[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 October 25, 1993.

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:

Health Care Financing Administration

    Please note that many of the HCFA 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).

Claudia Cooley,

Executive Secretary to the Department. 

                                  Office of the Secretary--Proposed Rule Stage                                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
 Number                                                                                                Number   
----------------------------------------------------------------------------------------------------------------
1113        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 
1114        Civil Money Penalties (CMPs) for Certain Hospital Physician Incentive Plans...........    0991-AA45 
1115        Civil Money Penalties (CMPs) for Certain Practices Relating to Medicare Supplemental                
            Policies..............................................................................    0991-AA53 
1116        Uniform Administrative Requirements for Grants and Cooperative Agreements.............    0991-AA56 
1117        Revisions to the PRO Sanctions Process................................................    0991-AA73 
1118        Clarification of the OIG Safe Harbor Anti-Kickback Provisions.........................   0991-AA74  
----------------------------------------------------------------------------------------------------------------


                                   Office of the Secretary--Final Rule Stage                                    
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
 Number                                                                                                Number   
----------------------------------------------------------------------------------------------------------------
1119        Civil Money Penalties and Exclusions for Assistants at Cataract Surgery...............    0991-AA37 
1120        Civil Money Penalties and Intermediate Sanctions for HMOs and Competitive Medical                   
            Plans.................................................................................    0991-AA44 
1121        Block Grant Programs..................................................................    0991-AA55 
1122        Civil Money Penalties for Physician Ownership of and Referral to Certain Health Care                
            Entities..............................................................................    0991-AA65 
1123        Additional Safe Harbor Provisions Under the Anti-Kickback Statute.....................    0991-AA66 
1124        Safe Harbors for Protecting Health Plans..............................................    0991-AA69 
1125        Governmentwide Guidance for New Restrictions on Lobbying; Interim Final Guidance......   0991-AA70  
----------------------------------------------------------------------------------------------------------------


                                   Office of the Secretary--Completed Actions                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
 Number                                                                                                Number   
----------------------------------------------------------------------------------------------------------------
1126        Equal Opportunity in Employment: Public Broadcasting, Public Radio, and Public                      
            Telecommunications Entities Receiving Federal Funds From the Corporation for Public                 
            Broadcasting..........................................................................    0991-AA22 
1127        Title VI of the CRA of 1964, Subpart B--National Origin Discrimination in Programs                  
            Receiving Fed. Financial Assistance From the DHHS Against Persons of Limited English                
            Proficiency...........................................................................   0991-AA72  
----------------------------------------------------------------------------------------------------------------


                                   Departmental Management--Final Rule Stage                                    
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
 Number                                                                                                Number   
----------------------------------------------------------------------------------------------------------------
1128        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   
----------------------------------------------------------------------------------------------------------------
1129        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 
1130        Old-Age, Survivors, and Disability Insurance and Supplemental Security Income                       
            Programs; Evaluation Guides for Determining Substantial Gainful Activity (SGA) (147P).    0960-AB73 
1131        Old-Age, Survivors, and Disability Insurance Program; Nonpayment of Benefits to                     
            Prisoners, Vocational Rehabilitation Exception (166P).................................    0960-AC16 
1132        Old-Age, Survivors and Disability Insurance and Supplemental Security Income Programs;              
            Vocational Factors Regulations Restructuring and Clarification (207P).................    0960-AC61 
1133        Old-Age, Survivors, and Disability Insurance and Supplemental Security Income                       
            Programs; Interim Disability Benefits (215P)..........................................    0960-AC76 
1134        Old-Age, Survivors, and Disability Insurance and Supplemental Security Income                       
            Programs; Appeals Council Notice Requirements (235P)..................................    0960-AC93 
1135        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 
1136        Supplemental Security Income Program; Augmented Benefits (271P).......................    0960-AD07 
1137        Old-Age, Survivors, and Disability Insurance and Supplemental Security Income for the               
            Aged, Blind, and Disabled; Representative Payee Reforms (295F)........................    0960-AD22 
1138        Old-Age, Survivors, and Disability Insurance and Supplemental Security Income for the               
            Aged, Blind, and Disabled; Fees for Representation of Claimants (296P)................    0960-AD23 
1139        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 
1140        Supplemental Security Income for the Aged, Blind, and Disabled; Exclusion From Income               
            and Resources of Victims' Compensation Payments and State Relocation Assistance (311P)    0960-AD36 
1141        Supplemental Security Income for the Aged, Blind, and Disabled; Reimbursement for VR                
            Services Furnished During Certain Months of Non-payment (315P)........................    0960-AD39 
1142        Code of Conduct for Administrative Law Judges and Administrative Appeals Judges of the              
            Social Security Administration (341P).................................................    0960-AD54 
1143        Election of Benefits Based on Age by Disabled Widow, Widower, and Surviving Divorced                
            Spouse Beneficiaries (343P)...........................................................    0960-AD56 
1144        Against Equity and Good Conscience (348P).............................................    0960-AD62 
1145        Old-Age, Survivors, and Disability Insurance Program; Revised Medical Criteria for                  
            Determination of Disability; Hemic and Lymphatic System, and Malignant Neoplastic                   
            Diseases (399P).......................................................................    0960-AD67 
1146        Procedures for Handling Earnings Reports (418P).......................................    0960-AD70 
1147        Federal OASDI and SSI; Computing Benefit Amounts, Disposing of Underpayments,                       
            Resolving Overpayments, and Payment Restriction (428P)................................    0960-AD72 
1148        Conduct of Representatives Under Title II or Title XVI (431P).........................    0960-AD73 
1149        Statement of Earnings and Benefit Estimate (415P).....................................    0960-AD74 
1150        Fees for Federal Administration of State Supplementary Payments in the SSI Program                  
            (376P)................................................................................    0960-AD75 
1151        Who May Protect a Potential Claimant's Filing Date or Application for Supplemental                  
            Security Income Benefits (408P).......................................................    0960-AD76 
1152        Reliable Information Which is Currently Available for Determining Benefit Amounts in                
            the Supplemental Security Income Program (NEWMAN) (434P)..............................    0960-AD77 
1153        Revised Medical Criteria for Determination of Disability, Endocrine System and Obesity              
            and Related Criteria (436P)...........................................................    0960-AD78 
1154        Federal Old-Age, Survivors, and Disability Insurance; Evidence Required to Presume a                
            Person Is Dead (443P).................................................................    0960-AD79 
1155        Revised Medical Criteria for Determination of Disability, Growth Impairments (444P)...    0960-AD80 
1156        Eligibility for Children of Armed Forces Personnel Residing Outside the United States               
            Other Than in Foreign Countries (452P)................................................    0960-AD81 
1157        Valuation of Certain In-Kind Support and Maintenance (ISM) Where There is a Cost-of-                
            Living Adjustment in SSI Benefits (454P)..............................................    0960-AD82 
1158        Relationship/Coverage Actions Note Initial Determinations/SSI Corrections (455P)......    0960-AD83 
1159        Replacement of Lost, Damaged or Stolen Excluded Resources (Hurricane Andrew) (458I)...    0960-AD85 
1160        Prevention of Adverse Effects on Eligibility and Benefit Amount When Spouse or Parent               
            Absent Due to Active Military Service (462P)..........................................   0960-AD86  
----------------------------------------------------------------------------------------------------------------


                                Social Security Administration--Final Rule Stage                                
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
 Number                                                                                                Number   
----------------------------------------------------------------------------------------------------------------
1161        Supplemental Security Income Program; Suspensions, Terminations, and Advance Notice of              
            Adverse Determinations (031F).........................................................    0960-AA22 
1162        Old-Age, Survivors, and Disability Insurance Program; Revised Medical Criteria for                  
            Determination of Disability; Musculoskeletal System (143F)............................    0960-AB01 
1163        Old-Age, Survivors, and Disability Insurance and Supplemental Security Income Program;              
            Continued Payment of Benefits to Persons in Vocational Rehabilitation Programs (131F).    0960-AB05 
1164        Supplemental Security Income Program; What Is Not Income (121F).......................    0960-AB09 
1165        Supplemental Security Income Program; Continuation of Benefits and Special Eligibility              
            for Certain Severely Impaired Recipients Who Work (171F)..............................    0960-AC22 
1166        Supplemental Security Income Program; Proceeds of a Loan, Payment of Pro Rata Share of              
            Household Operating Expenses (180F)...................................................    0960-AC42 
1167        Old-Age, Survivors, and Disability Insurance Program; Applicability of Government                   
            Pension to Certain Federal Employees (188F)...........................................    0960-AC46 
1168        Supplemental Security Income Program; Continuation of Full Benefit Standard for                     
            Certain Persons Temporarily Institutionalized (198F)..................................    0960-AC55 
1169        Old-Age, Survivors, and Disability Insurance Program; Medical Criteria for Evaluating               
            Mental Disorders for Adults (222F)....................................................    0960-AC74 
1170        Supplemental Security Income Program; Treatment of Augmented Veterans' Benefits (231F)    0960-AC82 
1171        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 
1172        Old-Age, Survivors, and Disability Insurance and Supplemental Security Income                       
            Programs; Deemed Application Date Based on Misinformation (267F)......................    0960-AD05 
1173        Supplemental Security Income Program; Financial Institution Accounts in the SSI                     
            Program (278F)........................................................................    0960-AD10 
1174        Old-Age, Survivors, and Disability Insurance and Supplemental Security Income for the               
            Aged, Blind, and Disabled; Updating Nomenclature (264F)...............................    0960-AD11 
1175        Supplemental Security Income for the Aged, Blind, and Disabled; Treatment of Certain                
            Royalties and Honoraria (310F)........................................................    0960-AD35 
1176        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 
1177        Supplemental Security Income Program; Treatment of Promissory Notes in Home                         
            Replacement Situations (182F).........................................................    0960-AD61 
1178        OASDI and SSI; Testing Modifications to the Disability Determination Procedures (359F)    0960-AD63 
1179        Reliable Information Which Is Currently Available for Determining Benefit Amounts in                
            the Supplemental Security Income Program (382F).......................................    0960-AD65 
1180        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 
1181        Compensation of Qualified Organizations Serving as Representative Payees Under Title                
            II and Title XVI (423F)...............................................................    0960-AD71 
1182        Temporary Increase in Sponsorship Period for Aliens Under the SSI Program (457F)......   0960-AD84  
----------------------------------------------------------------------------------------------------------------


                               Social Security Administration--Completed Actions                                
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
 Number                                                                                                Number   
----------------------------------------------------------------------------------------------------------------
1183        Old-Age, Survivors, and Disability Insurance Program; Revised Medical Criteria for                  
            Determination of Disability; Cardiovascular System (141F).............................    0960-AA99 
1184        Old-Age, Survivors, and Disability Insurance Program; Revised Medical Criteria for                  
            Determination of Disability; Respiratory System (142F)................................    0960-AB00 
1185        Supplemental Security Income Program; Exclusions From Income and Resources of Indian                
            Judgment Funds and Per Capita Distributions (201F)....................................    0960-AB86 
1186        Supplemental Security Income Program; Payment of Benefits Due Deceased Recipients                   
            (174F)................................................................................    0960-AC28 
1187        Old-Age, Survivors, and Disability Insurance and Supplemental Security Income                       
            Programs; Cancelled Consultative Examinations (181F)..................................    0960-AC40 
1188        Old-Age, Survivors, and Disability Insurance and Supplemental Security Income                       
            Programs; Determining Disability and Blindness; Fee Limitation Policy for Purchase of               
            Laboratory Tests (184P)...............................................................    0960-AC41 
1189        Old-Age, Survivors and Disability Insurance and Supplemental Security Income Programs;              
            Determination of Disability-- Disability-Determining State Agency Substantial Failure               
            (206F)................................................................................    0960-AC60 
1190        Old-Age, Survivors, and Disability Insurance Program; Suspension of Benefits of                     
            Deported Nazis; Exemption From Social Security Taxation Because of Religious Beliefs                
            (210F)................................................................................    0960-AC68 
1191        Supplemental Security Income Program; Redeterminations of Supplemental Security Income              
            Eligibility (223F)....................................................................    0960-AC77 
1192        Old-Age, Survivors, and Disability Insurance and Supplemental Security Income                       
            Programs; Medical Improvement Review Standard (MIRS)--Miscellaneous Changes (225P)....    0960-AC81 
1193        Old-Age, Survivors, and Disability Insurance and Supplemental Security Income                       
            Programs; Representation of Claimants for Benefits Under Title II or Title XVI (249F).    0960-AC87 
1194        Old-Age, Survivors, and Disability Insurance and Supplemental Security Income                       
            Programs; Standards Applicable in Determinations of Good Cause, Fault, and Good Faith               
            (247F)................................................................................    0960-AC88 
1195        Supplemental Security Income Program; Exclusion From Income of Domestic Commercial                  
            Transportation Tickets Received as Gifts in Determining SSI Income (253F).............    0960-AC97 
1196        Old-Age, Survivors, and Disability Insurance and Supplemental Security Income for the               
            Aged, Blind, and Disabled; Reopening Determinations and Decisions (279F)..............    0960-AD12 
1197        Old-Age, Survivors, and Disability Insurance; Suspension of Auxiliary Benefits When a               
            Disabled Worker Is in an Extended Period of Eligibility (303F)........................    0960-AD30 
1198        Old-Age, Survivors, and Disability Insurance; Continued Entitlement to Benefits of                  
            Deemed Spouse Despite Entitlement of Legal Spouse (304F)..............................    0960-AD31 
1199        Supplemental Security Income for the Aged, Blind, and Disabled; Exclusion From Income               
            and Resources of Earned Income Tax Credits (319F).....................................    0960-AD41 
1200        Old-Age, Survivors, and Disability Insurance and Supplemental Security Income;                      
            Limitation of Travel Expenses for Representation of Claimants at Administrative                     
            Proceedings (324F)....................................................................    0960-AD46 
1201        Time Limit for Disposition of Resources in the Supplemental Security Income Program                 
            (330F)................................................................................    0960-AD48 
1202        Old-Age, Survivors, and Disability Insurance and Supplemental Security Income for the               
            Aged, Blind, and Disabled; Payments for Vocational Rehabilitation Services (333F).....    0960-AD50 
1203        Old-Age, Survivors, and Disability Insurance and Supplemental Security Income                       
            Programs; Reorganization of Medical Evidence Regulations (340P).......................    0960-AD57 
1204        Old-Age, Survivors, and Disability Insurance Program; Considering an Application Filed              
            Under the Railroad Retirement Act as an Application for Social Security Benefits                    
            (342F)................................................................................    0960-AD59 
1205        SSI Program; SSI Maximum Payment Limit ($30) When Medicaid Is Not Paying Toward the                 
            Cost of Institutional Care Because the Individual Transferred a Resource (345F).......    0960-AD60 
1206        OASDI and SSI Programs; Performance Standards Revisions and Other Changes Involving                 
            Administrative Requirements and Procedures (381A).....................................    0960-AD64 
1207        Federal Old-Age, Survivors, and Disability Insurance Program; Technical Changes to                  
            Requirement for Entitlement to Widow(er)'s Benefits (404F)............................   0960-AD69  
----------------------------------------------------------------------------------------------------------------


          Public Health Service--Office of Assistant Secretary for Health (OASH)--Proposed Rule Stage           
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
 Number                                                                                                Number   
----------------------------------------------------------------------------------------------------------------
1208        Public Health Service Policies on Research Misconduct.................................   0905-AE02  
----------------------------------------------------------------------------------------------------------------


            Public Health Service--Office of Assistant Secretary for Health (OASH)--Final Rule Stage            
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
 Number                                                                                                Number   
----------------------------------------------------------------------------------------------------------------
1209        Privacy Act; Exempt System............................................................    0905-AD31 
1210        Standards of Compliance for Abortion-Related Services in Family Planning Service                    
            Projects..............................................................................   0905-AE03  
----------------------------------------------------------------------------------------------------------------


 Public Health Service--Substance Abuse and Mental Health Services Administration (SAMHSA)--Proposed Rule Stage 
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
 Number                                                                                                Number   
----------------------------------------------------------------------------------------------------------------
1211        Confidentiality of Substance Abuse Patient Records....................................    0905-AD97 
1212        Protection and Advocacy for Individuals With Mental Illness...........................    0905-AD99 
1213        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   
----------------------------------------------------------------------------------------------------------------
1214        Block Grants for Prevention and Treatment of Substance Abuse..........................    0905-AD98 
1215        Block Grants for Prevention and Treatment of Substance Abuse (Tobacco Provisions).....   0905-AE05  
----------------------------------------------------------------------------------------------------------------


