZED (198F)

Legal Authority:  PL 100-203, Sec 9115; PL 99-643, Sec 3

CFR Citation:  20 CFR 416.211; 20 CFR 416.413; 20 CFR 416.414; 20 CFR 
416.1149; 20 CFR 416.1167; 20 CFR 416.1325; 20 CFR 416.2040; 20 CFR 
416.410; 20 CFR 416.412; 20 CFR 416.640; 20 CFR 416.1147

Legal Deadline: None

Abstract: These regulations conform to statutory amendments which 
require continued payment for up to three months based on the full 
payment rate to certain persons eligible for SSI payments under 
sections 1619 or 1611 of the Social Security Act who enter certain 
medical or psychiatric institutions. Without the provisions, SSI 
benefits would be reduced or suspended.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            09/28/92                    57 FR 44519
NPRM Comment Period End         11/27/92
Final Action                    12/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Lawrence V. Dudar, Legal Assistant, Department of 
Health and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Blvd., Baltimore, MD 21235, 410 965-1759

RIN: 0960-AC55
_______________________________________________________________________

1392. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE PROGRAM; MEDICAL 
CRITERIA FOR EVALUATING MENTAL DISORDERS FOR ADULTS (222F)

Regulatory Plan:  This entry is Seq. No. 37 in Part II of this issue of 
the Federal Register.

RIN: 0960-AC74
_______________________________________________________________________

1393. SUPPLEMENTAL SECURITY INCOME PROGRAM; TREATMENT OF AUGMENTED 
VETERANS' BENEFITS (231F)

Legal Authority:  42 USC 1382a

CFR Citation:  20 CFR 416.1123

Legal Deadline: None

Abstract: These regulations describe the treatment of the dependent's 
portion of an augmented Department of Veterans Affairs benefit as 
income to the dependent by the SSI program.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            05/18/90                    55 FR 20612
NPRM Comment Period End         07/17/90
Final Action                    11/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Duane Heaton, Legal Assistant, Department of Health and 
Human Services, Social Security Administration, Office of Regulations, 
6401 Security Boulevard, Baltimore, MD 21235, 410 965-8470

RIN: 0960-AC82
_______________________________________________________________________

1394. SUPPLEMENTAL SECURITY INCOME PROGRAM; WAIVER OF SSI RULE FOR 
DEEMING TO CHILDREN THE INCOME AND RESOURCES OF THEIR PARENTS FOR CERTAIN 
DISABLED CHILDREN (252F)

Legal Authority:  42 USC 1382c(f)(2)

CFR Citation:  20 CFR 416.415; 20 CFR 416.1148; 20 CFR 416.1165; 20 CFR 
416.1202

Legal Deadline: None

Abstract: These proposed regulations reflect the provisions of section 
8010 of Pub. L. 101-239 which waive the SSI income and resource deeming 
rules (which deem the income and resources of a disabled child's 
parents to the child if the child is living at home) for disabled 
children who were eligible for SSI benefits while in a medical 
institution and who qualify for Medicaid under a State home care plan 
authorized under title XIX when deeming parental income and resources 
would make the disabled child ineligible for SSI benefits or eligible 
for a payment of less than the personal needs allowance. This was 
effective June 1, 1990.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            09/22/93                    58 FR 49249
NPRM Comment Period End         11/22/93
Final Action                    01/00/95

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Cassandra Bond, Legal Assistant, Department of Health 
and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1794

RIN: 0960-AC96
_______________________________________________________________________

1395. SSI PROGRAM; REDUCTION IN TIME WHEN INCOME AND RESOURCES OF 
SEPARATED COUPLES MUST BE TREATED AS JOINTLY AVAILABLE FOR PURPOSES OF 
SSI ELIGIBILITY AND BENEFITS (254F)

Legal Authority:  42 USC 1382c(b)

CFR Citation:  20 CFR 416.120(c); 20 CFR 416.305; 20 CFR 416.430; 20 
CFR 416.432; 20 CFR 416.532(c); 20 CFR 416.554; 20 CFR 416.1130(c); 20 
CFR 416.1147; 20 CFR 416.1801(c); 20 CFR 416.1802(b); 20 CFR 416.1806; 
20 CFR 416.1811; 20 CFR 416.1830(a); 20 CFR 416.1832(c); 20 CFR 
416.1832(d)

Legal Deadline: None

Abstract: This proposed regulation requires that a married couple be 
treated as separate individuals for purposes of SSI eligibility and 
benefit determination beginning with the month after the month they 
begin living apart. This change is effective October 1, 1990.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            03/08/94                    59 FR 10766
NPRM Comment Period End         05/09/94
Final Action                    12/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Duane Heaton, Legal Assistant, Department of Health and 
Human Services, Social Security Administration, Office of Regulations, 
6401 Security Boulevard, Baltimore, MD 21235, 410 965-8470

RIN: 0960-AC98
_______________________________________________________________________

1396. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL 
SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED; UPDATING NOMENCLATURE 
(264F)

Legal Authority:  42 USC 405; 42 USC 1302; 42 USC 1383

CFR Citation:  20 CFR 404; 20 CFR 410; 20 CFR 416; 20 CFR 422

Legal Deadline: None

Abstract: This regulation amends current regulations to replace 
outdated nomenclature and terminology, to eliminate little used rules 
and provisions which are no longer in effect, and to correct technical 
errors such as misspellings and incorrect cross-references.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Cassandra Bond, Legal Assistant, Department of Health 
and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1794

RIN: 0960-AD11
_______________________________________________________________________

1397. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL 
SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED; REPRESENTATIVE PAYEE 
REFORMS (295F)

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

RIN: 0960-AD22
_______________________________________________________________________

1398. ORGANIZATION AND PROCEDURES; PROCEDURES OF THE OFFICE OF HEARINGS 
AND APPEALS; AUTHORITY OF APPEALS OFFICERS TO DENY A REQUEST FOR APPEALS 
COUNCIL REVIEW (334F)

Legal Authority:  42 USC 405; 42 USC 1302; 42 USC 1383

CFR Citation:  20 CFR 422.205

Legal Deadline: None

Abstract: We propose to amend our regulations to give Appeals Officers 
of the Appeals Council authority to deny requests for review of hearing 
decisions. Presently, this authority rests only with members of the 
Appeals Council.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            01/10/94                     59 FR 1363
NPRM Comment Period End         03/11/94
Final Action                    03/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Lois Berg, Legal Assistant, Office of Regulations, 
Department of Health and Human Services, Social Security 
Administration, 6401 Security Boulevard, Baltimore, Maryland 21235, 410 
965-1713

RIN: 0960-AD45
_______________________________________________________________________

1399. OASDI AND SSI; TESTING MODIFICATIONS TO THE DISABILITY 
DETERMINATION PROCEDURES (359F)

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

RIN: 0960-AD63
_______________________________________________________________________

1400. RELIABLE INFORMATION WHICH IS CURRENTLY AVAILABLE FOR DETERMINING 
BENEFIT AMOUNTS IN THE SUPPLEMENTAL SECURITY INCOME PROGRAM (382F)

Legal Authority:  42 USC 1302; 42 USC 1382(a) to 1382(c); 42 USC 
1382(e); 42 USC 1382a; 42 USC 1382f; 42 USC 1383

CFR Citation:  20 CFR 416.420

Legal Deadline:  NPRM, Judicial, March 16, 1993.

Abstract: Pursuant to the Court order in Gould, et al. v. Sullivan, No. 
C2-87-964 (S.D. Ohio, October 2, 1992), we proposed a rule for 
determining benefits in the SSI program. Under section 1611(c)(4)(A) of 
the Social Security Act, if the Secretary determines that reliable 
information is currently available concerning the income and other 
circumstances of an individual for a month, the Secretary may use that 
information to determine an individual's SSI benefit amount for that 
month. This discretionary method of determining SSI benefit amounts is 
an exception to the use of information from a prior month, known as 
retrospective monthly accounting (RMA), as provided in section 
1611(c)(1) of the Act. The proposed rule explained that the Secretary 
has determined that no information exists which is reliable and 
currently available to use in computing SSI benefit amounts pursuant to 
section 1611(c)(4).

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            03/16/93                    58 FR 14191
NPRM Comment Period End         05/17/93
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Henry Lerner, Legal Assistant, Department of Health and 
Human Services, Social Security Administration, Office of Regulations, 
6401 Security Boulevard, Baltimore, MD 21235, 410 965-1762

RIN: 0960-AD65
_______________________________________________________________________

1401. COMPENSATION OF QUALIFIED ORGANIZATIONS SERVING AS REPRESENTATIVE 
PAYEES UNDER TITLE II AND TITLE XVI (423F)

Legal Authority:  42 USC 405(a); 42 USC 405(j); 42 USC 1302; 42 USC 
1383(a)(2)

CFR Citation:  20 CFR 404.2040; 20 CFR 404.2040a; 20 CFR 416.640; 20 
CFR 416.640a

Legal Deadline: None

Abstract: These additional changes to the final regulations which were 
published on June 1, 1992 will require a representative payee to set 
aside a personal needs allowance for all institutionalized 
beneficiaries; preclude a qualified organization that serves as 
representative payee from taking a fee from the personal needs 
allowance of all institutionalized beneficiaries; and allow a qualified 
organization to collect its fee for services from conserved benefits in 
certain limited circumstances.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Henry D. Lerner, Legal Assistant, Department of Health 
and Human Services, Social Security Administration, 6401 Security 
Boulevard, Baltimore, MD 21235, 410 965-1762

RIN: 0960-AD71
_______________________________________________________________________

1402. FEDERAL OASDI AND SSI; COMPUTING BENEFIT AMOUNTS, DISPOSING OF 
UNDERPAYMENTS, RESOLVING OVERPAYMENTS, AND PAYMENT RESTRICTION (428F)

Legal Authority:  42 USC 405(a); 42 USC 415(a)(7); 42 USC 1302(a)

CFR Citation:  20 CFR 404.213; 20 CFR 404.460; 20 CFR 404.503; 20 CFR 
404.510

Legal Deadline: None

Abstract: Current regulations on the windfall elimination provision do 
not explain how SSA will treat the purchase of noncovered retroactive 
service, e.g., the purchase of coverage for military service. The 
regulations will state that we will accept such service in determining 
whether an insured individual is exempt from the windfall provision 
because he or she became eligible before 1986 for a pension based on 
noncovered employment. The regulations will also include three 
technical amendments. First, we will delete a cross reference which 
erroneously indicates that a person otherwise eligible for an 
underpayment of benefits must be the parent of an insured individual. 
Second, we will change age 72 to age 70 regarding deductions for net 
earnings from self-employment. Third, we will delete the German 
Democratic Republic and Albania from the list of countries to which 
payment of benefits is restricted.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            07/20/94                    59 FR 37000
NPRM Comment Period End         09/19/94
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jack Schanberger, Legal Assistant, Department of Health 
and Human Services, Social Security Administration, 6401 Security 
Boulevard, Baltimore, MD 21235, 410 965-8471

RIN: 0960-AD72
_______________________________________________________________________

1403. FEDERAL OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE; EVIDENCE 
REQUIRED TO PRESUME A PERSON IS DEAD (443F)

Legal Authority:  42 USC 405(a); 42 USC 1102

CFR Citation:  20 CFR 404.720

Legal Deadline: None

Abstract: These proposed regulations reflect a new proposed policy 
providing that the presumption of death arises when the claimant 
establishes an individual has been absent from his or her residence and 
not heard from for 7 years. Once the presumption is made, the burden 
then shifts to us to rebut the presumption either by presenting 
evidence that the missing individual is still alive or by providing an 
explanation to account for the individual's absence in a manner 
consistent with continued life rather than death. Policy concerning the 
rebuttal of a presumption of death will also be provided in a new 
section to the regulations.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            07/20/94                    59 FR 37002
NPRM Comment Period End         09/19/94
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Henry D. Lerner, Legal Assistant, Department of Health 
and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1762

RIN: 0960-AD79
_______________________________________________________________________

1404. TEMPORARY INCREASE IN SPONSORSHIP PERIOD FOR ALIENS UNDER THE SSI 
PROGRAM (457F)

Legal Authority:  PL 103-152, sec 7

CFR Citation:  20 CFR 416.1160; 20 CFR 416.1204

Legal Deadline: None

Abstract: Section 7 of Pub. L. 103-152 amended section 1621 of the 
Social Security Act to temporarily increase the sponsorship period for 
aliens under the SSI program from 3 years to 5 years following the 
alien's date of lawful admission to the U.S. The increase in the 
sponsorship period is effective January 1, 1994. Beginning October 1, 
1996, the 3-year sponsorship period will be reinstated. We will amend 
our regulations to conform to the statutory changes. Any costs/savings 
are associated with the legislation and not with the regulations 
themselves.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Action                    06/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Lois Berg, Paralegal Specialist, Department of Health 
and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1713

RIN: 0960-AD84
_______________________________________________________________________

1405. REPLACEMENT OF LOST, DAMAGED OR STOLEN EXCLUDED RESOURCES 
(HURRICANE ANDREW) (458I)

Legal Authority:  42 USC 1302; 42 USC 1383

CFR Citation:  20 CFR 416.1232

Legal Deadline: None

Abstract: Some supplemental security income (SSI) recipients who were 
victims of Hurricane Andrew in south Florida have not been able to 
replace or repair their damaged homes and other excluded resources due 
to circumstances beyond their control. This means that some SSI 
recipients will be holding assets (insurance money) in amounts that 
will disqualify them for SSI benefits if held for periods exceeding the 
maximum 18-month period currently in regulations at section 416.1232. 
Since Hurricane Andrew occurred in August 1992, SSI recipients could 
become ineligible as early as March 1994. We are codifying in 
regulations, interim final rules which provide additional time for 
victims of Hurricane Andrew to replace or repair their damaged excluded 
resources without suffering loss or interruption of their SSI benefits.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Interim Final Rule              03/17/94                    59 FR 12544
NPRM Comment Period End         05/17/94
Final Action                    12/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Henry D. Lerner, Legal Assistant, Department of Health 
and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1762

RIN: 0960-AD85
_______________________________________________________________________

1406.  TECHNICAL CHANGES TO TITLE XVI (466F)

Legal Authority:  42 USC 1382; 42 USC 1382a; 42 USC 1382b; 42 USC 1382j

CFR Citation:  20 CFR 416.1236; 20 CFR 416 app

Legal Deadline: None

Abstract: We are amending the supplemental security income regulations 
by making technical changes to update the appendix at the end of 
Subpart K which lists exclusions from income in statutes other than the 
Social Security Act and to update the lists of statutory exclusions 
from resources contained in Subpart L.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Duane Heaton, Legal Assistant, Department of Health and 
Human Services, Social Security Administration, Office of Regulations, 
6401 Security Boulevard, Baltimore, MD 21235, 410 965-8470

RIN: 0960-AD89
_______________________________________________________________________

1407.  SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND OR 
DISABLED; EVIDENCE OF LAWFUL ADMISSION FOR PERMANENT RESIDENCE IN THE 
UNITED STATES (486F)

Legal Authority:  42 USC 1302; 42 USC 1382c(a)(1)(B); 42 USC 1382c(e); 
42 USC 1383

CFR Citation:  20 CFR 416.1615

Legal Deadline: None

Abstract: On September 20, 1993, the Immigration and Naturalization 
Service (INS) published a regulatory change concerning the documents 
which certify the alien status of a lawful permanent resident within 
the United States. The change which establishes INS Form I-551, Alien 
Registration Receipt Card, as the definitive evidence of lawful 
permanent resident status is effective September 20, 1994. Since aliens 
who apply for SSI benefits as lawful permanent residents must submit 
evidence of this status, we are revising the title XVI regulations to 
reflect the change in the INS regulations.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Action                    12/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Lois Berg, Paralegal Specialist, Department of Health 
and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1713

RIN: 0960-AD90
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Social Security Administration (SSA)
  
_______________________________________________________________________
  
1408. SUPPLEMENTAL SECURITY INCOME PROGRAM; WHAT IS NOT INCOME (121F)

CFR Citation:  20 CFR 416.1103(a)

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    07/01/94                    59 FR 33906

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Duane Heaton, 410 965-8470

RIN: 0960-AB09
_______________________________________________________________________

1409. SUPPLEMENTAL SECURITY INCOME PROGRAM; CONTINUATION OF BENEFITS AND 
SPECIAL ELIGIBILITY FOR CERTAIN SEVERELY IMPAIRED RECIPIENTS WHO WORK 
(171F)

CFR Citation:  20 CFR 416.260; 20 CFR 416.261; 20 CFR 416.262; 20 CFR 
416.265; 20 CFR 416.268; 20 CFR 416.269; 20 CFR 416.1112; 20 CFR 
416.1402; 20 CFR 416.264; 20 CFR 416.1403

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    08/12/94                    59 FR 41400

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Richard M. Bresnick, 410 965-1758

RIN: 0960-AC22
_______________________________________________________________________

1410. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL 
SECURITY INCOME PROGRAMS; DEEMED APPLICATION DATE BASED ON MISINFORMATION 
(267F)

CFR Citation:  20 CFR 404.612; 20 CFR 404.614; 20 CFR 404.615; 20 CFR 
404.633 (New); 20 CFR 404.902; 20 CFR 404.903; 20 CFR 416.310; 20 CFR 
416.325; 20 CFR 416.351 (New); 20 CFR 416.1402; 20 CFR 416.1403

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    08/31/94                    59 FR 44918

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Henry Lerner, 410 965-1762

RIN: 0960-AD05
_______________________________________________________________________

1411. SUPPLEMENTAL SECURITY INCOME PROGRAM; FINANCIAL INSTITUTION 
ACCOUNTS IN THE SSI PROGRAM (278F)

CFR Citation:  20 CFR 416.1201(b); 20 CFR 416.1208 (New)

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    05/31/94                    59 FR 27985

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Henry Lerner, 410 965-1762

RIN: 0960-AD10
_______________________________________________________________________

1412. SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED; 
TREATMENT OF CERTAIN ROYALTIES AND HONORARIA (310F)

CFR Citation:  20 CFR 416.1110; 20 CFR 416.1111; 20 CFR 416.1121

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    08/24/94                    59 FR 43470

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Duane Heaton, 410 965-8470

RIN: 0960-AD35
_______________________________________________________________________

1413. SUPPLEMENTAL SECURITY INCOME PROGRAM; TREATMENT OF PROMISSORY NOTES 
IN HOME REPLACEMENT SITUATIONS (182F)

CFR Citation:  20 CFR 416.1212

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    08/23/94                    59 FR 43283

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Henry Lerner, 410 965-1762

RIN: 0960-AD61
_______________________________________________________________________

1414. APPEAL RIGHTS FOLLOWING STATE-INITIATED MASS CHANGE IN FEDERALLY 
ADMINISTERED STATE SUPPLEMENTARY PAYMENTS RESULTING IN REDUCTION, 
SUSPENSION, OR TERMINATION OF STATE SUPPLEMENTARY PAYMENTS (383F)

CFR Citation:  20 CFR 416.1401; 20 CFR 416.1402; 20 CFR 416.1403

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    08/22/94                    59 FR 43035

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jack Schanberger, 410 965-8471

RIN: 0960-AD66
_______________________________________________________________________

1415. ELIGIBILITY FOR CHILDREN OF ARMED FORCES PERSONNEL RESIDING OUTSIDE 
THE UNITED STATES OTHER THAN IN FOREIGN COUNTRIES (452F)

CFR Citation:  20 CFR 416.215

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    08/12/94                    59 FR 41399

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Henry D. Lerner, 410 965-1762

RIN: 0960-AD81
_______________________________________________________________________

1416.  FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE; 
DETERMINING DISABILITY AND BLINDNESS; EXTENSION OF EXPIRATION DATE FOR 
THE LISTING OF IMPAIRMENTS, MENTAL DISORDERS IN ADULTS (477F)

Legal Authority:  42 USC 1302; 42 USC 1383; 42 USC 405

CFR Citation:  20 CFR 404.1500

Legal Deadline: None

Abstract: The Social Security Administration issues listings of 
impairments to evaluate disability and blindness under the Social 
Security and Supplemental security income (SSI) programs. This rule 
would extend the expiration date for the adult mental disorders 
listings. We propose no revisions to the medical criteria in the 
listings; they would remain the same as they now appear in the Code of 
Federal Regulations. This extension will ensure that we continue to 
have medical evaluation criteria in the listings to adjudicate claims 
for disability based on mental impairments at step three of our 
sequential evaluation process.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Action                    08/16/94                    59 FR 41974

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Richard M. Bresnick, Legal Assistant, Department of 
Health and Human Services, Social Security Administration, Office of 
Regulations, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-1758

RIN: 0960-AD94

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
 
Public Health Service (PHS)--Office of Assistant Secretary for Health 
(OASH)
  
_______________________________________________________________________
  
1417. PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT

Legal Authority:  42 USC 289b; 42 USC 290aa

CFR Citation:  42 CFR 93

Legal Deadline: None

Abstract: The proposed regulation will revise the definition of 
research misconduct, identify responsibilities of institutions 
receiving allegations of research misconduct involving PHS-supported 
research, provide a hearing opportunity for persons found to have 
engaged in research misconduct, and set forth other policies of the 
Department of Health and Human Services related to research integrity.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Dr. Lawrence Rhoades, Director, Division of Policy and 
Education, Office of Research Integrity, Department of Health and Human 
Services, Public Health Service, 5515 Security Lane, Suite 700, 
Rockville, MD 20852, 301 443-5300

RIN: 0905-AE02
_______________________________________________________________________

1418. STANDARDS OF COMPLIANCE FOR ABORTION-RELATED SERVICES IN FAMILY 
PLANNING SERVICE PROJECTS

Legal Authority:  42 USC 300a-4

CFR Citation:  42 CFR 59

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: State

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

RIN: 0905-AE03
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Public Health Service (PHS)--Office of Assistant Secretary for Health 
(OASH)
  
_______________________________________________________________________
  
1419. PRIVACY ACT; EXEMPT SYSTEM

CFR Citation:  45 CFR 5b

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    07/19/94                    59 FR 36717
Final Action Effective          08/18/94                    59 FR 36717

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AD31

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
 
Public Health Service (PHS)--Substance Abuse and Mental Health Services 
Administration (SAMHSA)
  
_______________________________________________________________________
  
1420. CONFIDENTIALITY OF SUBSTANCE ABUSE PATIENT RECORDS

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

CFR Citation:  42 CFR 2

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            08/18/94                    59 FR 42561
NPRM Comment Period End         10/17/94
Final Action                    03/00/95

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Tribal, Federal

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

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

RIN: 0905-AD97
_______________________________________________________________________

1421. PROTECTION AND ADVOCACY FOR INDIVIDUALS WITH MENTAL ILLNESS

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                            10/00/94
NPRM Comment Period End         01/00/95
Final Action                    04/00/95

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Local

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

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

RIN: 0905-AD99
_______________________________________________________________________

1422. COMMUNITY MENTAL HEALTH SERVICES BLOCK GRANTS

Legal Authority:  42 USC 300X-1, PL 102-321, ADAMHA Reorganization Act

CFR Citation:  45 CFR 96

Legal Deadline: None

Abstract: States and territories must submit annual applications which 
include State plans and implementation reports for services delivery to 
adults with serious mental illness and children with serious emotional 
disturbance under the Community Mental Health Services Block Grant 
statute. Regulatory action is necessary to establish uniform 
application format and to institute requirements with regard to 
addressing and reporting on the statutory criteria the Secretary must 
use to determine if applications comply with legislative mandates 
(sections 1911, 1920 and 1941-1954 of the Public Health Service Act, as 
amended by P.L. 102-321), thus meeting approval for grant award.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            02/00/95
NPRM Comment Period End         04/00/95

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Tribal

Agency Contact: Joseph Faha, Director, Div. of Legislation and External 
Affairs, Department of Health and Human Services, Public Health 
Service, Room 12C-15, Parklawn Building, 5600 Fishers Lane, Rockville, 
MD 20857, 301 443-4640

RIN: 0905-AE24
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Substance Abuse and Mental Health Services 
Administration (SAMHSA)
  
_______________________________________________________________________
  
1423. BLOCK GRANTS FOR PREVENTION AND TREATMENT OF SUBSTANCE ABUSE

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

CFR Citation:  45 CFR 96

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

Abstract: Sets requirements for block grants for prevention and 
treatment of substance abuse. The requirements include criteria for 
approval of State plans which must by statute be prescribed in 
regulations. These provisions are effective immediately. However, 
States have 90 days from the effective date to bring previously 
submitted FY 1993 applications into substantial compliance and need to 
submit applications in the prescribed format beginning only with 1994 
applications.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Interim Final Rule              03/31/93                    58 FR 17062
Interim Final Rule Comment 
Period End                      06/01/93
Final Action                    12/00/94

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Tribal

Additional Information: Alternate Contact: Sue Martone, DLEA, SAMHSA, 
PHS, 5600 Fishers Lane, Room 12C-15, Rockville, MD 20852; 301-443-4640

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

RIN: 0905-AD98
_______________________________________________________________________

1424. BLOCK GRANTS FOR PREVENTION AND TREATMENT OF SUBSTANCE ABUSE 
(TOBACCO PROVISIONS)

Regulatory Plan:  This entry is Seq. No. 45 in Part II of this issue of 
the Federal Register.

RIN: 0905-AE05

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
 
Public Health Service (PHS)--Centers for Disease Control and Prevention 
(CDC)
  
_______________________________________________________________________
  
1425. RESPIRATORY PROTECTIVE DEVICES

Regulatory Plan:  This entry is Seq. No. 46 in Part II of this issue of 
the Federal Register.

RIN: 0905-AB58
_______________________________________________________________________

1426. INTERSTATE SHIPMENT OF BIOLOGICAL MATERIAL THAT CONTAINS OR MAY 
CONTAIN INFECTIOUS SUBSTANCES

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

CFR Citation:  42 CFR 72

Legal Deadline: None

Abstract: The revised regulation will clarify and expand the 
requirements for proper packaging and handling of infectious substances 
during interstate shipment. The revised regulation will ensure that all 
biological material that could contain infectious substances is 
packaged in a manner for interstate shipment that minimizes the 
potential for leakage and possible contamination of the environment and 
minimizes direct physical contact with the contents by package 
handlers. The revised regulation is not expected to have a major impact 
on the cost of shipping these materials.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            03/02/90                     55 FR 7678
NPRM Comment Period End         05/09/90                     55 FR 7678
Final Action                    10/00/94
Final Action Effective          01/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jonathan Y. Richmond, Ph.D., Director, Office of Health 
and Safety, Centers for Disease Control and Prevention, Department of 
Health and Human Services, Public Health Service, 1600 Clifton Road 
NE., Mailstop F-05, Atlanta, GA 30333, 404 639-2453

RIN: 0905-AC89
_______________________________________________________________________

1427. MEDICAL EXAMINATION OF ALIENS

Legal Authority:  8 USC 1182; 8 USC 1224; 8 USC 1225; 42 USC 216; 42 
USC 249; 42 USC 252; PL 101-649

CFR Citation:  42 CFR 34

Legal Deadline: None

Abstract: This is a proposed revision in the regulations for the 
medical examination of aliens. The regulations were developed to 
provide for the physical and mental examination of aliens within the 
United States or in other countries as required by the Immigration and 
Nationality Act. This revision would update the regulations in 
accordance with current epidemiologic concepts and medical diagnostic 
standards.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Interim Final Rule              05/31/91                    56 FR 25000
Interim Final Comment Period End08/02/91                    56 FR 25000
Final Action                    00/00/00
Final Action Effective          00/00/00

Small Entities Affected: None

Government Levels Affected: State, Federal

Agency Contact: Charles R. McCance, Director, Division of Quarantine, 
Department of Health and Human Services, Public Health Service, Centers 
for Disease Control and Prevention, 1600 Clifton Road, Mailstop E-04, 
Atlanta, GA 30333, 404 639-8100

RIN: 0905-AD29

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)             Prerule Stage
 
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
  
1428. MEDICAL FOODS

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
ANPRM Comment Period End        00/00/00

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

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

RIN: 0905-AD91
_______________________________________________________________________

1429. SUNGLASSES; LABELING; ULTRAVIOLET RADIATION

Legal Authority:  21 USC 352

CFR Citation:  21 CFR 801

Legal Deadline: None

Abstract: The failure of sunglasses to block the transmittance of a 
sufficient amount of UV rays may result in macular degeneration, a 
condition affecting vision significantly. Not all sunglasses provide 
adequate protection for those at high risk. FDA believes that consumers 
should be aware of the degree of protection provided. FDA is publishing 
the ANPRM to gather additional information on the extent of the problem 
and to seek potential solutions.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

ANPRM                           12/00/94

Small Entities Affected: Undetermined

Government Levels Affected: None

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

RIN: 0905-AE35
_______________________________________________________________________

1430. INVESTIGATIONAL DEVICE EXEMPTION: COST RECOVERY

Legal Authority:  21 USC 360j (g)

CFR Citation:  21 CFR 812.7

Legal Deadline: None

Abstract: FDA is considering revising its regulation concerning 
recovering costs from patients for devices being investigated for 
safety and effectiveness information before commercial marketing. 
Presently, 21 CFR 812.7(b) prohibits investigators from charging 
subjects a price larger than that necessary to recover costs of 
manufacture, research, development and handling. FDA believes that this 
may encourage more widespread use of investigational devices than is 
appropriate. FDA is publishing this ANPRM to gather information on the 
nature and extent of the problem.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

ANPRM                           03/00/95

Small Entities Affected: Undetermined

Government Levels Affected: None

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

RIN: 0905-AE36
_______________________________________________________________________

1431.  DEVELOPMENT OF HAZARD ANALYSIS CRITICAL CONTROL POINTS FOR 
THE FOOD INDUSTRY; REQUEST FOR COMMENTS

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

RIN: 0905-AE60
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
  
1432. OVER-THE-COUNTER (OTC) DRUG REVIEW

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

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

Legal Deadline: None

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

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 03/00/95

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

Amendment (DPH Combinations) Cough/Cold (Comb.) Products  NPRM 03/00/95

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)

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

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

Anticaries Products  ANPRM 03/28/80 (45 FR 20666)  NPRM 09/30/85 (50 FR 
39854)  NPRM 06/15/88 (53 FR 22430)  Final Action 12/00/94

Antidiarrheal Products  ANPRM 03/21/75 (40 FR 12924)  NPRM 04/30/86 (51 
FR 16138)  Final Action 02/00/95

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Cough/Cold (Bronchodilator) Products  ANPRM 09/09/76 (41 FR 
38312)  NPRM 10/26/82 (47 FR 47520)  Final Action 10/02/86 (51 FR 
35326)  NPRM (Amendment)(Warning) 06/19/92 (57 FR 27662)  Final Action 
(Amendment)(Warning) 10/20/93 (58 FR 54238)

Cough/Cold (Combination) Products  ANPRM 09/09/76 (41 FR 38312)  NPRM 
08/12/88 (53 FR 30522)  NPRM (Amendment)(DPH Combinations) 03/00/
95  Final Action 00/00/00

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

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

Cough/Cold (Nasal Decongestant) Products  ANPRM 09/09/76 (41 FR 
38312)  NPRM 01/15/85 (50 FR 2220)  NPRM (Amendment) 06/19/92 (57 FR 
27658)  Final Action 08/23/94 (59 FR 43386)

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

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

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

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

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 03/00/95

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

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

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

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

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

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

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

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

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

Internal Analgesic Products  ANPRM 07/08/77 (42 FR 35346)  NPRM 11/16/
88 (53 FR 46204)  NPRM (Amendment) (Overindulgence) 12/24/91 (56 FR 
66762)  NPRM (Amdt.)(Sodium Bicarbonate) 02/02/94 (59 FR 5068)

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

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

Labeling of Drug Products for OTC Use  NPRM 04/05/93 (58 FR 
17553)  Final Action 01/28/94 (59 FR 3998)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Otic Products (Swimmers Ear)  NPRM 07/30/86 (51 FR 27366)  Final Action 
12/00/94

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

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

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

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

Poison Treatment Products  NPRM 01/15/85 (50 FR 2244)  Final Action 02/
00/95

Reporting of Adverse Reactions  NPRM 12/00/94

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

Skin Protectant Products  ANPRM 08/04/78 (43 FR 34628)  NPRM 02/15/83 
(48 FR 6820)  NPRM (Amendment) (Astringent) 04/03/89 (54 FR 
13490)  NPRM (Amendment) (Poison Ivy) 10/03/89 (54 FR 40808)  NPRM 
(Amendment) (Fvr Blister/Ext) 01/31/90 (55 FR 3362)  NPRM (Amendment) 
(Diaper Rash) 06/20/90 (55 FR 25204)  Final Action (Astringent) 10/21/
93 (58 FR 54466)  Final Action (Witch Hazel) 06/03/94 (59 FR 
28767)  Final Action 03/00/95

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

Sodium Labeling  NPRM 04/25/91 (56 FR 19222)  Final Action 03/00/95

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)  Second NPRM 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 11/
00/94

Vaginal Contraceptive Products  ANPRM 12/12/80 (45 FR 82014)  NPRM 10/
00/94

Vaginal Drug Products  ANPRM 10/13/83 (48 FR 46694)  Withdrawal 
Published 02/03/94 (59 FR 5226)

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

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

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/
95

Small Entities Affected: None

Government Levels Affected: None

Additional Information: ABSTRACT CONT: for ``Antimicrobial Products.'' 
NPRM for ``Alcohol (Topical) Products'' to be included in revised NPRM 
for ``Antimicrobial Products.'' The NPRM for ``Antimicrobial Products'' 
is being revised because it is being updated and split into two 
sections: first aid products and health care products.
SMALL ENTITIES AFFECTED: The effects, if any, vary depending on the 
individual rulemaking. However, the agency anticipates that the rules 
would not have a significant economic impact on a substantial number of 
small entities as defined by the Regulatory Flexibility Act.

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

RIN: 0905-AA06
_______________________________________________________________________

1433. NEW ANIMAL DRUG APPROVAL PROCESS; IMPLEMENTATION OF TITLE I OF THE 
GENERIC ANIMAL DRUG AND PATENT TERM RESTORATION ACT

Legal Authority:  21 USC 360b; 21 USC 371

CFR Citation:  21 CFR 514

Legal Deadline:  Final, Statutory, November 5, 1989.
The deadline applies to the GADPTRA sections. There is no deadline 
relating to the other sections.

Abstract: On December 17, 1991, the agency published a proposed 
revision of the existing regulations that is consistent with the 
current procedural regulations for human drugs where appropriate. The 
New Animal Drug Application (NADA) revisions articulate general 
requirements in regulations containing performance standards and would 
complement them through detailed guidelines on, among other matters, 
appropriate ways of meeting requirements for submission of chemistry, 
pharmacology, and statistical data that would better address the 
intricate scientific issues involved. A separate proposed rule for 
reporting requirements for marketed animal drugs also 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 approved after 1962.

Timetable:

New Animal Drug Approval Process  NPRM 12/17/91 (56 FR 65544)  NPRM 03/
00/95

Reporting Requirements for Marketed Animal Drugs  NPRM 12/17/91 (56 FR 
65581)  Final Action 03/00/95

Small Entities Affected: Businesses

Government Levels Affected: None

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

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

RIN: 0905-AA96
_______________________________________________________________________

1434. INFANT FORMULA ACT

Legal Authority:  21 USC 350a

CFR Citation:  21 CFR 107; 21 CFR 106

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Rule                      12/24/91                    56 FR 66566
NPRM                            07/00/95
NPRM Comment Period End         10/00/95
Current Good Mfg. Practices; Qual Control Proc  NPRM 07/00/95

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

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AC46
_______________________________________________________________________

1435. REPORTING OF ERRORS AND ACCIDENTS RELATING TO BLOOD SAFETY AND 
WITHDRAWAL OF PREVIOUSLY PROPOSED RULE

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 
effect the safety, purity, or potency of any distributed biological 
product (21 CFR 600.14). The reporting of certain errors or accidents 
occurring in the manufacture of blood and blood components is necessary 
so that FDA can respond where the public health may be endangered and 
provide added assurance as to the continued safety, identity, quality, 
purported quality, and purity of blood and blood components. FDA has 
determined that errors and accidents that are detected and corrected 
before a finished unit is removed from the unprocessed inventory and 
made available for release and distribution do not affect the safety of 
the blood supply and need not be reported to the agency. The proposed 
rule would require licensed establishments, unlicensed establishments, 
and transfusion services to report and keep records. The cost to 
licensed establishments would be minimal. (cont)

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            08/00/95
NPRM Comment Period End         12/00/95

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Procurement: This is a procurement-related action for which there is no 
statutory requirement. There is a paperwork burden associated with this 
action.
Additional Information: ABSTRACT CONT: Since they already are required 
to report, licensed establishments would only have to make some changes 
in standard operating procedures. Unlicensed establishments are already 
required to keep records and conduct investigations. Under the proposed 
rule they would have to establish reporting procedures and report to 
FDA. The transfusion services would have to assure their recordkeeping 
and investigation procedures are sufficient and establish reporting 
procedures. Reporting by transfusions services is expected to be 
minimal.

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

RIN: 0905-AD67
_______________________________________________________________________

1436. PROPOSED LABELING FOR DRUG PRODUCTS BASED ON FALSE OR FRAUDULENT 
DATA

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

CFR Citation:  21 CFR 201

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            10/00/94

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AD71
_______________________________________________________________________

1437. REVIEW OF WARNINGS, USE INSTRUCTIONS, AND PRECAUTIONARY INFORMATION 
UNDER SECTION 314 OF THE NATIONAL CHILDHOOD VACCINE INJURY ACT OF 1986

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                            06/00/95

Small Entities Affected: None

Government Levels Affected: State

Additional Information: 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-635), 1401 Rockville Pike, Suite 200N, 
Rockville, MD 20852-1448, 301 594-3074

RIN: 0905-AD72
_______________________________________________________________________

1438. PERFORMANCE STANDARD FOR THE INFANT APNEA MONITOR

Legal Authority:  21 USC 360d

CFR Citation:  21 CFR 800

Legal Deadline: None

Abstract: FDA is proposing a mandatory standard for infant apnea 
monitors which are intended for use on infants to detect cessation of 
breathing. The standard includes requirements for infant apnea monitors 
in four areas: Patient monitoring, electrical, mechanical and 
environmental, and labeling. FDA considered reliance upon voluntary 
standards to address risks presented by these devices but determined 
that a mandatory standard is necessary.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

ANPRM                           07/08/83                    48 FR 31392
NPRM                            10/00/94

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: James J. McCue, Jr., Chief, Operations Staff, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Devices and Radiological Health (HFZ-84), 2098 Gaither Road, 
Rockville, MD 20850, 301 594-4765

RIN: 0905-AD83
_______________________________________________________________________

1439. MAMMOGRAPHY QUALITY STANDARDS ACT OF 1992

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

RIN: 0905-AE19
_______________________________________________________________________

1440. CERTIFICATION OF DRUGS COMPOSED WHOLLY OR PARTLY OF INSULIN; FEES 
FOR CERTIFICATION OF DRUGS COMPOSED WHOLLY OR PARTLY OF INSULIN

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

CFR Citation:  21 CFR 429.40; 21 CFR 429.55

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            04/00/95

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AE28
_______________________________________________________________________

1441. ADVERSE EXPERIENCE REPORTING REQUIREMENTS FOR HUMAN DRUG AND 
LICENSED BIOLOGICAL PRODUCTS

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 agency proposes to amend its adverse experience reporting 
regulations for human drug products and licensed biological products to 
make the requirements consistent with a new single unified form (FDA 
Form 3500A) and require the use of this new reporting form. The new 
form was announced as part of FDA's MedWatch program. The proposed 
regulations would also revise certain definitions and reporting periods 
and formats as recommended by the International Conference on 
Harmonisation of Technical Requirements for Registration of 
Pharmaceuticals for Human Use (ICH) and the World Health Organization's 
Council for International Organizations of Medical Sciences (CIOMS). In 
addition, the proposal would amend the regulations governing the design 
of, and the analysis and reporting of data from, clinical studies. 
These proposed amendments are intended to provide more complete and 
accurate information that would enable sponsors, investigators, and FDA 
to determine early on the toxicity of investigational drugs during 
clinical studies.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            10/00/94

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AE29
_______________________________________________________________________

1442. ELECTRONIC SIGNATURES

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

CFR Citation:  21 CFR 11

Legal Deadline: None

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

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: ABSTRACT CONT: that preserves the integrity of 
the agency's enforcement activities.

Agency Contact: Paul J. Motise, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research (HFD-323), 7500 Standish Place, Rockville, MD 20855, 301 594-
1089

RIN: 0905-AE31
_______________________________________________________________________

1443. FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS

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 proposed regulation addresses the problem of certain 
financial arrangements and interests of clinical investigators that 
have the potential to bias the outcome of clinical trials. The problem 
is significant because clinical research data provide the basis for 
FDA's evaluation of drugs, biologics and devices for marketing. The 
regulation requires the sponsor of a product that is the subject of a 
marketing application to submit either a statement certifying that the 
clinical investigator is not a party to any problematic financial 
interests and arrangements or a statement disclosing problematic 
interests and arrangements to which the investigator is a party. This 
information would enable FDA to subject the relevant clinical research 
data to an appropriate level of scrutiny to test its reliability. 
Alternatives are to prohibit investigators from holding certain 
financial interests altogether or to require divestiture by the 
investigator of a prohibited interest. The estimated costs to industry 
associated with preparation, submission, and retention of the 
information required by this proposed rule are well below the $100 
million threshold that defines a significant (cont)

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: ABSTRACT CONT: regulatory action. The proposed 
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 proposed rule will strengthen the FDA 
review process.

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

RIN: 0905-AE32
_______________________________________________________________________

1444. EFFECTIVE DATE OF REQUIREMENT FOR SUBMISSION OF PREMARKET APPROVAL 
APPLICATIONS

Legal Authority:  21 USC 360e

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

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

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Notice                          05/06/94                    59 FR 23731
NPRM                            12/00/94

Small Entities Affected: Undetermined

Government Levels Affected: None

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

RIN: 0905-AE34
_______________________________________________________________________

1445. LATEX CONDOMS/GLOVES: EXPIRATION DATE LABELING

Legal Authority:  21 USC 351; 21 USC 352

CFR Citation:  21 CFR 801

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            11/00/94

Small Entities Affected: Undetermined

Government Levels Affected: None

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

RIN: 0905-AE37
_______________________________________________________________________

1446. AMALGAM INGREDIENT LABELING

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                            03/00/95

Small Entities Affected: Undetermined

Government Levels Affected: None

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

RIN: 0905-AE39
_______________________________________________________________________

1447. LATEX WARNING

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                            12/00/94

Small Entities Affected: Undetermined

Government Levels Affected: None

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

RIN: 0905-AE40
_______________________________________________________________________

1448. PREMARKET APPROVAL OF MEDICAL DEVICES; SUPPLEMENTAL APPLICATIONS

Legal Authority:  21 USC 360e

CFR Citation:  21 CFR 814.39

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            03/00/95

Small Entities Affected: Undetermined

Government Levels Affected: None

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

RIN: 0905-AE41
_______________________________________________________________________

1449. MEDICAL DEVICES; RESTRICTED DEVICES

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

CFR Citation:  21 CFR 801; 21 CFR 899

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            02/00/95

Small Entities Affected: Undetermined

Government Levels Affected: None

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

RIN: 0905-AE42
_______________________________________________________________________

1450. PRESCRIPTION DRUG PRODUCT LABELING; MEDICATION GUIDE

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

RIN: 0905-AE43
_______________________________________________________________________

1451. HEARING AIDS; PROFESSIONAL AND PATIENT LABELING; CONDITIONS FOR 
SALE

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                            12/00/94

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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

RIN: 0905-AE46
_______________________________________________________________________

1452.  HUMAN TISSUE INTENDED FOR TRANSPLANTATION: PROPOSED RULE

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

CFR Citation:  21 CFR 1270

Legal Deadline: None

Abstract: FDA is amending the regulations to require the registration 
of those establishments engaged in procurement, processing, storage, or 
distribution of human tissue intended for transplantation. It is also 
intended to clarify those requirements previously promulgated by the 
interim rule.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Interim Rule; Opport. for 
Comment                         12/14/93                    58 FR 65514
Interim Rule; Comment Period End03/14/94
NPRM                            02/00/95
NPRM Comment Period End         05/00/95

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

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

RIN: 0905-AE49
_______________________________________________________________________

1453.  FOODS DERIVED FROM NEW PLANT VARIETIES; PREMARKET 
NOTIFICATION

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

RIN: 0905-AE50
_______________________________________________________________________

1454.  CLASSIFICATION OF COMPUTER SOFTWARE PROGRAMS THAT ARE 
MEDICAL DEVICES

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

CFR Citation:  None

Legal Deadline: None

Abstract: FDA is announcing its intention to classify stand-alone 
computer software products that fit the definition of a medical device 
under the Federal Food, Drug, and Cosmetic Act. In so doing, the agency 
anticipates promulgating relevant exemptions by using a risk-based 
approach as required under the Medical Device Amendments to the act. 
Under this approach all medical software devices will be subject to the 
adulteration and misbranding provisions of the act. Moderate risk 
devices will additionally be subject to the registration, listing and 
good manufacturing practice requirements for adverse events and 
complaints. High risk devices would be the only products to require 
premarket submissions. FDA is seeking comment on potential criteria 
related to the intended uses of medical software devices that might be 
used in determining the level of risk as part of this document. FDA is 
also clarifying the manner in which FDA's current statutory authorities 
govern medical software devices under the act.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            03/00/95

Small Entities Affected: Undetermined

Government Levels Affected: None

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

RIN: 0905-AE58
_______________________________________________________________________

1455.  IRON CONTAINING DRUGS AND SUPPLEMENTS

Legal Authority:  21 USC 343; 21 USC 348; 21 USC 351; 21 USC 352

CFR Citation:  21 CFR 101; 21 CFR 170; 21 CFR 310

Legal Deadline: None

Abstract: FDA is 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.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            10/06/94                    59 FR 51030
NPRM Comment Period End         12/20/94

Small Entities Affected: Undetermined

Government Levels Affected: None

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

RIN: 0905-AE59
_______________________________________________________________________

1456.  NEW DRUG AND BIOLOGICAL PRODUCT LICENSE APPLICATIONS; 
REGULATIONS IMPLEMENTING THE PRESCRIPTION DRUG USER FEE ACT OF 1992 AND 
CLARIFYING EXISTING REGULATIONS

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

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

Legal Deadline: None

Abstract: FDA is proposing new regulations and amendments to current 
regulations governing the submission of applications for marketing 
approval for human drug and biological products to specify what must be 
submitted as a separate original marketing application, what may be 
combined in a single application, what changes to an approved 
application may be submitted as a supplement, and when applicants 
should respond to FDA action letters. FDA is taking this action to 
provide clear regulatory policy to industry and to assure fair and 
consistent implementation of the provisions of the Prescription Drug 
User Fee Act of 1992 (PDUFA). The new regulations codify longstanding 
policies as well as specific definitions and policies that have been 
developed and used to implement the PDUFA.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            11/00/94

Small Entities Affected: None

Government Levels Affected: State, Federal

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

RIN: 0905-AE61
_______________________________________________________________________

1457.  CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, 
PROCESSING, PACKING, OR HOLDING OF DRUGS; PROPOSED AMENDMENT OF CERTAIN 
REQUIREMENTS FOR FINISHED PHARMACEUTICALS

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                            11/00/94

Small Entities Affected: None

Government Levels Affected: Federal

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

RIN: 0905-AE63
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
  
1458. POLICIES CONCERNING USES OF SULFITING AGENTS

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 (cont)

Timetable:

Food Labeling; Declaration of Sulfiting Agents  NPRM 04/03/85 (50 FR 
13306)  Final Action 07/09/86 (51 FR 25012)  Effective Date 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 10/00/94

Revoking Use of Sulfiting Agents on Fruits & Vegetables, Etc.  NPRM 08/
14/85 (50 FR 32836)  Final Action 07/09/86 (51 FR 25021)  Effective 
date 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 02/00/95

Status of Use of Sulfit Agents on Minimally Procd & Froz Potatoes  NPRM 
02/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: ABSTRACT CONT: and to establish labeling 
requirements for sulfiting agents in standardized foods.
On March 15, 1990 (55 FR 9826), FDA issued a final rule prohibiting the 
use of sulfiting agents on ``fresh'' potatoes (55 FR 9826) and 
requested data and information concerning the use of sulfiting agents 
on frozen potatoes (55 FR 9834).
On August 3, 1990, the United States District Court for the Middle 
District of Pennsylvania declared the final rule concerning fresh 
potatoes to be ``null and void'' based on perceived procedural defects 
in the rulemaking proceeding. The Government appealed the district 
court's decision. On May 22, 1991, the U.S. Court of Appeals for the 
Third Circuit en banc affirmed, by an equally divided vote and without 
opinion, the decision of the district court invalidating on procedural 
grounds FDA's final rule revoking the GRAS status of the use of 
sulfiting agents on fresh potatoes.
FDA's reproposed rule will include the GRAS status of sulfiting agents 
on both minimally processed (formerly fresh) and frozen potatoes.

Agency Contact: JoAnn Ziyad, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Food Safety and Applied Nutrition (HFS-207), 200 C Street SW., 
Washington, DC 20204, 202 254-9528

RIN: 0905-AB52
_______________________________________________________________________

1459. ABBREVIATED NEW DRUG APPLICATION REGULATIONS (TITLE I OF THE ``DRUG 
PRICE COMPETITION AND PATENT TERM RESTORATION ACT OF 1984'')

Legal Authority:  21 USC 355 title I

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

Legal Deadline: None

Abstract: Until the passage of title I of the Drug Price Competition 
and Patent Term Restoration Act of 1984, abbreviated new drug 
application (ANDA) procedures were only available for generic products 
equivalent to pioneer drugs approved before 1962. Title I opened up the 
ANDA policy to generic copies of products approved after 1962. On July 
10, 1989 (54 FR 28872), FDA proposed regulations to implement Title I. 
The proposal provides for the submission of abbreviated new drug 
applications for generic versions of drug products first approved after 
1962. These new provisions will benefit consumers by making generic 
drug products available more quickly.
The agency is preparing the final rule in two segments. The final rule 
for the first segment, which establishes requirements for the format 
and content of an ANDA, suitability petitions, and certain 
administrative actions, published in the Federal Register of April 28, 
1992 (57 FR 17950). The agency is reviewing the public comments 
submitted in response to the proposed requirements for patent 
certification and exclusivity and preparing a final rule on the 
segment.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            07/10/89                    54 FR 28872
NPRM Comment Period End         10/10/89
NPRM Extension of Comment Period10/11/89                    54 FR 41629
NPRM Public Comment Period End  01/09/90
NPRM Extension of Comment Period01/16/90                     55 FR 1471
NPRM Public Comment Period End  04/09/90
Final Action Effective          11/02/94
Content and Format, Suitability Petitions  Final Action 04/28/92 (57 FR 
17950)

Patent Certification and Exclusivity  Final Action 10/03/94 (59 FR 
50338)

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AB63
_______________________________________________________________________

1460. CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS; 
NOTIFICATION OF CONSIGNEES RECEIVING BLOOD AND BLOOD COMPONENTS AT 
INCREASED RISK FOR TRANSMITTING HIV INFECTION

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 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 (cont)

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: Businesses, Organizations

Government Levels Affected: Undetermined

Additional Information: ABSTRACT CONT: plasma is found to be positive 
for the antibody to HIV; and to keep appropriate records when such 
notification has been made. In addition, the final rule will require 
hospital transfusion services to notify recipients of blood products of 
increased risk for transmitting HIV and to keep appropriate records of 
the notification process. The purpose of the rulemaking is to ensure 
the notification of consignees and blood transfusion recipients and 
that prompt and appropriate action is taken.

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

RIN: 0905-AC90
_______________________________________________________________________

1461. LEAD IN FOODS

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

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

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            06/01/89                    54 FR 23485
NPRM Comment Period End         07/31/89
Prohibit Use of Lead-Soldered Food Cans  NPRM 06/21/93 (58 FR 
33860)  Final Action 12/00/94

Prohibit Use of Tin-Coated Lead Foil Capsules on Wine Bottles  NPRM 11/
25/92 (57 FR 55485)  Final Action 02/00/95

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AC91
_______________________________________________________________________

1462. EXPEDITING APPROVAL FOR DRUGS INTENDED TO TREAT LIFE-THREATENING 
AND SEVERELY DEBILITATING ILLNESSES

Legal Authority:  21 USC 351 to 357; 21 USC 371; 42 USC 262

CFR Citation:  21 CFR 312

Legal Deadline: None

Abstract: In the Federal Register of October 21, 1988 (53 FR 41561), 
FDA issued an interim rule, effective upon date of publication, with 
opportunity for public comment, that set forth procedures designed to 
speed the availability of new therapies to desperately ill patients, 
while preserving appropriate guarantees for safety and effectiveness. 
These procedures are intended to facilitate the development, 
evaluation, and marketing of such products, especially where no 
satisfactory alternative therapies exist. These procedures reflect the 
recognition that physicians and patients are generally willing to 
accept greater risks or side effects from products that treat life-
threatening and severely debilitating illnesses. These procedures also 
reflect the recognition that the benefits of the drug need to be 
evaluated in light of the severity of the disease being treated. The 
procedures apply to life-threatening or severely debilitating 
illnesses. The agency is reviewing the public comments submitted in 
response to the interim rule and preparing a Federal Register document 
that will respond to these comments. The (cont)

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Interim Final Rule              10/21/88                    53 FR 41561
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Additional Information: ABSTRACT CONT: agency is also considering the 
recommendations contained in the report of the ``National Committee to 
Review Current Procedures for Approval of New Drugs for Cancer and 
AIDS.''

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

RIN: 0905-AC94
_______________________________________________________________________

1463. FEES FOR CERTIFICATION SERVICES; INSULIN AND COLOR ADDITIVE 
CERTIFICATION PROGRAMS

Legal Authority:  21 USC 502; 21 USC 506; 21 USC 701; 21 USC 706

CFR Citation:  21 CFR 80.10; 21 CFR 429.55

Legal Deadline: None

Abstract: In the Federal Register of October 4, 1991 (56 FR 50248), FDA 
issued an interim rule effective on November 4, 1991 with opportunity 
for public comment, revising the fee schedule for insulin certification 
services. The fees are intended to recover the full costs of operation 
of FDA's insulin certification program, including the unfunded 
liability of the Civil Service Retirement Fund and appropriate overhead 
costs of the Public Health Service and Department of Health and Human 
Services. FDA is also considering similar amendments to the regulations 
governing fees for the color additive certification program.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Interim Final Rule (Insulin)    10/04/91                    56 FR 50248
Interim Final Rule (Color 
Additives)                      11/00/94

Small Entities Affected: Undetermined

Government Levels Affected: None

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

RIN: 0905-AD34
_______________________________________________________________________

1464. PRESCRIPTION DRUG MARKETING ACT OF 1987; POLICY INFORMATION, 
GUIDANCE, AND CLARIFICATIONS

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

CFR Citation:  21 CFR 203

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: ABSTRACT CONT: information, guidance, and 
clarification of those sections of PDMA that are not related to State 
licensing of wholesale distributors.

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

RIN: 0905-AD44
_______________________________________________________________________

1465. IMPLEMENTATION OF THE SAFE MEDICAL DEVICES ACT OF 1990

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

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

Legal Deadline:
NPRM, Statutory, August 28, 1991, for Medical Device Tracking.
Final, Statutory, November 28, 1991, for Exemption ofHumanitarian 
Devices, etc.
Other, Statutory, December 1, 1991, for Classification ofTransitional 
Devices Notice.
Final, Statutory, November 28, 1992, for Medical Device Tracking.

Abstract: The Safe Medical Devices Act of 1990 (SMDA), enacted November 
28, 1990, was intended to assure marketed devices are safe and 
effective, FDA learns quickly of device problems, and has authority to 
remove defective devices from the market. The act directs or authorizes 
FDA to develop these regulations: Medical Device Reporting--This rule 
will require healthcare facilities and distributors to report deaths 
and serious injuries/illnesses related to medical devices. Medical 
Device Tracking--This regulation requires manufacturers to track 
certain devices to the user. Classification of Transitional Devices--
FDA issued a notice to require submission of adverse safety and 
effectiveness data on transitional devices. FDA will now propose to 
keep each device in class III, or reclassify it in class I or II. Good 
Manufacturing Practices for Medical Devices--FDA proposed to add 
preproduction design validation in existing CGMP regulations. Exemption 
of Humanitarian Devices--The proposed rule gives procedures for 
applications for certain premarket review exemptions for humanitarian 
devices. (cont)

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Civil Money Penalties  NPRM 05/26/93 (58 FR 30680)  Final Action 12/00/
95

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

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

Exemption of Humanitarian Devices  NPRM 12/21/92 (57 FR 60491)  Final 
Action 02/00/95

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

Medical Device Reporting  Notice (Public Conf.;Rqst for Info) 03/28/91 
(56 FR 12934)  NPRM 11/26/91 (56 FR 60024)  Final Rule (Distributor 
Reporting) 09/01/93 (58 FR 46514)  Final Action 12/00/94

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 00/00/00

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 10/00/94

Temporary Suspension of a Premarket Approval Application  NPRM 10/12/93 
(58 FR 52729)  Final Action 12/00/94

Small Entities Affected: None

Government Levels Affected: None

Additional Information: ABSTRACT CONT: Summaries of Safety and 
Effectiveness for Premarket Notification--A final rule will set forth 
information to be included in data summaries on which substantial 
equivalence determinations are made. Recall of Medical Devices--FDA 
will propose procedures for using its authority to order device recalls 
and notifications. Reports of Removal and Corrections--FDA will propose 
procedures for manufacturers to report to FDA health-related market 
removals and corrections of devices. Civil Money Penalties--FDA 
proposed regulations to establish procedures for a hearing to which 
persons are entitled before the imposition of civil money penalties. 
Procedural Changes in Medical Device Regulations--This final rule made 
revisions in regulations necessary because of procedural changes made 
by the SMDA. Premarket Review of Combination Products--FDA published a 
final rule establishing procedures for determining which FDA center 
will review premarket approval applications for products that are a 
combination of a device and a drug or biologic.