          Public Health Service--Centers for Disease Control and Prevention (CDC)--Proposed Rule Stage          
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
 Number                                                                                                Number   
----------------------------------------------------------------------------------------------------------------
1216        Respiratory Protective Devices........................................................   0905-AB58  
----------------------------------------------------------------------------------------------------------------


           Public Health Service--Centers for Disease Control and Prevention (CDC)--Final Rule Stage            
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
 Number                                                                                                Number   
----------------------------------------------------------------------------------------------------------------
1217        Interstate Shipment of Biological Material That Contains or May Contain Etiologic                   
            Agents................................................................................    0905-AC89 
1218        Medical Examination of Aliens.........................................................   0905-AD29  
----------------------------------------------------------------------------------------------------------------


                    Public Health Service--Food and Drug Administration (FDA)--Prerule Stage                    
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
 Number                                                                                                Number   
----------------------------------------------------------------------------------------------------------------
1219        Medical Foods.........................................................................    0905-AD91 
1220        Specific Requirements on Content and Format of Labeling for Human Prescription Drugs;               
            Addition of ``Geriatric Use'' Subsection in the Labeling..............................    0905-AE26 
1221        Certification of Drugs Composed Wholly or Partly of Insulin; Fees for Certification of              
            Drugs Composed Wholly of Partly of Insulin............................................    0905-AE28 
1222        Sunglass Labeling.....................................................................    0905-AE35 
1223        Investigational Device Exemption: Cost Recovery.......................................   0905-AE36  
----------------------------------------------------------------------------------------------------------------


                 Public Health Service--Food and Drug Administration (FDA)--Proposed Rule Stage                 
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
 Number                                                                                                Number   
----------------------------------------------------------------------------------------------------------------
1224        New Animal Drug Approval Process......................................................    0905-AA96 
1225        Policies Concerning Uses of Sulfiting Agents..........................................    0905-AB52 
1226        Infant Formula Act....................................................................    0905-AC46 
1227        Implementation of Title I of the Generic Animal Drug and Patent Term Restoration Act..    0905-AD15 
1228        Prescription Drug Marketing Act of 1987; Policy Information, Guidance, and                          
            Clarifications........................................................................    0905-AD44 
1229        Implementation of the Safe Medical Devices Act of 1990................................    0905-AD59 
1230        Reporting of Errors and Accidents Relating to Blood Safety and Withdrawal of                        
            Previously Proposed Rule..............................................................    0905-AD67 
1231        Proposed Labeling for Drug Products Based on False or Fraudulent Data.................    0905-AD71 
1232        Review of Warnings, Use Instructions, and Precautionary Information Under Section 314               
            of the National Childhood Vaccine Injury Act of 1986..................................    0905-AD72 
1233        Medical Devices; Infant Apnea Monitor; Development of Mandatory Standard..............    0905-AD83 
1234        Mammography Quality Standards Act of 1992.............................................    0905-AE19 
1235        Adverse Experience Reporting Requirements for Human Drug and Licensed Biological                    
            Products..............................................................................    0905-AE29 
1236        Electronic Signatures.................................................................    0905-AE31 
1237        Financial Disclosure by Clinical Investigators........................................    0905-AE32 
1238        Effective Date of Requirement for Submission of Premarket Approval Applications.......    0905-AE34 
1239        Latex Condoms/Gloves: Expiration Date Labeling........................................    0905-AE37 
1240        Amalgam Ingredient Labeling...........................................................    0905-AE39 
1241        Latex Warning.........................................................................    0905-AE40 
1242        Premarket Approval Applications: Supplements..........................................    0905-AE41 
1243        Restricted Devices....................................................................    0905-AE42 
1244        Prescription Drug Product Labeling; Medication Guide..................................    0905-AE43 
1245        Substances Prohibited for Use in Ruminant Feed........................................    0905-AE45 
1246        Hearing Aids; Professional and Patient Labeling; Conditions for Sale..................   0905-AE46  
----------------------------------------------------------------------------------------------------------------


                  Public Health Service--Food and Drug Administration (FDA)--Final Rule Stage                   
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
 Number                                                                                                Number   
----------------------------------------------------------------------------------------------------------------
1247        Over-the-Counter (OTC) Drug Review....................................................    0905-AA06 
1248        Abbreviated New Drug Application Regulations (Title I of the ``Drug Price Competition               
            and Patent Term Restoration Act of 1984'')............................................    0905-AB63 
1249        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 
1250        Lead in Foods.........................................................................    0905-AC91 
1251        Expediting Approval for Drugs Intended To Treat Life-Threatening and Severely                       
            Debilitating Illnesses................................................................    0905-AC94 
1252        Fees for Certification Services; Insulin and Color Additive Certification Programs....    0905-AD34 
1253        Mandatory HACCP Seafood Inspection Program............................................    0905-AD60 
1254        Bottled Water.........................................................................    0905-AD65 
1255        Specific Requirements on Content and Format of Labeling for Human Prescription Drugs;               
            Revision of ``Pediatric Use'' Subsection in the Labeling..............................    0905-AD76 
1256        Recordkeeping and Reporting: Electronic Products......................................    0905-AD78 
1257        General Biological Product Standards; Alternative Procedures and Exceptions...........    0905-AD82 
1258        Medical Devices; Protective Restraints; Revocation of Exemptions From 510(k) Premarket              
            Notification Procedures and Current Good Manufacturing Practices Regulations..........    0905-AD84 
1259        Threshold of Regulation Policy for Components of Food Contact Articles................    0905-AD86 
1260        Food Labeling Review..................................................................    0905-AD89 
1261        Levo-Alpha-Methadol (LAAM) in Maintenance; Joint Proposed Revision of Conditions for                
            Use...................................................................................    0905-AD92 
1262        Temporomandibular Joint Implant Classification........................................    0905-AD93 
1263        Clinical Investigator Disqualification................................................    0905-AD94 
1264        Revocation of Intraocular Lens Investigation Device Exemption.........................    0905-AD95 
1265        Dietary Supplement Label Review.......................................................    0905-AD96 
1266        Adverse Experience Reporting Required for Licensed Biological Products................    0905-AE18 
1267        Tamper-Evident Packaging Requirements for Over-The-Counter Human Drug Products........   0905-AE27  
----------------------------------------------------------------------------------------------------------------


                  Public Health Service--Food and Drug Administration (FDA)--Completed Actions                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
 Number                                                                                                Number   
----------------------------------------------------------------------------------------------------------------
1268        Voluntary, Fee-for-Service Seafood Inspection Program.................................    0905-AD23 
1269        Part 1260; Human Semen for Artificial Insemination....................................    0905-AD80 
1270        Investigational New Drug Applications.................................................    0905-AD85 
1271        Dietary Supplements...................................................................    0905-AD90 
1272        Proposal To Establish Procedures for the Safe Processing, Packaging, Storage, and                   
            Distribution of Smoked Fish, Smoke-Flavored Fish, and Salted Fish.....................   0905-AE21  
----------------------------------------------------------------------------------------------------------------


        Public Health Service--Health Resources and Services Administration (HRSA)--Proposed Rule Stage         
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
 Number                                                                                                Number   
----------------------------------------------------------------------------------------------------------------
1273        National Health Service Corps Loan Repayment Program; Grants for State Loan Repayment               
            Programs..............................................................................    0905-AC65 
1274        Organ Procurement and Transplantation Network Rules...................................    0905-AD26 
1275        Health Education Assistance Loan (HEAL) Program: Lenders' Performance Standards.......    0905-AD87 
1276        Grants for Nurse Practitioner and Nurse-Midwifery Programs............................    0905-AE11 
1277        Grants for Faculty Training Projects in Geriatric Medicine and Dentistry..............    0905-AE13 
1278        Medical Facility Construction and Modernization Requirements for Provision of Services              
            to Persons Unable to Pay..............................................................   0905-AE33  
----------------------------------------------------------------------------------------------------------------


          Public Health Service--Health Resources and Services Administration (HRSA)--Final Rule Stage          
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
 Number                                                                                                Number   
----------------------------------------------------------------------------------------------------------------
1279        National Vaccine Injury Compensation (NVIC) Program: Revisions to the Vaccine Injury                
            Table.................................................................................    0905-AD64 
1280        Maternal and Child Health (MCH) Project Grants........................................    0905-AD88 
1281        Medical Facility Construction and Modernization; Requirements for Provision of                      
            Services to Persons Unable To Pay.....................................................    0905-AE06 
1282        Grants for the Establishment of Departments of Family Medicine........................    0905-AE17 
1283        National Practitioner Data Bank for Adverse Information on Physicians and Other Health              
            Care Practitioners: Amendment to Data Bank Regulations To Comply With Court Order.....   0905-AE38  
----------------------------------------------------------------------------------------------------------------


         Public Health Service--Health Resources and Services Administration (HRSA)--Completed Actions          
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
 Number                                                                                                Number   
----------------------------------------------------------------------------------------------------------------
1284        Health Education Assistance Loan (HEAL) Program: School Collection Assistance.........    0905-AC87 
1285        Health Education Assistance Loan (HEAL) Program: Postjudgment Collections.............    0905-AD11 
1286        National Practitioner Data Bank for Adverse Information on Physicians and Other Health              
            Care Practitioners: Authorized Agents.................................................    0905-AE10 
1287        National Practitioner Data Bank for Adverse Information on Physicians and Other Health              
            Practitioners: Amendments to Collection of User Fees..................................    0905-AE15 
1288        Grants for Health Professions Projects in Geriatrics..................................   0905-AE16  
----------------------------------------------------------------------------------------------------------------


                    Public Health Service--Indian Health Service (IHS)--Proposed Rule Stage                     
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
 Number                                                                                                Number   
----------------------------------------------------------------------------------------------------------------
1289        Indian Health Service Loan Repayment Program Regulations..............................    0905-AC96 
1290        Indian Health Service Catastrophic Health Emergency Fund Program......................    0905-AC97 
1291        Revision of Indian Self-Determination Regulations.....................................    0905-AC98 
1292        Revision of Urban Indian Health Regulations...........................................    0905-AD20 
1293        Acquisition Under the Buy Indian Act..................................................   0905-AE09  
----------------------------------------------------------------------------------------------------------------


                      Public Health Service--Indian Health Service (IHS)--Final Rule Stage                      
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
 Number                                                                                                Number   
----------------------------------------------------------------------------------------------------------------
1294        Review of the Determination of an Indian Tribe's Resource Deficiency Level............   0905-AD21  
----------------------------------------------------------------------------------------------------------------


                Public Health Service--National Institutes of Health (NIH)--Proposed Rule Stage                 
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
 Number                                                                                                Number   
----------------------------------------------------------------------------------------------------------------
1295        Grants for Research Projects..........................................................    0905-AC02 
1296        National Institutes of Health AIDS Research Loan Repayment Program....................    0905-AD18 
1297        Hazardous Substances Basic Research and Training Grants...............................    0905-AD46 
1298        National Institutes of Health Construction Grants.....................................    0905-AD49 
1299        Training Grants.......................................................................    0905-AD56 
1300        National Institutes of Health Center Grants...........................................    0905-AE00 
1301        Responsibilities of Public Health Service Funded Institutions for Promoting                         
            Objectivity in Research...............................................................    0905-AE01 
1302        Grants for National Alcohol Research Centers..........................................   0905-AE08  
----------------------------------------------------------------------------------------------------------------


                  Public Health Service--National Institutes of Health (NIH)--Final Rule Stage                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
 Number                                                                                                Number   
----------------------------------------------------------------------------------------------------------------
1303        Traineeships..........................................................................    0905-AD28 
1304        Standards for Bone Marrow Registries and Centers......................................    0905-AD51 
1305        National Institute of Environmental Health Sciences Hazardous Waste Worker Training...    0905-AD69 
1306        National Heart, Lung, and Blood Institute Grants for Prevention and Control Projects..   0905-AE25  
----------------------------------------------------------------------------------------------------------------


                 Public Health Service--National Institutes of Health (NIH)--Completed Actions                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
 Number                                                                                                Number   
----------------------------------------------------------------------------------------------------------------
1307        Special Volunteer Services at the National Institutes of Health.......................    0905-AC95 
1308        Minority Biomedical Research Support Program..........................................    0905-AD47 
1309        National Heart, Lung, and Blood Institute Grants for Prevention and Control Projects..   0905-AD48  
----------------------------------------------------------------------------------------------------------------


          Public Health Service--Agency for Health Care Policy and Research (AHCPR)--Final Rule Stage           
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
 Number                                                                                                Number   
----------------------------------------------------------------------------------------------------------------
1310        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   
----------------------------------------------------------------------------------------------------------------
1311        Hospice Services (MB-7-P).............................................................    0938-AC52 
1312        Optional Payment System for Low Medicare Volume Skilled Nursing Facilities (BPD-409-P)    0938-AD02 
1313        Medicaid Eligibility of Poverty Level Groups and Extended Coverage of Services (MB-13-              
            F)....................................................................................    0938-AD17 
1314        Transfer of Resources for Less Than Fair Market Value (MB-10-P).......................    0938-AD18 
1315        Medicare Coverage of Outpatient Occupational Therapy Services (BPD-425-P).............    0938-AD32 
1316        Revisions to the Freedom of Information Regulations (OPA-1-P).........................    0938-AD60 
1317        New Minimum Standards for Medicare Supplemental (Medigap) Policies (BPD-491-P)........    0938-AD82 
1318        Clarification of ``Without Fault'' as It Applies to Physician Provider and Supplier                 
            Liability (BPD-719-P).................................................................    0938-AD95 
1319        Protection of Income and Resources for Community Spouse (MB-23-P).....................    0938-AE12 
1320        Physician Certification and Plan of Care Requirements and Inspection of Care Reviews                
            (HSQ-178-P)...........................................................................    0938-AE17 
1321        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 
1322        Post-Contract Beneficiary Protections and Other Provisions (OCC-011-F)................    0938-AE63 
1323        Coverage of Physician Assistant, Nurse Practitioner, and Clinical Nurse Specialist                  
            Services (BPD-708-P)..................................................................    0938-AF00 
1324        Utilization and Quality Control Peer Review Organizations (PRO): Confidential                       
            Information (HSQ-190-P)...............................................................    0938-AF03 
1325        Day Habilitation and Related Services (MB-37-P).......................................    0938-AF10 
1326        Medicaid Third Party Liability: Cost Effectiveness Waivers (MB-39-F)..................    0938-AF11 
1327        OBRA '90 and Miscellaneous Managed Care Technical Amendments (MB-044-P)...............    0938-AF15 
1328        Criteria for the Determination of Reasonable Costs for Medicare --Contracting Prepaid               
            Health Plans (OCC-018-F)..............................................................    0938-AF16 
1329        Provider Reimbursement Determinations and Appeals Revisions (BPD-727-P)...............    0938-AF28 
1330        Alternative Sanctions for Psychiatric Hospitals (HSQ-191-P)...........................    0938-AF32 
1331        Medicare, Medicaid, and CLIA Programs: Inspection and Certification Procedures for                  
            Laboratories (HSQ-193-P)..............................................................    0938-AF33 
1332        Medicaid Payment for Obstetrical and Pediatric Services--Adequate Payment Level                     
            Provision (MB-036-P)..................................................................    0938-AF62 
1333        Requirements for Enrollment of Medicaid Recipients Under Cost Effective Employer Based              
            Group Health Plans (MB-047-P).........................................................    0938-AF64 
1334        Clarification of Coverage of Inpatient Psychiatric Services (MB-060-P)................    0938-AF73 
1335        National Coverage Decisions: Rules for Risk Contracting HMOs and CMPs (BPD-732-F).....    0938-AF76 
1336        Part B Advance Payments to Physicians/Suppliers or Other Entities Furnishing Items or               
            Services Under Medicare Part B (BPO-105-P)............................................    0938-AF85 
1337        Federally Qualified Health Center Services (Medicaid) (MB-043-P)......................    0938-AF90 
1338        Revisions to Rules on Health Care Prepayment Plans (OCC-032-P)........................    0938-AF97 
1339        Change in Provider Agreement Regulations Related to Federal Employee Health Benefits                
            (BPD-748-F)...........................................................................    0938-AG03 
1340        Conditions of Participation for Rural Health Clinics (BPD-764-P)......................    0938-AG05 
1341        Intermediary and Carrier Functions (BPO-111-F)........................................    0938-AG06 
1342        Income and Eligibility Verification System (MB-66-P)..................................    0938-AG12 
1343        Medicare Appeals of Individual Claims (BPD-453-P).....................................    0938-AG18 
1344        Criteria for Approval of End-Stage Renal Disease (ESRD) Payment Exception Requests                  
            (BPD-763-P)...........................................................................    0938-AG20 
1345        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 
1346        Appointment of Representatives for Appeal (BPO-120-P).................................    0938-AG30 
1347        Enforcement Requirements for Renal Dialysis Facilities (HSQ-204-P)....................    0938-AG31 
1348        Disclosure of Confidential PRO Information for Research Purposes (HSQ-208-P)..........    0938-AG33 
1349        Community Supported Living Arrangements Services (MB-070-P)...........................    0938-AG35 
1350        Medicare Program: Limitations on Medicare Coverage of Intermittent Positive Pressure                
            Breathing Machine Therapy (BPD-781-PN)................................................    0938-AG44 
1351        Noncoverage of Electrostimulation of Salivary Glands for the Treatment of Xerostomia                
            (Dry Mouth) (BPD-782-PN)..............................................................    0938-AG45 
1352        Medicare Program: Changes to the Inpatient Hospital Prospective Payment Systems and                 
            Fiscal Year 1995 Rates (BPD-802-P)....................................................    0938-AG46 
1353        Telephone Requests for Review of Initial Determinations (BPO-121-P)...................    0938-AG48 
1354        Refinements to the Physician Fee Schedule Geographic Adjustment Factor Values and                   
            Other Changes (BPD-789-P).............................................................    0938-AG52 
1355        Conditions for Payment for Physicians' Services in Teaching Settings (BPD-792-P)......    0938-AG53 
1356        Date for Filing Medicare Cost Reports (BPD-794-P).....................................    0938-AG55 
1357        Limitations on Revisions to Final Administrative Cost Proposals (BPO-122-P)...........    0938-AG57 
1358        New Look Behind for Intermediate Care Facilities for the Mentally Retarded (ICFs/MR)                
            (HSQ-214-P)...........................................................................    0938-AG58 
1359        Effect of Change of Ownership on Provider and Supplier Penalties, Sanctions, and                    
            Overpayments (HSQ-215-P)..............................................................    0938-AG59 
1360        Institutional Plan Amendment Findings (MB-078-P)......................................    0938-AG60 
1361        Medicare Program: Limitations on Medicare Coverage of Cataract Surgery (BPD-797-PN)...    0938-AG65 
1362        Effects of Generally Accepted Accounting Principles (GAAP) on Reasonable Costs                      
            Determinations (BPD-800-P)............................................................    0938-AG66 
1363        Expansion of the Definition of Eye and Ear Specialty Hospitals (BPD-804-P)............    0938-AG67 
1364        Salary Equivalency Guidelines for Physical and Respiratory Therapy Services Furnished               
            Under Arrangements (BPD-808-PN).......................................................    0938-AG70 
1365        Medicaid: Optional Coverage of TB-Related Services for Individuals Infected with                    
            Tuberculosis (MB-082-P)...............................................................    0938-AG72 
1366        Medicaid Program: Nurse-Midwife Services (MB-085-P)...................................    0938-AG73 
1367        Proposed Payments to Disproportionate Share Hospitals for FY 1995 (MB-089-N)..........   0938-AG75  
----------------------------------------------------------------------------------------------------------------