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

RIN: 0905-AD59
_______________________________________________________________________

1466. MANDATORY HACCP SEAFOOD INSPECTION PROGRAM

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

CFR Citation:  21 CFR 123; 21 CFR 1240

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            01/28/94                     59 FR 4142
NPRM Comment Period End         03/29/94
Final Action                    06/00/95

Small Entities Affected: None

Government Levels Affected: None

Additional Information: 42 USC 264; 42 USC 271

Agency Contact: Philip Spiller, Deputy Director, Office of Seafood, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Food Safety and Applied Nutrition (HFS-401), 200 C Street 
SW., Washington, DC 20204, 202 254-3885

RIN: 0905-AD60
_______________________________________________________________________

1467. BOTTLED WATER

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

CFR Citation:  21 CFR 103

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

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

Timetable:

Beverages; Bottled Water  NPRM 01/05/93 (58 FR 393)  Final Action 04/
00/95

Microbiological Quality Standard  NPRM 10/06/93 (58 FR 25042)  Final 
Action 04/00/95

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 11/00/95

Quality Standards for 39 Contaminants  NPRM 01/05/93 (58 FR 382)  Final 
Action 10/00/94

Small Entities Affected: Undetermined

Government Levels Affected: None

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

RIN: 0905-AD65
_______________________________________________________________________

1468. SPECIFIC REQUIREMENTS ON CONTENT AND FORMAT OF LABELING FOR HUMAN 
PRESCRIPTION DRUGS; REVISION OF ``PEDIATRIC USE'' SUBSECTION IN THE 
LABELING

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

CFR Citation:  21 CFR 201

Legal Deadline: None

Abstract: In the Federal Register of October 16, 1992 (57 FR 47423), 
the agency proposed to amend its regulations pertaining to the specific 
content and format of prescription drug labeling by revising the 
current ``Pediatric Use'' subsection of professional labeling to 
provide for the inclusion of more complete information about use of a 
drug in children and about hazards associated with this use. This 
regulatory action is intended to respond to concerns in FDA and 
elsewhere that current prescription drug labeling does not contain 
adequate information about the use of drugs in children. 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                            10/16/92                    57 FR 47423
NPRM Comment Period End         12/15/92
Final Action                    10/00/94

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AD76
_______________________________________________________________________

1469. RECORDKEEPING AND REPORTING: ELECTRONIC PRODUCTS

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

CFR Citation:  21 CFR 1000; 21 CFR 1002

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

ANPRM                           07/02/82                    47 FR 29004
ANPRM                           11/16/82                    47 FR 51706
ANPRM                           07/01/85                    50 FR 27024
NPRM                            10/25/90                    55 FR 43066
NPRM Comment Period End         01/22/91
Final Action                    10/00/94

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AD78
_______________________________________________________________________

1470. GENERAL BIOLOGICAL PRODUCT STANDARDS; ALTERNATIVE PROCEDURES AND 
EXCEPTIONS

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                    06/00/95

Small Entities Affected: None

Government Levels Affected: Undetermined

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

RIN: 0905-AD82
_______________________________________________________________________

1471. MEDICAL DEVICES; PROTECTIVE RESTRAINTS; REVOCATION OF EXEMPTIONS 
FROM 510(K) PREMARKET NOTIFICATION PROCEDURES AND CURRENT GOOD 
MANUFACTURING PRACTICES REGULATIONS

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

CFR Citation:  21 CFR 880.6760; 21 CFR 890.3910

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            06/19/92                    57 FR 27397
NPRM Comment Period End         08/18/92
Final Action                    12/00/94

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Additional Information: ABSTRACT CONT: These costs will be offset by 
the saving of lives and reduced product liability exposure.

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

RIN: 0905-AD84
_______________________________________________________________________

1472. THRESHOLD OF REGULATION POLICY FOR COMPONENTS OF FOOD CONTACT 
ARTICLES

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

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

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            10/12/93                    58 FR 52719
Final Action                    06/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Edward J. Machuga, Consumer Safety Officer, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Food Safety and Applied Nutrition (HFS-216), 200 C Street SW., 
Washington, DC 20204, 202 254-9528

RIN: 0905-AD86
_______________________________________________________________________

1473. FOOD LABELING REVIEW

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

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

Legal Deadline: None

Abstract: The Nutrition Labeling and Education Act of 1990 (NLEA) 
requires that most foods bear nutrition labeling. In developing the 
final rules that were published on January 6, 1993, the agency 
identified three areas that should be the subject of additional 
rulemaking: a definition for the nutrient content claim ``healthy''; a 
definition for ``nonfunctional slack-fill''; and requirements for the 
identification of certain ingredients on food labels. Proposed 
regulations addressing these issues were published on January 6, 1993. 
On May 12, 1993, FDA announced that, in accordance with the NLEA, the 
regulation it proposed on January 6, 1993, on nonfunctional slack-fill 
was considered a final rule. Subsequently, on December 6, 1993, FDA 
issued a final rule responding to the comments received to the January 
6, 1993, proposal. FDA also proposed on June 15, 1993, to amend its 
January 6, 1993, final rules on nutrient content and health claims to 
have 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 (cont)

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 03/00/95

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

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 04/00/
95

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Additional Information: ABSTRACT CONT: small restaurant firms for one 
year. Finally, the agency proposed January 4, 1994, to establish 
reference daily intakes based on the 9th and 10th editions of the 
National Research Council's Recommended Dietary Allowances. These 
actions were proposed following reconsideration of the provisions in 
question.

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

RIN: 0905-AD89
_______________________________________________________________________

1474. LEVO-ALPHA-METHADOL (LAAM) IN MAINTENANCE; JOINT PROPOSED REVISION 
OF CONDITIONS FOR USE

Legal Authority:  21 USC 355; 21 USC 371; 21 USC 823; 42 USC 241(d); 42 
USC 290ee-3; 42 USC 257a

CFR Citation:  21 CFR 291

Legal Deadline: None

Abstract: The Food and Drug Administration and the National Institute 
on Drug Abuse are reviewing comments on an interim rule that revised 
the conditions for the treatment of narcotic addiction to provide for 
the use of LAAM in the maintenance treatment of narcotic addicts. The 
interim rule allows narcotic treatment programs to provide an 
additional treatment drug for use in the maintenance treatment of 
narcotic addicts.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Interim Final Rule              07/20/93                    58 FR 38704
Interim Final Rule Comment 
Period End                      09/20/93
Final Action                    03/00/95

Small Entities Affected: None

Government Levels Affected: State, Local

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

RIN: 0905-AD92
_______________________________________________________________________

1475. TEMPOROMANDIBULAR JOINT IMPLANT CLASSIFICATION

Legal Authority:  21 USC 360c; 21 USC 360e

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

Legal Deadline: None

Abstract: The final rule would classify into class III (Premarket 
approval) certain temporomandibular joint (TMJ) prostheses including 
the interarticular disc prosthesis (the interpositional implant), the 
mandibular condyle prosthesis, and the glenoid fossa prosthesis. This 
action would allow FDA to require manufacturers of these devices to 
submit premarket approval applications demonstrating the safety and 
effectiveness of these devices. The devices present a risk of implant 
loosening or displacement; foreign body reaction; degenerative changes 
to the natural articulating surfaces; infection; and loss of implant 
integrity.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            09/18/92                    57 FR 43165
NPRM Comment Period End         12/08/92                    57 FR 56876
Reproposal                      02/14/94                     59 FR 6935
Final Action                    12/00/94

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AD93
_______________________________________________________________________

1476. DISQUALIFICATION OF CLINICAL INVESTIGATORS

Legal Authority:  21 USC 360j(g)

CFR Citation:  21 CFR 812

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            10/06/93                    58 FR 52144
Final Action                    02/00/95

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0905-AD94
_______________________________________________________________________

1477. INVESTIGATIONAL DEVICE EXEMPTION; INTRAOCULAR LENSES

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                    02/00/95

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AD95
_______________________________________________________________________

1478. DIETARY SUPPLEMENT LABEL REVIEW

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

CFR Citation:  21 CFR 101

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

Abstract: With the publication of various final rules on January 6, 
1993, the agency completed action on its food labeling initiative under 
the Nutrition Labeling and Education Act of 1990. Rulemaking on 
nutrition labeling of dietary supplements was delayed due to 
requirements of the Dietary Supplement Act of 1992 (DSA), which amended 
the law to provide that the agency would issue proposed regulations for 
dietary supplements by June 15, 1993, and final regulations by December 
31, 1993. Three proposed regulations were developed and published on 
June 18, 1993; Health Claims for Dietary Supplements, Nutrient Content 
Claims for Dietary Supplements, and Mandatory Nutrition Labeling for 
Dietary Supplements. On October 14, 1993, FDA published a proposal to 
not authorize health claims on the labels of dietary supplements of 5 
nutrient/disease relationships: (1) Dietary fiber and cancer (2) 
Dietary Fiber and CVD, (3) Antioxidants and Cancer, (4) Omega-3 fatty 
acids and CHD, (5) Zinc and immune function in the elderly. In 
addition, FDA also published a proposed rule to authorize the use of 
health claims about the relationship of folates and neural tube 
defects. On January 4, 1994, FDA published notices (cont)

Timetable:

Health Claims and Label Statements; Dietary Supplements  NPRM Folic 
Acid and Neural Tube Def 10/14/93 (58 FR 53254)  Final Action 00/00/00

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

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)

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Additional Information: ABSTRACT CONT: stating that it considered the 
proposals to be final regulations by operational statute. However, the 
notices also stated that FDA considers the October 14, 1993, 
rulemakings to be ongoing. The agency intends to continue rulemaking 
with respect to folates and to issue a final rule as quickly as 
possible. FDA is also considering new scientific information that may 
support health claims for some of the nutrient-disease relationships 
given above. If this information is sufficient to support claims, the 
agency will repropose to allow those claims.

Agency Contact: John Hathcock, Director, Divisions of Science and 
Applied Technology, Office of Special Nutritionals, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Food Safety and Applied Nutrition (HFS-465), 200 C Street SW., 
Washington, DC 20204, 301 594-6006

RIN: 0905-AD96
_______________________________________________________________________

1479. ADVERSE EXPERIENCE REPORTING REQUIRED FOR LICENSED BIOLOGICAL 
PRODUCTS

Legal Authority:  21 USC 321; 21 USC 351; 21 USC 352; 21 USC 353; 21 
USC 355; 21 USC 360; 21 USC 371; 21 USC 374; 42 USC 216; 42 USC 262; 42 
USC 263; 42 USC 263a; 42 USC 264; 42 USC 300aa-25

CFR Citation:  21 CFR 600

Legal Deadline: None

Abstract: FDA is amending the regulations to require manufacturers, 
packers, and distributors (hereafter referred to as LICENSED 
MANUFACTURERS) of licensed biological products to report to FDA within 
15 working days all adverse experiences associated with the use of a 
biological product that are both serious and unexpected; any 
significant increase in the frequency of a serious, but expected 
adverse experience; periodically all other adverse experiences; and 
product distribution and disposition data. FDA is taking this action to 
provide a mechanism under which LICENSED MANUFACTURERS would inform the 
agency, on a timely basis, of any unanticipated safety problems with 
marketed biological products.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            03/29/90                    55 FR 11611
NPRM Comment Period End         05/29/90
Final Action                    11/00/94

Small Entities Affected: None

Government Levels Affected: State

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

RIN: 0905-AE18
_______________________________________________________________________

1480. SPECIFIC REQUIREMENTS ON CONTENT AND FORMAT OF LABELING FOR HUMAN 
PRESCRIPTION DRUGS; ADDITION OF ``GERIATRIC USE'' SUBSECTION IN THE 
LABELING

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

CFR Citation:  21 CFR 201

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            11/01/90                    55 FR 46134
NPRM Comment Period End         12/31/90
Final Action                    11/00/94

Small Entities Affected: Undetermined

Government Levels Affected: None

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

RIN: 0905-AE26
_______________________________________________________________________

1481. TAMPER-EVIDENT PACKAGING REQUIREMENTS FOR OVER-THE-COUNTER HUMAN 
DRUG PRODUCTS

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

CFR Citation:  21 CFR 211

Legal Deadline: None

Abstract: On January 18, 1994 (59 FR 2542), the agency proposed to 
amend its tamper-resistant packaging requirements to require that all 
over-the-counter (OTC) human drug products marketed in two-piece, hard 
gelatin capsules be sealed. The proposal also solicited public comments 
on whether additional regulatory changes, such as packaging performance 
standards, may be necessary. FDA has required tamper-resistant 
packaging features for OTC drug products since 1982. The tamper-
resistant packaging regulations were revised in 1989 in response to 
continuing tamper incidents. Despite the regulatory protection provided 
by the regulations, two-piece, hard gelatin capsules remain vulnerable 
to malicious tampering and were implicated in tampering incidents in 
1991. This proposed 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                    06/00/95

Small Entities Affected: Undetermined

Government Levels Affected: None

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

RIN: 0905-AE27
_______________________________________________________________________

1482. SUBSTANCES PROHIBITED FOR USE IN RUMINANT FEED

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

CFR Citation:  21 CFR 589.2000

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            08/29/94                    59 FR 44584
Final Action                    04/00/95

Small Entities Affected: Undetermined

Government Levels Affected: None

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

RIN: 0905-AE45
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
  
1483. IMPLEMENTATION OF TITLE I OF THE GENERIC ANIMAL DRUG AND PATENT 
TERM RESTORATION ACT

CFR Citation:  21 CFR 514

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Merged With RIN 0905-AA96       07/15/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Lonnie W. Luther, 301 594-1623

RIN: 0905-AD15

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
 
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
  
_______________________________________________________________________
  
1484. NATIONAL HEALTH SERVICE CORPS LOAN REPAYMENT PROGRAM; GRANTS FOR 
STATE LOAN REPAYMENT PROGRAMS

Legal Authority:  PL 100-177; PL 101-597

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

Legal Deadline: None

Abstract: The National Health Service Corps (NHSC) Revitalization 
Amendments of 1990, PL 101-597, amends Section 338B of the PHS Act 
which authorizes the NHSC Loan Repayment Program. These Amendments also 
revise the State Loan Repayment Program at Section 338I of the PHS Act. 
The interim rule relating to both these programs as published April 3, 
1989, will be revised to reflect the 1990 amendments. Regulations 
governing the Special Repayment Program established under PL 100-177 
were published on 11/6/91 in final form under RIN 0905-AD58, separate 
from this NPRM (RIN 0905-AC65). The amended NHSC Loan Repayment Program 
(RIN 0905-AD57) removes the provision which limits the Secretary's loan 
repayment to one month in advance of services.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Interim Final Rule              04/03/89                    56 FR 13458
NPRM                            01/00/95

Small Entities Affected: None

Government Levels Affected: State

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

RIN: 0905-AC65
_______________________________________________________________________

1485. ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK RULES

Regulatory Plan:  This entry is Seq. No. 44 in Part II of this issue of 
the Federal Register.

RIN: 0905-AD26
_______________________________________________________________________

1486. HEALTH EDUCATION ASSISTANCE LOAN (HEAL) PROGRAM: LENDERS'/ HOLDERS' 
PERFORMANCE STANDARDS

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

CFR Citation:  42 CFR 60

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

Abstract: This Notice of Proposed Rulemaking proposes to amend 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                            10/00/94

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AD87
_______________________________________________________________________

1487.  NATIONAL VACCINE INJURY COMPENSATION PROGRAM: REVISIONS 
AND ADDITIONS TO THE VACCINE INJURY TABLE - II

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                            03/00/95

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AE52
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
  
_______________________________________________________________________
  
1488. NATIONAL VACCINE INJURY COMPENSATION PROGRAM (VICP): REVISIONS TO 
THE VACCINE INJURY TABLE

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

CFR Citation:  42 CFR 100

Legal Deadline:  NPRM, Statutory, December 22, 1990.
Section 312 of PL 99-660 requires the Secretary to propose regulations 
to amend the Vaccine Injury Table, based on the findings of the 
Institute of Medicine (IOM) study, (cont)

Abstract: The National Vaccine Injury Compensation Program (VICP), 
administered by the Secretary, and governed by subtitle 2 of title XXI 
of the Public Health Service Act, as enacted by the National Childhood 
Vaccine Injury Act of 1986 (the Act), provides a system of no-fault 
compensation for certain individuals who have been injured by specific 
childhood vaccines. The nature of the injuries, disabilities, 
illnesses, conditions, and deaths which will be presumed to result from 
the administration of specific vaccines, and the time period in which 
the first symptom or manifestation of onset must occur for this 
presumption to apply, are outlined in section 2114 of the Act in what 
is known as the Vaccine Injury Table. This Final Rule makes refinements 
to the Vaccine Injury Table to more accurately reflect current 
scientific knowledge about the conditions that result from vaccines 
which will result in appropriate compensation for injuries related to 
vaccines.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            08/14/92                    57 FR 36878
Public Hearing                  10/29/92                    57 FR 49055
NPRM Comment Period End         02/11/93
Final Action                    10/00/94

Small Entities Affected: None

Government Levels Affected: None

Additional Information: LEGAL DEADLINE CONT: within 3 years of the 
effective date of title III (12/22/87). Since the IOM study was not 
completed until August 1991, it was not possible to meet this legal 
deadline. This section also requires the Final regulation to be 
published 6 months after the NPRM. Given the 180-day comment period, 
the 6-month requirement is an impossibility.

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, 5600 Fishers 
Lane, Parklawn Building, Room 8A35, Rockville, Maryland 20857, 301 443-
6593

RIN: 0905-AD64
_______________________________________________________________________

1489. GRANTS FOR FACULTY TRAINING PROJECTS IN GERIATRIC MEDICINE AND 
DENTISTRY

Legal Authority:  42 USC 216; 42 USC 294o

CFR Citation:  42 CFR 57, subpart PP

Legal Deadline: None

Abstract: This final amends the Grants for Faculty Training Projects in 
Geriatric Medicine and Dentistry regulations to bring the existing 
regulations into conformity with technical amendments made by the 
Health Professions Extension Amendments of 1992 (Pub. L. 102-408); to 
propose two new definitions for ``relevant advanced training or 
experience'' and ``geriatric psychiatry''; and to remove a section 
regarding the period of time for fellowship appointments for more 
flexibility in implementing the program.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            03/03/94                    59 FR 10104
NPRM Comment Period End         04/04/94
Final Action                    10/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Neil H. Sampson, Director, Division of Associated, 
Dental & Public Health Professions, BHPr, Department of Health and 
Human Services, Health Resources and Services Administration, Room 8-
101, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857, 301 
443-6853

RIN: 0905-AE13
_______________________________________________________________________

1490. GRANTS FOR THE ESTABLISHMENT OF DEPARTMENTS OF FAMILY MEDICINE

Legal Authority:  42 USC 216; 42 USC 293k

CFR Citation:  42 CFR 57, subpart R

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            07/19/94                    59 FR 36733
NPRM Comment Period End         08/18/94                    59 FR 36733
Final Action                    12/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Marc L. Rivo, M.D., Director, Division of Medicine, 
Bureau of Health Professions, Department of Health and Human Services, 
Health Resources and Services Administration, Room 4C-25, Parklawn 
Building, 5600 Fishers Lane, Rockville, MD 20857, 301 443-6190

RIN: 0905-AE17
_______________________________________________________________________

1491. MEDICAL FACILITY CONSTRUCTION AND MODERNIZATION REQUIREMENTS FOR 
PROVISION OF SERVICES TO PERSONS UNABLE TO PAY (NURSING HOMES)

Legal Authority:  42 USC 291 et seq; 42 USC 300q et seq

CFR Citation:  42 CFR 124 subpart F

Legal Deadline: None

Abstract: The current regulations stipulate that an indigent is 
ineligible for Hill-Burton uncompensated services if the individual is 
covered under a third-party insurance or governmental program. This 
requirement has created major compliance problems for many Hill-Burton 
obligated nursing homes. In most of these nursing homes, the only 
individuals who meet the income eligibility requirements for receipt of 
Hill-Burton uncompensated services (Category A and B eligibility) are 
also covered by their State's Medicaid program; hence, they are by 
definition ineligible for Hill-Burton uncompensated services. The 
proposed regulations would address this problem by establishing a third 
income-eligibility level (Category C) for nursing homes, which would 
allow individuals whose annual incomes are greater than those under 
Category A and B to be eligible for nursing home services. This would 
result in a limit substantially above the Medicaid income eligibility 
limit, thus allowing more individuals to be eligible for services in 
Hill-Burton nursing homes.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            04/04/94                    59 FR 15693
NPRM Comment Period End         06/03/94                    59 FR 15693
Final Action                    10/00/94

Small Entities Affected: Organizations

Government Levels Affected: None

Agency Contact: Charlotte G. Pascoe, Director, Division of Facilities 
Compliance, Bureau of Health Resources Development, Department of 
Health and Human Services, Public Health Service, 5600 Fishers Lane, 
Room 11-19, Parklawn Building, Rockville, Maryland 20857, 301 443-5656

RIN: 0905-AE33
_______________________________________________________________________

1492. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON 
PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: AMENDMENT TO DATA BANK 
REGULATIONS TO COMPLY WITH COURT ORDER

Legal Authority:  42 USC 11101 et seq

CFR Citation:  45 CFR 60

Legal Deadline: None

Abstract: These regulations amend the current regulations under section 
60.7(a) and (c) to require reporting of medical malpractice payments 
only by entities which make these payments on behalf of physicians and 
other health care practitioners, deleting the requirement of reporting 
by persons who make such payments.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Action                    11/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Thomas C. Croft, Director, Division of Quality 
Assurance, Bureau of Health Professions, Department of Health and Human 
Services, Health Resources and Services Administration, Room 8-67, 
Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857, 301 
443-2300

RIN: 0905-AE38
_______________________________________________________________________

1493.  FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE ACT OF 1992

Legal Authority:  42 USC 216; 42 USC 233

CFR Citation:  42 CFR 6

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AE48
_______________________________________________________________________

1494.  NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON 
PHYSICIANS, DENTISTS, AND OTHER HEALTH CARE PRACTITIONERS: DEBT 
COLLECTION METHODS

Legal Authority:  42 USC 11101 et seq

CFR Citation:  45 CFR 60

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Action                    03/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Thomas C. Croft, Director, Division of Quality 
Assurance, Bureau of Health Professions, Department of Health and Human 
Services, Health Resources and Services Administration, Room 8-67, 
Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857, 301 
443-2300

RIN: 0905-AE53
_______________________________________________________________________

1495.  TECHNICAL AMENDMENTS TO THE HEALTH PROFESSIONS, NURSING, 
AND ALLIED HEALTH TRAINING GRANT PROGRAMS UNDER 42 CFR PARTS 57 AND 58

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 title 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                    03/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Betty B. Hambleton, Chief, Planning, Evaluation and 
Legislation, Branch, Office of Research & Planning/BHPr, Department of 
Health and Human Services, Health Resources and Services 
Administration, Room 8A-55, Parklawn Building, 5600 Fishers Lane, 
Rockville, Maryland 20857, 301 443-1590

RIN: 0905-AE54
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
  
_______________________________________________________________________
  
1496. MATERNAL AND CHILD HEALTH (MCH) PROJECT GRANTS

CFR Citation:  42 CFR 51a

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    07/19/94                    59 FR 36703
Final Action Effective          08/18/94                    59 FR 36703

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Federal

Agency Contact: Lynn Squire, 301 443-2778

RIN: 0905-AD88
_______________________________________________________________________

1497. MEDICAL FACILITY CONSTRUCTION AND MODERNIZATION; REQUIREMENTS FOR 
PROVISION OF SERVICES TO PERSONS UNABLE TO PAY (CHARITABLE FACILITIES)

CFR Citation:  42 CFR 124 subpart F

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    08/30/94                    59 FR 44634
Final Action Effective          08/30/94

Small Entities Affected: Organizations

Government Levels Affected: None

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

RIN: 0905-AE06
_______________________________________________________________________

1498. GRANTS FOR NURSE PRACTITIONER AND NURSE-MIDWIFERY PROGRAMS

CFR Citation:  42 CFR 57, subpart Y

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn Pending nursing 
reauthorizing legislation       07/06/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Marla E. Salmon, ScD. RN, 301 443-5786

RIN: 0905-AE11

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
 
Public Health Service (PHS)--Indian Health Service (IHS)
  
_______________________________________________________________________
  
1499. INDIAN HEALTH SERVICE LOAN REPAYMENT PROGRAM REGULATIONS

Legal Authority:  PL 100-713

CFR Citation:  42 CFR 36

Legal Deadline: None

Abstract: Public Law 100-713, enacted November 23, 1988, authorized a 
program in which health professionals would have their health 
professions education loans repayed in amounts up to a maximum of 
$25,000 per year in exchange for service in an Indian health program. 
The Secretary is directed to implement some provisions by regulations, 
i.e., waiver provision. P. L. 102-573 raised the maximum to $35,000 for 
repayment of educational loans.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            11/00/94
NPRM Comment Period End         02/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Linus Everling, Chief, Scholarship Branch, Indian 
Health Service, Department of Health and Human Services, Public Health 
Service, 12300 Twinbrook Parkway, Suite 100, Rockville, MD 20852, 301 
443-6197

RIN: 0905-AC96
_______________________________________________________________________

1500. INDIAN HEALTH SERVICE CATASTROPHIC HEALTH EMERGENCY FUND PROGRAM

Legal Authority:  PL 100-713

CFR Citation:  42 CFR 36

Legal Deadline: None

Abstract: Public Law 100-713, enacted November 23, 1988, authorized a 
new program establishing a catastrophic health emergency fund. The 
Secretary is directed to establish the program by regulations 
consistent with provisions of the Law including a definition of a 
catastrophic disease.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            01/00/95
NPRM Comment Period End         03/00/95

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AC97
_______________________________________________________________________

1501. REVISION OF URBAN INDIAN HEALTH REGULATIONS

Legal Authority:  PL 100-713

CFR Citation:  42 CFR 36

Legal Deadline: None

Abstract: P.L. 100-713, enacted November 23, 1988, requires the 
Secretary to prescribe, by regulation, the criteria for selecting urban 
Indian organizations to enter into contracts.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            01/00/95
NPRM Comment Period End         03/00/95

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AD20
_______________________________________________________________________

1502. ACQUISITION UNDER THE BUY INDIAN ACT

Legal Authority:  25 USC 47

CFR Citation:  48 CFR ch 3, app A

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/00/94
NPRM Comment Period End         03/00/95

Small Entities Affected: None

Government Levels Affected: Tribal

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

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

RIN: 0905-AE09
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Indian Health Service (IHS)
  
_______________________________________________________________________
  
1503. REVISION OF INDIAN SELF-DETERMINATION REGULATIONS

Regulatory Plan:  This entry is Seq. No. 47 in Part II of this issue of 
the Federal Register.

RIN: 0905-AC98
_______________________________________________________________________

1504. REVIEW OF THE DETERMINATION OF AN INDIAN TRIBE'S RESOURCE 
DEFICIENCY LEVEL

Legal Authority:  PL 100-713

CFR Citation:  42 CFR 36

Legal Deadline: None

Abstract: P.L. 100-713, enacted November 23, 1988, requires the 
Secretary to establish, by regulation, procedures which would allow any 
Indian tribe to petition the Secretary for a review of any 
determination of the health resources deficiency level of such tribe.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            10/10/91                    56 FR 51189
NPRM Comment Period End         12/09/91                    56 FR 51189
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AD21

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
 
Public Health Service (PHS)--National Institutes of Health (NIH)
  
_______________________________________________________________________
  
1505. GRANTS FOR RESEARCH PROJECTS

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 the Food and Drug Administration 
previously omitted from the regulations.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            10/00/94

Small Entities Affected: Undetermined

Government Levels Affected: None

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

RIN: 0905-AC02
_______________________________________________________________________

1506. NATIONAL INSTITUTES OF HEALTH AIDS RESEARCH LOAN REPAYMENT PROGRAM

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                            12/00/94

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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

RIN: 0905-AD18
_______________________________________________________________________

1507. HAZARDOUS SUBSTANCES BASIC RESEARCH AND TRAINING GRANTS

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                            12/00/94

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AD46
_______________________________________________________________________

1508. NATIONAL INSTITUTES OF HEALTH CONSTRUCTION GRANTS

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

CFR Citation:  42 CFR 52b

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/00/94

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AD49
_______________________________________________________________________

1509. STANDARDS FOR BONE MARROW REGISTRIES AND CENTERS

Legal Authority:  42 USC 216; 42 USC 274k

CFR Citation:  42 CFR 122

Legal Deadline:  Final, Statutory, May 14, 1991.

Abstract: Regulations will be proposed to implement title I of PL 101-
616, Transplant Amendments Act of 1990, which added section 379 to the 
Public Health Service Act. Section 379 authorizes the Secretary to 
establish and maintain a National Bone Marrow Donor Registry, and 
further provides that the Secretary shall establish and enforce 
criteria, standards, and procedures for entities participating in the 
National Bone Marrow Donor Program, including the National Registry.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Paul R. McCurdy, MD, Special Assistant for Clinical 
Hematology, Div. of Blood Diseases and Resources, NHLBI, Department of 
Health and Human Services, Public Health Service, Federal Building, 
Room 516, 7550 Wisconsin Avenue, Bethesda, MD 20892, 301 496-8387

RIN: 0905-AD51
_______________________________________________________________________

1510. TRAINING GRANTS

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                            12/00/94

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AD56
_______________________________________________________________________

1511. NATIONAL INSTITUTES OF HEALTH CENTER GRANTS

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)(b); 42 USC 285c-8; ...

CFR Citation:  42 CFR 52a

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/00/94

Small Entities Affected: None

Government Levels Affected: None

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

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

RIN: 0905-AE00
_______________________________________________________________________

1512. GRANTS FOR NATIONAL ALCOHOL RESEARCH CENTERS

Legal Authority:  42 USC 216, 285n-2

CFR Citation:  42 CFR 54a

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            10/00/94

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AE08
_______________________________________________________________________

1513.  NATIONAL INSTITUTES OF HEALTH CLINICAL RESEARCH LOAN 
REPAYMENT PROGRAM FOR INDIVIDUALS FROM DISADVANTAGED BACKGROUNDS

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

CFR Citation:  42 CFR 68a

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/00/94

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AE56
_______________________________________________________________________

1514.  UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING PROFESSIONS 
NEEDED BY THE NIH

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

CFR Citation:  42 CFR 68B

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            03/00/95

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AE57
_______________________________________________________________________

1515.  TRAINEESHIPS (TERMINATION POLICIES)

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

CFR Citation:  42 CFR 63

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            03/00/95

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AE62
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
  
_______________________________________________________________________
  
1516. TRAINEESHIPS

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 concerning National Institutes of Health, and 
National Library Medicine traineeships will be revised in their 
entirety to cover traineeships awarded under sections 404 E(d)(2), 
405(b)(1)(C), 472, and 485B of the PHS act.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            08/06/93                    58 FR 42039
NPRM Comment Period End         10/05/93
Final Action                    12/00/94

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AD28
_______________________________________________________________________

1517. NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES HAZARDOUS WASTE 
WORKER TRAINING

Legal Authority:  42 USC 9660a; 42 USC 1816

CFR Citation:  42 CFR 65

Legal Deadline: None

Abstract: Regulations concerning the NIEHS Hazardous Waste Worker 
Training Program will be amended to make them applicable to grants 
administered under the Hazardous Materials Employee Training Grant 
Program. The grants are authorized under section 118 of the Hazardous 
Materials Transportation Act (HMTA), 49 USC App. 1816, as amended by 
the Hazardous Materials Transportation Uniform Safety Act (HMTUSA) of 
1990, P.L. 101-615.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            09/29/93                    58 FR 50897
NPRM Comment Period End         11/29/93
Final Action                    12/00/94

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AD69
_______________________________________________________________________

1518. RESPONSIBILITIES OF PUBLIC HEALTH SERVICE-FUNDED INSTITUTIONS FOR 
PROMOTING OBJECTIVITY IN RESEARCH

Regulatory Plan:  This entry is Seq. No. 48 in Part II of this issue of 
the Federal Register.

RIN: 0905-AE01
_______________________________________________________________________

1519. NATIONAL HEART, LUNG, AND BLOOD INSTITUTE GRANTS FOR PREVENTION AND 
CONTROL PROJECTS

Legal Authority:  42 USC 216; 42 USC 285b-1

CFR Citation:  42 CFR 52e

Legal Deadline: None

Abstract: Regulations governing NHLBI grants for prevention and control 
projects will be amended to conform them to changes in PHS Act section 
419 made by the NIH Revitalization Act of 1993.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Action                    12/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: John J. Migliore, NIH Regulations Officer, Department 
of Health and Human Services, Public Health Service, National 
Institutes of Health, 9000 Rockville Pike, Bldg 31, Rm 1B25, Center DR 
MSC 2075, Bethesda, MD 20892-2075, 301 496-2832

RIN: 0905-AE25
_______________________________________________________________________

1520.  NATIONAL LIBRARY OF MEDICINE GRANTS

Legal Authority:  42 USC 216; 42 USC 286b-5

CFR Citation:  42 CFR 59a

Legal Deadline: None

Abstract: Regulations governing National Library of Medicine grants for 
establishing, expanding, and improving basic medical library resources 
are being amended to reflect the change in the maximum award amount 
from $750,000 to $1,000,000 as authorized by the National Institutes of 
Health Revitalization Act of 1993.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Action                    12/00/94

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AE55
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Public Health Service (PHS)--National Institutes of Health (NIH)
  
_______________________________________________________________________
  
1521.  HEALTH AND HUMAN SERVICES POLICY FOR PROTECTION OF HUMAN 
SUBJECTS

Legal Authority:  5 USC 301; 42 USC 289

CFR Citation:  45 CFR 46

Legal Deadline: None

Abstract: HHS is amending its Human Subjects Protection regulations to 
rescind the provision requiring prior review and advice from an Ethical 
Advisory Board for research applications and proposals involving in 
vitro fertilization of human ova as a prerequisite to funding by HHS 
and its components. The provision was nullified by the National 
Institutes of Health Revitalization Act of 1993. The regulations are 
being amended to reflect this statutory nullification.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Action                    06/01/94                    59 FR 28276
Final Action Effective          06/01/94                    59 FR 28276

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: F. William Dommel, Jr., J.D., Office of Protection from 
Research Risks, NIH, Department of Health and Human Services, Public 
Health Service, NIH, Bldg. 31, Room 5B63, 9000 Rockville Pike, 
Bethesda, MD 20892-001, 301 496-7005

RIN: 0905-AE47

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
 
Public Health Service (PHS)--Agency for Health Care Policy and Research 
(AHCPR)
  
_______________________________________________________________________
  
1522. HEALTH SERVICES RESEARCH, EVALUATION, DEMONSTRATION, AND 
DISSEMINATION PROJECTS; PEER REVIEW OF GRANTS AND CONTRACTS

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

CFR Citation:  42 CFR 67

Legal Deadline: None

Abstract: This final rule revises the regulations under 42 CFR part 67 
governing grants for health services research and grants for health 
services research centers made by the former National Center for Health 
Services Research and Health Care Technology Assessment (NCHSR). Public 
Law 101-239, enacted on December 19, 1989, established the Agency for 
Health Care Policy and Research to replace the NCHSR, and in title IX 
of the PHS Act and section 1142 of the Social Security Act provided the 
new agency with a much expanded role in health services research. The 
final rule will reflect applicable provisions of these statutes, as 
amended by P.L. 102-410.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Linda K. Demlo, Ph.D., Director, Office of Program 
Development, Agency for Health Care Policy and Research, Department of 
Health and Human Services, Public Health Service, Suite 603, 2101 East 
Jefferson Street, Rockville, MD 20852, 301 594-2453

RIN: 0905-AD30

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
 
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
  
1523. HOSPICE SERVICES (MB-7-P)

Legal Authority:  42 USC 1396d(a)(18); 42 USC 1396d(o); 42 USC 
1396a(a)(13)(D); 42 USC 1396o(a)(2)(E)

CFR Citation:  42 CFR 418.32; 42 CFR 435.218; 42 CFR 435.231; 42 CFR 
440.185; 42 CFR 447.53; 42 CFR 447.327; 42 CFR 447.381 to 447.384; 42 
CFR 435.726; 42 CFR 435.735; 42 CFR 436.231

Legal Deadline: None

Abstract: This regulation would implement section 9505 of PL 99-272 by 
establishing eligibility and coverage requirements, payment procedures 
and conditions of participation for optional Medicaid coverage of 
hospice care. It would also implement section 9435(b) of PL 99-509 
regarding payment for hospice care for individuals residing in a 
nursing facility or intermediate care facility in a State that has not 
elected to cover hospice services. It also would implement sections 
4705 and 4717 of PL 101-508 which further clarifies conditions for 
payment and the scope of benefits.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Organizations

Government Levels Affected: State

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

RIN: 0938-AC52
_______________________________________________________________________

1524. TRANSFER OF RESOURCES FOR LESS THAN FAIR MARKET VALUE (MB-10-P)

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) of the Social Security Act, which was extensively 
revised by section 303(b) of MCCA '88 (PL 100-360) as amended by 
section 608(d)(16)(B) of FSA '88 (PL 100-485) and section 6411(e)(1) of 
based services with no time limit on the penalty if these individuals 
or their spouses made transfers of assets (including establishing 
trusts under certain conditions) for less than fair market value during 
a prohibited period. The period of ineligibility applies if the 
individual or spouse made a transfer of assets for less than fair 
market value at any time during or after the 36-month period 
immediately before a date established according to a formula 
established in the law.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            04/00/95

Small Entities Affected: None

Government Levels Affected: State, Local

Additional Information: ABSTRACT CONT: This rule will also reflect 
statutory revisions mandated by OBRA '93.

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

RIN: 0938-AD18
_______________________________________________________________________

1525. MEDICARE COVERAGE OF OUTPATIENT OCCUPATIONAL THERAPY SERVICES (BPD-
425-P)

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

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

Legal Deadline: None

Abstract: This rule would implement section 9337 of PL 99-509 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 PL 101-239 which increased the payment limit for 
outpatient occupational therapy services provided by independent 
practitioners. This proposed rule would also redesignate current 
subpart Q of part 405 of the Medicare rules as new part 485.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            01/00/95

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0938-AD32
_______________________________________________________________________

1526. REVISIONS TO THE FREEDOM OF INFORMATION REGULATIONS (OPA-1-P)

Legal Authority:  5 USC 552; EO 12600

CFR Citation:  42 CFR 401.101 to 401.104; 42 CFR 401.110 to 401.112; 42 
CFR 401.120 to 401.125; 42 CFR 401.130 to 401.138; 42 CFR 401.140 to 
401.145; 42 CFR 401.150 to 401.154

Legal Deadline: None

Abstract: This rule proposes changes to the regulations implementing 
the Freedom of Information Act (FOIA). The regulations are being 
revised based on HCFA's experience with the FOIA in administering the 
Medicare and Medicaid programs. This rule would also conform HCFA's 
FOIA regulations to regulations published by the Department of Health 
and Human Services, as well as to guidance issued by the Office of 
Management and Budget, the Department of Justice, Presidential 
Executive Order 12600, and to the Freedom of Information Reform Act of 
1986.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Martha DiSario, Acting Director, Office of Public 
Affairs, Department of Health and Human Services, Health Care Financing 
Administration, Room 435-H HHH Building, 200 Independence Avenue SW., 
Washington, DC 20201, 202 690-6113

RIN: 0938-AD60
_______________________________________________________________________

1527. NEW MINIMUM STANDARDS FOR MEDICARE SUPPLEMENTAL (MEDIGAP) POLICIES 
(BPD-491-P)

Legal Authority:  42 USC 1395u; 42 USC 1395ss

CFR Citation:  42 CFR 403.200; 42 CFR 403.201; 42 CFR 403.205; 42 CFR 
403.206; 42 CFR 403.210; 42 CFR 403.211 to 403.220; 42 CFR 403.222; 42 
CFR 403.224; 42 CFR 403.226; 42 CFR 403.228; 42 CFR 403.229; 42 CFR 
403.231; 42 CFR 403.332; 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, and 
1990. 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 and the Medicare Catastrophic 
Coverage Repeal Act of 1989.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            04/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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

RIN: 0938-AD82
_______________________________________________________________________

1528. FEE SCHEDULE FOR PAYMENT OF CLINICAL PSYCHOLOGIST SERVICES (BPD-
495-P)

Legal Authority:  42 USC 1395k(a)(2)(B)(iii); 42 USC 1395x(gg); 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 410

Legal Deadline: None

Abstract: This interim final rule with comment period establishes fee 
schedules for payment for therapeutic and miscellaneous diagnostic 
services furnished under Medicare Part B by clinical psychologists or 
incident to the services of a clinical psychologist. It implements a 
portion of section 4077(b) of OBRA '87 as amended.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            01/00/95

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Elisa Tunanidas, Health Insurance Specialist, Division 
of Medical Services Payment, Department of Health and Human Services, 
Health Care Financing Administration, 1-H-5, ELR, 6325 Security 
Boulevard, Baltimore, Maryland 21207, 410 966-4505

RIN: 0938-AD84
_______________________________________________________________________

1529. CLARIFICATION OF ``WITHOUT FAULT'' AS IT APPLIES TO PHYSICIAN 
PROVIDER AND SUPPLIER LIABILITY (BPD-719-P)

Legal Authority:  42 USC 1395gg

CFR Citation:  42 CFR 405.350 to 405.355; 42 CFR 405.356 to 405.361; 20 
CFR 404.506 to 510

Legal Deadline: None

Abstract: This rule would amend the Medicare regulations to clarify our 
interpretation of ``without fault'' as it applies to physician, 
provider, supplier and beneficiary liability for overpayments. This 
definition would result in greater uniformity of determinations by 
carriers and intermediaries. Additionally, this proposed rule would 
incorporate in HCFA regulations pertinent portions of Social Security 
Administration regulations dealing with ``without fault.''

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            08/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Paul Olenick, Director, Division of Medicare 
Eligibility Policy, Department of Health and Human Services, Health 
Care Financing Administration, Room 401, EHR, 6325 Security Boulevard, 
Baltimore, Maryland 21207, 410 966-4472

RIN: 0938-AD95
_______________________________________________________________________

1530. PROTECTION OF INCOME AND RESOURCES FOR COMMUNITY SPOUSE (MB-23-P)

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)(A) of the FSA (PL 100-485), section 
6411(e)(3) of OBRA '89 (PL 101-239) and section 4714 of OBRA '90 (PL 
101-508). 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                            12/00/94

Small Entities Affected: Undetermined

Government Levels Affected: State, Local

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

RIN: 0938-AE12
_______________________________________________________________________

1531. PHYSICIAN CERTIFICATION AND PLAN OF CARE REQUIREMENTS AND 
INSPECTION OF CARE REVIEWS (HSQ-178-P)

Legal Authority:  42 USC 1396b(g); 42 USC 1396a(a)(30); 42 USC 
1396a(a)(44)

CFR Citation:  42 CFR 400; 42 CFR 440; 42 CFR 441; 42 CFR 456; 42 CFR 
483

Legal Deadline: None

Abstract: This proposed rule would make the requirements for physician 
certification and development of a plan of care general State plan 
requirements. States would no longer be required to make quarterly 
showings that they had determined compliance with those requirements or 
with utilization review. A quarterly demonstration to the Secretary of 
an effective program of medical review as demonstrated by a 
satisfactory utilization control program would be limited to 
Inspections of Care (IOCs) in participating Intermediate Care 
Facilities/Mentally Retarded (ICFs/MR) and psychiatric hospitals. This 
rule will establish review criteria specifically for ICFs/MRs that 
ensure essential client protections and focus on the provision of 
active treatment. This rule will also clarify utilization control 
requirements included in 42 CFR part 456, Subpart S.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Helene Fredeking, Director, Division of Long Term Care 
Services, Department of Health and Human Services, Health Care 
Financing Administration, 2-D-2, ME, 6325 Security Boulevard, 
Baltimore, Maryland 21207, 410 966-6807

RIN: 0938-AE17
_______________________________________________________________________

1532. MEDICAID PAYMENT OF MEDICARE COST SHARING FOR QUALIFIED MEDICARE 
BENEFICIARIES AND QUALIFIED DISABLED AND WORKING INDIVIDUALS AND 
SPECIFIED LOW-INCOME MEDICARE BENEFICIARIES (MB-031-P)

Legal Authority:  42 USC 1396a(a)(10)(E); Clause VIII of the matter 
following 42 USC 1396a(a)(10)(F); 42 USC 1396a(e)(8); 42 USC 
1396a(m)(4); 42 USC 1396a(n); 42 USC 1396b(f)(4); 42 USC 1396d(a); 42 
USC 1396d(p); 42 USC 1302

CFR Citation:  42 CFR 431.625; 42 CFR 435; 42 CFR 436; 42 CFR 441.256; 
42 CFR 447.600 to 447.620; 42 CFR 447.51; 42 CFR 447.53

Legal Deadline: None

Abstract: These rules would propose to require States to include in 
their State plans payment of Medicare cost-sharing for specified low-
income Medicare beneficiaries (SLMBS), Qualified Medicare Beneficiaries 
(QMB) and Qualified Disabled and Working Individuals (QDWI). The 
territories have the option to do the same. We would define cost-
sharing, specify criteria for determining QMB status, propose 
requirements and options for payment amounts and limitations, and 
provide for Federal financial participation in State payments for 
Medicare cost-sharing on behalf of QMBs. For QDWIs Federal financial 
participation would be limited to Medicare, Part A premium. The changes 
would implement provisions of MCCA '88 as modified by the FSA '88, TMRA 
'88, OBRA '89, and OBRA '90. Many of these provisions went into effect 
January 1, 1989.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: State, Local

Additional Information: TIMETABLE: Pending consultation with outside 
groups and resolution of complex issues.

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

RIN: 0938-AE38
_______________________________________________________________________

1533. COVERAGE OF PHYSICIAN ASSISTANT, NURSE PRACTITIONER, AND CLINICAL 
NURSE SPECIALIST SERVICES (BPD-708-P)

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

CFR Citation:  42 CFR 405; 42 CFR 410

Legal Deadline: None

Abstract: This proposed rule would conform Medicare regulations to the 
provisions in sections 9338 of OBRA '86, 4076(a) of OBRA '87, 6114 of 
OBRA '89, and 4155 of OBRA '90. These sections amended portions of the 
Social Security Act (the Act) concerning the coverage of and payment 
for certain services described in section 1861(s)(2)(K) of the Act that 
are performed by physician assistants, nurse practitioners, and 
clinical nurse specialists.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: TIMETABLE: Pending publication of 0938-AF01 
(BPD-709-F).

Agency Contact: William Larson, Program Analyst, Office of Coverage & 
Eligibility Policy, Department of Health and Human Services, Health 
Care Financing Administration, Room 401, EHR, 6325 Security Blvd., 
Baltimore, MD 21207, 410 966-4639

RIN: 0938-AF00
_______________________________________________________________________

1534. PROVIDER REIMBURSEMENT DETERMINATIONS AND APPEALS REVISIONS (BPD-
727-P)

Legal Authority:  42 USC 1395oo

CFR Citation:  42 CFR 405

Legal Deadline: None

Abstract: This regulation would update and clarify regulations 
governing the Provider Reimbursement Review Board and would deal with 
such issues as the parties to a Board hearing, jurisdiction of the 
Board, time periods for filing appeals, and the definition of ``good 
cause'' for late filings. The Board has authority to adjudicate 
disputes between providers and intermediaries under section 1878 of the 
Social Security Act.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            05/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Paul Olenick, Director, Division of Medicare & 
Eligibility Policy, Department of Health and Human Services, Health 
Care Financing Administration, Room 401, EHR, 6325 Security Boulevard, 
Baltimore, Maryland 21207, 410 966-4472

RIN: 0938-AF28
_______________________________________________________________________

1535. ALTERNATIVE SANCTIONS FOR PSYCHIATRIC HOSPITALS (HSQ-191-P)

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 (PL 101-239) and section 4755 of OBRA 
'90 (PL 101-508).
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                            07/00/95

Small Entities Affected: Undetermined

Government Levels Affected: State, Federal

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

RIN: 0938-AF32
_______________________________________________________________________

1536. MEDICAID PAYMENT FOR OBSTETRICAL AND PEDIATRIC SERVICES--ADEQUATE 
PAYMENT LEVEL PROVISION (MB-036-P)

Legal Authority:  42 USC 1396a(a)(30)(A); 42 USC 1396a(s); 42 USC 
1396r-7

CFR Citation:  42 CFR 430.12; 42 CFR 430.16; 42 CFR 447.204; 42 CFR 
447.300; 42 CFR 447.301; 42 CFR 447.393; 42 CFR 447.397

Legal Deadline: None

Abstract: This rule would implement section 1902(a)(30)(A) of the 
Social Security Act, which requires that Medicaid payment rates be 
established at a level to ensure access to services for Medicaid 
recipients is at least equal to the access available to the general 
population in the geographic area. It would also implement section 1926 
of the Social Security Act by establishing State plan requirements 
concerning obstetrical and pediatric services.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: State

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

Agency Contact: Bernard Truffer, Director, Division of Payment Policy, 
Department of Health and Human Services, Health Care Financing 
Administration, Room 291 EHR, 6325 Security Boulevard, Baltimore, 
Maryland 21207, 410 966-0691

RIN: 0938-AF62
_______________________________________________________________________

1537. CLARIFICATION OF COVERAGE OF INPATIENT PSYCHIATRIC SERVICES (MB-
060-P)

Legal Authority:  42 USC 1396d(h)(l)(A)

CFR Citation:  42 CFR 440; 42 CFR 441

Legal Deadline: None

Abstract: This rule would establish settings, other than psychiatric 
hospitals, in which inpatient psychiatric services may be covered under 
State Medicaid plans. It would implement section 4755(a)(1) of OBRA 
'90.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            11/00/94

Small Entities Affected: Undetermined

Government Levels Affected: State

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

RIN: 0938-AF73
_______________________________________________________________________

1538. FEDERALLY QUALIFIED HEALTH CENTER SERVICES (MEDICAID) (MB-043-P)

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 (PL 101-239) and 
section 4704 of OBRA '90 (PL 101-508) and reflect statutory revisions 
mandated.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            04/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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

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

RIN: 0938-AF90
_______________________________________________________________________

1539. MINIMUM PHYSICIAN QUALIFICATIONS FOR CERTAIN SERVICES (MB-059-P)

Legal Authority:  42 USC 1396b(i)

CFR Citation:  42 CFR 441

Legal Deadline: None

Abstract: This rule would establish qualifications that physicians must 
meet as a condition for payment under Medicaid for services furnished 
to children under 21 and to pregnant women (and women during the 60 
days following termination of pregnancy). Section 4752(e) of PL 101-508 
establishes these requirements for services furnished on or after 
January 1, 1992. The regulation and legislation are intended to assure 
that high quality services are furnished to women and children.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            08/06/93                    58 FR 42041
NPRM Comment Period End         10/06/93                    58 FR 42042
Second NPRM                     04/00/95

Small Entities Affected: Undetermined

Government Levels Affected: State

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

RIN: 0938-AF92
_______________________________________________________________________

1540. REVISIONS TO RULES ON HEALTH CARE PREPAYMENT PLANS (OMC-016-P)

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                            03/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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

RIN: 0938-AF97
_______________________________________________________________________

1541. CONDITIONS OF PARTICIPATION FOR RURAL HEALTH CLINICS (BPD-764-P)

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

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

Legal Deadline: None

Abstract: This rule would update our regulations to incorporate several 
health care coverage and payment provisions contained in Public Laws 
100-203, 101-239, and 101-508 (the OBRAs '87, '89, and '90) and would 
propose administrative changes that clarify policy related to sharing 
space between rural health centers and other entities, such as 
physician offices.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            08/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Jacqueline Sheridan, Chief, Health Organizations 
Branch, Department of Health and Human Services, Health Care Financing 
Administration, Room 401, EHR, 6325 Security Boulevard, Baltimore, 
Maryland 21207, 410 966-4635

RIN: 0938-AG05
_______________________________________________________________________

1542. INCOME AND ELIGIBILITY VERIFICATION SYSTEM (MB-66-P)

Legal Authority:  42 USC 1320b-7

CFR Citation:  42 CFR 435.940; 42 CFR 435.945; 42 CFR 435.948; 42 CFR 
435.952; 42 CFR 435.953; 42 CFR 435.955; 42 CFR 435.960; 42 CFR 435.965

Legal Deadline: None

Abstract: This rule would amend our regulations to allow States more 
flexibility to limit their income and eligibility verification system 
data match requests to only those matches that are productive or 
useful. States would be required to submit plans of alternative income 
and eligibility verification system procedures for approval by HCFA. 
The flexibility offered by this change would afford States the freedom 
to design more efficient data matches.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: State

Additional Information: 
TIMETABLE: Pending publication of AFDC regulation (RIN 0970-AB13).

Agency Contact: Donna Jarosinski, Program Analyst, Medicaid Bureau, 
Department of Health and Human Services, Health Care Financing 
Administration, Room 273, EHR, 6325 Security Boulevard, Baltimore, MD 
21207, 410 966-5928

RIN: 0938-AG12
_______________________________________________________________________

1543. MEDICARE APPEALS OF INDIVIDUAL CLAIMS (BPD-453-P)

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 implement sections 9313(a)(1) and 9341 of PL 
99-509. Section 9313(a)(1) permits providers, physicians or suppliers 
to represent beneficiaries, with certain limitations, in pursuing 
appeals of adverse determinations regarding claims for benefits under 
Medicare Part A or Part B. Section 9341 extends to Medicare Part B 
claimants the right to a hearing before an administrative law judge if 
the amount in controversy is at least $500 and to judicial review, 
provided the amount in controversy is at least $1000. Section 9341 also 
limits the review of national coverage determinations and prohibits 
judicial review of any regulation or instruction, initially issued 
before January 1, 1981, relating to a method of determining the amount 
of payment under Part B.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            05/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Paul Olenick, Director, Division of Medicare 
Eligibility Policy, BPD, Department of Health and Human Services, 
Health Care Financing Administration, Room 401, EHR Building, 6325 
Security Boulevard, Baltimore, Maryland 21207, 410 966-4472

RIN: 0938-AG18
_______________________________________________________________________

1544. END-STAGE RENAL DISEASE (ESRD) PAYMENT EXCEPTION REQUESTS AND ORGAN 
PROCUREMENT COSTS (BPD-763-P)

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 would 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. We are 
proposing to compute the acquisition costs of hearts and livers using 
the same method we now use to pay for the acquisition costs of kidneys.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Michael Powell, Health Insurance Specialist, Division 
of Special Payment Programs, BPD, Department of Health and Human 
Services, Health Care Financing Administration, Room 1-A-5, EHR 
Building, 6325 Security Boulevard, Baltimore, Maryland 21207, 410 966-
4557

RIN: 0938-AG20
_______________________________________________________________________

1545. APPOINTMENT OF REPRESENTATIVES FOR APPEAL (BPO-120-P)

Legal Authority:  42 USC 1395ff

CFR Citation:  42 CFR 405.870; 42 CFR 405.701(c)

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                            07/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Betsy Horne, Chief Appeals Branch, Bureau of Program 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, G-C-1 Meadows East Building, 6325 SEcurity 
Boulevard, Baltimore, Maryland 21207, 410 966-4292

RIN: 0938-AG30
_______________________________________________________________________

1546. ENFORCEMENT REQUIREMENTS FOR RENAL DIALYSIS FACILITIES (HSQ-204-P)

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) broadens the Secretary's authority to 
impose alternative sanctions on suppliers of end-stage renal disease 
services when the noncompliance of the supplier does not immediately 
jeopardize patient health and safety. Alternative sanctions provide 
HCFA with a more flexible response to facility deficiencies short of 
termination.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            06/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Debbie Schoenemann, Chief, Survey and Certification 
Procedures Branch, HSQ, Department of Health and Human Services, Health 
Care Financing Administration, 6325 Security Boulevard, Baltimore, 
Maryland 21207, 410 966-6771

RIN: 0938-AG31
_______________________________________________________________________

1547. DISCLOSURE OF CONFIDENTIAL PRO INFORMATION FOR RESEARCH PURPOSES 
(HSQ-208-P)

Legal Authority:  42 USC 1320c-9

CFR Citation:  42 CFR 1320c-9

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                            00/00/00

Small Entities Affected: Organizations

Government Levels Affected: State, Federal

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

RIN: 0938-AG33
_______________________________________________________________________

1548. COMMUNITY SUPPORTED LIVING ARRANGEMENTS SERVICES (MB-070-P)

Legal Authority:  42 USC 1395u

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

Legal Deadline: None

Abstract: This rule would specify requirements that must be met in 
order for a State to be eligible to provide community supported living 
arrangements services to individuals with developmental disabilities as 
an optional Medicaid service.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            08/00/95

Small Entities Affected: Undetermined

Government Levels Affected: State

Additional Information: 
TIMETABLE: Pending resolution of Complex Policy Issues.

Agency Contact: Mary Jean Duckett, Chief, Home and Community Based 
Waivers Branch, MB, Department of Health and Human Services, Health 
Care Financing Administration, Room 400, EHR Building, 6325 Security 
Boulevard, Baltimore, Maryland 21207, 410 966-5640

RIN: 0938-AG35
_______________________________________________________________________

1549. TELEPHONE REQUESTS FOR REVIEW OF INITIAL DETERMINATIONS (BPO-121-P)

Legal Authority:  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.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            02/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Rosalind Little, Appeals Branch, Division of Appeals 
and Communication, Department of Health and Human Services, Health Care 
Financing Administration, G-C-1 Meadows East Building, 6325 Security 
Boulevard, Baltimore, Maryland 21207, 410 966-6972

RIN: 0938-AG48
_______________________________________________________________________

1550. CONDITIONS FOR PAYMENT FOR PHYSICIANS' SERVICES IN TEACHING 
SETTINGS (BPD-792-P)

Legal Authority:  42 USC 1302; 42 USC 1395w

CFR Citation:  42 CFR 405; 42 CFR 415

Legal Deadline: None

Abstract: This rule would establish in regulations current coverage and 
payment policy concerning teaching physicians' services. It would also 
establish in regulations certain policies relating to the coverage and 
payment of the services of residents in settings other than hospitals. 
This proposed rule will supersede the proposed rule published on 
February 7, 1989 (54 FR 5946).

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: None

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

Agency Contact: William Morse, Program Analyst, Physician and 
Practitioner Payment Branch, Department of Health and Human Services, 
Health Care Financing Administration, 1-H-5, ELR, 6325 Security 
Boulevard, Baltimore, Maryland 21207, 410 966-4520

RIN: 0938-AG53
_______________________________________________________________________

1551. NEW LOOK BEHIND FOR INTERMEDIATE CARE FACILITIES FOR THE MENTALLY 
RETARDED (ICFS/MR) (HSQ-214-P)

Legal Authority:  42 USC 1396i

CFR Citation:  42 CFR 442.116

Legal Deadline: None

Abstract: The rule would add regulations to delineate HCFA/DHHS 
authority to cancel the Medicaid approval of an intermediate care 
facility for the mentally retarded (ICF/MR) if HCFA determines that the 
facility has failed to meet Medicaid certification requirements. The 
rule would also eliminate the current regulatory policy by which States 
are entitled to up to 120 days of FFP for ICFs/MR having been 
terminated from the Medicaid program, while their appeals are pending.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            08/00/95

Small Entities Affected: None

Government Levels Affected: Undetermined

Agency Contact: Pamela V. Vocke, Director, Division of Program 
Operations, Health Standards and Quality Bureau, Department of Health 
and Human Services, Health Care Financing Administration, Room 2-D-2, 
ME Building, 6325 Security Boulevard, Baltimore, Maryland 21207, 410 
966-7089

RIN: 0938-AG58
_______________________________________________________________________

1552. EFFECT OF CHANGE OF OWNERSHIP ON PROVIDER AND SUPPLIER PENALTIES, 
SANCTIONS, AND OVERPAYMENTS (HSQ-215-P)

Legal Authority:  42 USC 1395hh

CFR Citation:  42 CFR 405.1803; 42 CFR 405.1811; 42 CFR 405.1835; 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 and suppliers. It would state that all 
Medicare penalties and sanctions are automatically assigned to a new 
owner unless otherwise stated in the change of ownership. It would also 
extend the same principle to overpayments; i.e., we would amend the 
regulations on provider overpayments to require the new owner of a 
provider or a supplier to be liable for any Medicare overpayments paid 
to the previous owner unless otherwise stated in the change of 
ownership. Finally, we would clarify the effect of a leasing 
arrangement has on a provider agreement and on supplier approval.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            02/00/95

Small Entities Affected: None

Government Levels Affected: Undetermined

Agency Contact: Pamela V. Vocke, Director of Program Operations, Health 
Standards and Quality Bureau, Department of Health and Human Services, 
Health Care Financing Administration, Room 2-D-2, ME Building, 6325 
Security Boulevard, Baltimore, Maryland 21207, 410 966-7089

RIN: 0938-AG59
_______________________________________________________________________

1553. INSTITUTIONAL PLAN AMENDMENT FINDINGS (MB-078-P)

Regulatory Plan:  This entry is Seq. No. 49 in Part II of this issue of 
the Federal Register.