                             Health Care Financing Administration--Final Rule Stage                             
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
 Number                                                                                                Number   
----------------------------------------------------------------------------------------------------------------
1368        Medicaid Eligibility and Coverage Requirements (MB-001-F).............................    0938-AA58 
1369        Deduction of Incurred Medical Expenses (Spenddown) (MB-020-F).........................    0938-AB07 
1370        Payment for Clinical Diagnostic Laboratory Services (BPD-309-F).......................    0938-AB50 
1371        Home and Community-Based Services and Respiratory Care for Ventilator-Dependent                     
            Individuals (MB-8-FC).................................................................    0938-AC55 
1372        Participation in CHAMPUS and CHAMPVA, Hospital Admissions for Veterans, Discharge                   
            Rights Notice, and Hospital Responsibility for Emergency Care (BPD-393-FC)............    0938-AC58 
1373        Denial of Payment for Substandard Quality Care (HSQ-132-F)............................    0938-AC84 
1374        Revised Effective Date of Medicare/Medicaid Provider Agreement and Supplier                         
            Participation (HSQ-139-F).............................................................    0938-AC88 
1375        Changes Concerning Suspension of Medicare Payments and Determinations of Allowable                  
            Interest Expense (BPO-118-FC).........................................................    0938-AC99 
1376        Changes Concerning the Definition of Accrual Basis of Accounting (BPD-366-F)..........    0938-AD01 
1377        Criteria and Procedures for Making Medical Services Coverage Decisions That Relate to               
            Health Care Technology (BPD-432-F)....................................................    0938-AD07 
1378        Revisions to Conditions of Participation for Hospitals and Conditions for Coverage of               
            Suppliers of End-Stage Renal Disease Services (BPD-421-F).............................    0938-AD11 
1379        Prohibition on Unbundling of Hospital Outpatient Services (BPD-426-F).................    0938-AD33 
1380        Changes to Peer Review Organization Regulations (HSQ-135-F)...........................    0938-AD38 
1381        Home and Community-Based Services for the Elderly (MB-019-F)..........................    0938-AD55 
1382        Payment for Durable Medical Equipment and Orthotic and Prosthetic Devices (BPD-494-F).    0938-AD65 
1383        Medicare Secondary Payer for Disabled Active Individuals (BPD-482-FC).................    0938-AD73 
1384        Medicare Coverage of Home Health Services, Medicare Conditions of Participation and                 
            Home Health Aide Supervision (BPD-469-F)..............................................    0938-AD78 
1385        Appeals for Enrollees of Prepaid Health Care Plans (OCC-020-F)........................    0938-AD79 
1386        Omnibus Nursing Home Reform Requirements (BPD-488-FC).................................    0938-AD81 
1387        Fee Schedule for Payment of Therapeutic and Diagnostic Services Other Than                          
            Psychological Testing Provided by Clinical Psychologists and Clinical Social Workers                
            (BPD-495-IFC).........................................................................    0938-AD84 
1388        Survey and Certification of Skilled Nursing Facilities and Nursing Facilities and                   
            Enforcement Procedures (HSQ-156-F)....................................................    0938-AD94 
1389        HMO Organizational Structure and Services (OCC-019-F).................................    0938-AE25 
1390        ''Confined to the Home'' Requirements for Home Health Services (BPD-626-F)............    0938-AE34 
1391        Payment Adjustments for Hospitals That Serve a Disproportionate Number of Low-Income                
            Patients (MB-017-IFC).................................................................    0938-AE35 
1392        Survey Requirements and Alternative Sanctions for Home Health Agencies (HSQ-169-F)....    0938-AE39 
1393        Hospital Standard for HIV Infectious Blood (BPD-633-F)................................    0938-AE40 
1394        Medicare, Medicaid, and CLIA Programs: Regulations Implementing the Clinical                        
            Laboratory Improvement Amendments of 1988 (CLIA '88) (HSQ-202-F)......................    0938-AE47 
1395        Conditions of Coverage for Organ Procurement Organizations (BPD-646-FC)...............    0938-AE48 
1396        Preadmission Screening and Annual Resident Review (BPD-661-F).........................    0938-AE49 
1397        Extended Medicaid Eligibility for Certain Individuals (MB-026-F)......................    0938-AE51 
1398        Resident Assessment in Long-Term Care Facilities (HSQ-180-F)..........................    0938-AE61 
1399        Conforming Provisions for 1988 HMO Amendments (OCC-012-F).............................    0938-AE64 
1400        Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Services (MB-28-F)....    0938-AE72 
1401        Payment for Nursing and Allied Health Science Education (BPD-685-F)...................    0938-AE79 
1402        Uniform Electronic Cost Reporting System for Hospitals (BPD-689-F)....................    0938-AE80 
1403        Medicare Coverage of Prescription Drugs Used in Immunosuppressive Therapy (BPD-424-F).    0938-AE94 
1404        Fire Safety Standards for Hospitals, Long-Term Care Facilities, and Intermediate Care               
            Facilities for the Mentally Retarded (BPD-650-F)......................................    0938-AE97 
1405        Coverage of Screening Pap Smears (BPD-705-F)..........................................    0938-AE98 
1406        Medicare Coverage of Clinical Psychologist, Other Psychologist, and Clinical Social                 
            Worker Services--Medicare (BPD-706-F).................................................    0938-AE99 
1407        Allowing Certifications and Recertifications by Nurse Practitioners and Clinical Nurse              
            Specialists for Certain Services (BPD-709-F)..........................................    0938-AF01 
1408        Changes to the Long-Term Care Facility Survey Process (HSQ-175-FC)....................    0938-AF02 
1409        Case Management (MB-27-F).............................................................    0938-AF07 
1410        Required Coverage of Nurse Practitioner Services--Medicaid (MB-41-F)..................    0938-AF12 
1411        Payment for Federally Qualified Health Center (FQHC) Services (BPD-728-F).............    0938-AF14 
1412        Medicare Coverage of Screening Mammography (BPD-724-F)................................    0938-AF26 
1413        Physician Ownership of and Referrals to Health Care Facilities That Furnish Clinical                
            Laboratory Services and Financial Relationship Reporting Requirements (BPD-674-F).....    0938-AF40 
1414        Medicaid Payment for Covered Outpatient Drugs Under Rebate Agreements (MB-046-IFC)....    0938-AF42 
1415        Medicare and Medicaid Programs; Advance Directives (BPD-718-F)........................    0938-AF50 
1416        Partial Hospitalization Services in Community Mental Health Centers (BPD-736-F).......    0938-AF53 
1417        Medicaid Drug Use Review Program and Electronic Claims Management System for                        
            Outpatient Drug Claims (MB-050-F).....................................................    0938-AF67 
1418        Referral to Child Support Enforcement Agencies of Medicaid Families With an Absent                  
            Parent (MB-051-F).....................................................................    0938-AF68 
1419        Medicaid: Outstationed Intake Locations for Certain Low-Income Pregnant Women, Infants              
            and Children (MB-052-IFC).............................................................    0938-AF69 
1420        Optional Spenddown (MB-055-IFC).......................................................    0938-AF72 
1421        Medicare and Medicaid Programs: Requirements for Physician Incentive Plans in Prepaid               
            Health Care Organizations (OCC-024-F).................................................    0938-AF74 
1422        Application of Interest Charges to Medicare Secondary Payer Recoveries (BPO-108-GN)...    0938-AF87 
1423        Minimum Physician Qualifications for Certain Services (MB-059-P)......................    0938-AF92 
1424        Retroactive Enrollment (OCC-031-F)....................................................    0938-AF98 
1425        Payment for Preadmission Services (BPD-731-F).........................................    0938-AG00 
1426        Payment for Extracorporeal Shock Wave Lithotripsy Services Furnished by Ambulatory                  
            Surgical Centers (BPD-762-FN).........................................................    0938-AG04 
1427        Revised Medicaid Management Information Systems (MB-38-FN)............................    0938-AG10 
1428        Intermediary and Carrier Checks That Are Lost, Stolen, Defaced, Mutilated, Destroyed,               
            or Paid on Forged Endorsements (BPO-114-FC)...........................................    0938-AG16 
1429        Revisions to the Definition of End-Stage Renal Disease and Resumption of Entitlement                
            (BPD-738-F)...........................................................................    0938-AG19 
1430        Medicare Program: Proposed Additions to and Deletions From the Current List of Covered              
            Surgical Procedures for Ambulatory Surgical Centers (BPD-776-FN)......................    0938-AG27 
1431        Medicare Program: Special Payment Limits for Home Blood Glucose Monitors (BPD-778-FN).    0938-AG28 
1432        General Evaluation Criteria and Standards for Evaluating Performance of Contract (HSQ-              
            207-GNC)..............................................................................    0938-AG32 
1433        Changes in Physician Attestation Requirements (BPD-769-F).............................    0938-AG34 
1434        Withdrawal of Coverage of Diagnostic Nocturnal Penile Tumescence Testing (Impotence                 
            Testing) (BPD-780-FN).................................................................    0938-AG43 
1435        Part A Premium for 1995 for the Uninsured Aged and for Certain Disabled Individuals                 
            Who Have Exhausted Other Entitlement (OACT-046-N).....................................    0938-AG49 
1436        Medicare Program: Monthly Actuarial Rates and Monthly Supplementary Medical Insurance               
            Premium Rates Beginning January 1, 1995 (OACT-047-N)..................................    0938-AG50 
1437        Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance                   
            Amounts for 1995 (OACT-048-N).........................................................    0938-AG51 
1438        Reductions in Payments for HHA Services (BPD-793-NC)..................................    0938-AG54 
1439        Reductions in Payments for SNF Services (BPD-795-NC)..................................    0938-AG56 
1440        Required Laboratory Procedures for Rural Health Clinics (BPD-783-FC)..................    0938-AG62 
1441        Freedom of Choice Waiver; Conforming Changes (MB-68-IFC)..............................    0938-AG63 
1442        Self-Implementing Coverage and Payment Provisions: 1993 Legislation (BPD-791-FC)......    0938-AG64 
1443        Payment to Swing Bed Hospitals (BPD-805-FC)...........................................    0938-AG68 
1444        Physician Performance Standard Rates of Increase for FY 1995 and Physician Fee                      
            Schedule Update for CY 1995 (BPD-807-FNC).............................................    0938-AG69 
1445        Categorization of CLIA Tests and Personnel Modifications (HSQ-216-FC).................    0938-AG71 
1446        Final Limitations on Aggregate Payments to Disproportionate Share Hospitals: Federal                
            Fiscal Year 1994 (MB-088-N)...........................................................    0938-AG74 
1447        Small Business Innovation Research Grants for FY 95 (ORD-068-N).......................    0938-AG76 
1448        Medicaid Program: Fees for Vaccine Administration Under Pediatric Immunization Program              
            (MB-084-N)............................................................................   0938-AG77  
----------------------------------------------------------------------------------------------------------------