RIN: 0938-AG60
_______________________________________________________________________

1554. MEDICARE PROGRAM: LIMITATIONS ON MEDICARE COVERAGE OF CATARACT 
SURGERY (BPD-797-PN)

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

CFR Citation:  None

Legal Deadline: None

Abstract: This notice would announce the Medicare program's proposal to 
adopt certain recommendations set forth by the Agency for Health Care 
Policy and Research and the Guidelines for Cataract Practice in order 
to define medical necessity with respect to Medicare coverage of 
cataract surgery and Nd:YAG capsulotomy. This would reinforce our 
policy of noncoverage for most preoperative testing for cataract 
surgery, as set forth in the Medicare Coverage Issues Manual.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Proposed Notice                 02/00/95

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: Karen Fink, Health Insurance Specialist, Office of 
Coverage and Eligibility Policy, Department of Health and Human 
Services, Health Care Financing Administration, Room 401, EHR, 6325 
Security Boulevard, Baltimore, Maryland 21297, 410 966-4643

RIN: 0938-AG65
_______________________________________________________________________

1555. EFFECTS OF GENERALLY ACCEPTED ACCOUNTING PRINCIPLES (GAAP) ON 
REASONABLE COSTS DETERMINATIONS (BPD-800-P)

Legal Authority:  42 USC 1395x(v)

CFR Citation:  42 CFR 413.20; 42 CFR 413.24

Legal Deadline: None

Abstract: This proposed rule would clarify our policy on the 
application of generally accepted accounting principles (GAAP) for 
Medicare reimbursement purposes. We would specify that the use of GAAP 
is required for cost reporting purposes but that the Secretary is not 
required to follow GAAP in determining Medicare reimbursement.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: John Eppinger, Program Analyst, Department of Health 
and Human Services, Health Care Financing Administration, Room 1-F-5, 
ELR, 6325 Security Boulevard, Baltimore, Maryland 21207, 410 966-4518

RIN: 0938-AG66
_______________________________________________________________________

1556. EXPANSION OF THE DEFINITION OF EYE AND EAR SPECIALTY HOSPITALS 
(BPD-804-P)

Legal Authority:  42 USC 1395(l)(i)(4)

CFR Citation:  42 CFR 413

Legal Deadline: None

Abstract: Hospitals designated as eye or eye and ear hospitals receive 
a blended payment for the facility costs of ambulatory surgical 
procedures based on 75 percent of costs and 25 percent of the 
ambulatory surgical center rate for cost reporting periods beginning 
before January 1, 1995. In accordance with section 13532 of OBRA '93, 
this proposed rule would expand the definition of eye or eye and ear 
hospitals. The expanded definition would extend eligibility for 
designation as an eye or eye and ear hospital to hospitals meeting 
specified criteria.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            06/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Carolyn Muller, Payment Policy Branch, Department of 
Health and Human Services, Health Care Financing Administration, Room 
1-F-5, ELR, 6325 Security Boulevard, Baltimore, Maryland 21207, 410 
966-4589

RIN: 0938-AG67
_______________________________________________________________________

1557. SALARY EQUIVALENCY GUIDELINES FOR PHYSICAL AND RESPIRATORY THERAPY 
SERVICES FURNISHED UNDER ARRANGEMENTS (BPD-808-PN)

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

CFR Citation:  42 CFR 413.106

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Proposed Notice                 10/00/95

Small Entities Affected: Undetermined

Government Levels Affected: None

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

RIN: 0938-AG70
_______________________________________________________________________

1558. MEDICAID: OPTIONAL COVERAGE OF TB-RELATED SERVICES FOR INDIVIDUALS 
INFECTED WITH TUBERCULOSIS (MB-082-P)

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

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                            01/00/95

Small Entities Affected: None

Government Levels Affected: State, Local

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

RIN: 0938-AG72
_______________________________________________________________________

1559. PROPOSED PAYMENTS TO DISPROPORTIONATE SHARE HOSPITALS FOR FY 1995 
(MB-089-N)

Legal Authority:  42 USC 1396r-4(f)

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

Legal Deadline:  Other, Statutory, October 1, 1994.
The Social Security Act requires publication of preliminary amounts by 
the beginning of each Federal fiscal year.

Abstract: This notice will contain the preliminary Fiscal Year 1995 
national target and each State's allotment for disproportionate share 
hospital (DSH) payments. DSH payments are payment adjustments made to 
Medicaid participating hospitals that serve a large number of Medicaid 
recipients and other low-income individuals with special needs. 
Implementing regulations require that a notice be published before the 
start of each FFY with the preliminary amounts for the FFY.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Proposed Notice                 10/00/94

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Richard Strauss, Analyst, Division of Financial 
Management, Department of Health and Human Services, Health Care 
Financing Administration, Room 273, EHR, 6325 Security Boulevard, 
Baltimore, Maryland 21207, 410 966-2019

RIN: 0938-AG75
_______________________________________________________________________

1560.  REVISION OF MEDICARE HOSPITAL CONDITIONS OF PARTICIPATION 
(BPD-745-P)

Regulatory Plan:  This entry is Seq. No. 50 in Part II of this issue of 
the Federal Register.

RIN: 0938-AG79
_______________________________________________________________________

1561.  PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH 
THEY HAVE FINANCIAL RELATIONSHIPS--EXPANDED TO DESIGNATED HEALTH SERVICES 
(BPD-809-P)

Regulatory Plan:  This entry is Seq. No. 51 in Part II of this issue of 
the Federal Register.

RIN: 0938-AG80
_______________________________________________________________________

1562.  HOME HEALTH AGENCY (HHA) CONDITIONS OF PARTICIPATION (BPD-
819-P)

Regulatory Plan:  This entry is Seq. No. 52 in Part II of this issue of 
the Federal Register.

RIN: 0938-AG81
_______________________________________________________________________

1563.  END STAGE RENAL DISEASE (ESRD) CONDITIONS OF COVERAGE 
(BPD-818-P)

Regulatory Plan:  This entry is Seq. No. 53 in Part II of this issue of 
the Federal Register.

RIN: 0938-AG82
_______________________________________________________________________

1564.  DISTINCT PARTS AND COSTING FOR SKILLED NURSING FACILITIES 
AND NURSING FACILITIES (BPD-815-P)

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

CFR Citation:  42 CFR 409; 42 CFR 483

Legal Deadline: None

Abstract: In this proposed rule we would define ``distinct part'' by 
specifying that a distinct part is a physically identifiable unit of an 
institution (that is, an entire ward wing, floor, or building) 
including all beds in the unit. This rule also proposes an alternative 
approach for calculating Medicare payments to a skilled nursing 
facility (SNF). This new ``distinct costing'' procedure would enable a 
participating SNF to establish a distinct costing area within the SNF 
for its relatively high intensity residents so that it can isolate and 
fully capture the routine cost of their care without resorting to the 
use of arbitrary certification boundaries to achieve this result.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            06/00/95

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: William Ullman, Health Insurance Specialist, Department 
of Health and Human Services, Health Care Financing Administration, 
Room 401, EHR, 6325 Security Boulevard, Baltimore, Maryland 21207, 401 
966-5667

RIN: 0938-AG84
_______________________________________________________________________

1565.  EXTENSION OF CERTAIN EFFECTIVE DATES FOR CLINICAL 
LABORATORY REQUIREMENTS AND PERSONNEL REQUIREMENTS FOR CYTOLOGISTS (HSQ-
217-FC)

Legal Authority:  42 USC 263a

CFR Citation:  42 CFR 493.855; 42 CFR 493.1201; 42 CFR 493.1202; 42 CFR 
493.1203; 42 CFR 493.1213; 42 CFR 493.1215; 42 CFR 493.1217; 42 CFR 
493.1218; 42 CFR 493.1223; 42 CFR 493.1443

Legal Deadline: None

Abstract: This rule will extend the date by which a laboratory must 
enroll in an HHS-approved cytology proficiency testing program. It also 
extends the date by which an individual with a doctoral degree must 
possess board certification to qualify as a director of a laboratory 
that performs high complexity testing. In addition, we are extending 
the phase-in for minimum quality control requirements for unmodified, 
moderate complexity testing cleared through the Food and Drug 
Administration premarket notification on premarket approval processes. 
The date extensions do not reduce current requirements for quality test 
performance. Rather, they take into account more realistic timeframes 
based on actual experience.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            10/00/94

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Kathleen Kremann, Health Insurance Specialist, 
Department of Health and Human Services, Health Care Financing 
Administration, Meadowwood East Building, 6325 Security Boulevard, 
Baltimore, Maryland 21207, 410 597-5906

RIN: 0938-AG86
_______________________________________________________________________

1566.  CLINICAL LABORATORY IMPROVEMENT AMENDMENT (CLIA) FEE 
SCHEDULES (HSQ-219-FC)

Legal Authority:  PL 100-578

CFR Citation:  42 CFR 493.638; 42 CFR 493.649

Legal Deadline: None

Abstract: The preamble to this final rule with comment period announces 
updated fees that laboratories must pay as required by CLIA '88. Fee 
increases are necessary to meet the costs of program administration, 
which are to be borne by the laboratories. In addition, technical 
conforming changes are made to the regulations to ensure consistent and 
complete references.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            03/00/95

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Ed Mortimore, Health Insurance Specialist, Department 
of Health and Human Services, Health Care Financing Administration, 
Meadowwood East Building, 6325 Security Boulevard, Baltimore, Maryland 
21207, 410 597-2140

RIN: 0938-AG87
_______________________________________________________________________

1567.  APPROVAL OF THE AMERICAN SOCIETY FOR HISTOCOMPATIBILITY 
AND IMMUNOGENETICS FOR THE SPECIALTY OF HISTOCOMPATIBILITY (HSQ-220-N)

Legal Authority:  42 USC 263a

CFR Citation:  42 CFR 493.501

Legal Deadline: None

Abstract: This notice announces HCFA's approval of the American Society 
for Histocompatibility and Immunogenetics as an accrediting 
organization for clinical laboratories under the Clinical Laboratory 
Improvement Amendments at 1988 for the specialty of histocompatibility. 
The effect of this notice is to exempt laboratories accredited by the 
American Society for Histocompatibility from having to be surveyed by 
Medicare surveyors for that specialty, except for validation and 
complaint investigation surveys.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            10/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Anthony Tirone, Director, Office of Survey and 
Certification, HSQB, Department of Health and Human Services, Health 
Care Financing Administration, 2-D-2, Meadows East Building, 6325 
Security Boulevard, Baltimore, Maryland 21207, 410 966-6763

RIN: 0938-AG88
_______________________________________________________________________

1568.  MEDICAID: COVERAGE OF REHABILITATION SERVICES (MB-076-P)

Legal Authority:  42 USC 1396d(a)(13)

CFR Citation:  42 CFR 440.130; 42 CFR 440.110; 42 CFR 440.90

Legal Deadline: None

Abstract: The rule would amend the Medicaid regulations to redefine 
rehabilitation services furnished as medical assistance under the 
Medicaid program. The rule also would clarify the limitations on and 
conditions for providing rehabilitation services in various settings. 
These amendments incorporate and interpret a statutory change to the 
definition of rehabilitation services made by section 4719 of OBRA '90.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Organizations

Government Levels Affected: State

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

RIN: 0938-AG89
_______________________________________________________________________

1569.  MEDICAID: NOMINAL COPAYMENTS FOR INSTITUTIONAL SERVICES 
FOR MEDICAID RECIPIENTS (MB-090-FC)

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                            01/00/95

Small Entities Affected: None

Government Levels Affected: State

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

RIN: 0938-AG90
_______________________________________________________________________

1570.  WAGE INDEX USED TO ADJUST PAYMENT RATES FOR HOSPICE 
SERVICES UNDER THE MEDICARE PROGRAM (BPD-820-N)

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 that we use to adjust 
payment rates in different areas of the country, which reflect local 
differences in area wage levels. We are considering development of this 
proposed rule through a ``negotiated rulemaking'' proceeding under the 
Negotiated Rulemaking Act of 1990. The next step will be to publish a 
notice of intent to form an advisory committee to negotiate the wage 
index.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Notice of Intent                10/00/94

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Randal S. Ricktor, Health Insurance Specialist, 
Department of Health and Human Services, Health Care Financing 
Administration, 6325 Security Boulevard, Baltimore, MD 21207, 410 966-
5650

RIN: 0938-AG93
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
  
1571. PAYMENT FOR CLINICAL DIAGNOSTIC LABORATORY SERVICES (BPD-309-F)

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

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

Legal Deadline: None

Abstract: This regulation will incorporate provisions of Public Laws 
98-369, 99-272, 99-509, 100-203, 100-647, 101-239 and 101-508 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 the 
OBRA '93.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: None

Additional Information: 
TIMETABLE: Pending publication of RIN 0938-AF40.

Agency Contact: Ron Wren, Health Insurance Specialist, Department of 
Health and Human Services, Health Care Financing Administration, Room 
1-H-5 ELR, 6325 Security Blvd., Baltimore, MD 21207, 410 966-4506

RIN: 0938-AB50
_______________________________________________________________________

1572. HOME AND COMMUNITY-BASED SERVICES AND RESPIRATORY CARE FOR 
VENTILATOR-DEPENDENT INDIVIDUALS (MB-8-FC)

Legal Authority:  42 USC 1396n(c)

CFR Citation:  42 CFR 435.726; 42 CFR 435.735; 42 CFR 440.180; 42 CFR 
441.301; 42 CFR 441.302; 42 CFR 441.303; 42 CFR 441.304; 42 CFR 
441.305; 42 CFR 441.306; 42 CFR 441.307; 42 CFR 441.308; 42 CFR 
441.310; 42 CFR 440.185; 42 CFR 440.250

Legal Deadline: None

Abstract: This rule revises the regulations for home and community 
based services as required by section 9502 of PL 99-272, sections 9408 
and 9411 of PL 99-509, sections 4102 and 4118 of PL 100-203, sections 
411(k)(10)(A) and 411(k)(10)(H) of PL 100-360, section 8427 of PL 100-
647, and sections 4741 and 4742 of PL 101-508.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            06/01/88                    53 FR 19950
NPRM Comment Period End         07/31/88                    53 FR 19950
Final Rule With Comment Period  07/25/94                    59 FR 37702
Effective Date                  08/24/94                    59 FR 37702
Comment Period End              09/23/94                    59 FR 37702
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: State, Local

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

RIN: 0938-AC55
_______________________________________________________________________

1573. PARTICIPATION IN CHAMPUS AND CHAMPVA, HOSPITAL ADMISSIONS FOR 
VETERANS, DISCHARGE RIGHTS NOTICE, AND HOSPITAL RESPONSIBILITY FOR 
EMERGENCY CARE (BPD-393-FC)

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 formally implements statutory requirements 
that require Medicare participating hospitals with emergency 
departments to provide upon request medical examinations and treatments 
for individuals with emergency medical conditions and women in labor. A 
participating hospital that has specialized capabilities or facilities 
(such as burn, shock trauma, or neonatal intensive care units) must 
accept an appropriate transfer if they have the capacity to treat the 
individual. Hospitals failing to meet those requirements may have their 
Medicare provider agreements terminated, and hospitals and responsible 
physicians may be subject to civil money penalties. Under section 9122 
of PL 99-272, 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 PL 99-509, which requires Medicare hospitals to give 
patients a notice of their discharge rights.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Jacqueline Sheriden, Chief, Health Organizations 
Branch, Department of Health and Human Services, Health Care Financing 
Administration, Room 401 EHR Bldg., 6325 Security Blvd., Baltimore, MD 
21207, 410 966-4635

RIN: 0938-AC58
_______________________________________________________________________

1574. DENIAL OF PAYMENT FOR SUBSTANDARD QUALITY CARE (HSQ-132-F)

Legal Authority:  42 USC 1320c-3(a); 42 USC 1395cc(a)(1)(K); 42 USC 
1395u; 42 USC 1395pp(b)

CFR Citation:  42 CFR 462.105; 42 CFR 466; 42 CFR 473; 42 CFR 476; 42 
CFR 489.21

Legal Deadline: None

Abstract: This final rule implements section 9403 of PL 99-272; section 
9353(c) of PL 99-509; section 4096(a) of PL 100-203; and section 4205 
of PL 101-508. In accordance with these statutory provisions, Peer 
Review Organizations (PROs) are authorized to deny Medicare payment to 
a physician or hospital for services furnished that are of substandard 
quality. Beneficiaries are protected from liability for the cost of the 
services where payment is denied because services were of substandard 
quality.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            01/08/89                     54 FR 1956
NPRM Comment Period End         03/20/89                     54 FR 1956
Final Action                    00/00/00

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: 
TIMETABLE: Pending review in light of the Health Care Quality 
Improvement Initiative under the PRO program.

Agency Contact: Harvey Brook, Office of Peer Review, Department of 
Health and Human Services, Health Care Financing Administration, 2-D-2 
Meadows East Bldg., 6300 Security Blvd., Baltimore, MD 21207, 410 966-
6853

RIN: 0938-AC84
_______________________________________________________________________

1575. REVISED EFFECTIVE DATE OF MEDICARE/MEDICAID PROVIDER AGREEMENT AND 
SUPPLIER PARTICIPATION (HSQ-139-F)

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

CFR Citation:  42 CFR 440.10; 42 CFR 440.70; 42 CFR 442.13; 42 CFR 
488.11; 42 CFR 489.13; 42 CFR 498.3

Legal Deadline: None

Abstract: This rule will establish uniform rules for determining the 
effective date of participation for all providers and suppliers whose 
Medicare or Medicaid approval requires onsite surveys by the State 
survey agency. Also, it provides criteria for determining the effective 
date of participation for those providers and suppliers who are deemed 
to meet the conditions by an accreditation. It would also specify that 
those dissatisfied with a decision on their effective date of 
participation under Medicare are entitled to a Medicare reconsideration 
and hearing on the decision.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            10/08/92                    57 FR 46362
NPRM Comment Period End         12/07/92
Final Action                    04/00/95

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Federal

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

RIN: 0938-AC88
_______________________________________________________________________

1576. CHANGES CONCERNING SUSPENSION OF MEDICARE PAYMENTS AND 
DETERMINATIONS OF ALLOWABLE INTEREST EXPENSE (BPO-118-FC)

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 413.153; 42 CFR 405.370; 42 CFR 413.5(c)(3); 42 
CFR 405.371; 42 CFR 405.372; 42 CFR 405.373; 42 CFR 405.375

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: None

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

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

RIN: 0938-AC99
_______________________________________________________________________

1577. CHANGES CONCERNING THE DEFINITION OF ACCRUAL BASIS OF ACCOUNTING 
(BPD-366-FC)

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

CFR Citation:  42 CFR 413.24

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0938-AD01
_______________________________________________________________________

1578. OPTIONAL PAYMENT SYSTEM FOR LOW MEDICARE VOLUME SKILLED NURSING 
FACILITIES (BPD-409-F)

Legal Authority:  42 USC 1395yy(d)

CFR Citation:  42 CFR 413.200; 42 CFR 413.202; 42 CFR 413.204; 42 CFR 
413.208; 42 CFR 413.210; 42 CFR 413.212; 42 CFR 413.214; 42 CFR 
413.216; 42 CFR 413.220; 42 CFR 413.221; 42 CFR 413.1; 42 CFR 413.24

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: Undetermined

Agency Contact: William Goeller, Director, Division of Payment and 
Reporting Policy, Department of Health and Human Services, Health Care 
Financing Administration, Room 1-F-5 ELR, 6325 Security Blvd., 
Baltimore, MD 21207, 410 966-4513

RIN: 0938-AD02
_______________________________________________________________________

1579. CRITERIA AND PROCEDURES FOR MAKING MEDICAL SERVICES COVERAGE 
DECISIONS THAT RELATE TO HEALTH CARE TECHNOLOGY (BPD-432-F)

Legal Authority:  42 USC 1395y

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

Legal Deadline: None

Abstract: The final rule establishes in regulations generally 
applicable criteria and procedures for determining whether a service is 
``reasonable and necessary'' under the Medicare program; it sets forth 
the coverage decisionmaking process; and it summarizes and provides an 
analysis of the public comments that we received in response to the 
January 30, 1989 proposed rule (54 FR 4302). The objective of the 
criteria and procedures set forth in this rule is to ensure that 
Federal funds are expended only for medical services that are 
appropriate to meet an individual's medical needs.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            01/30/89                     54 FR 4302
NPRM Comment Period End         03/31/89                     54 FR 4302
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

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

Agency Contact: Walter Rutemueller, Chief, Special Coverages Isues 
Branch, Department of Health and Human Services, Health Care Financing 
Administration, 401 East High Rise Bldg., 6325 Security Blvd., 
Baltimore, MD 21207, 410 966-5395

RIN: 0938-AD07
_______________________________________________________________________

1580. REVISIONS TO CONDITIONS OF PARTICIPATION FOR HOSPITALS AND 
CONDITIONS FOR COVERAGE OF SUPPLIERS OF END-STAGE RENAL DISEASE SERVICES 
(BPD-421-F)

Legal Authority:  42 USC 1395x(e)(6)(B); 42 USC 1395x(ee); PL 99-509, 
Sec 9339(d)

CFR Citation:  42 CFR 405; 42 CFR 482

Legal Deadline: None

Abstract: This final rule will require hospitals, as a condition of 
participation, to provide a discharge planning process for patients in 
accordance with section 9305(c) of PL 99-509. Revisions will also 
implement section 6025 of PL 101-239 to allow a doctor of dental 
surgery or dental medicine to be a hospital medical director if the 
laws of the State in which the hospital is located permit. The preamble 
to this final rule withdraws proposed regulations for the 
qualifications of laboratory directors under section 9339(d) of PL 99-
509. The information collection burden of several end-stage renal 
disease regulations is reduced.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            06/16/88                    53 FR 22506
NPRM Comment Period End         08/15/88                    53 FR 22506
Final Action                    10/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jacqueline Sheridan, Chief, Health Organizations 
Branch, Department of Health and Human Services, Health Care Financing 
Administration, Room 401 EHR, 6325 Security Blvd., Baltimore, MD 21207, 
410 966-4635

RIN: 0938-AD11
_______________________________________________________________________

1581. MEDICAID ELIGIBILITY OF POVERTY LEVEL GROUPS AND EXTENDED COVERAGE 
OF SERVICES (MB-13-F)

Legal Authority:  42 USC 1396a(a)(10); 42 USC 1396a(l); 42 USC 
1396a(f); 42 USC 1396a(m); 42 USC 1396b(f); 42 USC 1396r-1; 42 USC 
1396a(a)(47); 42 USC 1396a(e)(6); 42 USC 1396a(e)(7); 42 USC 
1396a(a)(17)

CFR Citation:  42 CFR 431; 42 CFR 435; 42 CFR 436; 42 CFR 440; 42 CFR 
447

Legal Deadline: None

Abstract: This rule will amend the Medicaid regulations to incorporate 
changes relating to Medicaid eligibility groups and coverage of 
services made by the Medicare Catastrophic Coverage Act of 1988 (PL 
100-360), OBRAs '90, '89, '87, and '86 (PL 101-508, PL 101-239, PL 100-
203 and PL 99-509), and the Homeless Eligibility Clarification Act of 
the Anti-Drug Abuse Act of 1986 (PL 99-570). This rule will add 
eligibility groups of pregnant women, infants and children, and aged 
and disabled individuals with incomes up to specified percentage of the 
Federal poverty line; clarify eligibility of homeless individuals; and 
add provisions for the presumptive eligibility period for pregnant 
women who, based on preliminary information, appear to meet income 
requirements under Medicaid.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            03/23/94                    59 FR 13666
NPRM Comment Period End         05/23/94
Final Action                    06/00/95

Small Entities Affected: None

Government Levels Affected: State, Local

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

RIN: 0938-AD17
_______________________________________________________________________

1582. PROHIBITION ON UNBUNDLING OF HOSPITAL OUTPATIENT SERVICES (BPD-426-
F)

Regulatory Plan:  This entry is Seq. No. 54 in Part II of this issue of 
the Federal Register.

RIN: 0938-AD33
_______________________________________________________________________

1583. CHANGES TO PEER REVIEW ORGANIZATION REGULATIONS (HSQ-135-F)

Legal Authority:  42 USC 1395y(a); 42 USC 1320c; 42 USC 1396a(a)(30); 
42 USC 1395cc(a)

CFR Citation:  42 CFR 400.200; 42 CFR 411.15; 42 CFR 431.630; 42 CFR 
433.15; 42 CFR 462.1; 42 CFR 462.101; 42 CFR 462.102; 42 CFR 462.106; 
42 CFR 462.107; 42 CFR 66.1; 42 CFR 466.71; 42 CFR 466.76; 42 CFR 
466.78; 42 CFR 466.83

Legal Deadline: None

Abstract: This rule will set forth several changes to regulations that 
govern Peer Review Organizations (PROs) and is based on statutory 
changes contained in COBRA '85 (PL 99-272) and OBRA '86 (PL 99-503). 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                    03/00/95

Small Entities Affected: None

Government Levels Affected: Undetermined

Agency Contact: Harvey Brook, Office of Peer Review, Department of 
Health and Human Services, Health Care Financing Administration, Rm. 2-
D-2 Meadows East Bldg., 6325 Security Blvd., Baltimore, MD. 21207, 410 
966-6853

RIN: 0938-AD38
_______________________________________________________________________

1584. PAYMENT FOR DURABLE MEDICAL EQUIPMENT AND ORTHOTIC AND PROSTHETIC 
DEVICES (BPD-494-F)

Legal Authority:  42 USC 1395m(a); 42 USC 1395x(n)

CFR Citation:  42 CFR 405.501; 42 CFR 405.514; 42 CFR 414.200; 42 CFR 
414.202; 42 CFR 414.210; 42 CFR 414.220; 42 CFR 414.222; 42 CFR 
414.226; 42 CFR 414.228; 42 CFR 414.229; 42 CFR 410.36; 42 CFR 410.38; 
42 CFR 414.232

Legal Deadline: None

Abstract: This final rule responds to comments received in response to 
the final rule with comment period (57 FR 57675) implementing section 
4062 of PL 100-203 and sections 4152 and 4153 of PL 101-508. That rule 
established fee schedules and payment methodologies that govern 
payments for six categories of durable medical equipment and orthotic 
and prosthetic devices. If changes are warranted based on our 
evaluation of comments, they will be incorporated in this final rule. 
It will also reflect statutory revisions mandated by OBRA '93.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Interim Final Rule              12/07/92                    57 FR 57675
Effective Date                  01/06/93                    57 FR 57675
Public Comment Period End       02/05/93                    57 FR 57675
Final Action                    03/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: William Long, Program Analyst, Division of Medical 
Services Payment, Department of Health and Human Services, Health Care 
Financing Administration, Room 1-H-5 ELR, 6325 Security Blvd., 
Baltimore, MD 21207, 410 966-5655

RIN: 0938-AD65
_______________________________________________________________________

1585. MEDICARE SECONDARY PAYER FOR DISABLED INDIVIDUALS (BPD-482-FC)

Legal Authority:  42 USC 1395y(b)

CFR Citation:  42 CFR 411

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            03/08/90                     55 FR 8491
NPRM Comment Period End         05/08/90                     55 FR 8491
Final Action                    01/00/95

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0938-AD73
_______________________________________________________________________

1586. MEDICARE COVERAGE OF HOME HEALTH SERVICES, MEDICARE CONDITIONS OF 
PARTICIPATION AND HOME HEALTH AIDE SUPERVISION (BPD-469-F)

Legal Authority:  42 USC 1395x(m); 42 USC 1395x(o); 42 USC 1395x(f); 42 
USC 1395x(n); 42 USC 1395f(dd)

CFR Citation:  42 CFR 409; 42 CFR 413; 42 CFR 418; 42 CFR 484

Legal Deadline: None

Abstract: These regulations establish home health aide supervision and 
duty requirements applicable to all home health agencies and hospices 
that provide home health aide services under the Medicare program. In 
addition, these regulations codify longstanding policies concerning the 
limitations and exclusions applicable to home health services covered 
under the Medicare program. The rule also clarifies policies concerning 
exclusions for drugs and biological and prosthetic devices.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            09/27/91                    56 FR 49154
NPRM Comment Period End         11/26/91                    56 FR 49154
Final Action                    11/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: John Thomas, Health Insurance Specialist, Div. of 
Provider Services Coverage Policy, Department of Health and Human 
Services, Health Care Financing Administration, Room 401 EHR, 6325 
Security Blvd., Baltimore, Md. 21207, 410 966-4623

RIN: 0938-AD78
_______________________________________________________________________

1587. APPEALS FOR ENROLLEES OF PREPAID HEALTH CARE PLANS (OMC-008-F)

Legal Authority:  42 USC 1395mm; 42 USC 1395l(a)(1)(A)

CFR Citation:  42 CFR 405; 42 CFR 417; 42 CFR 482

Legal Deadline: None

Abstract: This rule will amend or establish regulations relating to 
appeal rights and procedures for Medicare beneficiaries who are 
enrolled in health maintenance organizations (HMOs), competitive 
medical plans (CMPs), and health care prepayment plans (HCPPs). 
Specifically, the rule will extend to HMO and CMP members the right to 
request review by a PRO of early hospital discharges; impose a 60-day 
limit for HMOs and CMPs to process requests by beneficiaries for 
reconsideration of decisions on denied services or claims; and require 
HCPPs to establish appeal procedures for enrollees who are Medicare 
beneficiaries. These changes are aimed at improving efficiency and at 
providing beneficiaries equitable appeal rights, regardless of their 
enrollment status.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            10/07/92                    57 FR 46119
NPRM Comment Period End         12/07/92                    57 FR 46119
Final Action                    11/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Maureen Miller, Program Analyst, Office of Managed 
Care, Department of Health and Human Services, Health Care Financing 
Administration, Room 4360 Cohen Building, 330 Independence Ave. SW., 
Washington, DC 20201, 202 619-0129

RIN: 0938-AD79
_______________________________________________________________________

1588. OMNIBUS NURSING HOME REFORM REQUIREMENTS (BPD-488-FC)

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

Legal Deadline: None

Abstract: This rule will implement several provisions of OBRA '87 other 
than those implemented through the rules published on February 2, 1989, 
and September 26, 1991, governing long term care facility participation 
in the Medicare and Medicaid programs effective October 1, 1990, and 
State requirements for Federal financial participation. The provisions 
include Federal standards for evaluating State waivers of nursing 
facility nurse staffing requirements, use of physical and chemical 
restraints in nursing facilities, qualifications of nursing home 
administrators, notices of Medicaid rights to be given to persons 
admitted to nursing facilities, and other technical changes.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            02/05/92                     57 FR 4516
NPRM Comment Period End         04/06/92                     57 FR 4516
Final Rule With Comment Period  05/00/95

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Agency Contact: Bill Ullman, Health Insurance Specialist Long Term Care 
Branch, Department of Health and Human Services, Health Care Financing 
Administration, Room 401, EHR, 6325 Security Boulevard, Baltimore, 
Maryland 21207, 410 966-5667

RIN: 0938-AD81
_______________________________________________________________________

1589. SURVEY AND CERTIFICATION OF SKILLED NURSING FACILITIES AND NURSING 
FACILITIES AND ENFORCEMENT PROCEDURES (HSQ-156-F)

Regulatory Plan:  This entry is Seq. No. 55 in Part II of this issue of 
the Federal Register.