                            Health Care Financing Administration--Completed Actions                             
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
 Number                                                                                                Number   
----------------------------------------------------------------------------------------------------------------
1449        Payment for the Cost of Malpractice Insurance for Hospitals Excluded From the                       
            Prospective Payment System (BPD-437-P)................................................    0938-AC97 
1450        Changes Concerning the Investment Income Offset Policy (BPD-481-P)....................    0938-AD72 
1451        Diagnosis Codes on Physician Bills (BPD-610-F)........................................    0938-AE06 
1452        HMOs: Group Specific Ratings (OCC-009-F)..............................................    0938-AE24 
1453        Aggregation of Medicare Claims for Administrative Law Judge (ALJ) Hearings and                      
            Judicial Review (BPD-694-F)...........................................................    0938-AE93 
1454        General Notice on Medicare Secondary Payment (BPO-94-GN)..............................    0938-AF05 
1455        Granting and Withdrawal of Deeming Authority to National Accreditation Organizations                
            (HSQ-159-F)...........................................................................    0938-AF17 
1456        Self-Implementing Coverage and Payment Provisions of Omnibus Budget Reconciliation Act              
            of 1990 (BPD-725-N)...................................................................    0938-AF27 
1457        Preadmission Review and Authorization, Outpatient Surgery, Preadmission Diagnostic                  
            Testing, and Same Day Surgery Under Medicaid (MB-021P)................................    0938-AF35 
1458        Durable Medical Equipment (DME) Medical Necessity Forms (BPD-734-FC)..................    0938-AF51 
1459        Injectables for Osteoporosis (BPD-735-FC).............................................    0938-AF52 
1460        Medicare Coverage of EPO for Home Use by Home Dialysis Patients (BPD-737-F)...........    0938-AF54 
1461        Designation of Regional Carriers To Process Claims for Durable Medical Equipment,                   
            Prosthetics, Orthotics, and Supplies (BPO-102-F)......................................    0938-AF59 
1462        Uniform Payment Mechanism for Hospitals Under Part A of Medicare (BPO-104-FN).........    0938-AF60 
1463        Medicaid Qualifying Trusts (MB-011-P).................................................    0938-AF61 
1464        Exemption of Low-Income Pregnant Women From Eligibility Condition of Establishing                   
            Paternity and Seeking Support (MB-048-F)..............................................    0938-AF65 
1465        Home and Community-Based Care as an Optional Service (MB-053-IFC).....................    0938-AF70 
1466        Revisions to Criteria and Standards for Evaluating Intermediaries and Carriers (BP0-                
            083-F)................................................................................    0938-AF84 
1467        Medicare Program: Peer Review Organization; General Criteria and Standards for                      
            Evaluating Performance of Contract Obligations (HSQ-200-NC)...........................    0938-AF89 
1468        Computer Matching and Privacy Protection for Medicaid Eligibility (MB-057-F)..........    0938-AF91 
1469        Medicare Program: Coverage of Certified Nurse-Midwife Services (BPD-496-P)............    0938-AG02 
1470        Medicaid Prescription Drug Coverage: Scope and Limitations (MB-067-P).................    0938-AG13 
1471        Use of Federally Standardized Claims Processing Forms and Procedures (MB-069-P).......    0938-AG14 
1472        Update of EPO Payment Rate for 1993 (BPD-768-PN)......................................    0938-AG15 
1473        Revisions to Payment Policies Under the Physician Fee Schedule (BPD-770-FC)...........    0938-AG22 
1474        Physician Performance Standard Rates of Increase for 1994 (BPD-774-FC)................    0938-AG25 
1475        Medicaid Coverage of Personal Care Services Outside the Home (MB-071-P)...............    0938-AG36 
1476        Medicaid Covered Outpatient Drugs Under Drug Rebate (DVA Law) (MB-072-P)..............    0938-AG37 
1477        Part A Premium for 1994 for the Uninsured Aged and for Certain Disabled Individuals                 
            Who Have Exhausted Other Entitlement (OACT-043-N).....................................    0938-AG39 
1478        Monthly Actuarial Rates and Monthly Supplementary Medical Insurance Premium Rates                   
            Beginning January 1, 1994 (OACT-044-N)................................................    0938-AG40 
1479        Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance                   
            Amounts for 1994 (OACT-045-N).........................................................    0938-AG41 
1480        Schedule of Limits on Home Health Agency Costs Per Visit for Cost Reporting Periods                 
            Beginning on or After July 1, l994 (BPD-786-NC).......................................    0938-AG47 
1481        Limitations on Aggregate Payments to Disproportionate Share Hospitals: Federal Fiscal               
            Year 1994 (MB-079-N)..................................................................   0938-AG61  
----------------------------------------------------------------------------------------------------------------


                         Administration for Children and Families--Proposed Rule Stage                          
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
 Number                                                                                                Number   
----------------------------------------------------------------------------------------------------------------
1482        Foster Care, Adoption Assistance, and Child Welfare Services..........................    0970-AA97 
1483        Amendments to Developmental Disabilities Rules........................................    0970-AB11 
1484        Child Abuse and Neglect State Grant Program...........................................    0970-AB23 
1485        Standards for Safe Transportation.....................................................    0970-AB24 
1486        Title IV-E Training...................................................................    0970-AB25 
1487        State Legalization Impact Assistance Grant............................................    0970-AB28 
1488        Standards for Purchase of Facilities..................................................    0970-AB31 
1489        National Voter Registration Act of 1993 Provisions Affecting Public Assistance                      
            Agencies..............................................................................    0970-AB32 
1490        Child Care--Revised Regulations.......................................................    0970-AB33 
1491        Family Preservation and Support.......................................................    0970-AB34 
1492        Notice of Proposed Rulemaking for the Administration of Native Americans 45 CFR Part                
            1336..................................................................................    0970-AB37 
1493        Interstate Case Closure...............................................................    0970-AB41 
1494        Refugee Resettlement Program: Miscellaneous Changes...................................    0970-AB42 
1495        Direct Payments to Indian Tribes and Tribal Organizations under Title IV-B, Subpart 1.    0970-AB44 
1496        Repatriation - Advance Approval of Costs..............................................   0970-AB45  
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Final Rule Stage                           
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
 Number                                                                                                Number   
----------------------------------------------------------------------------------------------------------------
1497        Aid to Families With Dependent Children Program; Extension of Medicaid Eligibility                  
            When Support Collections Result in Termination of AFDC Eligibility....................    0970-AA07 
1498        Revisions of Child Support Enforcement Program and Audit Regulations..................    0970-AA74 
1499        Head Start Performance Standards for Infants, Toddlers, and Pregnant Women............    0970-AB04 
1500        Technical Changes to the AFDC Program as Required by OBRA 90..........................    0970-AB14 
1501        Block Grant Programs (Low-Income Home Energy Assistance Program --LIHEAP) FY 91 and FY              
            92 Provisions.........................................................................    0970-AB15 
1502        Block Grant Programs (Low-Income Home Energy Assistance Program--LIHEAP)--FY 93 and FY              
            94 Provisions.........................................................................    0970-AB16 
1503        Family Violence Prevention and Services...............................................    0970-AB18 
1504        Statewide Automated Child Welfare Information System..................................    0970-AB38 
1505        Automatic Data Processing Equipment and Services; Conditions for Federal Financial                  
            Participation and General Administration - Public Assistance Programs.................    0970-AB39 
1506        Paternity Establishment Provisions of the Omnibus Budget Reconciliation Act of 1993...   0970-AB40  
----------------------------------------------------------------------------------------------------------------


                          Administration for Children and Families--Completed Actions                           
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
 Number                                                                                                Number   
----------------------------------------------------------------------------------------------------------------
1507        Disregards of Income and Resources....................................................    0970-AA70 
1508        Essential Persons.....................................................................    0970-AA93 
1509        Adoption and Foster Care Analysis and Reporting System................................    0970-AB05 
1510        Social Services Block Grant Information Collection....................................    0970-AB06 
1511        Refugee Cash Assistance and Refugee Medical Assistance................................    0970-AB27 
1512        Elimination of Enhanced Funding for AFDC..............................................    0970-AB35 
1513        Increase in Stepparent Income Disregard...............................................   0970-AB36  
----------------------------------------------------------------------------------------------------------------


                                  Administration on Aging--Proposed Rule Stage                                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
 Number                                                                                                Number   
----------------------------------------------------------------------------------------------------------------
1514        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)
  
_______________________________________________________________________
 
1113. NONDISCRIMINATION REQUIREMENTS (INCLUDING ON THE BASIS OF SEX OR 
RELIGION) APPLICABLE TO BLOCK GRANTS AND STANDARD NONDISCRIMINATION 
PROCEDURES APPLICABLE TO CERTAIN OTHER PROGRAMS

Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Yes

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                     51 FR 2806
Second NPRM                     06/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Office of the Secretary (OS)
  
_______________________________________________________________________
 
1114. CIVIL MONEY PENALTIES (CMPS) FOR CERTAIN HOSPITAL PHYSICIAN 
INCENTIVE PLANS

Significance:
Subject to OMB review: Undetermined

Legal Authority:  PL 99-509, Sec 9313

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                            09/00/94
NPRM Comment Period End         11/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Office of the Secretary (OS)
  
_______________________________________________________________________
 
1115. CIVIL MONEY PENALTIES (CMPS) FOR CERTAIN PRACTICES RELATING TO 
MEDICARE SUPPLEMENTAL POLICIES

Significance:
Subject to OMB review: Undetermined

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Office of the Secretary (OS)
  
_______________________________________________________________________
 
1116. UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND COOPERATIVE 
AGREEMENTS

Significance:
Subject to OMB review: Yes

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. OMB will update rules for governmental grantees at a 
future time.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            05/00/94
Final Action                    09/00/94
45 CFR 74  NPRM 06/24/87 (52 FR 23729)  NPRM Comment Period End 08/23/
87

45 CFR 92  NPRM 11/04/88 (53 FR 44715)  NPRM Comment Period End 01/03/
89  NPRM Canceled 10/29/90 (55 FR 45289)

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Office of the Secretary (OS)
  
_______________________________________________________________________
 
1117. REVISIONS TO THE PRO SANCTIONS PROCESS

Significance:
Subject to OMB review: Yes

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

CFR Citation:  42 CFR 1004

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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

RIN: 0991-AA73
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Office of the Secretary (OS)
  
_______________________________________________________________________
 
1118. CLARIFICATION OF THE OIG SAFE HARBOR ANTI-KICKBACK PROVISIONS

Significance:
Subject to OMB review: Undetermined

Legal Authority:  PL 100-93, sec 14

CFR Citation:  42 CFR 1001

Legal Deadline: None

Abstract: This rule would clarify various aspects of the original set 
of safe harbor provisions that were published on July 29, 1991 (56 FR 
35953) and that are currently set forth in 42 CFR 1001.952(a)-(k). This 
clarifying rule would modify the final safe harbor provisions to give 
greater clarity to their original intent.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            08/00/94
NPRM Comment Period End         10/00/94

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

RIN: 0991-AA74
_______________________________________________________________________
  

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Office of the Secretary (OS)
  
_______________________________________________________________________
 
1119. CIVIL MONEY PENALTIES AND EXCLUSIONS FOR ASSISTANTS AT CATARACT 
SURGERY

Significance:
Subject to OMB review: Undetermined

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                    10/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Office of the Secretary (OS)
  
_______________________________________________________________________
 
1120. CIVIL MONEY PENALTIES AND INTERMEDIATE SANCTIONS FOR HMOS AND 
COMPETITIVE MEDICAL PLANS

Legal Authority:  PL 99-509, Sec 9312; PL 99-509, Sec 9434; PL 100-203, 
Sec 4014; PL 100-360, Sec 224; PL 100-360, Sec 411; PL 101-239, Sec 
6411

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

Legal Deadline: None

Abstract: This final rule will broaden the Secretary's authority to 
impose intermediate sanctions and civil money penalties against 
eligible organizations that substantially fail to provide Medicare or 
Medicaid enrollees with required medically necessary items and 
services, or that practice certain marketing, enrollment, reporting or 
claims payment abuses.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            07/22/91                    56 FR 33403
NPRM Comment Period End         09/20/91
Final Action                    08/00/94

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-AA44
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Office of the Secretary (OS)
  
_______________________________________________________________________
 
1121. BLOCK GRANT PROGRAMS

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Regulatory Plan entry: Undetermined

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: Glenn Kamber, Department of Health and Human Services, 
Office of the Secretary, 200 Independence Avenue SW., Washington, DC 
20201, 202 690-7150

RIN: 0991-AA55
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Office of the Secretary (OS)
  
_______________________________________________________________________
 
1122. 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)

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                    10/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Office of the Secretary (OS)
  
_______________________________________________________________________
 
1123. ADDITIONAL SAFE HARBOR PROVISIONS UNDER THE ANTI-KICKBACK STATUTE

Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Yes

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                    10/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Office of the Secretary (OS)
  
_______________________________________________________________________
 
1124. SAFE HARBORS FOR PROTECTING HEALTH PLANS

Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Yes

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                    09/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Office of the Secretary (OS)
  
_______________________________________________________________________
 
1125. GOVERNMENTWIDE GUIDANCE FOR NEW RESTRICTIONS ON LOBBYING; INTERIM 
FINAL GUIDANCE

Significance:
Subject to OMB review: Yes

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
_______________________________________________________________________
  

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Office of the Secretary (OS)
  
_______________________________________________________________________
 
1126. EQUAL OPPORTUNITY IN EMPLOYMENT: PUBLIC BROADCASTING, PUBLIC RADIO, 
AND PUBLIC TELECOMMUNICATIONS ENTITIES RECEIVING FEDERAL FUNDS FROM THE 
CORPORATION FOR PUBLIC BROADCASTING

CFR Citation:  45 CFR 87.1-40

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn - The proposed 
regulation is of low priority.  02/14/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Marcella Haynes, 202 619-0671

RIN: 0991-AA22
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Office of the Secretary (OS)
  
_______________________________________________________________________
 
1127. TITLE VI OF THE CRA OF 1964, SUBPART B--NATIONAL ORIGIN 
DISCRIMINATION IN PROGRAMS RECEIVING FED. FINANCIAL ASSISTANCE FROM THE 
DHHS AGAINST PERSONS OF LIMITED ENGLISH PROFICIENCY

CFR Citation:  45 CFR 80

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn - If warranted based 
on funding, may be reintroduced.02/14/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Marcella Haynes, 202 619-0671

RIN: 0991-AA72
_______________________________________________________________________
  

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Departmental Management (HHSDM)
  
_______________________________________________________________________
 
1128. IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT IN AGENCY 
PROCEEDINGS

Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Yes

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                    05/00/94
Final Action Effective          05/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Eileen Bradley, 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)
  
_______________________________________________________________________
 
1129. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL 
SECURITY INCOME PROGRAMS; ADJUSTMENTS IN SSI BENEFITS ON ACCOUNT OF 
RETROACTIVE BENEFITS UNDER TITLE II (061P)

Significance:
Subject to OMB review: Undetermined

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1130. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL 
SECURITY INCOME PROGRAMS; EVALUATION GUIDES FOR DETERMINING SUBSTANTIAL 
GAINFUL ACTIVITY (SGA) (147P)

Significance:
Subject to OMB review: Undetermined

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                            04/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1131. 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                            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-AC16
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1132. OLD-AGE, SURVIVORS AND DISABILITY INSURANCE AND SUPPLEMENTAL 
SECURITY INCOME PROGRAMS; VOCATIONAL FACTORS REGULATIONS RESTRUCTURING 
AND CLARIFICATION (207P)

Significance:
Subject to OMB review: Undetermined

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1133. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL 
SECURITY INCOME PROGRAMS; INTERIM DISABILITY BENEFITS (215P)

Significance:
Subject to OMB review: Undetermined

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1134. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL 
SECURITY INCOME PROGRAMS; APPEALS COUNCIL NOTICE REQUIREMENTS (235P)

Significance:
Subject to OMB review: Undetermined

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: Philip Berge, Legal Assistant, Department of Health and 
Human Services, Social Security Administration, Office of Regulations, 
6401 Security Boulevard, Baltimore, MD 21235, 410 965-1769

RIN: 0960-AC93
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1135. 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) and (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                    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-AC98
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1136. SUPPLEMENTAL SECURITY INCOME PROGRAM; AUGMENTED BENEFITS (271P)

Significance:
Subject to OMB review: Undetermined

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1137. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL 
SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED; REPRESENTATIVE PAYEE 
REFORMS (295F)

Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Yes

Legal Authority:  PL 101-508, Sec 5105

CFR Citation:  20 CFR 404.902; 20 CFR 404.2001; 20 CFR 404.2011; 20 CFR 
404.2022; 20 CFR 404.2024; 20 CFR 404.2025; 20 CFR 404.2030; 20 CFR 
404.2041; 20 CFR 404.2050; 20 CFR 416.601; 20 CFR 416.611; 20 CFR 
416.622; 20 CFR 416.624; 20 CFR 416.625; 20 CFR 416.630; ...

Legal Deadline: None

Abstract: These regulations, which reflect certain provisions of PL 
101-508, modify existing representative payee procedures by requiring 
the Social Security Administration (SSA) to do a more extensive 
investigation of representative payee applicants; generally limit to 1 
month the deferral or suspension of direct payment of benefits pending 
selection of a payee; provide stricter standards in determining the 
fitness of representative payee applicants to manage benefit payments 
on behalf of beneficiaries; require SSA to repay to the beneficiary or 
an alternate payee, an amount equal to any misused funds resulting from 
SSA's negligent failure to investigate or monitor a representative 
payee; and require SSA to compile and maintain a centralized file of 
certain beneficiary and payee information.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            03/15/94                    59 FR 11949
NPRM Comment Period End         05/16/94
Final Action                    12/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Philip Berge, Legal Assistant, Department of Health and 
Human Services, Social Security Administration, Office of Regulations, 
6401 Security Boulevard, Baltimore, MD 21235, 410 965-1769

RIN: 0960-AD22
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1138. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL 
SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED; FEES FOR 
REPRESENTATION OF CLAIMANTS (296P)

Significance:
Subject to OMB review: Undetermined

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: Philip Berge, Legal Assistant, Department of Health and 
Human Services, Social Security Administration, Office of Regulations, 
6401 Security Boulevard, Baltimore, MD 21235, 410 965-1769

RIN: 0960-AD23
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1139. OASDI AND SSI FOR THE AGED, BLIND AND DISABLED; CONTINUATION OF 
BENEFITS ON ACCOUNT OF PARTICIPATION IN A NON-STATE VR PROGRAM (299P)

Significance:
Subject to OMB review: Undetermined

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1140. SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED; 
EXCLUSION FROM INCOME AND RESOURCES OF VICTIMS' COMPENSATION PAYMENTS AND 
STATE RELOCATION ASSISTANCE (311P)

Significance:
Subject to OMB review: Yes

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                            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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1141. SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED; 
REIMBURSEMENT FOR VR SERVICES FURNISHED DURING CERTAIN MONTHS OF NON-
PAYMENT (315P)

Significance:
Subject to OMB review: Undetermined

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1142. CODE OF CONDUCT FOR ADMINISTRATIVE LAW JUDGES AND ADMINISTRATIVE 
APPEALS JUDGES OF THE SOCIAL SECURITY ADMINISTRATION (341P)

Significance:
Subject to OMB review: Undetermined

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: Philip Berge, Legal Assistant, Office of Regulations, 
Department of Health and Human Services, Social Security 
Administration, 6401 Security Boulevard, Baltimore, MD 21235, 410 965-
1769

RIN: 0960-AD54
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1143. ELECTION OF BENEFITS BASED ON AGE BY DISABLED WIDOW, WIDOWER, AND 
SURVIVING DIVORCED SPOUSE BENEFICIARIES (343P)

Significance:
Subject to OMB review: Undetermined

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                            07/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1144. AGAINST EQUITY AND GOOD CONSCIENCE (348P)

Significance:
Subject to OMB review: Undetermined

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1145. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE PROGRAM; REVISED 
MEDICAL CRITERIA FOR DETERMINATION OF DISABILITY; HEMIC AND LYMPHATIC 
SYSTEM, AND MALIGNANT NEOPLASTIC DISEASES (399P)

Significance:
Subject to OMB review: Yes

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

CFR Citation:  20 CFR 404.1500ff.appendix 1

Legal Deadline: None

Abstract: Sections 7.00 and 107.00 (hemic and lymphatic system), and 
13.00 and 113.00 (malignant neoplastic diseases) of appendix 1 to 
Subpart P of Part 404 of the Disability Regulations (404.1501 through 
404.1599) describe those impairments which are considered severe enough 
to prevent a person from engaging in any gainful activity, or in the 
case of a child under age 18, age-appropriate activities. We are 
proposing revisions to these sections to ensure that the medical 
evaluation criteria are up-to-date and consistent with the latest 
advances in medical knowledge and treatment. The Supplemental Security 
Income program incorporates and uses the same medical criteria as the 
Old-Age, Survivors, and Disability Insurance program.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/00/94
Interim Final Rule              10/00/95
Final Action                    10/00/95

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, Baltimore, MD 21235, 410 965-6243

RIN: 0960-AD67
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1146. PROCEDURES FOR HANDLING EARNINGS REPORTS (418P)

Significance:
Subject to OMB review: Undetermined

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                            09/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1147. FEDERAL OASDI AND SSI; COMPUTING BENEFIT AMOUNTS, DISPOSING OF 
UNDERPAYMENTS, RESOLVING OVERPAYMENTS, AND PAYMENT RESTRICTION (428P)

Significance:
Subject to OMB review: Undetermined

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                            05/00/94

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-AD72
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1148. CONDUCT OF REPRESENTATIVES UNDER TITLE II OR TITLE XVI (431P)

Significance:
Subject to OMB review: Undetermined

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: Philip Berge, Legal Assistant, Department of Health and 
Human Services, Social Security Administration, 6401 Security 
Boulevard, Baltimore, MD 21235, 410 965-1769

RIN: 0960-AD73
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1149. STATEMENT OF EARNINGS AND BENEFIT ESTIMATE (415P)

Significance:
Subject to OMB review: Yes

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                            08/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1150.  FEES FOR FEDERAL ADMINISTRATION OF STATE SUPPLEMENTARY 
PAYMENTS IN THE SSI PROGRAM (376P)

Significance:
Subject to OMB review: Yes

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1151.  WHO MAY PROTECT A POTENTIAL CLAIMANT'S FILING DATE OR 
APPLICATION FOR SUPPLEMENTAL SECURITY INCOME BENEFITS (408P)

Significance:
Subject to OMB review: Undetermined

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1152.  RELIABLE INFORMATION WHICH IS CURRENTLY AVAILABLE FOR 
DETERMINING BENEFIT AMOUNTS IN THE SUPPLEMENTAL SECURITY INCOME PROGRAM 
(NEWMAN) (434P)

Significance:
Subject to OMB review: Undetermined

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1153.  REVISED MEDICAL CRITERIA FOR DETERMINATION OF DISABILITY, 
ENDOCRINE SYSTEM AND OBESITY AND RELATED CRITERIA (436P)

Significance:
Subject to OMB review: Undetermined

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

CFR Citation:  20 CFR 404.1500ff, appendix 1

Legal Deadline: None

Abstract: Sections 9.00 and 109.00 of appendix 1 to subpart P of part 
404 of the Disability Regulations (404.1501 through 404.1599) describe 
those impairments which are considered severe enough to prevent a 
person from engaging in any gainful activity, or in the case of a child 
under age 18, age-appropriate activities. We are proposing to revise 
the criteria in these sections to reflect advances in medical 
knowledge, treatment, and methods of evaluating endocrine impairments. 
The Supplemental Security Income program incorporates and uses the same 
medical criteria as the Old-Age, Survivors and Disability Insurance 
program.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Cassandra A. 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-AD78
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1154.  FEDERAL OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE; 
EVIDENCE REQUIRED TO PRESUME A PERSON IS DEAD (443P)

Significance:
Subject to OMB review: Undetermined

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                            09/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Philip Berge, Legal Assistant, Department of Health and 
Human Services, Social Security Administration, Office of Regulations, 
6401 Security Boulevard, Baltimore, MD 21235, 410 965-1769

RIN: 0960-AD79
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1155.  REVISED MEDICAL CRITERIA FOR DETERMINATION OF DISABILITY, 
GROWTH IMPAIRMENTS (444P)

Significance:
Subject to OMB review: Undetermined

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

CFR Citation:  29 CFR 404.1500ff appendix 1

Legal Deadline: None

Abstract: Section 100.00 of part B of appendix 1 to subpart P of part 
404 of the Disability Regulations (404.1501 through 404.1599) describe 
those impairments which are considered severe enough to prevent a child 
under age 18 from engaging in age-appropriate activities. We are 
proposing revisions to the criteria in Part B of the Listing of 
Impairments that we use to evaluate growth impairments of persons under 
the age of 18 who claim Social Security or Supplemental Security Income 
benefits based on Disability under Title II and Title XVI of the Social 
Security Act. The revisions contained in these regulations reflect 
advances in medical knowledge, treatment, and methods of evaluating 
growth impairments. The Supplemental Security Income program 
incorporates and uses the same medical criteria as the Old-Age, 
Survivors, and Disability Insurance program.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/00/94
Final Action                    09/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Harry 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-AD80
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1156.  ELIGIBILITY FOR CHILDREN OF ARMED FORCES PERSONNEL 
RESIDING OUTSIDE THE UNITED STATES OTHER THAN IN FOREIGN COUNTRIES (452P)

Significance:
Subject to OMB review: Undetermined

Legal Authority:  42 USC 1382c

CFR Citation:  20 CFR 416.215

Legal Deadline: None

Abstract: Effective November 1, 1993, section 13734 of Pub. L. 103-66 
provides that supplemental security income (SSI) benefits may continue 
to be paid to blind or disabled children who are United States citizens 
and accompany their military parents to assignments in Puerto Rico or 
the territories and possessions of the United States. Prior 
legislation, which allowed continuation of SSI payments to children 
whose parents were stationed in foreign countries as of April 1990, did 
not permit continuation of SSI payments to these children. This change 
in the law requires that we revise the regulation at 20 CFR 416.215.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            05/00/94

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-AD81
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1157.  VALUATION OF CERTAIN IN-KIND SUPPORT AND MAINTENANCE (ISM) 
WHERE THERE IS A COST-OF-LIVING ADJUSTMENT IN SSI BENEFITS (454P)

Significance:
Subject to OMB review: Undetermined

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                            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 Boulevard, Baltimore, MD 21235, 410 965-1759

RIN: 0960-AD82
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1158.  RELATIONSHIP/COVERAGE ACTIONS NOTE INITIAL DETERMINATIONS/
SSI CORRECTIONS (455P)

Significance:
Subject to OMB review: Undetermined

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1159.  REPLACEMENT OF LOST, DAMAGED OR STOLEN EXCLUDED RESOURCES 
(HURRICANE ANDREW) (458I)

Significance:
Subject to OMB review: Undetermined

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

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1160.  PREVENTION OF ADVERSE EFFECTS ON ELIGIBILITY AND BENEFIT 
AMOUNT WHEN SPOUSE OR PARENT ABSENT DUE TO ACTIVE MILITARY SERVICE (462P)

Significance:
Subject to OMB review: Undetermined

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
_______________________________________________________________________
  

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1161. SUPPLEMENTAL SECURITY INCOME PROGRAM; SUSPENSIONS, TERMINATIONS, 
AND ADVANCE NOTICE OF ADVERSE DETERMINATIONS (031F)

Significance:
Subject to OMB review: Undetermined

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1162. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE PROGRAM; REVISED 
MEDICAL CRITERIA FOR DETERMINATION OF DISABILITY; MUSCULOSKELETAL SYSTEM 
(143F)

Significance:
Subject to OMB review: Yes

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

CFR Citation:  20 CFR 404.1500ff, appendix 1

Legal Deadline: None

Abstract: Sections 1.00 and 101.00 of appendix 1 to the Disability 
Regulations (404.1501 through 404.1599) describe those musculoskeletal 
impairments which are considered severe enough to prevent a person from 
doing any gainful activity or, in the case of a child under age 18, 
age-appropriate activities. We are proposing comprehensive revisions to 
these sections to ensure that the medical evaluation criteria are up to 
date and consistent with the latest advances in medicine. The 
Supplemental Security Income program incorporates by reference and uses 
the same medical criteria as the Old-Age, Survivors, and Disability 
Insurance program.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/21/93                    58 FR 67574
NPRM Comment Period End         02/22/94
Final Action                    12/00/94

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 Blvd., Baltimore, MD 21235, 410 965-1758

RIN: 0960-AB01
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1163. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL 
SECURITY INCOME PROGRAM; CONTINUED PAYMENT OF BENEFITS TO PERSONS IN 
VOCATIONAL REHABILITATION PROGRAMS (131F)

Significance:
Subject to OMB review: Undetermined

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1164. SUPPLEMENTAL SECURITY INCOME PROGRAM; WHAT IS NOT INCOME (121F)

Significance:
Subject to OMB review: Yes

Legal Authority:  42 USC 1382a

CFR Citation:  20 CFR 416.1103(a)

Legal Deadline: None

Abstract: The rule changes SSI policy to consider Department of 
Veterans Affairs payments resulting from unusual medical expenses not 
to be income for SSI purposes.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            08/24/88                    53 FR 32252
NPRM Comment Period End         10/24/88
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-AB09
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1165. SUPPLEMENTAL SECURITY INCOME PROGRAM; CONTINUATION OF BENEFITS AND 
SPECIAL ELIGIBILITY FOR CERTAIN SEVERELY IMPAIRED RECIPIENTS WHO WORK 
(171F)

Significance:
Subject to OMB review: Undetermined

Legal Authority:  PL 99-643, Sec 2; PL 99-643, Sec 4; PL 101-508, Sec 
5032; PL 101-508, Sec 5033; 42 USC 1382a; 42 USC 1382h

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

Legal Deadline: None

Abstract: These proposed regulations will implement statutory changes 
contained in sections 2 and 4 of PL 99-643. These provisions: (1) make 
section 1619 of the Social Security Act permanent; and (2) simplify the 
transitions among regular SSI status, special benefit status, and 
special Supplemental Security Income status for Medicaid purposes. The 
proposed regulations also will involve the statutory change contained 
in sections 5032 and 5033 of Pub. L. 101-508 which eliminate the age-65 
limit for eligibility for special Supplemental Security Income status 
for Medicaid purposes and which liberalizes the impairment-related work 
exclusion of section 1612(b)(4)(B)(ii).

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            10/08/93                    58 FR 52458
NPRM Comment Period End         12/07/93
Final Action                    12/00/94

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 Blvd., Baltimore, MD 21235, 410 965-1758

RIN: 0960-AC22
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1166. 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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1167. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE PROGRAM; APPLICABILITY 
OF GOVERNMENT PENSION TO CERTAIN FEDERAL EMPLOYEES (188F)

Significance:
Subject to OMB review: Undetermined

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1168. 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                    06/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1169. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE PROGRAM; MEDICAL 
CRITERIA FOR EVALUATING MENTAL DISORDERS FOR ADULTS (222F)

Significance:
Subject to OMB review: Undetermined
Regulatory Plan entry: Yes

Legal Authority:  42 USC 405; 42 USC 1382c

CFR Citation:  20 CFR 404.1500ff, app 1; 20 CFR 404.1520a; 20 CFR 
404.1528; 20 CFR 416.920a; 20 CFR 416.928

Legal Deadline: None

Abstract: These amendments revise the medical evaluation criteria for 
mental disorders for the Social Security and Supplemental Security 
Income disability programs. The revisions will reflect advances in 
medical treatment and in methods of evaluating certain mental 
impairments and will provide up-to-date medical criteria for use in the 
evaluation of disability claims based on mental disorders.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            07/18/91                    56 FR 33130
NPRM Comment Period End         09/18/91
Final Action                    08/00/94

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-AC74
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1170. SUPPLEMENTAL SECURITY INCOME PROGRAM; TREATMENT OF AUGMENTED 
VETERANS' BENEFITS (231F)

Significance:
Subject to OMB review: Undetermined

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                    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-AC82
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1171. SUPPLEMENTAL SECURITY INCOME PROGRAM; WAIVER OF SSI RULE FOR 
DEEMING TO CHILDREN THE INCOME AND RESOURCES OF THEIR PARENTS FOR CERTAIN 
DISABLED CHILDREN (252F)

Significance:
Subject to OMB review: Undetermined

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                    00/00/00

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1172. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL 
SECURITY INCOME PROGRAMS; DEEMED APPLICATION DATE BASED ON MISINFORMATION 
(267F)

Significance:
Subject to OMB review: Undetermined

Legal Authority:  42 USC 402(j); 42 USC 1383(e); PL 101-239, Sec 10302

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

Legal Deadline: None

Abstract: These regulations implement section 10302 of P.L. 101-239 
which provides for the establishment of a deemed filing date of an 
application for Social Security or Supplemental Security Income 
benefits in any case where it is determined to the satisfaction of the 
Secretary that an individual failed to apply for these benefits because 
of misinformation provided to the individual by an officer or employee 
of the Social Security Administration about the individual's 
eligibility for the benefits.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            10/16/92                    57 FR 47415
NPRM; Amendment                 01/22/93                     58 FR 5687
NPRM Comment Period End         03/23/93
Final Action                    05/00/94

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-AD05
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1173. SUPPLEMENTAL SECURITY INCOME PROGRAM; FINANCIAL INSTITUTION 
ACCOUNTS IN THE SSI PROGRAM (278F)

Significance:
Subject to OMB review: Yes

Legal Authority:  42 USC 1383

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

Legal Deadline: None

Abstract: Title XVI of the Act and SSI regulations are silent on the 
issue of how funds held in accounts at financial institutions are 
attributed for resource purposes. These regulations provide criteria to 
be used for determining ownership of financial institution accounts.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            05/27/92                    57 FR 22187
NPRM Comment Period End         07/27/92
Final Action                    04/00/94

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-AD10
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1174. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL 
SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED; UPDATING NOMENCLATURE 
(264F)

Significance:
Subject to OMB review: Undetermined

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1175. SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED; 
TREATMENT OF CERTAIN ROYALTIES AND HONORARIA (310F)

Significance:
Subject to OMB review: Undetermined

Legal Authority:  PL 101-508, Sec 5034(a)(1)(B); 42 USC 1382a(a)(1)(E)

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

Legal Deadline: None

Abstract: These regulations amend the Supplemental Security Income 
regulations to reflect a statutory change in the treatment of royalties 
in connection with any publication of the works of an individual and 
that portion of honoraria received for services rendered, from unearned 
income to earned income.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            10/08/93                    58 FR 52464
NPRM Comment Period End         12/07/93
Final Action                    09/00/94