RIN: 0938-AD94
_______________________________________________________________________

1590. HMO ORGANIZATIONAL STRUCTURE AND SERVICES (OMC-007-F)

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

CFR Citation:  42 CFR 417.100; 42 CFR 417.101; 42 CFR 417.103; 42 CFR 
417.104; 42 CFR 417.107

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
NPRM Comment Period End         09/13/93                    58 FR 38170
Final Action                    06/00/95

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0938-AE25
_______________________________________________________________________

1591. ``CONFINED TO THE HOME'' REQUIREMENTS FOR HOME HEALTH SERVICES 
(BPD-626-F)

Legal Authority:  42 USC 1395f(a)(2)(C); 42 USC 1395n(a)(2)(A)

CFR Citation:  42 CFR 409.42

Legal Deadline: None

Abstract: This rule clarifies when a home health patient is considered 
``confined to the home'' in order to receive home health benefits.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            10/07/91                    56 FR 50542
NPRM Comment Period End         12/06/91
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: John Thomas, Health Insurance Specialist, Long Term 
Care Branch, Department of Health and Human Services, Health Care 
Financing Administration, Room 401 EHR, 6325 Security Blvd., Baltimore, 
MD 21207, 410 966-4623

RIN: 0938-AE34
_______________________________________________________________________

1592. SURVEY REQUIREMENTS AND ALTERNATIVE SANCTIONS FOR HOME HEALTH 
AGENCIES (HSQ-169-F)

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                    03/00/95

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Local, Federal

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

RIN: 0938-AE39
_______________________________________________________________________

1593. HOSPITAL STANDARD FOR HIV INFECTIOUS BLOOD (BPD-633-F)

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

CFR Citation:  42 CFR 482

Legal Deadline: None

Abstract: This final rule will require hospitals to notify either each 
recipient or each recipient's physician whenever potentially HIV 
infectious blood has been administered, and to provide each recipient 
with information to obtain testing and counseling. 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                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Joanne Sinsheimer, Chief, Long Term Care Branch, Div. 
of Provider Services Coverage Policy, Department of Health and Human 
Services, Health Care Financing Administration, Room 401 EHR, 6325 
Security Blvd, Baltimore, MD 21207, 410 966-4620

RIN: 0938-AE40
_______________________________________________________________________

1594. MEDICARE, MEDICAID, AND CLIA PROGRAMS: REGULATIONS IMPLEMENTING THE 
CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 (CLIA '88) (HSQ-202-F)

Regulatory Plan:  This entry is Seq. No. 56 in Part II of this issue of 
the Federal Register.

RIN: 0938-AE47
_______________________________________________________________________

1595. CONDITIONS OF COVERAGE FOR ORGAN PROCUREMENT ORGANIZATIONS (BPD-
646-FC)

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 sets forth changes to the conditions of 
coverage for organ procurement organizations (OPOs). It deals with the 
definition of an OPO service area, expansion of the qualifications for 
the Board of Directors, OPO assistance to be provided to hospitals in 
establishing and implementing protocols governing organ procurement 
activity, establishing criteria for allocating organs, and organ 
testing for AIDS.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Claude Mone, Health Insurance Specialist, Department of 
Health and Human Services, Health Care Financing Administration, 401, 
EHR, 6325 Security Boulevard, Baltimore, Maryland 21207, 410 966-5666

RIN: 0938-AE48
_______________________________________________________________________

1596. PREADMISSION SCREENING AND ANNUAL RESIDENT REVIEW (BPD-661-F)

Legal Authority:  42 USC 1395r

CFR Citation:  42 CFR 483

Legal Deadline:  NPRM, Statutory, March 19, 1990.

Abstract: The final rule with comment period published November 30, 
1992, (57 FR 56450) implemented sections 4211 of OBRA '87, section 6901 
of OBRA '89, and section 4801 of OBRA '90. The provisions included: (1) 
State requirements for preadmission screening and annual resident 
review of individuals with mental illness or mental retardation who are 
applicants to or residents of nursing facilities that are certified for 
Medicaid; and (2) appeals systems for persons who may be transferred or 
discharged from facilities or who wish to dispute a determination made 
in the preadmission screening and annual review process. The changes in 
this rule included OBRA '90 provisions defining ``severe mental 
illness'' and ``specialized services'' which will reduce State review 
workloads and clarify Medicaid matching payment for the States. 
Following analysis of the public comments, we may issue a final 
rulemaking document.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            03/23/90                    55 FR 10951
NPRM Comment Period End         05/22/90                    55 FR 10951
Final Rule With Comment Period  11/30/92                    57 FR 56450
Public Comment Period End       01/29/93                    57 FR 56450
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Jan Earle, Program Analyst, Medicaid Bureau, Department 
of Health and Human Services, Health Care Financing Administration, 
Room 401, EHR, 6325 Security Boulevard, Baltimore, Maryland 21207, 410 
966-0103

RIN: 0938-AE49
_______________________________________________________________________

1597. EXTENDED MEDICAID ELIGIBILITY FOR CERTAIN INDIVIDUALS (MB-026-F)

Legal Authority:  42 USC 1396r-6; 42 USC 1396r(b)

CFR Citation:  42 CFR 435; 42 CFR 436; 42 CFR 440; 42 CFR 447

Legal Deadline: None

Abstract: This regulation will revise current regulations to reflect 
that participants in work supplement programs are deemed to be AFDC 
recipients under the State plan and make Medicaid eligibility mandatory 
for those individuals; to provide extended Medicaid benefits to certain 
families when they become ineligible for AFDC solely because of 
increased earnings from, or hours of, employment; and to revise certain 
conditions of eligibility that minor parents and pregnant minors must 
meet before receiving Medicaid benefits.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/14/93                    58 FR 65312
NPRM Comment Period End         02/11/94                    58 FR 65312
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: State, Federal

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

RIN: 0938-AE51
_______________________________________________________________________

1598. RESIDENT ASSESSMENT IN LONG-TERM CARE FACILITIES (HSQ-180-F)

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

CFR Citation:  42 CFR 483

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

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/28/92                    57 FR 61614
NPRM Comment Period End         02/26/93                    57 FR 61614
Final Action                    06/00/95

Small Entities Affected: Businesses

Government Levels Affected: State

Agency Contact: Sue Nonemaker, Program Analyst, Division of Long Term 
Care, Department of Health and Human Services, Health Care Financing 
Administration, 2-D-2, ME, 6325 Security Boulevard, Baltimore, Maryland 
21207, 410 966-6825

RIN: 0938-AE61
_______________________________________________________________________

1599. POST-CONTRACT BENEFICIARY PROTECTIONS AND OTHER PROVISIONS (OMC-
003-F)

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                    08/00/95

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, Room 
4360 Cohen Building, 330 Independence Ave. SW., Washington, DC 20201, 
202 619-2158

RIN: 0938-AE63
_______________________________________________________________________

1600. CONFORMING PROVISIONS FOR 1988 HMO AMENDMENTS (OMC-004-F)

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 employee health plan 
contributions.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            07/05/91                    56 FR 30723
Public Comment Period End       09/03/91                    56 FR 30723
Final Action                    04/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Marty Abeln, Office of Managed Care, Department of 
Health and Human Services, Health Care Financing Administration, Room 
4360, Cohen Building, 330 Independence Ave. SW., Washington, DC 20201, 
202 205-9582

RIN: 0938-AE64
_______________________________________________________________________

1601. EARLY AND PERIODIC SCREENING, DIAGNOSTIC, AND TREATMENT (EPSDT) 
SERVICES (MB-28-F)

Regulatory Plan:  This entry is Seq. No. 57 in Part II of this issue of 
the Federal Register.

RIN: 0938-AE72
_______________________________________________________________________

1602. PAYMENT FOR NURSING AND ALLIED HEALTH SCIENCE EDUCATION (BPD-685-F)

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.
Section 6205(b)(2) of PL 101-239 required that a proposed rule be 
published before July 1, 1990 and that a final rule not be effective 
before 10/01/90.

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 PL 101-239. 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 PL 101-508, which provides that, effective with cost reporting 
periods beginning on or after October 1, 1990, under certain 
conditions, costs incurred by a hospital or educational institution 
related to the hospital for clinical training are treated as pass-
through costs and paid on the basis of reasonable cost even though the 
hospital does not operate the education programs.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            09/22/92                    57 FR 43659
NPRM Comment Period End         11/23/92                    57 FR 43659
Final Action                    07/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Nancy Edwards, Chief, Payment Limitations and 
Exclusions Branch, Department of Health and Human Services, Health Care 
Financing Administration, 1-H-1 ELR, 6325 Security Blvd., Baltimore, 
Maryland 21207, 410 966-4531

RIN: 0938-AE79
_______________________________________________________________________

1603. UNIFORM ELECTRONIC COST REPORTING SYSTEM FOR HOSPITALS (BPD-689-F)

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

CFR Citation:  42 CFR 413.20; 42 CFR 413.24; 42 CFR 413.40; 42 CFR 
412.52

Legal Deadline: None

Abstract: This rule will implement section 1886(f)(1)(B) of the Social 
Security Act, which requires the Secretary to place into effect a 
standardized electronic cost reporting format and allows the Secretary 
to waive the requirement where such implementation would result in a 
financial hardship for a hospital. Under this rule, all hospitals are 
required to submit their cost reports, for hospital cost reporting 
periods beginning on or after October 1, 1989, in a uniform electronic 
format.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Federal

Agency Contact: William Goeller, Director, Division of Payment and 
Reporting Policy, Department of Health and Human Services, Health Care 
Financing Administration, Room 1-F-5, ELR, 6325 Security Blvd., 
Baltimore, MD 21207, 410 966-4513

RIN: 0938-AE80
_______________________________________________________________________

1604. MEDICARE COVERAGE OF PRESCRIPTION DRUGS USED IN IMMUNOSUPPRESSIVE 
THERAPY (BPD-424-F)

Legal Authority:  42 USC 1395x(s)(2)(J)

CFR Citation:  42 CFR 410

Legal Deadline: None

Abstract: This final rule amends the regulations to reflect section 
9335(c) of OBRA '86 and section 4075 of OBRA '87. These statutory 
provisions provide Medicare coverage for prescription drugs used in 
immunosuppressive therapy furnished to an individual who receives an 
organ transplant for which Medicare payment is made for a period of one 
year after the transplant procedure. The final rule will also reflect 
statutory revisions mandated by OBRA 1993.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            01/19/88                     53 FR 1383
NPRM Comment Period End         03/21/88                     53 FR 1383
Final Action                    10/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Walter Rutemueller, Chief, Special Coverage Issues 
Branch, Department of Health and Human Services, Health Care Financing 
Administration, Room 401, EHR, 6325 Security Blvd., Baltimore, MD 
21207, 410 966-5395

RIN: 0938-AE94
_______________________________________________________________________

1605. FIRE SAFETY STANDARDS FOR HOSPITALS, LONG-TERM CARE FACILITIES, AND 
INTERMEDIATE CARE FACILITIES FOR THE MENTALLY RETARDED (BPD-650-F)

Legal Authority:  42 USC 1395x; 42 USC 1396d

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

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Joanne Sinsheimer, Chief, Long Term Care Branch, Div. 
of Provider Services Coverage Policy, Department of Health and Human 
Services, Health Care Financing Administration, Room 401, EHR, 6325 
Security Blvd., Baltimore, MD 21207, 410 966-4620

RIN: 0938-AE97
_______________________________________________________________________

1606. COVERAGE OF SCREENING PAP SMEARS (BPD-705-F)

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

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

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            11/26/93                    58 FR 62312
NPRM Comment Period End         01/24/94                    58 FR 62312
Final Action                    07/00/95

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: William Larson, Program Analyst, Medical Services 
Branch, Department of Health and Human Services, Health Care Financing 
Administration, Room 401, EHR, 6325 Security Blvd., Baltimore, MD 
21207, 410 966-4639

RIN: 0938-AE98
_______________________________________________________________________

1607. MEDICARE COVERAGE OF CLINICAL PSYCHOLOGIST, OTHER PSYCHOLOGIST, AND 
CLINICAL SOCIAL WORKER SERVICES--MEDICARE (BPD-706-F)

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                    08/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Regina Walker, Program Analyst, Office of Coverage & 
Eligibility Policy, Department of Health and Human Services, Health 
Care Financing Administration, Room 401, EHR, 6325 Security Blvd., 
Baltimore, MD 21207, 410 966-6735

RIN: 0938-AE99
_______________________________________________________________________

1608. ALLOWING CERTIFICATIONS AND RECERTIFICATIONS BY NURSE PRACTITIONERS 
AND CLINICAL NURSE SPECIALISTS FOR CERTAIN SERVICES (BPD-709-F)

Legal Authority:  42 USC 1395f(a)

CFR Citation:  42 CFR 424

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            06/28/91                    56 FR 29609
NPRM Comment Period End         08/27/91                    56 FR 29609
Final Action                    12/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Joanne Sinsheimer, Chief, Long Term Care Branch, Div. 
of Provider Services Coverage Policy, Department of Health and Human 
Services, Health Care Financing Administration, Room 401 EHR, 6325 
Security Blvd., Baltimore, MD 21207, 410 966-4620

RIN: 0938-AF01
_______________________________________________________________________

1609. CHANGES TO THE LONG-TERM CARE FACILITY SURVEY PROCESS (HSQ-175-FC)

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

_________________________________________________________________________

Final Rule With Comment Period  00/00/00

Small Entities Affected: None

Government Levels Affected: State, Local, Federal

Additional Information: 
TIMETABLE: Pending court ruling.

Agency Contact: Pam Vocke, Director, Division of Program Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, 2-D-2, ME, 6325 Security Blvd., Baltimore, MD 21207, 
410 966-7089

RIN: 0938-AF02
_______________________________________________________________________

1610. CASE MANAGEMENT (MB-27-F)

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 would 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                    06/00/95

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Local

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

RIN: 0938-AF07
_______________________________________________________________________

1611. MEDICAID THIRD PARTY LIABILITY: COST EFFECTIVENESS WAIVERS (MB-39-
F)

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

CFR Citation:  42 CFR 433.138; 42 CFR 433.139

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: State

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

RIN: 0938-AF11
_______________________________________________________________________

1612. REQUIRED COVERAGE OF NURSE PRACTITIONER SERVICES--MEDICAID (MB-41-
F)

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

CFR Citation:  42 CFR 440

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/23/91                    56 FR 66392
NPRM Comment Period End         02/22/92                    56 FR 66392
Final Action                    01/00/95

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0938-AF12
_______________________________________________________________________

1613. PAYMENT FOR FEDERALLY QUALIFIED HEALTH CENTER (FQHC) SERVICES (BPD-
728-F)

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

CFR Citation:  42 CFR 405; 42 CFR 491

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Effective Date                  06/12/92                    57 FR 24961
Final Rule with Comment Period  06/12/92                    57 FR 24961
Public Comment Period End       08/11/92                    57 FR 24961
Final Action                    12/00/94

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Jackie Sheridan, Chief, Health Organizations Branch, 
Department of Health and Human Services, Health Care Financing 
Administration, Room 441, EHR, 6325 Security Blvd., Baltimore, MD 
21207, 410 966-4635

RIN: 0938-AF14
_______________________________________________________________________

1614. OBRA '90 AND MISCELLANEOUS MANAGED CARE TECHNICAL AMENDMENTS (OMC-
018-FC)

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

CFR Citation:  42 CFR 434.21 to 44; 42 CFR 447.361; 42 CFR 447.362

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: Businesses, Organizations

Government Levels Affected: State, Local

Agency Contact: Jane McClard, Office of Managed Care, Department of 
Health and Human Services, Health Care Financing Administration, Room 
233, ELR, 6325 Security Blvd., Baltimore, MD 21207, 410 966-5321

RIN: 0938-AF15
_______________________________________________________________________

1615. CRITERIA FOR THE DETERMINATION OF REASONABLE COSTS FOR MEDICARE --
CONTRACTING PREPAID HEALTH PLANS (OMC-006-F)

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 remove the absolute payment limit that is to 
be applied to Prepaid Health Organizations with cost contracts under 
section 1876 of the Social Security Act. This regulation will also set 
forth the revised criteria that HCFA will use in determining claimed 
costs that are reasonable and therefore reimbursable for prepaid health 
organizations with cost contracts under section 1876 and agreements 
under section 1833.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            02/22/94                     59 FR 8435
NPRM Comment Period End         04/25/94                     59 FR 8435
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: A. G. D'Alberto, Office of Managed Care, Department of 
Health and Human Services, Health Care Financing Administration, 1-G-2 
Oak Meadows, 6325 Security Boulevard, Baltimore, Maryland 21207, 410 
966-7610

RIN: 0938-AF16
_______________________________________________________________________

1616. PHYSICIAN OWNERSHIP OF AND REFERRALS TO HEALTH CARE FACILITIES THAT 
FURNISH CLINICAL LABORATORY SERVICES AND FINANCIAL RELATIONSHIP REPORTING 
REQUIREMENTS (BPD-674-FC)

Regulatory Plan:  This entry is Seq. No. 58 in Part II of this issue of 
the Federal Register.

RIN: 0938-AF40
_______________________________________________________________________

1617. MEDICAID PAYMENT FOR COVERED OUTPATIENT DRUGS UNDER REBATE 
AGREEMENTS (MB-046-IFC)

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

CFR Citation:  42 CFR 447

Legal Deadline: None

Abstract: This rule will incorporate section 4401 of OBRA '90 which 
concern reimbursement for prescribed drugs. Section 4401 amended title 
XIX of the Social Security Act to add specific requirements for payment 
for covered outpatient drugs. In general, 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.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Interim Final Rule              12/00/94

Small Entities Affected: Businesses

Government Levels Affected: State

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

RIN: 0938-AF42
_______________________________________________________________________

1618. MEDICARE AND MEDICAID PROGRAMS; ADVANCE DIRECTIVES (BPD-718-F)

Legal Authority:  42 USC 1395cc

CFR Citation:  42 CFR 417.436; 42 CFR 417.801; 42 CFR 431.20; 42 CFR 
431.107; 42 CFR 434.28; 42 CFR 483.10; 42 CFR 484.10; 42 CFR 489.10; 42 
CFR 489.100; 42 CFR 489.104; 42 CFR 498.3; 42 CFR 417.472; 42 CFR 
489.102

Legal Deadline: None

Abstract: The final rules will make minor changes in the interim rule, 
which implemented statutory provisions effective in December, 1991. 
They will amend the Medicare and Medicaid regulations governing 
provider agreements and contracts to establish requirements for States, 
hospitals, nursing facilities, skilled nursing facilities, providers of 
home health care or personal care services, hospice programs and 
prepaid health plans concerning advance directives. An advance 
directive is a written instruction, such as a living will or durable 
power of attorney for health care, recognized under State law, relating 
to the provision of health care when an individual's condition makes 
him or her unable to express his or her wishes. The intent of these 
provisions is to enhance an individual's control over medical treatment 
decisions. These rules implement sections 4206 and 4751 of OBRA '90.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Interim Final Rule With Comment 
Period                          03/06/92                     57 FR 8194
Public Comment Period End       05/05/92                     57 FR 8194
Final Action                    04/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jacqueline Sheridan, Chief, Health Organizations 
Branch, Department of Health and Human Services, Health Care Financing 
Administration, Room 401, EHR, 6325 Security Boulevard, Baltimore, 
Maryland 21207, 410 966-4635

RIN: 0938-AF50
_______________________________________________________________________

1619. PARTIAL HOSPITALIZATION SERVICES IN COMMUNITY MENTAL HEALTH CENTERS 
(BPD-736-F)

Legal Authority:  42 USC 1395k(a)(2)(J); 42 USC 1395x(ff)(3); 42 USC 
1395cc(e)(2)

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

Legal Deadline: None

Abstract: In accordance with section 4162 of OBRA '90, this interim 
final rule sets forth the coverage criteria and payment methodology for 
partial hospitalization services furnished in community mental health 
centers. It also specifies the requirements a community mental health 
center must meet in order to enter into a Medicare provider agreement 
to furnish partial hospitalization services.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Interim Final Rule              02/11/94                     59 FR 6570
Interim Final Rule Effective    03/13/94                     59 FR 6570
Comment Period End              04/12/94                     59 FR 6570
Final Action                    08/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jackie Sheridan, Chief, Health Organizations Branch, 
Department of Health and Human Services, Health Care Financing 
Administration, Room 401, EHR, 6325 Security Boulevard, Baltimore, 
Maryland 21207, 410 966-4635

RIN: 0938-AF53
_______________________________________________________________________

1620. REQUIREMENTS FOR ENROLLMENT OF MEDICAID RECIPIENTS UNDER COST 
EFFECTIVE EMPLOYER BASED GROUP HEALTH PLANS (MB-047-F)

Legal Authority:  42 USC 1396a(a)(10); 42 USC 1396a(u)(l); 42 USC 
1396d(a); 42 USC 1396a(a)(25); 42 USC 1396a(e); 42 USC 1396e

CFR Citation:  42 CFR 435.2; 42 CFR 435.3; 42 CFR 435.10; 42 CFR 
435.186; 42 CFR 435.188

Legal Deadline: None

Abstract: This rule will amend our regulations to provide for 
continuation of payment of health insurance premiums for individuals 
who are entitled to elect COBRA continuation coverage under a group 
health plan provided by an employer with 75 or more employees; require 
Medicaid recipients to apply for enrollment in employer-based cost 
effective group health plans as a condition of Medicaid eligibility; 
require State agencies to pay for premiums, deductibles, coinsurances 
and other cost sharing obligations under employer-based cost effective 
group health plans, and define ``COBRA continuation coverage'' and 
``COBRA beneficiaries.''

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            06/20/94                    59 FR 31569
NPRM Comment Period End         08/19/94                    59 FR 31569
Final Action                    00/00/00

Small Entities Affected: Businesses, Organizations

Government Levels Affected: State, Federal

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

RIN: 0938-AF64
_______________________________________________________________________

1621. REFERRAL TO CHILD SUPPORT ENFORCEMENT AGENCIES OF MEDICAID FAMILIES 
WITH AN ABSENT PARENT (MB-051-F)

Legal Authority:  42 USC 1396k

CFR Citation:  42 CFR 433.160

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                    06/00/95

Small Entities Affected: None

Government Levels Affected: None

Additional Information: MB-041-F will incorporate response to public 
comments made on 0938-AF65, MB-048-F.

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

RIN: 0938-AF68
_______________________________________________________________________

1622. MEDICAID: OUTSTATIONED INTAKE LOCATIONS FOR CERTAIN LOW-INCOME 
PREGNANT WOMEN, INFANTS AND CHILDREN (MB-052-IFC)

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

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 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
Comment Period End              11/22/94                    59 FR 48805
Effective Date                  11/24/94                    59 FR 48805
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: State, Local

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

RIN: 0938-AF69
_______________________________________________________________________

1623. OPTIONAL SPENDDOWN (MB-055-IFC)

Legal Authority:  42 USC 1396b(f)(2); 42 USC 1396a(a)(17)

CFR Citation:  42 CFR 435; 42 CFR 436

Legal Deadline: None

Abstract: This rule would allow States to choose the option of a 
variation of the spenddown for medically needy individuals. Under the 
regular spenddown program a medically needy individual becomes eligible 
for Medicaid by spending down income in excess of the medically needy 
income standard until the standard is reached. Under the optional 
program, an applicant could choose to pay an amount equal to their 
excess income to the State instead of becoming eligible only after 
incurring expenses. This option was provided by section 4723 of OBRA 
'90.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Interim Final Rule With Comment 
Period                          00/00/00

Small Entities Affected: None

Government Levels Affected: State, Local

Additional Information: TIMETABLE: Pending consultation with outside 
organizations.

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

RIN: 0938-AF72
_______________________________________________________________________

1624. MEDICARE AND MEDICAID PROGRAMS: REQUIREMENTS FOR PHYSICIAN 
INCENTIVE PLANS IN PREPAID HEALTH CARE ORGANIZATIONS (OMC-010-F)

Regulatory Plan:  This entry is Seq. No. 59 in Part II of this issue of 
the Federal Register.

RIN: 0938-AF74
_______________________________________________________________________

1625. NATIONAL COVERAGE DECISIONS: RULES FOR RISK CONTRACTING HMOS AND 
CMPS (OMC-019-F)

Legal Authority:  42 USC 1395mm(c)(2)

CFR Citation:  42 CFR 417

Legal Deadline: None

Abstract: Under this rule, Health Maintenance Organizations (HMOs) and 
Competitive Medical Plans (CMPs) that have entered into risk contracts 
with HCFA will be protected against large unanticipated cost increases 
that will result from having to furnish a new or increased Medicare 
benefit established by a national coverage decision. When the Secretary 
estimates that the new or increased benefit will result in a 
significant change in the HMO's or CMP's costs, the organization will 
not be required to furnish the service to its Medicare enrollees until 
the cost has been taken into account in determining the monthly per 
capita amounts that HCFA pays the HMO or CMP. This rule would implement 
section 4204(c) of OBRA '90.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            02/22/94                     59 FR 8429
Public Comment Period End       04/25/94                     59 FR 8429
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0938-AF76
_______________________________________________________________________

1626. PART B ADVANCE PAYMENTS TO PHYSICIANS/SUPPLIERS OR OTHER ENTITIES 
FURNISHING ITEMS OR SERVICES UNDER MEDICARE PART B (BPO-105-F)

Legal Authority:  42 USC 1395u(c)

CFR Citation:  42 CFR 421.212

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Samuel Guida, Director, Division of Account Management 
& Collection, Department of Health and Human Services, Health Care 
Financing Administration, Room 1-E-6, ME Building, 6325 Security 
Boulevard, Baltimore, Maryland 21207, 410 966-7495

RIN: 0938-AF85
_______________________________________________________________________

1627. APPLICATION OF INTEREST CHARGES TO MEDICARE SECONDARY PAYER 
RECOVERIES (BPO-108-GN)

Legal Authority:  31 USC 3711; 31 USC 3717

CFR Citation:  42 CFR 401.601; 42 CFR 405.376; 45 CFR 30.16; 45 CFR 
30.13

Legal Deadline: None

Abstract: This notice announces that HCFA is proceeding under its 
authority to charge interest on secondary payer payments overdue to 
HCFA. Experience has shown that parties owing monies to HCFA are not 
motivated to make timely payments and require followup efforts to 
collect the payments. The existing regulation at 42 CFR 401.607, which 
authorizes claims collection (including interest), and other 
authorities are being invoked to stimulate prompt payment.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Notice                          04/00/95

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: John Albert, Program Analyst, Div. of Entitlement & 
Benefit Coordination, Department of Health and Human Services, Health 
Care Financing Administration, Room 3-E-5 ME Building, 6325 Security 
Boulevard, Baltimore, Maryland 21207, 410 966-7457

RIN: 0938-AF87
_______________________________________________________________________

1628. RETROACTIVE ENROLLMENT (OMC-015-F)

Legal Authority:  42 USC 1395mm

CFR Citation:  42 CFR 417

Legal Deadline: None

Abstract: This regulation will allow retroactive enrollment of up to 90 
days for individuals enrolling with an eligible organization (which has 
a risk-sharing contract under section 1876 of the Social Security Act) 
under a health benefit plan operated, sponsored, or contributed to, by 
the individual's employer or former employer (or the employer or former 
employer of the individual's spouse). The regulation implements section 
4204(e) of the Omnibus Budget Reconciliation Act of 1990, PL 101-508. 
In addition, the rule will permit the Secretary to authorize 
retroactive disenrollment in specific cases.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/27/93                    58 FR 68366
Public Comment Period End       02/25/94                    58 FR 68366
Final Action                    07/00/95

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0938-AF98
_______________________________________________________________________

1629. PAYMENT FOR PREADMISSION SERVICES (BPD-731-F)

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

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

Legal Deadline: None

Abstract: This rule implements 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. Included are services (other than ambulance 
services) by a hospital (or by an entity wholly owned or operated by 
the hospital) to the patient during the three days immediately 
preceding the date of the patient's admission if the services are 
diagnostic services (including clinical diagnostic laboratory tests), 
or are other services related to the admission (as defined by the 
Secretary).