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-AD35
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1176. 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                    12/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Philip Berge, Legal Assistant, Office of Regulations, 
Department of Health and Human Services, Social Security 
Administration, 6401 Security Boulevard, Baltimore, Maryland 21235, 410 
965-1769

RIN: 0960-AD45
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1177. SUPPLEMENTAL SECURITY INCOME PROGRAM; TREATMENT OF PROMISSORY NOTES 
IN HOME REPLACEMENT SITUATIONS (182F)

Significance:
Subject to OMB review: Undetermined

Legal Authority:  42 USC 1382; 42 USC 1382(b)

CFR Citation:  20 CFR 416.1212

Legal Deadline: None

Abstract: This proposed regulation explains how the Social Security 
Administration (SSA) treats promissory notes and similar installment 
sales contracts and the proceeds generated therefrom when received as a 
result of the sale of a home which is excluded from resources under the 
Supplemental Security Income (SSI) program. This proposed regulation 
provides for application of the ``home replacement exclusion'' in these 
situations where timely reinvestment of the installments into another 
home, which is similarly excludable as the principal place of 
residence, is made.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            10/13/93                    58 FR 52943
NPRM Comment Period End         12/13/93
Final Action                    10/00/94

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0960-AD61
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1178. OASDI AND SSI; TESTING MODIFICATIONS TO THE DISABILITY 
DETERMINATION PROCEDURES (359F)

Significance:
Subject to OMB review: Undetermined
Regulatory Plan entry: Yes

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

CFR Citation:  20 CFR 404.906; 20 CFR 416.1406

Legal Deadline: None

Abstract: We propose to add new rules which would establish authority 
to test modifications to the disability determination procedures that 
we follow under titles II and XVI of the Social Security Act. On a 
limited basis, we may test procedures designed to improve the 
disability claims process. These models are designed to provide us with 
comprehensive information regarding the effect of these procedures on 
the disability process. They would enable us to measure whether, and to 
what degree, the disability process may be improved, especially with 
respect to obtaining the correct decision earlier in the process and 
shortening aggregate processing times. We would measure costs and 
determine the feasibility of each model. The intended result of testing 
these models would be to enable SSA to make recommendations for 
national implementation of improvements to the disability process.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            10/22/93                    58 FR 54532
NPRM Comment Period End         01/05/94
Final Action                    09/00/94

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0960-AD63
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1179. 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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1180. APPEAL RIGHTS FOLLOWING STATE-INITIATED MASS CHANGE IN FEDERALLY 
ADMINISTERED STATE SUPPLEMENTARY PAYMENTS RESULTING IN REDUCTION, 
SUSPENSION, OR TERMINATION OF STATE SUPPLEMENTARY PAYMENTS (383F)

Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Yes

Legal Authority:  42 USC 405(a); 42 USC 1302(a); 42 USC 1382e; 42 USC 
1383(d)(1)

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

Legal Deadline: None

Abstract: The regulation addresses the problem of appeals filed by 
supplemental security income recipients whose payments are reduced, 
suspended or terminated because of a decrease in the amount of 
federally administered State supplementary payments. The decrease 
results from a State-initiated across-the-board reduction in the amount 
of State supplementary payments due to legislative or executive action 
by a State. The Social Security Administration cannot change the 
State's decision to reduce the amount of State supplementary payments. 
Therefore, in cases where State-initiated change in the amount of State 
supplementary payments cause a reduction, suspension or termination of 
those payments, only our calculation of the amount of the change in an 
individual's State supplementary payment amount resulting from the 
change is an initial determination subject to administrative and 
judicial review and continuation of benefits. may be appealed.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            08/10/93                    58 FR 42514
NPRM Comment Period End         10/12/93
Final Action                    09/00/94

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-AD66
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1181. COMPENSATION OF QUALIFIED ORGANIZATIONS SERVING AS REPRESENTATIVE 
PAYEES UNDER TITLE II AND TITLE XVI (423F)

Significance:
Subject to OMB review: Undetermined

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: Philip Berge, Legal Assistant, Department of Health and 
Human Services, Social Security Administration, 6401 Security 
Boulevard, Baltimore, MD 21235, 410 965-1769

RIN: 0960-AD71
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1182.  TEMPORARY INCREASE IN SPONSORSHIP PERIOD FOR ALIENS UNDER 
THE SSI PROGRAM (457F)

Significance:
Subject to OMB review: Undetermined

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                    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-AD84
_______________________________________________________________________
  

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1183. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE PROGRAM; REVISED 
MEDICAL CRITERIA FOR DETERMINATION OF DISABILITY; CARDIOVASCULAR SYSTEM 
(141F)

Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Yes

CFR Citation:  20 CFR 404.1500ff, appendix 1

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    02/10/94                     59 FR 6468

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Irving Darrow, 410 966-0512

RIN: 0960-AA99
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1184. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE PROGRAM; REVISED 
MEDICAL CRITERIA FOR DETERMINATION OF DISABILITY; RESPIRATORY SYSTEM 
(142F)

CFR Citation:  20 CFR 404.1500ff, appendix 1

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    10/07/93                    58 FR 52346

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Cassandra Bond, 410 965-1794

RIN: 0960-AB00
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1185. SUPPLEMENTAL SECURITY INCOME PROGRAM; EXCLUSIONS FROM INCOME AND 
RESOURCES OF INDIAN JUDGMENT FUNDS AND PER CAPITA DISTRIBUTIONS (201F)

CFR Citation:  20 CFR 416K Appendix; 20 CFR 416.1234; 20 CFR 416.1236

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    02/23/94                     59 FR 8530

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Duane Heaton, 410 965-8470

RIN: 0960-AB86
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1186. SUPPLEMENTAL SECURITY INCOME PROGRAM; PAYMENT OF BENEFITS DUE 
DECEASED RECIPIENTS (174F)

Significance:
Subject to OMB review: Yes

CFR Citation:  20 CFR 416.340(d); 20 CFR 416.345(e); 20 CFR 416.533; 20 
CFR 416.536; 20 CFR 416.537(b); 20 CFR 416.538(a); 20 CFR 416.538(b); 
20 CFR 416.538(c); 20 CFR 416.538(d); 20 CFR 416.542(b); 20 CFR 
416.542(c); 20 CFR 416.543; 20 CFR 416.1402(k); 20 CFR 416.1402(l); 20 
CFR 416.1402(m); ...

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    10/13/93                    58 FR 52909

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Lawrence V. Dudar, 410 965-1795

RIN: 0960-AC28
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1187. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL 
SECURITY INCOME PROGRAMS; CANCELLED CONSULTATIVE EXAMINATIONS (181F)

CFR Citation:  20 CFR 404.1624; 20 CFR 416.1024

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

No Action Expected in Next 12 
mos                             02/14/94

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0960-AC40
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1188. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL 
SECURITY INCOME PROGRAMS; DETERMINING DISABILITY AND BLINDNESS; FEE 
LIMITATION POLICY FOR PURCHASE OF LABORATORY TESTS (184P)

CFR Citation:  20 CFR 404.1624a (New); 20 CFR 416.1024a (New)

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

No Action Expected in Next 12 
mos                             02/14/94

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0960-AC41
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1189. OLD-AGE, SURVIVORS AND DISABILITY INSURANCE AND SUPPLEMENTAL 
SECURITY INCOME PROGRAMS; DETERMINATION OF DISABILITY--DISABILITY-
DETERMINING STATE AGENCY SUBSTANTIAL FAILURE (206F)

CFR Citation:  20 CFR 404.1641; 20 CFR 404.1670; 20 CFR 404.1680; 20 
CFR 404.1682; 20 CFR 404.1683; 20 CFR 416.1041; 20 CFR 416.1070; 20 CFR 
416.1080; 20 CFR 416.1082; 20 CFR 416.1083

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

No Action Expected in Next 12 
mos                             02/14/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Cassandra A. Bond, 410 965-1794

RIN: 0960-AC60
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1190. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE PROGRAM; SUSPENSION OF 
BENEFITS OF DEPORTED NAZIS; EXEMPTION FROM SOCIAL SECURITY TAXATION 
BECAUSE OF RELIGIOUS BELIEFS (210F)

CFR Citation:  20 CFR 404.305; 20 CFR 404.464; 20 CFR 404.1039 (New); 
20 CFR 404.1068; 20 CFR 404.1075

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    12/10/93                    58 FR 64886

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Lawrence V. Dudar, 410 965-1759

RIN: 0960-AC68
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1191. SUPPLEMENTAL SECURITY INCOME PROGRAM; REDETERMINATIONS OF 
SUPPLEMENTAL SECURITY INCOME ELIGIBILITY (223F)

CFR Citation:  20 CFR 416.204

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    12/10/93                    58 FR 64892

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Duane Heaton, 410 965-8470

RIN: 0960-AC77
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1192. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL 
SECURITY INCOME PROGRAMS; MEDICAL IMPROVEMENT REVIEW STANDARD (MIRS)--
MISCELLANEOUS CHANGES (225P)

CFR Citation:  20 CFR 404.1579; 20 CFR 404.1594; 20 CFR 404.1598; 20 
CFR 416.994; 20 CFR 416.994a; 20 CFR 416.998

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

No Action Expected in Next 12 
mos                             02/14/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Harry J. Short, 410 965-6243

RIN: 0960-AC81
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1193. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL 
SECURITY INCOME PROGRAMS; REPRESENTATION OF CLAIMANTS FOR BENEFITS UNDER 
TITLE II OR TITLE XVI (249F)

CFR Citation:  20 CFR 404.1705; 20 CFR 416.1505

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    12/10/93                    58 FR 64883

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Philip Berge, 410 965-1769

RIN: 0960-AC87
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1194. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL 
SECURITY INCOME PROGRAMS; STANDARDS APPLICABLE IN DETERMINATIONS OF GOOD 
CAUSE, FAULT, AND GOOD FAITH (247F)

CFR Citation:  20 CFR 404; 20 CFR 416

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    01/12/94                     59 FR 1629

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Philip Berge, 410 965-1769

RIN: 0960-AC88
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1195. SUPPLEMENTAL SECURITY INCOME PROGRAM; EXCLUSION FROM INCOME OF 
DOMESTIC COMMERCIAL TRANSPORTATION TICKETS RECEIVED AS GIFTS IN 
DETERMINING SSI INCOME (253F)

CFR Citation:  20 CFR 416.1124; 20 CFR 416.1161

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    12/03/93                    58 FR 63887

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Irving Darrow, 410 966-0512

RIN: 0960-AC97
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1196. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL 
SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED; REOPENING 
DETERMINATIONS AND DECISIONS (279F)

CFR Citation:  20 CFR 404.987; 20 CFR 416.1487

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    02/23/94                     59 FR 8532

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Henry Lerner, 410 965-1762

RIN: 0960-AD12
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1197. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE; SUSPENSION OF 
AUXILIARY BENEFITS WHEN A DISABLED WORKER IS IN AN EXTENDED PERIOD OF 
ELIGIBILITY (303F)

CFR Citation:  20 CFR 401a; 20 CFR 1529a

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    12/10/93                    58 FR 64882

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Lawrence V. Dudar, 410 965-1795

RIN: 0960-AD30
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1198. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE; CONTINUED ENTITLEMENT 
TO BENEFITS OF DEEMED SPOUSE DESPITE ENTITLEMENT OF LEGAL SPOUSE (304F)

CFR Citation:  20 CFR 404.331; 20 CFR 404.332; 20 CFR 404.336; 20 CFR 
404.337; 20 CFR 404.340; 20 CFR 404.341; 20 CFR 404.346

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    12/10/93                    58 FR 64890

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Lawrence V. Dudar, 410 965-1759

RIN: 0960-AD31
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1199. SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED; 
EXCLUSION FROM INCOME AND RESOURCES OF EARNED INCOME TAX CREDITS (319F)

CFR Citation:  20 CFR 416.210; 20 CFR 416.1110; 20 CFR 416.1111; 20 CFR 
416.1112; 20 CFR 416.1161; 20 CFR 416.1210; 20 CFR 416.1235 (New)

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    12/03/93                    58 FR 63888

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0960-AD41
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1200. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL 
SECURITY INCOME; LIMITATION OF TRAVEL EXPENSES FOR REPRESENTATION OF 
CLAIMANTS AT ADMINISTRATIVE PROCEEDINGS (324F)

CFR Citation:  20 CFR 404.999c(d); 20 CFR 416.1498(d)

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    03/08/94                     59 FR 8529

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Philip Berge, 410 965-1769

RIN: 0960-AD46
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1201. TIME LIMIT FOR DISPOSITION OF RESOURCES IN THE SUPPLEMENTAL 
SECURITY INCOME PROGRAM (330F)

CFR Citation:  20 CFR 416.1242

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    11/15/93                    58 FR 60103

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Henry Lerner, 410 965-1762

RIN: 0960-AD48
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1202. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL 
SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED; PAYMENTS FOR 
VOCATIONAL REHABILITATION SERVICES (333F)

Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Yes

CFR Citation:  20 CFR 404; 20 CFR 416

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    03/15/94                    59 FR 11899

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jack Schanberger, 410 965-8471

RIN: 0960-AD50
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1203. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE AND SUPPLEMENTAL 
SECURITY INCOME PROGRAMS; REORGANIZATION OF MEDICAL EVIDENCE REGULATIONS 
(340P)

CFR Citation:  20 CFR 404; 20 CFR 416

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

No Action Expected in Next 12 
Mos                             02/14/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Alicia Matthews, 410 965-1713

RIN: 0960-AD57
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1204. OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE PROGRAM; CONSIDERING 
AN APPLICATION FILED UNDER THE RAILROAD RETIREMENT ACT AS AN APPLICATION 
FOR SOCIAL SECURITY BENEFITS (342F)

CFR Citation:  20 CFR 404.611

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    11/16/93                    58 FR 60381

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jack Schanberger, 410 965-8471

RIN: 0960-AD59
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1205. SSI PROGRAM; SSI MAXIMUM PAYMENT LIMIT ($30) WHEN MEDICAID IS NOT 
PAYING TOWARD THE COST OF INSTITUTIONAL CARE BECAUSE THE INDIVIDUAL 
TRANSFERRED A RESOURCE (345F)

CFR Citation:  20 CFR 416.414

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    12/10/93                    58 FR 64893

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Lawrence V. Dudar, 410 965-1759

RIN: 0960-AD60
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1206. OASDI AND SSI PROGRAMS; PERFORMANCE STANDARDS REVISIONS AND OTHER 
CHANGES INVOLVING ADMINISTRATIVE REQUIREMENTS AND PROCEDURES (381A)

CFR Citation:  20 CFR 404.1640; 20 CFR 404.1641; 20 CFR 404.1642; 20 
CFR 404.1643; 20 CFR 404.1644; 20 CFR 404.1645; 20 CFR 404.1650; 20 CFR 
416.1040; 20 CFR 416.1041; 20 CFR 416.1042; 20 CFR 416.1043; 20 CFR 
416.1044; 20 CFR 416.1045; 20 CFR 416.1050

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

No Action Expected in Next 12 
Months                          02/14/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Alicia Matthews, 410 965-1713

RIN: 0960-AD64
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Social Security Administration (SSA)
  
_______________________________________________________________________
 
1207. FEDERAL OLD-AGE, SURVIVORS, AND DISABILITY INSURANCE PROGRAM; 
TECHNICAL CHANGES TO REQUIREMENT FOR ENTITLEMENT TO WIDOW(ER)'S BENEFITS 
(404F)

CFR Citation:  20 CFR 404.335

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    03/30/94                    59 FR 14746

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Harry Short, 410 965-6243

RIN: 0960-AD69
_______________________________________________________________________
  

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Office of Assistant Secretary for Health 
(OASH)
  
_______________________________________________________________________
 
1208. PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT

Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Yes

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                            03/00/95

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
_______________________________________________________________________
  

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Office of Assistant Secretary for Health 
(OASH)
  
_______________________________________________________________________
 
1209. PRIVACY ACT; EXEMPT SYSTEM

Significance:
Subject to OMB review: Yes

Legal Authority:  5 USC 552a; 5 USC 301

CFR Citation:  45 CFR 5b-11

Legal Deadline: None

Abstract: The Department of Health and Human Services proposes to 
exempt a new system of records, 09-37-0021, ``Public Health Service 
Records Related to Investigations of Scientific Misconduct'' from 
certain requirements of the Privacy Act. The purpose of this exemption 
is to protect records compiled in the course of an allegation 
assessment and/or investigation and to protect the identity of the 
confidential source of information. There are no known costs associated 
with the NPRM. The benefits will be that the investigative files will 
not be disclosed inappropriately and promises to withhold identities of 
confidential sources will be honored.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            06/12/92                    57 FR 25004
NPRM Comment Period End         07/13/92                    57 FR 25004
Final Action                    07/00/94

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AD31
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Office of Assistant Secretary for Health 
(OASH)
  
_______________________________________________________________________
 
1210. STANDARDS OF COMPLIANCE FOR ABORTION-RELATED SERVICES IN FAMILY 
PLANNING SERVICE PROJECTS

Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Yes

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                    10/00/94

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, P.O.Box 23783, Washington, DC 20026-3783, 202 690-8335

RIN: 0905-AE03
_______________________________________________________________________
  

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Substance Abuse and Mental Health Services 
Administration (SAMHSA)
  
_______________________________________________________________________
 
1211. CONFIDENTIALITY OF SUBSTANCE ABUSE PATIENT RECORDS

Significance:
Subject to OMB review: Undetermined
Regulatory Plan entry: Undetermined

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                            06/00/94
NPRM Comment Period End         08/00/94
Final Action                    11/00/94

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Tribal, Federal

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

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

RIN: 0905-AD97
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Substance Abuse and Mental Health Services 
Administration (SAMHSA)
  
_______________________________________________________________________
 
1212. PROTECTION AND ADVOCACY FOR INDIVIDUALS WITH MENTAL ILLNESS

Significance:
Subject to OMB review: Undetermined
Regulatory Plan entry: Undetermined

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

CFR Citation:  45 CFR subchapter H

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. 
These requirements are intended to be published with revisions to 45 
CFR 1385 et seq. These rules govern formula grants from the 
Administration on Developmental Disabilities for protecting and 
advocating for individuals with developmental disabilities.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            06/00/94
NPRM Comment Period End         08/00/94
Final Action                    10/00/94

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Local

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

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

RIN: 0905-AD99
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Substance Abuse and Mental Health Services 
Administration (SAMHSA)
  
_______________________________________________________________________
 
1213.  COMMUNITY MENTAL HEALTH SERVICES BLOCK GRANTS

Significance:
Subject to OMB review: Undetermined
Regulatory Plan entry: Undetermined

Legal Authority:  42 USC 300X-1, P.L. 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                            09/00/94
NPRM Comment Period End         11/00/94

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)
  
_______________________________________________________________________
 
1214. BLOCK GRANTS FOR PREVENTION AND TREATMENT OF SUBSTANCE ABUSE

Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Undetermined

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                    06/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Substance Abuse and Mental Health Services 
Administration (SAMHSA)
  
_______________________________________________________________________
 
1215. BLOCK GRANTS FOR PREVENTION AND TREATMENT OF SUBSTANCE ABUSE 
(TOBACCO PROVISIONS)

Significance:
Subject to OMB review: Yes
Economically significant: Yes
Regulatory Plan entry: Undetermined

Legal Authority:  42 USC 300x-21

CFR Citation:  45 CFR 96; 45 CFR 130

Legal Deadline: None

Abstract: Sets standards and procedures for enforcement of State law 
against sale of tobacco products to minors as a condition of full 
funding of Federal block grants to States for prevention and treatment 
of substance abuse. These requirements apply beginning in fiscal year 
1994 except, under certain conditions, in fiscal year 1995.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            08/26/93                    58 FR 45156
NPRM Comment Period End         10/25/93                    58 FR 45156
Final Action                    07/00/94

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Tribal

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

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

RIN: 0905-AE05
_______________________________________________________________________
  

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Centers for Disease Control and Prevention 
(CDC)
  
_______________________________________________________________________
 
1216. RESPIRATORY PROTECTIVE DEVICES

Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Yes

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

CFR Citation:  30 CFR 11; 42 CFR 84

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            08/27/87                    52 FR 32402
First Public Hearing            01/20/88                    52 FR 37639
Second Public Hearing           01/27/88                    52 FR 37639
NPRM Public Comment Period End  03/28/88                     53 FR 5595
Second NPRM                     04/00/94
Second NPRM Comment Period End  05/00/94
Final Action                    00/00/00
Final Action Effective          00/00/00

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AB58
_______________________________________________________________________
  

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Centers for Disease Control and Prevention 
(CDC)
  
_______________________________________________________________________
 
1217. INTERSTATE SHIPMENT OF BIOLOGICAL MATERIAL THAT CONTAINS OR MAY 
CONTAIN ETIOLOGIC AGENTS

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 etiologic agents 
during interstate shipment. The revised regulation will ensure that all 
biological material that could contain etiologic agents 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                    06/00/94
Final Action Effective          09/00/94

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., Atlanta, GA 30333, 404 639-3883

RIN: 0905-AC89
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Centers for Disease Control and Prevention 
(CDC)
  
_______________________________________________________________________
 
1218. 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-104, 
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)
  
_______________________________________________________________________
 
1219. MEDICAL FOODS

Significance:
Subject to OMB review: Yes
Economically significant: Undetermined
Regulatory Plan entry: Undetermined

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                           09/00/94
ANPRM Comment Period End        11/00/94

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, Public Health Service, Food and Drug Administration, Center 
for Food Safey and Applied Nutrition, 200 C St. SW Washington, DC 
20204, 202 205-5372

RIN: 0905-AD91
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)             Prerule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1220.  SPECIFIC REQUIREMENTS ON CONTENT AND FORMAT OF LABELING 
FOR HUMAN PRESCRIPTION DRUGS; ADDITION OF ``GERIATRIC USE'' SUBSECTION IN 
THE LABELING

Significance:
Subject to OMB review: Undetermined

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                    55 FR 46134
ANPRM                           10/00/94

Small Entities Affected: Undetermined

Government Levels Affected: None

Agency Contact: Thomas C. Kuchenberg, Regulatory Counsel, Department of 
Health and Human Services, Public Health Service, Division Regulatory 
Affairs, Food and Drug, Administration, Center for Drug Evaluation, and 
Research (HFD-362), 301 594-1046

RIN: 0905-AE26
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)             Prerule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1221.  CERTIFICATION OF DRUGS COMPOSED WHOLLY OR PARTLY OF 
INSULIN; FEES FOR CERTIFICATION OF DRUGS COMPOSED WHOLLY OF PARTLY OF 
INSULIN

Significance:
Subject to OMB review: Undetermined

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

_________________________________________________________________________

ANPRM                           06/00/94

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AE28
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)             Prerule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1222.  SUNGLASS LABELING

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Regulatory Plan entry: Undetermined

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                           06/00/94

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, CDRH (HFZ-
84), 2098 Gaither Road, Rockville, MD 20850, 301 594-4765

RIN: 0905-AE35
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)             Prerule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1223.  INVESTIGATIONAL DEVICE EXEMPTION: COST RECOVERY

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Regulatory Plan entry: Undetermined

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                           06/00/94

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, CDRH (HFZ-
84), 2098 Gaither Road, Rockville, MD 20850, 301 594-4765

RIN: 0905-AE36
_______________________________________________________________________
  

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1224. NEW ANIMAL DRUG APPROVAL PROCESS

Significance:
Subject to OMB review: Undetermined

Legal Authority:  21 USC 360b; 21 USC 371

CFR Citation:  21 CFR 514.1; 21 CFR 514.8

Legal Deadline: None

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 NADA proposed rule to incorporate 
some recent changes in procedure.

Timetable:

New Animal Drug Approval Process  NPRM 12/17/91 (56 FR 65544)  NPRM 10/
00/94

Reporting Requirements for Marketed Animal Drugs  NPRM 12/17/91 (56 FR 
65581)  Final Action 10/00/94

Small Entities Affected: Undetermined

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.

Agency Contact: Andrew J. Beaulieu, Deputy Director, Office of New 
Animal Drug Evaluation, Department of Health and Human Services, Public 
Health Service, Center for Veterinary Medicine (HFV-101), 7500 Standish 
Place, Rockville, MD 20855, 301 594-1623

RIN: 0905-AA96
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1225. POLICIES CONCERNING USES OF SULFITING AGENTS

Significance:
Subject to OMB review: Yes
Economically significant: Undetermined
Regulatory Plan entry: Yes

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)  Final Action 
Effective 08/09/86 (51 FR 25021)

Status of the Use of Sulfiting Agents on Shrimp  NPRM 12/19/88 (53 FR 
51065)  Tentative Final Rule 09/00/94

Status of Use of Sulfit Agents on Minimally Procd & Froz Potatoes  NPRM 
09/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1226. INFANT FORMULA ACT

Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Yes

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 Action                    12/24/91                    56 FR 66566
NPRM                            09/00/94
NPRM Comment Period End         11/00/94
Current Good Mfg. Practices; Qual Control Proc  NPRM 05/00/94

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

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AC46
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1227. IMPLEMENTATION OF TITLE I OF THE GENERIC ANIMAL DRUG AND PATENT 
TERM RESTORATION ACT

Significance:
Subject to OMB review: Undetermined
Regulatory Plan entry: Yes

Legal Authority:  21 USC 360b

CFR Citation:  21 CFR 514

Legal Deadline:  Final, Statutory, November 15, 1989.

Abstract: The agency proposes to amend its regulations to implement 
title I of the Generic Animal Drug and Patent Term Restoration Act 
which established new standards for marketing approval of generic 
copies of animal drug products approved after 1962.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            10/00/94

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Lonnie W. Luther, Chief, Generic Animal Drug and 
Quality Control Staff, Department of Health and Human Services, Public 
Health Service, Center for Veterinary Medicine (HFV-102), 7500 Standish 
Place, Rockville, MD 20855, 301 594-1623

RIN: 0905-AD15
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1228. 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                            04/00/94

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: Philip L. Chao, Regulatory Counsel, Division of 
Regulatory Affairs, Department of Health and Human Services, Food and 
Drug Administration, Center for Drug Evaluation and Research, 7500 
Standish Place, Rockville, MD 20855, 301 594-1049

RIN: 0905-AD44
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1229. IMPLEMENTATION OF THE SAFE MEDICAL DEVICES ACT OF 1990

Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Yes

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 of Humanitarian 
Devices, etc.
Other, Statutory, December 1, 1991, for Classification of Transitional 
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 06/00/
94

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)  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)  Final Action 11/23/93 (58 FR 61952)

Exemption of Humanitarian Devices  NPRM 12/21/92 (57 FR 60491)  Final 
Action 07/00/94

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 05/00/94

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  Notice 04/00/94

Recall of Medical Devices  NPRM 04/00/94

Reports of Removals and Corrections of Medical Devices  NPRM 03/23/94 
(59 FR 13828)

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 04/00/94

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

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

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 Penalties--FDA proposed 
regulations to establish procedures for a hearing to which persons are 
entitled before the imposition of civil 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, Department of Health and Human 
Services, Food and Drug Administration, Center for Devices and 
Radiological Health, 2098 Gaither Road, Rockville, MD 20850, 301 594-
4765

RIN: 0905-AD59
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1230. 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 blood establishments 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 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                            02/00/95
NPRM Comment Period End         06/00/95

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1231. 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 
sections 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                            04/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Philip L. Chao, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Division of 
Regulatory Affairs, Center for Drug Evaluation and Research (HFD-362), 
301 594-1049

RIN: 0905-AD71
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1232. 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:  Not applicable

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                            11/00/94

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, 1401 Rockville Pike, Suite 200N (HFM-635), 
Rockville, MD 20852-1448, 301 594-3074

RIN: 0905-AD72
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1233. MEDICAL DEVICES; INFANT APNEA MONITOR; DEVELOPMENT OF MANDATORY 
STANDARD

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                            04/00/94

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 Rd. 
Rockville, MD 20850, 301 594-4765

RIN: 0905-AD83
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1234. MAMMOGRAPHY QUALITY STANDARDS ACT OF 1992

Significance:
Subject to OMB review: Undetermined

Legal Authority:  PL 102-539 Mammography Quality Standards Act of 1992

CFR Citation:  21 CFR 900

Legal Deadline:  Final, Statutory, July 27, 1993.
Standards for accreditation bodies are required by July 27, 1993.

Abstract: The purpose of the Mammography Quality Standards Act of 1992, 
enacted October 27, 1992, is to assure quality in all aspects of the 
practice of mammography. The primary mechanism for this is oversight of 
all mammography facilities through a certification and inspection 
program. Only facilities certified by the Secretary will be permitted 
to produce, process, or interpret mammographic images. The statute also 
requires the establishment of an advisory committee to set regulatory 
quality standards and also provides for the establishment of 
surveillance systems to evaluate breast cancer screening programs.
Regulations are required in several areas: Issuance and denial of 
certificates; standards for accreditation bodies; approval or 
withdrawal of approval of accreditation bodies; quality standards for 
facilities; certification of personnel, an inspection program, a user 
fee program, and an enforcement program. The statute mandates other 
activities for which regulations may also be necessary, although not 
specifically required.

Timetable:

Accrediting Bodies and Quality Standards  Reproposal 01/00/95

Approval of Accrediting Bodies  Interim Final 12/21/93 (58 FR 67558)

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

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Federal

Agency Contact: Richard E. Gross, Office of Health and Industry 
Programs, Department of Health and Human Services, Food and Drug 
Administration, HFZ-200, 1901 Chapman Ave., Rockville, MD 20857, 301 
443-4600

RIN: 0905-AE19
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1235.  ADVERSE EXPERIENCE REPORTING REQUIREMENTS FOR HUMAN DRUG 
AND LICENSED BIOLOGICAL PRODUCTS

Significance:
Subject to OMB review: Yes

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

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                            05/00/94

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AE29
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1236.  ELECTRONIC SIGNATURES

Significance:
Subject to OMB review: Undetermined

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 that preserves the integrity of the agency's 
enforcement

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

ANPRM                           07/21/92                    57 FR 32185
ANPRM Comment Period End        10/19/92                    57 FR 32185
NPRM                            06/00/94

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: Federal

Additional Information: activities.