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
Public Comment Period End       03/14/94                     59 FR 1654
Final Action                    00/00/00

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Bill Ullman, Health Insurance Specialist Div. of 
Provider Services Coverage Policy, Department of Health and Human 
Services, Health Care Financing Administration, 401 East High Rise 
Building, 6325 Security Boulevard, Baltimore, MD 21207, 410 966-5667

RIN: 0938-AG00
_______________________________________________________________________

1630. CHANGE IN PROVIDER AGREEMENT REGULATIONS RELATED TO FEDERAL 
EMPLOYEE HEALTH BENEFITS (BPD-748-F)

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 enrolled in a Federal Employee 
Health Benefits (FEHB) plan but who are not entitled to receive 
hospital benefits under Medicare Part A (Hospital Insurance) may not 
exceed the hospital payments established for Medicare purposes for 
inpatient hospital services. The rule will also amend current Medicare 
regulations to authorize HCFA to consider termination or nonrenewal of 
a hospital's Medicare provider agreement for knowingly and willfully 
failing to accept, on a repeated basis, the Medicare rate as payment in 
full from an FEHB plan. This rule will implement section 7002(f) of 
OBRA '90, enacted November 5, 1990.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Jackie Sheridan, Chief, Health Organizations Branch, 
Department of Health and Human Services, Health Care Financing 
Administration, 401 EHR, 6325 Security Boulevard, Baltimore, MD 21207, 
410 966-4635

RIN: 0938-AG03
_______________________________________________________________________

1631. PAYMENT FOR EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY SERVICES 
FURNISHED BY AMBULATORY SURGICAL CENTERS (BPD-762-FN)

Legal Authority:  42 USC 1395l(i)(2)

CFR Citation:  42 CFR 416.120; 42 CFR 416.125; 42 CFR 416.130

Legal Deadline: None

Abstract: This notice complies with the court order by the U.S. 
District Court for the District of Columbia on March 12, 1992, in The 
American Lithotripsy Society v. Louis W. Sullivan, M.D. The court order 
stays implementation of the Medicare payment rate announced on December 
31, 1991 (56 FR 67666) for Extracorporeal Shock Wave Lithotripsy 
Services furnished in Medicare Participating Ambulatory Surgical 
Centers and use of the payment rate in determining the Medicare 
allowance in hospital out-patient departments until the Secretary 
publishes certain information relevant to the setting of the 
Extracorporeal Shock Wave Lithotripsy Rate, receives comments, and 
publishes a final notice.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Proposed Notice                 10/01/93                    58 FR 51355
Public Comment Period End       12/30/93                     58 FR 6128
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Joan H. Sanow, Health Insurance Specialist, Division of 
Special Payment Programs, Department of Health and Human Services, 
Health Care Financing Administration, Room 1-A-5, ELR, 6325 Security 
Boulevard, Baltimore, MD 21207-5187, 410 966-5723

RIN: 0938-AG04
_______________________________________________________________________

1632. INTERMEDIARY AND CARRIER FUNCTIONS (BPO-111-N)

Legal Authority:  42 USC 1395h; 42 USC 1395u

CFR Citation:  42 CFR 421.100; 42 CFR 421.200

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Alan Bromberg, Program Analyst, Div. of Contractor 
Planning & Managemt, BPO, Department of Health and Human Services, 
Health Care Financing Administration, 3-F-1 ME Building, 6325 Security 
Boulevard, Baltimore, MD 21207, 410 966-7441

RIN: 0938-AG06
_______________________________________________________________________

1633. REVISED MEDICAID MANAGEMENT INFORMATION SYSTEMS (MB-38-FN)

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. (Systems concepts without prescribing a particular 
system design or solution.)

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Proposed Notice                 11/22/93                    58 FR 61692
Public Comment Period End       01/21/94                    58 FR 61692
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Richard Friedman, Director, Division of Payment 
Systems, Medicaid Bureau, Department of Health and Human Services, 
Health Care Financing Administration, Room 273, ELR, 6325 Security 
Boulevard, Baltimore, MD 21207, 410 966-3292

RIN: 0938-AG10
_______________________________________________________________________

1634. REVISIONS TO THE DEFINITION OF END-STAGE RENAL DISEASE AND 
RESUMPTION OF ENTITLEMENT (BPD-738-F)

Legal Authority:  42 USC 426-1

CFR Citation:  42 CFR 406.13

Legal Deadline: None

Abstract: This rule revises the definition of end-stage renal disease 
to clarify that only those individuals whose kidneys have failed and 
for whom the disease is expected to be a life-long affliction are 
eligible for Medicare and end-stage renal disease benefits. This rule 
also specifies that Medicare enrollment resumes for individuals who 
again begin a regular course of renal dialysis treatments after a 
previous course is terminated (with or without kidney transplant) and 
include the same considerations for those who have a second transplant.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            01/06/94                      59 FR 714
NPRM Comment Period End         03/07/94                      59 FR 714
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Paul Olenick, Director, Division of Medicare 
Eligibility Policy, BPD, Department of Health and Human Services, 
Health Care Financing Administration, Room 401, EHR Building, 6325 
Security Boulevard, Baltimore, Maryland 21207, 410 966-4472

RIN: 0938-AG19
_______________________________________________________________________

1635. 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)

Legal Authority:  42 USC 1395rr

CFR Citation:  42 CFR 405.2140; 42 CFR 405.2150

Legal Deadline: None

Abstract: This rule incorporates by reference, in our regulations, the 
Association for the Advancement of Medical Instrumentation (AAMI) 
guidelines for monitoring the quality of water used in dialysis as 
published in ``Hemodialyzers System, Second Edition.'' It also updates 
an existing incorporation by reference to reflect the 1992 edition AAMI 
voluntary guidelines and standards on ``Recommended Practice for Reuse 
of Hemodialyzers.'' These guidelines clarify certain issues and reflect 
current medically acceptable dialysis standards and techniques.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            02/14/94                     59 FR 6937
NPRM Comment Period End         04/15/94                     59 FR 6937
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jackie Sheridan, Chief, Health Organizations Branch, 
BPD, Department of Health and Human Services, Health Care Financing 
Administration, Room 401, EHR Building, 6325 Security Boulevard, 
Baltimore, Maryland 21207, 410 966-4635

RIN: 0938-AG21
_______________________________________________________________________

1636. MEDICARE PROGRAM: PROPOSED ADDITIONS TO AND DELETIONS FROM THE 
CURRENT LIST OF COVERED SURGICAL PROCEDURES FOR AMBULATORY SURGICAL 
CENTERS (BPD-776-FN)

Legal Authority:  42 USC 1395i(1)

CFR Citation:  None

Legal Deadline: None

Abstract: This notice implements sections 1833(i)(l) of the Social 
Security Act, which requires, in part, that the list of covered 
ambulatory surgical center (ASC) procedures be reviewed and updated at 
least every 2 years. The last update was published December 31, 1991. 
This notice announces specific proposed additions to, and deletions 
from, the list of surgical procedures for which facility services are 
covered when the procedures are performed in a Medicare participating 
ASC. The notice also announces changes to our criteria for deleting 
procedures from the ASC list. Additionally, it announces the assignment 
of payment groups for each addition. Finally, it reflects statutory 
revisions mandated by OBRA '93.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Proposed Notice                 12/14/93                    58 FR 65357
Public Comment Period End       02/14/94                    58 FR 65357
Final Action                    01/00/95

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Jacqueline Sheridan, Chief, Health Organizations 
Branch, BPD, Department of Health and Human Services, Health Care 
Financing Administration, 6325 Security Boulevard, Baltimore, Maryland 
21207, 410 966-4635

RIN: 0938-AG27
_______________________________________________________________________

1637. MEDICARE PROGRAM: SPECIAL PAYMENT LIMITS FOR HOME BLOOD GLUCOSE 
MONITORS (BPD-778-FN)

Legal Authority:  42 USC 1395l; 42 USC 1395u(b)

CFR Citation:  None

Legal Deadline: None

Abstract: This notice establishes special payment limits for standard 
home blood glucose monitors, identified as code EO607 of the HCFA 
common procedure coding system. The notice is intended to prevent 
excessive payment for these items.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Proposed Notice                 01/06/94                      59 FR 755
Comment Period End              03/07/94                      59 FR 755
Final Action                    02/00/95

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Joel Kaiser, Health Insurance Specialist, Medical 
Services Payment Branch, BPD, Department of Health and Human Services, 
Health Care Financing Administration, Room 1-H-5, ELR, 6325 Security 
Boulevard, Baltimore, Maryland 21207, 410 966-4499

RIN: 0938-AG28
_______________________________________________________________________

1638. GENERAL EVALUATION CRITERIA AND STANDARDS FOR EVALUATING 
PERFORMANCE OF CONTRACT (HSQ-207-GNC)

Legal Authority:  42 USC 1320c-2(h)(2)

CFR Citation:  42 CFR 462

Legal Deadline: None

Abstract: The notice provides general criteria and standards that will 
be used to evaluate the effective and efficient performance of 
Utilization 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      02/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Nancy Lafferty, Program Analyst, Department of Health 
and Human Services, Health Care Financing Administration, Room 2-D-2, 
Meadows East Building, 6325 Security Boulevard, Baltimore, Maryland 
21207, 410 966-6783

RIN: 0938-AG32
_______________________________________________________________________

1639. WITHDRAWAL OF COVERAGE OF DIAGNOSTIC NOCTURNAL PENILE TUMESCENCE 
TESTING (IMPOTENCE TESTING) (BPD-780-FN)

Legal Authority:  42 USC 1395y

CFR Citation:  None

Legal Deadline: None

Abstract: This notice announces the Medicare program's intent to 
withdraw coverage for diagnostic nocturnal tumescence (NPT) testing in 
the sleep disorder clinic and to exclude coverage for nocturnal penile 
tumescence testing by plethysmography and other monitoring devices in 
all settings. Public Health Service studies show that NPT testing is 
not a reliable index for evaluating impotence. Therefore, it does not 
meet HCFA's criteria for effectiveness.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Proposed Notice                 01/04/94                      59 FR 308
Public Comment Period End       03/07/94                      59 FR 309
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Maxine Hormats, Special Coverage Issues Branch, 
Department of Health and Human Services, Health Care Financing 
Administration, Room 401, EHR Building, 6325 Security Boulevard, 
Baltimore, Maryland 21207, 410 966-4630

RIN: 0938-AG43
_______________________________________________________________________

1640. MEDICARE PROGRAM: LIMITATIONS ON MEDICARE COVERAGE OF INTERMITTENT 
POSITIVE PRESSURE BREATHING MACHINE THERAPY (BPD-781-FN)

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

CFR Citation:  None

Legal Deadline: None

Abstract: Intermittent positive pressure breathing (IPPB) machine 
therapy is currently covered under Medicare as durable medical 
equipment for patients whose ability to breathe is severally impaired. 
Based on a Public Health Service recommendation, we propose to place 
limitations on Medicare coverage of IPPB machine therapy.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Proposed Notice                 06/29/94                    59 FR 33520
Comment Period End              08/29/94                    59 FR 33520
Final Action                    00/00/00

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Walter Rutenmueller, Chief, Special Coverage Issues 
Branch, Department of Health and Human Services, Health Care Financing 
Administration, Room 401, EHR Building, 6325 Security Boulevard, 
Baltimore, Maryland 21207, 410 966-5395

RIN: 0938-AG44
_______________________________________________________________________

1641. NONCOVERAGE OF ELECTROSTIMULATION OF SALIVARY GLANDS FOR THE 
TREATMENT OF XEROSTOMIA (DRY MOUTH) (BPD-782-FN)

Legal Authority:  42 USC 1395y

CFR Citation:  None

Legal Deadline: None

Abstract: This notice announces the Medicare program's intent to 
exclude from coverage electrostimulation of the salivary glands in the 
treatment of xerostomia secondary to Sjogren's Syndrome. Public Health 
Service (PHS) studies show that there is insufficient data to establish 
the clinical utility of electrostimulation to evaluate its long-term 
effectiveness, or to identify those xerostomia patients who would 
benefit from this procedure. Also, PHS reports that electrostimulation 
is not widely accepted as a treatment for xerostomia secondary to 
Sjogren's Syndrome.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Proposed Notice                 05/23/94                    59 FR 26653
Comment Period End              07/22/94                    59 FR 26653
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Francina Spencer, Special Coverage Issues Branch, 
Department of Health and Human Services, Health Care Financing 
Administration, Room 401, EHR Building, 6325 Security Boulevard, 
Baltimore, Maryland 21207, 410 966-4614

RIN: 0938-AG45
_______________________________________________________________________

1642. PART A PREMIUM FOR 1995 FOR THE UNINSURED AGED AND FOR CERTAIN 
DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER ENTITLEMENT (OACT-046-N)

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

CFR Citation:  None

Legal Deadline:  Other, Statutory, September 30, 1994.
Other deadline is for publication of Notice.

Abstract: This notice announces the hospital insurance premium for 
calendar year 1995 under Medicare's hospital insurance program (Part A) 
for the uninsured aged and for certain disabled individuals who have 
exhausted other entitlement. The uninsured aged are those individuals 
who are not insured under the Social Security or Railroad Retirement 
Acts and do not otherwise meet the requirements for entitlement to 
Medicare Part A. The disabled beneficiaries are those who lose monthly 
Social Security cash payments because they returned to work even though 
their disability continues. Section 1818(d) of the Social Security Act 
specifies the method to be used to determine this amount.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Notice                          10/00/94

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, 1705 Whitehead Building, 6325 Security 
Boulevard, Baltimore, Maryland 21207, 410 966-6389

RIN: 0938-AG49
_______________________________________________________________________

1643. MEDICARE PROGRAM: MONTHLY ACTUARIAL RATES AND MONTHLY SUPPLEMENTARY 
MEDICAL INSURANCE PREMIUM RATES BEGINNING JANUARY 1, 1995 (OACT-047-N)

Legal Authority:  42 USC 1395r

CFR Citation:  None

Legal Deadline:  Other, Statutory, September 30, 1994.
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, 1995. It also announces the monthly SMI premium 
rate to be paid by all enrollees during the 12 months beginning January 
1, 1995.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Notice                          10/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Carter Warfield, Director, Division of Supplementary 
Medical Insurance, Department of Health and Human Services, Health Care 
Financing Administration, Room M-1, 1705 Whitehead Bulding, 6325 
Security Boulevard, Baltimore, Maryland 21207, 410 966-6396

RIN: 0938-AG50
_______________________________________________________________________

1644. INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED CARE 
SERVICES COINSURANCE AMOUNTS FOR 1995 (OACT-048-N)

Legal Authority:  42 USC 1395e

CFR Citation:  None

Legal Deadline:  Other, Statutory, September 15, 1994.
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 1995 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                          10/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: John Wandishin, Director, Division of Hospital 
Insurance, Department of Health and Human Services, Health Care 
Financing Administration, Room M-l, 1705 Whitehead Building, 6325 
Security Boulevard, Baltimore, Maryland 21207, 410 966-6389

RIN: 0938-AG51
_______________________________________________________________________

1645. REVISIONS TO GEOGRAPHIC PRACTICE COST INDICES, PAYMENT POLICIES AND 
ADJUSTMENTS TO THE RELATIVE VALUE UNITS UNDER THE PHYSICIAN FEE SCHEDULE 
FOR CY 1995 (BPD-789-FC)

Regulatory Plan:  This entry is Seq. No. 60 in Part II of this issue of 
the Federal Register.

RIN: 0938-AG52
_______________________________________________________________________

1646. REDUCTIONS IN PAYMENTS FOR HHA SERVICES (BPD-793-NC)

Legal Authority:  42 USC 1302; 42 USC 1395x(r)(1); 42 USC 1395hh; PL 
103-66, Sec 13564

CFR Citation:  42 CFR None

Legal Deadline: None

Abstract: This notice in accordance with PL 103-66, provides that there 
be no changes in home health services cost limits for cost reporting 
periods beginning on or after July 1, 1994 and before July 1, 1996. 
This notice also requires the Secretary, when granting or extending 
exceptions to cost limits, to limit any exception to the amount that 
would have been granted if there were no restrictions on changes in the 
cost limits.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Notice With Comment Period      11/00/94

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Robert Kuhl, Division of Payment and Reporting Policy, 
Department of Health and Human Services, Health Care Financing 
Administration, Room 1-F-5, ELR, 6325 Security Boulevard, Baltimore, 
Maryland 21207, 410 966-4597

RIN: 0938-AG54
_______________________________________________________________________

1647. DATE FOR FILING MEDICARE COST REPORTS (BPD-794-F)

Legal Authority:  42 USC 1395g

CFR Citation:  42 CFR 405.376; 42 CFR 413.24

Legal Deadline: None

Abstract: This rule will extend the time frame providers have to file 
cost reports from no later than 3 months after the close of the period 
covered by the report to no later than 5 months after the close of that 
period. This change is necessary to ensure that providers have an 
adequate amount of time to file complete and accurate cost reports. We 
would define what HCFA considers to be an ``acceptable'' cost report 
submission.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            05/25/94                    59 FR 26998
Public Comment Period End       07/25/94                    59 FR 26998
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Katie Walker, Payment Policy Branch, Department of 
Health and Human Services, Health Care Financing Administration, Room 
1-F-5, ELR, 6325 Security Boulevard, Baltimore, Maryland 21207, 410 
966-7278

RIN: 0938-AG55
_______________________________________________________________________

1648. FREEDOM OF CHOICE WAIVER; CONFORMING CHANGES (OMC-021-F)

Legal Authority:  42 USC 1302

CFR Citation:  42 CFR 431.55; 42 CFR 431.57

Legal Deadline: None

Abstract: This rule amends existing Medicaid regulations on freedom of 
choice waivers granted under section 1915(b) of the Social Security Act 
(Act) to conform them to the amendments made to the Act by sections 
4604 and 4742 of OBRA '90.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Interim Final Rule With Public 
Comment Period End              02/01/94                     59 FR 4597
Effective Date                  03/03/94                     59 FR 4597
Comment Period End              04/04/94                     59 FR 4597
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: State

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

RIN: 0938-AG63
_______________________________________________________________________

1649. PAYMENT TO SWING BED HOSPITALS (BPD-805-FC)

Legal Authority:  42 USC 1395tt

CFR Citation:  42 CFR 413.53; 42 CFR 413.114

Legal Deadline: None

Abstract: This final rule with comment period would implement section 
4008(j) of PL 101-508 by setting forth a new methodology for payment of 
routine extended care services provided in a swing bed hospital. 
Medicare payment for such services is determined 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. These rates will be determined 
prospectively based on the most recent SNF cost reporting data 
available. In accordance with PL 101-508, this rule also provides 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.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Rule With Comment Period  05/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Katie Walker, Director, Division of Payment and 
Reporting Policy, Department of Health and Human Services, Health Care 
Financing Administration, Room 1-F-5, ELR, 6325 Security Boulevard, 
Baltimore, Maryland 21207, 410 966-7278

RIN: 0938-AG68
_______________________________________________________________________

1650. PHYSICIAN PERFORMANCE STANDARD RATES OF INCREASE FOR FY 1995 AND 
PHYSICIAN FEE SCHEDULE UPDATE FOR CY 1995 (BPD-807-FNC)

Legal Authority:  42 USC 1302; 42 USC 1395w-4; 42 USC 1395hh

CFR Citation:  None

Legal Deadline:  Final, Statutory, October 31, 1994.

Abstract: This notice announces the calendar year (CY) 1995 updates to 
the Medicare physician fee schedule and the Federal fiscal year (FY) 
1995 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), 
respectively, of the Social Security Act.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Notice With Comment Period10/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Bernard Patashnik, Director, Division of Medical 
Services Payment, Department of Health and Human Services, Health Care 
Financing Administration, Room 1-H-5, ELR, 6325 Security Boulevard, 
Baltimore, Maryland 21207, 410 966-4497

RIN: 0938-AG69
_______________________________________________________________________

1651. CATEGORIZATION OF CLIA TESTS AND PERSONNEL MODIFICATIONS (HSQ-216-
FC)

Legal Authority:  42 USC 263a; 42 USC 1302; 42 USC 1395

CFR Citation:  42 CFR 493.2; 42 CFR 493.3; 42 CFR 493.5; 42 CFR 493.7; 
42 CFR 493.9; 42 CFR 493.17; 42 CFR 493.18; 42 CFR 493.19; 42 CFR 
493.20; 42 CFR 493.21; 42 CFR 493.25; 42 CFR 493.35; 42 CFR 493.37; 42 
CFR 493.39; 42 CFR 493.43; ...

Legal Deadline: None

Abstract: This final rule with comment period responds to comments 
received concerning two previously published rules (57 FR 7002 and 58 
FR 5215) for implementing CLIA. In this rule, we expand personnel 
requirements so that more people are qualified to perform high 
complexity tests and physician performed (now called provider-
performed) microscopy procedures and to supervise high complexity 
testing.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Rule With Comment Period  10/00/94

Small Entities Affected: Businesses

Government Levels Affected: State

Agency Contact: Judith Yost, Chief Laboratory & Home Health Services 
Branch, HSQB, Department of Health and Human Services, Health Care 
Financing Administration, Room 1-C-2 MWE, 6325 Security Boulevard, 
Baltimore, Maryland 21207, 410 597-5907

RIN: 0938-AG71
_______________________________________________________________________

1652. MEDICAID PROGRAM: NURSE-MIDWIFE SERVICES (MB-085-P)

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 36479
NPRM Comment Period End         09/16/94                    59 FR 36479
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0938-AG73
_______________________________________________________________________

1653. MEDICAID PROGRAM: FEES FOR VACCINE ADMINISTRATION UNDER PEDIATRIC 
IMMUNIZATION PROGRAM (MB-084-NC)

Regulatory Plan:  This entry is Seq. No. 61 in Part II of this issue of 
the Federal Register.

RIN: 0938-AG77
_______________________________________________________________________

1654.  CRITERIA FOR MEDICARE COVERAGE OF LUNG TRANSPLANTS (BPD-
812-NC)

Legal Authority:  42 USC 1395y

CFR Citation:  None

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Notice With Comment Period      10/00/94

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0938-AG83
_______________________________________________________________________

1655.  INFORMATION, COUNSELING, AND ASSISTANCE GRANTS PROGRAMS: 
MEDICARE PROGRAM (OBS-001-FC)

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 403

Legal Deadline: None

Abstract: This rule establishes, for fiscal years 1994 and beyond, a 
minimum level of funding for grants made to States to provide Medicare 
beneficiaries with information, counseling, and assistance related to 
obtaining adequate and appropriate health insurance coverage. It also 
establishes in regulations the condition for eligibility for these 
grants, limitations on the use of grant funds in certain circumstances, 
and annual reporting requirements. This grant program is in accordance 
with OBRA '90.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Effective Date                  10/07/94
Final Rule With Comment Period  10/07/94                    59 FR 51125
Comment Period End              12/06/94
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Eric Lang, Health Insurance Specialist, Office of 
Beneficiary Services, Department of Health and Human Services, Health 
Care Financing Administration, Room 600, EHR, 6325 Security Boulevard, 
Baltimore, Maryland 21207, 410 966-3193

RIN: 0938-AG91
_______________________________________________________________________

1656.  QUALIFIED HEALTH MAINTENANCE ORGANIZATIONS: TECHNICAL 
AMENDMENTS (OMC-009-FC)

Legal Authority:  42 USC 1302; 42 USC 1395hh; 42 USC 300e; 42 USC 300e-
5; 42 USC 300e-9; 31 USC 9701

CFR Citation:  42 CFR 417

Legal Deadline: None

Abstract: This rule clarifies and updates portions of the HCFA 
regulations that pertain to Federal qualification of health maintenance 
organizations (HMOs), continued regulation of qualified HMOs, inclusion 
of qualified HMOs in employee health benefits plans offered by 
employers, and administration of outstanding loans and loan guarantees 
that were awarded before October 1, l986, under the Public Health 
Service Act.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Rule With Comment Period  10/03/94                    59 FR 49834
Effective Date                  10/31/94                    59 FR 49834
Comment Period End              11/29/94                    59 FR 49834
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Tracy Jensen, Health Insurance Specialist, Office of 
Managed Care, Department of Health and Human Services, Health Care 
Financing Administration, Room 4360, Cohen Building, 200 Independence 
Avenue SW., Washington, DC 20201, 202 619-2158

RIN: 0938-AG92
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
  
1657. MEDICAID ELIGIBILITY AND COVERAGE REQUIREMENTS (MB-001-F)

CFR Citation:  42 CFR 435; 42 CFR 436

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    08/22/94                    59 FR 43050
Final Action Effective          08/18/94

Small Entities Affected: None

Government Levels Affected: State, Local

Agency Contact: Marinos Svolos, 410 966-4451

RIN: 0938-AA58
_______________________________________________________________________

1658. DEDUCTION OF INCURRED MEDICAL EXPENSES (SPENDDOWN) (MB-020-F)

CFR Citation:  42 CFR 435.732; 42 CFR 435.831; 42 CFR 436.831

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn No further action 
needed.                         07/26/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Marinos Svolos, 410 966-4451

RIN: 0938-AB07
_______________________________________________________________________

1659. HOME AND COMMUNITY-BASED SERVICES FOR THE ELDERLY (MB-019-F)

CFR Citation:  42 CFR 435.3; 42 CFR 435.217; 42 CFR 435.726; 42 CFR 
435.735; 42 CFR 436.2; 42 CFR 436.217; 42 CFR 440.250; 42 CFR 441.10; 
42 CFR 441.350 to 441.357; 42 CFR 441.360; 42 CFR 441.365; 42 CFR 
400.203; 42 CFR 440.1; 42 CFR 440.181

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn                       07/26/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Robert Wardwell, 410 966-5659

RIN: 0938-AD55
_______________________________________________________________________

1660. PAYMENT ADJUSTMENTS FOR HOSPITALS THAT SERVE A DISPROPORTIONATE 
NUMBER OF LOW-INCOME PATIENTS (MB-017-IFC)

CFR Citation:  42 CFR 412; 42 CFR 440; 42 CFR 447

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn                       07/26/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Bernard Truffer, 410 966-1357

RIN: 0938-AE35
_______________________________________________________________________

1661. UTILIZATION AND QUALITY CONTROL PEER REVIEW ORGANIZATIONS (PRO): 
CONFIDENTIAL INFORMATION (HSQ-190-P)

CFR Citation:  42 CFR 476

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    07/18/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Harvey Brook, 410 966-6853

RIN: 0938-AF03
_______________________________________________________________________

1662. DAY HABILITATION AND RELATED SERVICES (MB-37-P)

CFR Citation:  42 CFR 440

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn - Combined with 0938-
AF89 (MB-076-P)                 04/01/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Robert Wardwell, 410 966-5659

RIN: 0938-AF10
_______________________________________________________________________

1663. MEDICARE COVERAGE OF SCREENING MAMMOGRAPHY (BPD-724-F)

CFR Citation:  42 CFR 405.534; 42 CFR 405.535; 42 CFR 410.1; 42 CFR 
410.10; 42 CFR 411.15; 42 CFR 413.123; 42 CFR 494.50

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    09/30/94                    59 FR 49826
Final Action Effective          10/01/94                    59 FR 49826

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: William Larson, 410 966-4639

RIN: 0938-AF26
_______________________________________________________________________

1664. MEDICARE, MEDICAID, AND CLIA PROGRAMS: INSPECTION AND CERTIFICATION 
PROCEDURES FOR LABORATORIES (HSQ-193-P)

CFR Citation:  42 CFR 493

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn by HCFA - no further 
action anticipated              09/19/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Pam Vocke, 410 966-7089

RIN: 0938-AF33
_______________________________________________________________________

1665. MEDICAID DRUG USE REVIEW PROGRAM AND ELECTRONIC CLAIMS MANAGEMENT 
SYSTEM FOR OUTPATIENT DRUG CLAIMS (MB-050-F)

CFR Citation:  42 CFR 456

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    09/23/94                    59 FR 48811
Final Action Effective          10/24/94                    59 FR 48811

Small Entities Affected: Businesses

Government Levels Affected: State

Agency Contact: Al Beachley, 410 966-3325

RIN: 0938-AF67
_______________________________________________________________________

1666. INTERMEDIARY AND CARRIER CHECKS THAT ARE LOST, STOLEN, DEFACED, 
MUTILATED, DESTROYED, OR PAID ON FORGED ENDORSEMENTS (BPO-114-FC)

CFR Citation:  42 CFR 424.350; 42 CFR 424.352; 42 CFR 424.354

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    07/26/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Samuel Guida, 410 966-7495

RIN: 0938-AG16
_______________________________________________________________________

1667. CHANGES IN PHYSICIAN ATTESTATION REQUIREMENTS (BPD-769-F)

CFR Citation:  42 CFR 412.46(c)

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    05/09/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jackie Sheridan, 410 966-4635

RIN: 0938-AG34
_______________________________________________________________________

1668. MEDICARE PROGRAM: CHANGES TO THE INPATIENT HOSPITAL PROSPECTIVE 
PAYMENT SYSTEMS AND FISCAL YEAR 1995 RATES (BPD-802-F)

CFR Citation:  42 CFR 412; 42 CFR 413

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    09/01/94                    59 FR 45330
Final Action Effective          10/01/94                    59 FR 45330

Small Entities Affected: Businesses, Organizations

Government Levels Affected: State, Federal

Agency Contact: Lana Price, 410 966-4529

RIN: 0938-AG46
_______________________________________________________________________

1669. REDUCTIONS IN PAYMENTS FOR SNF SERVICES (BPD-795-NC)

CFR Citation:  42 CFR 413.30

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn by HCFA - no further 
action necessary.               09/01/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Robert Kuhl, 410 966-4597

RIN: 0938-AG56
_______________________________________________________________________

1670. LIMITATIONS ON REVISIONS TO FINAL ADMINISTRATIVE COST PROPOSALS 
(BPO-122-P)

CFR Citation:  42 CFR 421.10

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn                       06/30/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Don Posen, 410 966-7533

RIN: 0938-AG57
_______________________________________________________________________

1671. REQUIRED LABORATORY PROCEDURES FOR RURAL HEALTH CLINICS (BPD-783-F)

CFR Citation:  42 CFR 491.9

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn                       04/21/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jacqueline Sheridan, 410 966-4635

RIN: 0938-AG62
_______________________________________________________________________

1672. SELF-IMPLEMENTING COVERAGE AND PAYMENT PROVISIONS: 1993 LEGISLATION 
(BPD-791-F)

CFR Citation:  42 CFR 405.2137; 42 CFR 405.2163; 42 CFR 405.2401; 42 
CFR 406.32; 42 CFR 408.20; 42 CFR 410.10; 42 CFR 410.52; 42 CFR 410.60; 
42 CFR 413.157; 42 CFR 413.124; 42 CFR 413.130; 42 CFR 418.306

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

No comments received on 05/25/94 
rule; no action necessary.      10/06/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Matt Plonski, 410 966-4662

RIN: 0938-AG64
_______________________________________________________________________

1673. FINAL LIMITATIONS ON AGGREGATE PAYMENTS TO DISPROPORTIONATE SHARE 
HOSPITALS: FEDERAL FISCAL YEAR 1994 (MB-088-N)

CFR Citation:  42 CFR 447.297; 42 CFR 447.298

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    05/02/94

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State

Agency Contact: Richard Strauss, 410 966-2019

RIN: 0938-AG74
_______________________________________________________________________

1674. SMALL BUSINESS INNOVATION RESEARCH GRANTS FOR FY 95 (ORD-068-N)

CFR Citation:  None

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Notice                    10/03/94                    59 FR 50246

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Carl Hackerman, 410 966-6644

RIN: 0938-AG76
_______________________________________________________________________

1675.  MEDICARE AND MEDICAID PROGRAMS; MEDICARE-MEDICAID COVERAGE 
DATA BANK REQUIREMENTS: PRELIMINARY GUIDANCE (BPO-125-N)

Legal Authority:  42 USC 1320b-14

CFR Citation:  None

Legal Deadline: None

Abstract: This notice informs the public about section 1144 of the 
Social Security Act, which is self-implementing, and provides 
preliminary guidance to employers who are required to report 
information about all individuals covered by group health plans to a 
newly established Medicare-Medicaid Coverage Data Bank. Information in 
the data bank will be used to help identify situations where employer 
group health plans are responsible for making primary payments for 
services received by Medicare or Medicaid beneficiaries. This notice 
provides: information on the background and legislative authority for 
the data bank; definitions of key terms; reporting requirements; the 
identity of entities that are required to, or may, report; reporting 
dates; penalties for noncompliance; and methods of reporting.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Action                    05/10/94                    59 FR 24167

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Tribal, Federal

Agency Contact: William Zavoina, Department of Health and Human 
Services, Health Care Financing Administration, Bureau of Program 
Operations, 1445 Meadows East Bldg., Baltimore, MD 21207, 410 966-7461

RIN: 0938-AG78

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
 
Administration for Children and Families (ACF)
  
_______________________________________________________________________
  
1676. FOSTER CARE, ADOPTION ASSISTANCE, AND CHILD WELFARE SERVICES

Legal Authority:  42 USC 627

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

Legal Deadline: None

Abstract: This NPRM will propose criteria the Department will use to 
verify that a State has met statutory requirements and is eligible to 
receive additional funds under section 427 of the Social Security Act. 
The proposed rule will contain the specific criteria by which State 
performance in meeting the requirements of section 427 is determined, 
the percentage levels and other standards for case record compliance, 
and procedures for conducting compliance reviews.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            06/00/95

Small Entities Affected: None

Government Levels Affected: State

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

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

RIN: 0970-AA97
_______________________________________________________________________

1677. AMENDMENTS TO DEVELOPMENTAL DISABILITIES RULES

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.

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            01/00/95

Small Entities Affected: None

Government Levels Affected: State

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

Agency Contact: John Doyle, Director, Administration and Planning 
Staff, Administration on Developmental Disabilities, Department of 
Health and Human Services, Administration for Children and Families, 
200 Independence Avenue, SW., Room 315D, Washington, DC 20201, 202 690-
5504

RIN: 0970-AB11
_______________________________________________________________________

1678. STANDARDS FOR SAFE TRANSPORTATION

Legal Authority:  42 USC 9801 et seq

CFR Citation:  45 CFR 1310

Legal Deadline: None

Abstract: The NPRM will propose Head Start Performance Standards for 
the safe transportation of Head Start children, including vehicle 
requirements, driver qualifications and training and safety rules for 
children and staff while enroute and loading and unloading of vehicles.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            01/00/95

Small Entities Affected: Organizations

Government Levels Affected: None

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start Bureau, Department of Health and Human Services, Administration 
for Children and Families, P.O. Box 1182, Washington, DC 20013, 202 
205-8569

RIN: 0970-AB24
_______________________________________________________________________

1679. TITLE IV-E TRAINING

Legal Authority:  42 USC 674

CFR Citation:  45 CFR 235; 45 CFR 1356.60

Legal Deadline: None

Abstract: Section 474 of the Social Security Act authorizes Federal 
matching for training personnel employed or preparing for employment by 
the State or local child welfare agency at 75 percent instead of 50 
percent as for other administrative costs. This NPRM will clarify what 
is included in the higher reimbursement rate.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            01/00/95

Small Entities Affected: Undetermined

Government Levels Affected: State

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

RIN: 0970-AB25
_______________________________________________________________________

1680. STANDARDS FOR PURCHASE OF FACILITIES

Legal Authority:  42 USC 9801 et seq

CFR Citation:  45 CFR 1309

Legal Deadline: None

Abstract: This regulation will propose standards for the purchase of 
facilities as required by the Head Start Improvement Act of 1992.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            10/00/94

Small Entities Affected: Organizations

Government Levels Affected: None

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start Bureau, Department of Health and Human Services, Administration 
for Children and Families, P.O. Box 1182, Washington, DC 20013, 202 
205-8569

RIN: 0970-AB31
_______________________________________________________________________

1681. NATIONAL VOTER REGISTRATION ACT OF 1993 PROVISIONS AFFECTING PUBLIC 
ASSISTANCE AGENCIES

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                            10/00/94

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, 202 
401-9289

RIN: 0970-AB32
_______________________________________________________________________

1682. FAMILY PRESERVATION AND SUPPORT

Legal Authority:  42 USC 430 to 435

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

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            10/04/94                    59 FR 50646
NPRM Comment Period End         12/05/94

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 1187, Washington, DC 
20013, 202 205-8618

RIN: 0970-AB34
_______________________________________________________________________

1683. NOTICE OF PROPOSED RULEMAKING FOR THE ADMINISTRATION OF NATIVE 
AMERICANS 45 CFR PART 1336

Legal Authority:  42 USC 2991

CFR Citation:  45 CFR 1336

Legal Deadline: None

Abstract: The regulations propose to amend 45 CFR part 1336 to 
implement new legislative requirements. It will incorporate an appeals 
procedure affording applicants the opportunity to appeal based on 
organizational ineligibility or activities deemed ineligible, when 
determined by the ANA Commissioner. Native American organizations are 
expected to welcome these changes which provide for an appeal of 
appeals decisions and comport with recent amendments to the statute.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            03/00/95
Final Action                    03/00/96

Small Entities Affected: Organizations

Government Levels Affected: None

Agency Contact: Sharon McCully, Director, Planning and Support, 
Department of Health and Human Services, Administration for Children 
and Families, 200 Independence Ave SW., Washington, DC 20201, 020 690-
5780

RIN: 0970-AB37
_______________________________________________________________________

1684. INTERSTATE CASE CLOSURE

Legal Authority:  42 USC 1102

CFR Citation:  45 CFR 303

Legal Deadline: None

Abstract: This regulation proposes to make critical changes to aid 
States in converting their caseloads to automated systems by 1995. Its 
scope is limited to interstate case closure issues, and should provide 
helpful guidance to States in eliminating from their caseloads cases 
which can no longer be worked. States have been requesting such 
criteria for the past several years. The intent of this regulation is 
to lessen State burdens, rather than to create new ones. This measure 
would complement welfare reform efforts by helping States to streamline 
their caseloads as they move to automated systems, thus preparing them 
for changes in the welfare system.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: State, Local, Federal

Agency Contact: Susan Notar, Program Specialist, Office of Child 
Support Enforcement, Department of Health and Human Services, 
Administration for Children and Families, 370 L'Enfant Promenade SW., 
Washington, DC 20447, 202 401-4606

RIN: 0970-AB41
_______________________________________________________________________

1685. DIRECT PAYMENTS TO INDIAN TRIBES AND TRIBAL ORGANIZATIONS UNDER 
TITLE IV-B, SUBPART 1

Legal Authority:  42 USC 628

CFR Citation:  45 CFR 1357.40

Legal Deadline: None

Abstract: This NPRM will propose to amend the regulations governing 
direct payments to Indian Tribes and Indian Tribal Organizations (ITOs) 
for child welfare services under title IV-B, subpart 1. It will 
eliminate the requirement that to be eligible, Indian Tribes and ITOs 
must provide services under contract (or grant) with the Secretary of 
the Interior under section 102 of the Indian Self-Determination Act. It 
will also add a description of the formula used to calculate the amount 
of Federal funds available to eligible Tribes and ITOs under title IV-
B, subpart 1.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            10/00/94

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State, Tribal

Agency Contact: Michael Ambrose, Director, Division of Child Welfare, 
Children's Bureau, ACYF, Department of Health and Human Services, 
Administration for Children and Families, P.O. Box 1182, Washington, DC 
20013, 202 205-8618

RIN: 0970-AB44
_______________________________________________________________________

1686. REPATRIATION - ADVANCE APPROVAL OF COSTS

Legal Authority:  42 USC 1313

CFR Citation:  45 CFR 212

Legal Deadline: None

Abstract: This document proposes to amend the regulations concerning 
the U.S. Repatriate Program. The proposal is to require agencies 
providing assistance to groups of United States citizens who are 
returned from foreign countries to the United States by the Department 
of State due to war, threat of war, civil disorder, or natural disaster 
to request advance approval from the Administration of Children and 
Families to incur expenses for planning receptions for such groups, for 
implementing such plans. This action is necessary in order for the 
Department to control the limited funding available for such 
activities.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            08/19/94                    59 FR 42795
NPRM Comment Period End         10/18/94
Final Action                    08/00/95

Small Entities Affected: None

Government Levels Affected: Undetermined

Agency Contact: David B. Smith, Director, Division of State 
Legalization and, Repatriation, Department of Health and Human 
Services, Administration for Children and Families, 370 L'Enfant 
Promenade SW., Washington, DC 20447, 202 401-9255

RIN: 0970-AB45
_______________________________________________________________________

1687.  REDUCTION OF REPORTING REQUIREMENTS FOR THE STATE SYSTEMS 
ADVANCE PLANNING DOCUMENT (APD) PROCESS

Legal Authority:  42 USC 1302

CFR Citation:  45 CFR 95.600

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            01/00/95

Small Entities Affected: Undetermined

Government Levels Affected: None

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

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

RIN: 0970-AB46
_______________________________________________________________________

1688.  BLOCK GRANT PROGRAMS (LOW INCOME HOME ENERGY ASSISTANCE 
PROGRAM --LIHEAP)--FY 1995 AND FY 1996 PROVISIONS

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: -- Inclusion of new Assurance 16, to require grantees 
to submit as a part of their annual application a description of their 
annual application a description of their ``self-sufficiency'' 
activities and to submit a report to DHHS on the effect of these 
activities; -- Inclusion of allowable uses of DOE rules for 
weatherization services provided with LIHEAP funds; -- 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: -- Consideration of different 
weighting of factors under the allocation formula for the leveraging 
incentive program; -- Hearing requirements for adult disallowances; -- 
Allotments for territories; and, -- Standards for reviewing grantee 
interpretations of -- statutory requirements.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/00/94

Small Entities Affected: None

Government Levels Affected: State, Tribal

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

RIN: 0970-AB47
_______________________________________________________________________

1689.  AUTOMOBILE RESOURCE LIMIT

Regulatory Plan:  This entry is Seq. No. 62 in Part II of this issue of 
the Federal Register.

RIN: 0970-AB48
_______________________________________________________________________

1690.  ADMINISTRATIVE FLEXIBILITY RULE

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 earnings.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            01/00/95

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Mack Storrs, Director, Division of AFDC Program, 
Department of Health and Human Services, Administration for Children 
and Families, 370 L'Enfant Promenade SW., Washington, DC 20447, 202 
401-9289

RIN: 0970-AB49
_______________________________________________________________________

1691.  HEAD START INITIATIVE ON FAMILIES WITH INFANTS AND 
TODDLERS

Regulatory Plan:  This entry is Seq. No. 63 in Part II of this issue of 
the Federal Register.

RIN: 0970-AB50
_______________________________________________________________________

1692.  FLEXIBILITY IN THE UTILIZATION OF INFORMATION OBTAINED 
THROUGH THE INCOME ELIGIBILITY VERIFICATION SYSTEM

Legal Authority:  42 USC 1302

CFR Citation:  45 CFR 205.55; 45 CFR 205.56; 45 CFR 205.60; 45 CFR 
205.62

Legal Deadline: None

Abstract: States will be given the flexibility to eliminate certain 
data matches and/or to selectively match only certain categories of 
recipients or applicants. In addition, States can also adjust the 
timeframes for follow-up of match ``hits''. States must demonstrate 
that their proposed changes will result in a more efficient and cost 
effective matching operation.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/00/94

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Mack Storrs, Director, Division of AFDC Program, 
Department of Health and Human Services, Administration for Children 
and Families, 370 L'Enfant Promenade SW., Washington, DC 20447, 202 
401-9289

RIN: 0970-AB51
_______________________________________________________________________

1693.  DESIGNATION OF ALTERNATIVE AGENCY TO SERVE INDIAN TRIBAL 
CHILDREN

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 serves the tribe is terminated.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            01/00/95

Small Entities Affected: Organizations

Government Levels Affected: Tribal

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start, Bureau, Department of Health and Human Services, Administration 
for Children and Families, P.O. Box 1182, 370 L'Enfant Promenade SW., 
Washington, DC 20013, 202 205-8569

RIN: 0970-AB52
_______________________________________________________________________

1694.  INCOME ELIGIBILITY CRITERIA FOR INDIAN TRIBES

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                            01/00/95

Small Entities Affected: Organizations

Government Levels Affected: Tribal

Agency Contact: Douglas Klafehan, Deputy Associate Commissioner, Heat 
Start, Bureau, Department of Health and Human Services, Administration 
for Children and Families, P.O. Box 1182, Washington, DC 20013, 202 
205-8569

RIN: 0970-AB53
_______________________________________________________________________

1695.  CONSTRUCTION OF HEAD START FACILITIES

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                            03/00/95

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: Local, Tribal

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start, Bureau, Department of Health and Human Services, Administration 
for Children and Families, P.O. Box 1182, Washington, DC 20013, 202 
205-8569

RIN: 0970-AB54
_______________________________________________________________________

1696.  QUALITY STANDARDS FOR HEAD START PROGRAMS

Legal Authority:  42 USC 9801

CFR Citation:  45 CFR 1301; 45 CFR 1304; 45 CFR 1309

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

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            05/00/95

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: Local, Tribal

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start Bureau, Department of Health and Human Services, Administration 
for Children and Families, P.O. Box 1182, Washington, DC 20013, 202 
205-8569

RIN: 0970-AB55
_______________________________________________________________________

1697.  HEAD START FELLOWSHIPS PROGRAM

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                            12/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start Bureau, Department of Health and Human Services, Administration 
for Children and Families, P.O. Box 1182, Washington, DC 20013, 202 
205-8569

RIN: 0970-AB56
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Administration for Children and Families (ACF)
  
_______________________________________________________________________
  
1698. AID TO FAMILIES WITH DEPENDENT CHILDREN PROGRAM; EXTENSION OF 
MEDICAID ELIGIBILITY WHEN SUPPORT COLLECTIONS RESULT IN TERMINATION OF 
AFDC ELIGIBILITY

Legal Authority:  42 USC 606; 42 USC 1302; PL 98-378, Sec 20; PL 100-
485, Sec 303(e)

CFR Citation:  42 CFR 435; 42 CFR 436; 45 CFR 233

Legal Deadline: None

Abstract: This final rule, which implements section 20 of the Child 
Support Enforcement Amendments of 1984 (Pub. L. 98-378), specifies that 
in any case where the collection or increased collection of support 
under title IV-D of the Social Security Act contributes in whole or 
part to a family's ineligibility for AFDC, the family is deemed, but 
only for the purpose of Medicaid eligibility, to be receiving AFDC for 
a period of four calendar months after the last month of AFDC 
eligibility. This applies only to families who receive AFDC in three of 
the six months immediately preceding the month of ineligibility. 
``Received'' includes those individuals denied an AFDC payment solely 
because of a payment under $10, the recoupment of an overpayment, or 
because the payment is determined to be zero as a result of rounding.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            11/27/92                    57 FR 56294
Final Action                    12/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Mack A. Storrs, Director, Division of AFDC Program, 
Department of Health and Human Services, Administration for Children 
and Families, 370 L'Enfant Promenade SW., Washington, DC 20447, 202 
401-9289

RIN: 0970-AA07
_______________________________________________________________________

1699. BLOCK GRANT PROGRAMS (LOW-INCOME HOME ENERGY ASSISTANCE PROGRAM --
LIHEAP) FY 91 AND FY 92 PROVISIONS

Legal Authority:  42 USC 8621 et seq

CFR Citation:  45 CFR 96

Legal Deadline: None

Abstract: This final rule amends the Department's regulations governing 
the administration of block grant programs; this rule applies to the 
Low-Income Home Energy Assistance Program (LIHEAP). The rule revises 
provisions included in an interim final rule published 01/16/92, that 
amended the block grant regulations and implemented changes to the 
LIHEAP statute which were made by the Augustus F. Hawkins Human 
Services Reauthorization Act of 1990 (Pub. L. 101-501). These changes 
involve the Department's response to formal complaints, a reduction in 
the percent of LIHEAP funds that grantees may carry forward from one 
fiscal year to the next, waiver authority to increase the percent of 
LIHEAP funds that grantees may use for weatherization from 15% to 25%, 
a requirement for additional outreach and intake services under certain 
circumstances, and a new leveraging incentive program. This final rule 
also makes several related, largely technical amendments to the block 
grant regulations.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Interim Final Rule              01/16/92                     57 FR 1960
Final Action                    12/00/94

Small Entities Affected: None

Government Levels Affected: State

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

RIN: 0970-AB15
_______________________________________________________________________

1700. BLOCK GRANT PROGRAMS (LOW-INCOME HOME ENERGY ASSISTANCE PROGRAM--
LIHEAP)--FY 93 AND FY 94 PROVISIONS

Legal Authority:  42 USC 8621 et seq

CFR Citation:  45 CFR 96

Legal Deadline: None

Abstract: The final rule will amend the DHHS block grant regulations to 
implement changes to the Low Income Home Energy Assistance Program 
(LIHEAP) statute which were made by the Augustus F. Hawkins Services 
Reauthorization Act (HRSA) of 1990 (Pub. L. 101-501) and language in 
the fiscal year 1993 appropriations statute (Pub. L. 102-394) that will 
affect grantee administration of the LIHEAP program in fiscal years 
1993 and 1994. The major changes effective FY 93 and FY 94 is: -- 
Ending of authority to transfer LIHEAP funds to other block grant 
programs. This rule also contains proposed requirements for an 
application completion date in order for Indian tribes and tribal 
organizations to receive Community Service Block Grant program funds. 
The rule includes certain submission and completion dates for States 
applying for Community Services, Social Services and LIHEAP block grant 
funds to cover requirements under the Cash Management Improvement Act 
of 1990, P.L. 101-453. Finally, this final rule includes changes 
proposed

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            11/16/93                    58 FR 60498
Final Action                    12/00/94

Small Entities Affected: None

Government Levels Affected: State

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

RIN: 0970-AB16
_______________________________________________________________________

1701. FAMILY VIOLENCE PREVENTION AND SERVICES

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                    01/00/95

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Local

Agency Contact: Margaret Washnitzer, Director, Division of State 
Assistance, Office of Community Services, Department of Health and 
Human Services, Administration for Children and Families, 370 L'Enfant 
Promenade SW., Washington, DC 20447, 202 401-2333

RIN: 0970-AB18
_______________________________________________________________________

1702. CHILD ABUSE AND NEGLECT STATE GRANT PROGRAM

Legal Authority:  42 USC 5101

CFR Citation:  45 CFR 1340

Legal Deadline: None

Abstract: The primary purpose of this NPRM will be to propose revisions 
to 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                    03/00/95

Small Entities Affected: None

Government Levels Affected: State

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

RIN: 0970-AB23
_______________________________________________________________________

1703. STATE LEGALIZATION IMPACT ASSISTANCE GRANT

Legal Authority:  PL 99-603; PL 102-394

CFR Citation:  45 CFR 402

Legal Deadline: None

Abstract: This rule amends the SLIAG regulations to implement the 
amendment to IRCA that directs the Secretary to reallocate any SLIAG 
funds not expended by States by December 30, 1994 to States which had 
expended their entire allocations, based on each State's percentage 
share of total unreimbursed legalization alien costs in all States. The 
reallocated funds will be available until June 30, 1995.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            05/31/94                    59 FR 28038
Final Action                    12/00/94

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: David B. Smith, Director, Division of State 
Legalization and Repatriation, Department of Health and Human Services, 
Administration for Children and Families, 370 L'Enfant Promenade SW., 
Washington, DC 20447, 202 401-9255

RIN: 0970-AB28
_______________________________________________________________________

1704. CHILD CARE--REVISED REGULATIONS

Legal Authority:  42 USC 1302

CFR Citation:  Not yet determined

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                    12/00/94

Small Entities Affected: None

Government Levels Affected: Undetermined

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

RIN: 0970-AB33
_______________________________________________________________________

1705. STATEWIDE AUTOMATED CHILD WELFARE INFORMATION SYSTEM

Legal Authority:  PL 103-66

CFR Citation:  45 CFR 1355; 45 CFR 1356

Legal Deadline: None

Abstract: These interim final rules implement section 13713 of the 
Omnibus Budget Reconciliation Act of 1993, Public Law 103-66 signed by 
the President on August 10, 1993.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Interim Final Rule              12/22/93                    58 FR 87939
Final Action                    12/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Naomi B. Marr, Director, Office of Information Systems 
Mgmt, Department of Health and Human Services, Administration for 
Children and Families, 300 E Hubert Humphrey Building, 200 Independence 
Ave. SW., Washington, DC 20201, 202 401-6960

RIN: 0970-AB38
_______________________________________________________________________

1706. CHILD SUPPORT ENFORCEMENT PROGRAM: PATERNITY ESTABLISHMENT AND 
REVISION OF CHILD SUPPORT ENFORCEMENT PROGRAM AND AUDIT REGULATIONS

Legal Authority:  42 USC 663(h); 42 USC 604(d); 42 USC 652(a)(1); 42 
USC 652(a)(4)

CFR Citation:  45 CFR 301; 45 CFR 302; 45 CFR 303; 45 CFR 305

Legal Deadline:  Other, Statutory, October 1, 1993.
Statutory effective date; the law allows for a later effective date in 
States needing to enact State laws.

Abstract: This final rule contains provisions regarding both paternity 
establishment and the audit. The paternity establishment provisions 
which implement the requirements of section 13721 of the Omnibus Budget 
Reconciliation Act of 1993 (OBRA'93) require States to adopt a variety 
of procedures designed to streamline the paternity establishment 
process. These include the use of default orders, a presumption of 
paternity based on genetic test results, conditions for admission of 
genetic test results as evidence, and expedited decision-making process 
for paternity cases in which title IV-D services are being provided. In 
addition, this final regulation amends regulations governing the audit 
of State Child Support Enforcement (IV-D) programs and the imposition 
of financial penalties for failure to substantially comply with the 
requirements of title IV-D of the Act. This regulation specifies how 
audits will evaluate State compliance with the requirements set forth 
in title IV-D of the Act and Federal regulations, including 
requirements resulting from the Family Support Act

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            11/29/93                    58 FR 62599
Final Action                    10/00/94

Small Entities Affected: None

Government Levels Affected: State, Local, Federal

Additional Information: This regulation includes RIN 0970-AA74 which is 
hereby withdrawn.

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

RIN: 0970-AB40
_______________________________________________________________________

1707. REFUGEE RESETTLEMENT PROGRAM: MISCELLANEOUS CHANGES

Legal Authority:  8 USC 1522

CFR Citation:  45 CFR 400

Legal Deadline: None

Abstract: We are proposing to make miscellaneous changes to existing 
regulations at 45 CFR Part 400.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            08/12/94                    59 FR 41417
Interim Final Rule              08/00/95

Small Entities Affected: None

Government Levels Affected: State, Local

Agency Contact: Toyo A. Biddle, Deputy Director, Division of Policy 
Analysis, Department of Health and Human Services, Administration for 
Children and Families, 370 L'Enfant Promenade SW., Washington, D.D. 
20447, 202 401-9250

RIN: 0970-AB42
_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Administration for Children and Families (ACF)
  
_______________________________________________________________________
  
1708. REVISIONS OF CHILD SUPPORT ENFORCEMENT PROGRAM AND AUDIT 
REGULATIONS

CFR Citation:  45 CFR 301; 45 CFR 305

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn - Combined With RIN 
0970-AB40                       08/19/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Lourdes Henry, 202 401-5440

RIN: 0970-AA74
_______________________________________________________________________

1709. HEAD START PERFORMANCE STANDARDS FOR INFANTS, TODDLERS, AND 
PREGNANT WOMEN

CFR Citation:  45 CFR 1307

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn                       08/19/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Douglas Klafehn, 202 205-8569

RIN: 0970-AB04
_______________________________________________________________________

1710. TECHNICAL CHANGES TO THE AFDC PROGRAM AS REQUIRED BY OBRA 90

CFR Citation:  45 CFR 205; 45 CFR 233

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    05/19/94                    59 FR 26141

Small Entities Affected: None

Government Levels Affected: State, Local, Federal

Agency Contact: Mack A. Storrs, 202 401-9289

RIN: 0970-AB14
_______________________________________________________________________

1711. AUTOMATIC DATA PROCESSING EQUIPMENT AND SERVICES; CONDITIONS FOR 
FEDERAL FINANCIAL PARTICIPATION AND GENERAL ADMINISTRATION - PUBLIC 
ASSISTANCE PROGRAMS

CFR Citation:  45 CFR 95; 45 CFR 205

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    06/15/94                    59 FR 30707

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: William Davis, 202 401-6404

RIN: 0970-AB39

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
 
Administration on Aging (AOA)
  
_______________________________________________________________________
  
1712. 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

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

CFR Citation:  45 CFR 1321; 45 CFR 1324; 45 CFR 1326; 45 CFR 1327; 45 
CFR 1328

Legal Deadline:  NPRM, Statutory, April 1, 1993. Final, Statutory, June 
1, 1993.

Abstract: The Administration on Aging (AoA) is proposing to revise the 
current rules governing State agencies, area agencies on aging, Indian 
tribes, organizations serving older individuals who are Hawaiian 
Natives, and service providers providing services and advocating on 
behalf of older individuals who are eligible for supportive and 
nutrition services under the Older Americans Act of 1965, as amended.
The purpose of these revisions is to provide a structure for the 
operation of the Act's Title VII program for vulnerable elder rights 
protection activities under a new 45 CFR part 1327 of these 
regulations; establish competitive guidelines and procedures for the 
making of Title IV grants and contracts, under a new 45 CFR part 1324 
of these regulations; and clarify new program and policy directions in 
the development of intrastate funding formulas, as well as past 
omissions, under 45 CFR parts 1321, 1326, and 1328 of these current 
regulations. We believe that these additions and revisions will assist 
State agencies, area agencies on aging, Indian tribes, organizations 
serving older individuals who are Hawaiian Natives, and service (cont)

Timetable:

Balance of OAA Amendments  NPRM 11/00/94

Elder Rights Protection  NPRM 10/00/94

Intrastate Funding Formulas  NPRM 03/17/94 (59 FR 12728)  NPRM Comment 
Period End 05/16/94  Final Action 10/00/94

Small Entities Affected: Organizations

Government Levels Affected: State, Tribal

Additional Information: ABSTRACT CONT: providers in the development and 
provision of community-based services.

Agency Contact: William F. Benson, Deputy Assistant Secretary for 
Aging, Department of Health and Human Services, Administration on 
Aging, 330 Independence Avenue SW., Room 4760, Cohen Bldg., Washington, 
DC 20201, 202 619-0556

RIN: 0985-AA00
[FR Doc. 94-23418 Filed 11-10-94; 8:45 am]
BILLING CODE 4150-04-F