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

RIN: 0905-AE31
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1237.  FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS

Significance:
Subject to OMB review: Yes
Economically significant: Undetermined
Regulatory Plan entry: Undetermined

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                            04/00/94
NPRM Comment Period End         07/00/94
Final Action                    10/00/95

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AE32
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1238.  EFFECTIVE DATE OF REQUIREMENT FOR SUBMISSION OF PREMARKET 
APPROVAL APPLICATIONS

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Regulatory Plan entry: Undetermined

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

_________________________________________________________________________

NPRM                            06/00/94

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, CDRH (HFZ-
84), 2098 Gaither Road, Rockville, MD 20857, 301 594-4765

RIN: 0905-AE34
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1239.  LATEX CONDOMS/GLOVES: EXPIRATION DATE LABELING

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Regulatory Plan entry: Undetermined

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                            04/00/94

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, CDRH (HFZ-
84), 2098 Gaither Road, Rockville, MD 20850, 301 594-4765

RIN: 0905-AE37
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1240.  AMALGAM INGREDIENT LABELING

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Regulatory Plan entry: Undetermined

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                            07/00/94

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, CDRH (HFZ-
84), 2098 Gaither Road, Rockville, MD 20850, 301 594-4765

RIN: 0905-AE39
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1241.  LATEX WARNING

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Regulatory Plan entry: Undetermined

Legal Authority:  21 USC 352

CFR Citation:  21 CFR 801

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            06/00/94

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, (HFZ-84), 
2098 Gaither Road, Rockville, MD 20850, 301 594-4765

RIN: 0905-AE40
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1242.  PREMARKET APPROVAL APPLICATIONS: SUPPLEMENTS

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Regulatory Plan entry: Undetermined

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. 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                            06/00/94

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, CDRH (HFZ-
84), 2098 Gaither Road, Rockville, MD 20850, 301 594-4765

RIN: 0905-AE41
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1243.  RESTRICTED DEVICES

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Regulatory Plan entry: Undetermined

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                            05/00/94

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, CDRH (HFZ-
84), 2098 Gaither Road, Rockville, MD 20850, 301 594-4765

RIN: 0905-AE42
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1244.  PRESCRIPTION DRUG PRODUCT LABELING; MEDICATION GUIDE

Significance:
Subject to OMB review: Yes
Economically significant: Yes
Regulatory Plan entry: Undetermined

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

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

Legal Deadline: None

Abstract: This proposed rule would require that labeling, written in 
nontechnical language and directed at patients, be dispensed with 
prescription drug and biological products that are primarily used on an 
out-patient basis without the direct supervision of a health care 
professional. The patient labeling would inform the patient about the 
product and would include such information as the product's approved 
uses, contraindications, proper administration, adverse drug reactions 
and cautions for specific populations. The proposed rule would require 
manufacturers and/or distributors of these products to prepare patient 
labeling, and would require dispensers to provide the patient labeling 
to each patient or agent of the patient receiving a covered product. 
FDA is proposing this rule to promote the safe and effective use of 
prescription drug products by patients and to ensure that patients have 
the opportunity to be informed of a drug product's risks and benefits.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Agency Contact: Louis A. Morris, Chief, Marketing Practices & 
Communication Branch, (HFD-240), Department of Health and Human 
Services, Public Health Service, 5600 Fishers Lane, Rockville, MD 
20857, 301 594-6818

RIN: 0905-AE43
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1245.  SUBSTANCES PROHIBITED FOR USE IN RUMINANT FEED

Significance:
Regulatory Plan entry: Undetermined

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                            04/00/94
NPRM Comment Period End         07/00/94
Final Action                    12/00/94

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)       Proposed Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1246.  HEARING AIDS; PROFESSIONAL AND PATIENT LABELING; 
CONDITIONS FOR SALE

Significance:
Subject to OMB review: Yes
Economically significant: Undetermined
Regulatory Plan entry: Undetermined

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                    58 FR 59695
NPRM                            06/00/94

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department 
of Health and Human Services, Public Health Service, CDRH (HFZ-84), 
2098 Gaither Road, Rockville, MD 20850, 301 594-4765

RIN: 0905-AE46
_______________________________________________________________________
  

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1247. OVER-THE-COUNTER (OTC) DRUG REVIEW

Significance:
Subject to OMB review: Undetermined

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)

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

Anorectal Products  ANPRM 05/27/80 (45 FR 35576)  NPRM 08/15/88 (53 FR 
30756)  Final Action 08/03/90 (55 FR 31776)  Final Action (LYCD) 09/02/
93 (58 FR 46746)  Final Action (Witch Hazel) 07/00/94

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 09/00/94

Antidiarrheal Products  ANPRM 03/21/75 (40 FR 12924)  NPRM 04/30/86 (51 
FR 16138)  Final Action 09/00/94

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 04/00/94

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) 09/00/94

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)  Published 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) 08/00/94

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)  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 09/00/94

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 00/00/00

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 00/00/00

Leg Muscle Cramps (Nocturnal Relief) Products  ANPRM 10/01/82 (47 FR 
43562)  NPRM 11/08/85 (50 FR 46588)  Final Action 09/00/94

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) 04/00/94

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 
09/00/94

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 09/
00/94

Reporting of Adverse Reactions  NPRM 06/00/94

Skin Bleaching Products  ANPRM 11/03/78 (43 FR 51546)  NPRM 09/03/82 
(47 FR 39108)  NPRM (Reproposed) 09/00/94

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) 07/00/94  Final Action 00/
00/00

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 00/00/00

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)

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 07/
00/94

Vaginal Contraceptive Products  ANPRM 12/12/80 (45 FR 82014)  NPRM 07/
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) 09/00/
94

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-210), 5600 Fishers Lane, Rockville, MD 20857, 301 295-
8000

RIN: 0905-AA06
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1248. ABBREVIATED NEW DRUG APPLICATION REGULATIONS (TITLE I OF THE ``DRUG 
PRICE COMPETITION AND PATENT TERM RESTORATION ACT OF 1984'')

Significance:
Subject to OMB review: Undetermined

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

Patent Certification and Exclusivity  Final Action 06/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Philip L. Chao, 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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1249. 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 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 identifying, 
testing, and counseling transfusion recipients who are 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 notify consignees 
promptly whenever a blood donor who has previously donated blood or 
source plasma is found to be positive for the antibody to HIV; and to 
keep appropriate records when such notification has been made. In 
addition, the final (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: 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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1250. LEAD IN FOODS

Significance:
Regulatory Plan entry: Undetermined

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                    54 FR 23485
Prohibit Use of Lead-Soldered Food Cans  NPRM 06/21/93 (58 FR 
33860)  Final Action 08/00/94

Prohibit Use of Tin-Coated Lead Foil Capsules on Wine Bottles  NPRM 11/
25/92 (57 FR 55485)  Final Action 08/00/94

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AC91
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1251. EXPEDITING APPROVAL FOR DRUGS INTENDED TO TREAT LIFE-THREATENING 
AND SEVERELY DEBILITATING ILLNESSES

Significance:
Subject to OMB review: Undetermined

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: Philip L. Chao, 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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1252. FEES FOR CERTIFICATION SERVICES; INSULIN AND COLOR ADDITIVE 
CERTIFICATION PROGRAMS

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Regulatory Plan entry: Undetermined

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
Final Action (Color Additives)  12/00/94

Small Entities Affected: Undetermined

Government Levels Affected: None

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

RIN: 0905-AD34
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1253. MANDATORY HACCP SEAFOOD INSPECTION PROGRAM

Significance:
Subject to OMB review: Yes
Economically significant: Yes
Regulatory Plan entry: Yes

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                     50 FR 4142
Final Action                    02/00/95

Small Entities Affected: Businesses

Government Levels Affected: Federal

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1254. BOTTLED WATER

Significance:
Regulatory Plan entry: Undetermined

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 07/
00/94

Microbiological Quality Standard  NPRM 10/06/93 (58 FR 25042)  Final 
Action 11/00/94

Quality Standard for Lead and Copper  NPRM 01/05/93 (58 FR 389)  Final 
Action 05/00/94

Quality Standards for 24 Contaminants  NPRM 08/04/93 (58 FR 41612)

Quality Standards for 35 Contaminants  Final Action 09/00/94

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

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1255. SPECIFIC REQUIREMENTS ON CONTENT AND FORMAT OF LABELING FOR HUMAN 
PRESCRIPTION DRUGS; REVISION OF ``PEDIATRIC USE'' SUBSECTION IN THE 
LABELING

Significance:
Subject to OMB review: Undetermined

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                    57 FR 47423
Final Action                    06/00/94

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), 301 594-1049

RIN: 0905-AD76
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1256. 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; 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                    55 FR 43066
Final Action                    06/00/94

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AD78
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1257. 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                    12/00/94

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, 1401 Rockville Pike, Suite 200N 
(HFM-635), Rockville, MD 20852-1448, 301 594-3074

RIN: 0905-AD82
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1258. 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                    57 FR 27397
Final Action                    06/00/94

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 Rd., Rockville, MD 20850, 
301 594-4765

RIN: 0905-AD84
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1259. THRESHOLD OF REGULATION POLICY FOR COMPONENTS OF FOOD CONTACT 
ARTICLES

Significance:
Regulatory Plan entry: Undetermined

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 proposing 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 proposal lists the criteria which must be met for a 
food-contact material to be reviewed under this policy and identifies 
the types of data that FDA will need for its review. This policy will 
reduce regulatory cost and delays and thereby bring important and 
innovative products to market faster.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AD86
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1260. FOOD LABELING REVIEW

Significance:
Subject to OMB review: Yes
Economically significant: Undetermined
Regulatory Plan entry: Undetermined

Legal Authority:  15 USC 1453; 15 USC 1454; 15 USC 1455; 21 USC 321; 21 
USC 331; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 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 05/00/94

Nutrient Content, Definition of the Term, Healthy  NPRM 01/06/93 (58 FR 
2944)  Final Action 09/00/94

Protein Hydrolysates; Broth in Tuna; and/or Labeling  NPRM (Declaration 
of Ingredients) 01/06/93 (58 FR 2950)  Final Action (Dec. of 
Ingredients) 12/00/94

Reference Daily Intakes  NPRM 01/04/94 (59 FR 427)  Final Action 08/00/
94

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, Public Health 
Service, Center for Food Safety and Applied Nutrition, (HFS-150) 200 C 
St. SW Washington, DC 20204, 202 205-4561

RIN: 0905-AD89
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1261. LEVO-ALPHA-METHADOL (LAAM) IN MAINTENANCE; JOINT PROPOSED REVISION 
OF CONDITIONS FOR USE

Significance:
Subject to OMB review: Undetermined

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 issuing an interim rule, to be effective upon date of 
publication with opportunity for public comment, that revises the 
conditions for the treatment of narcotic addiction to provide for the 
use of LAAM, when approved, in the maintenance treatment of narcotic 
addicts. This action will allow narcotic treatment programs to provide 
an additional treatment drug for use in the maintenance treatment of 
narcotic addicts. The only narcotic drug currently approved for use in 
the treatment of narcotic addiction is methadone.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Interim Final Rule              07/20/93                    58 FR 38704
Interim Final Rule Comment 
Period End                      09/20/93                    58 FR 38704
Final Action                    11/00/94

Small Entities Affected: None

Government Levels Affected: State, Local

Agency Contact: Thomas C. Kuchenberg, Regulatory Counsel, Department of 
Health and Human Services, Public Health Service, Division of 
Regulatory Affairs, Food and Drug Administration, Center for Drug 
Evaluation and Research, 301 594-1046

RIN: 0905-AD92
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1262. 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                    08/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department 
of Health and Human Services, Public Health Service, FDA, CDRH (HFZ-
84), 2098 Gaither Rd., Rockville, MD 20850, 301 594-4765

RIN: 0905-AD93
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1263. CLINICAL INVESTIGATOR DISQUALIFICATION

Significance:
Subject to OMB review: Undetermined

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                    09/00/94

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department 
of Health and Human Services, Public Health Service, FDA, CDRH (HFZ-
84), 2098 Gaither Rd., Rockville, MD 20850, 301 594-4765

RIN: 0905-AD94
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1264. REVOCATION OF INTRAOCULAR LENS INVESTIGATION DEVICE EXEMPTION

Significance:
Subject to OMB review: Undetermined

Legal Authority:  21 USC 360j(g)

CFR Citation:  21 CFR 813; 21 CFR 812

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            10/06/93                    58 FR 52142
Final Action                    09/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department 
of Health and Human Services, Public Health Service, FDA, CDRH (HFZ-
84), 2098 Gaither Rd., Rockville, MD 20850, 301 594-4765

RIN: 0905-AD95
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1265. DIETARY SUPPLEMENT LABEL REVIEW

Significance:
Subject to OMB review: Yes
Economically significant: Undetermined
Regulatory Plan entry: Undetermined

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 09/00/94

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 Nutrionals, Department of Health 
and Human Services, Food and Drug Administration, Center for Food 
Safety and Applied Nutrition, 200 C St. SW., Washington, DC 20204, 202 
594-6006

RIN: 0905-AD96
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1266. ADVERSE EXPERIENCE REPORTING REQUIRED FOR LICENSED BIOLOGICAL 
PRODUCTS

Significance:
Subject to OMB review: Yes

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                    55 FR 11611
Final Action                    05/00/94

Small Entities Affected: Businesses, Organizations

Government Levels Affected: State

Agency Contact: Paula McKeever, Consumer Safety Officer, Department of 
Health and Human Services, Public Health Service, 1401 Rockville Pike, 
Suite 200N, Rockville, MD 20852-1448, 301 594-3074

RIN: 0905-AE18
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1267.  TAMPER-EVIDENT PACKAGING REQUIREMENTS FOR OVER-THE-COUNTER 
HUMAN DRUG PRODUCTS

Significance:
Subject to OMB review: Undetermined

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                     59 FR 2542
Final Action                    04/00/95

Small Entities Affected: Undetermined

Government Levels Affected: None

Agency Contact: Howard P. Muller, Regulatory Counsel, Department of 
Health and Human Services, Public Health Service, Division of 
Regulatory Affairs, Food and, Drug Administration, Center for Drug E, 
Evaluation and Research (HFD-362), 301 594-1049

RIN: 0905-AE27
_______________________________________________________________________
  

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1268. VOLUNTARY, FEE-FOR-SERVICE SEAFOOD INSPECTION PROGRAM

CFR Citation:  21 CFR 197

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn - replaced by the 
Seafood HACCP Program (RIN 0905-
AD60)                           01/28/94                     59 FR 4142

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Mary Snyder, 202 254-3888

RIN: 0905-AD23
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1269. PART 1260; HUMAN SEMEN FOR ARTIFICIAL INSEMINATION

CFR Citation:  21 CFR 1260

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

No action planned in the next 12 
months                          03/15/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Ann Reed Gaines, 301 594-3074

RIN: 0905-AD80
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1270. INVESTIGATIONAL NEW DRUG APPLICATIONS

CFR Citation:  21 CFR 312

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

No action planned in the next 12 
months                          04/01/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Ilisa B. Bernstein, 301 443-1382

RIN: 0905-AD85
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1271. DIETARY SUPPLEMENTS

CFR Citation:  Not yet determined

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

No action planned in the next 12 
months                          03/15/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Judith Kraus, 202 205-5372

RIN: 0905-AD90
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Public Health Service (PHS)--Food and Drug Administration (FDA)
  
_______________________________________________________________________
 
1272. PROPOSAL TO ESTABLISH PROCEDURES FOR THE SAFE PROCESSING, 
PACKAGING, STORAGE, AND DISTRIBUTION OF SMOKED FISH, SMOKE-FLAVORED FISH, 
AND SALTED FISH

CFR Citation:  21 CFR 122

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn - merged into Seafood 
HACCP Program (RIN 0905-AD60)   01/28/94                     59 FR 4142

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Mary I. Snyder, 202 254-3888

RIN: 0905-AE21
_______________________________________________________________________
  

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
  
_______________________________________________________________________
 
1273. NATIONAL HEALTH SERVICE CORPS LOAN REPAYMENT PROGRAM; GRANTS FOR 
STATE LOAN REPAYMENT PROGRAMS

Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Undetermined

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                            10/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
  
_______________________________________________________________________
 
1274. ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK RULES

Significance:
Subject to OMB review: Yes

Legal Authority:  42 USC 1320b-8 section 1138 of the Social Security 
Act; 42 USC 274 Section 372 of the Public Health Service Act

CFR Citation:  42 CFR 121

Legal Deadline: None

Abstract: Section 1138 of the Social Security Act requires Medicare and 
Medicaid participating hospitals that perform organ transplants to be 
members of and abide by the rules and requirements of the Organ 
Procurement and Transplantation Network (OPTN) as established by 
section 372 of the Public Health Service Act. Section 1138 also 
requires that for organ procurement costs attributable to payments to 
an Organ Procurement Organization (OPO) to be paid by Medicare or 
Medicaid, the OPO must be a member of and abide by the rules and 
requirements of the OPTN. No other entity (for example, a 
histocompatibility laboratory) is required to be a member of or abide 
by the rules of the OPTN under the provisions of the statute. It is the 
Department's position that no rule, requirement, policy, or other 
issuance of the OPTN will be considered to be a ``rule or requirement'' 
of the Network within the meaning of section 1138 unless the Secretary 
has formally approved that rule. The OPTN is currently in operation and 
these rules will impose no further cost or provide any benefit other 
than that which now exists.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00
NPRM Comment Period End         00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Judy Braslow, Director, Division of Organ 
Transplantation, Bureau of Health Resources Development, Department of 
Health and Human Services, Public Health Service, Room 11A-22, Parklawn 
Building, 5600 Fishers Lane, Rockville, MD 20857, 301 443-7577

RIN: 0905-AD26
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
  
_______________________________________________________________________
 
1275. HEALTH EDUCATION ASSISTANCE LOAN (HEAL) PROGRAM: LENDERS' 
PERFORMANCE STANDARDS

Significance:
Subject to OMB review: Yes

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                            04/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
  
_______________________________________________________________________
 
1276. GRANTS FOR NURSE PRACTITIONER AND NURSE-MIDWIFERY PROGRAMS

Significance:
Subject to OMB review: Yes

Legal Authority:  42 USC 216; 42 USC 296m

CFR Citation:  42 CFR 57, subpart Y

Legal Deadline: None

Abstract: This Notice of Proposed Rulemaking amends the Grants for 
Nurse Practitioner and Nurse Midwifery Programs regulations to bring 
the existing regulations into conformity with amendments made by the 
Health Professions Extension Amendments of 1992 (Pub. L. 102-408) and 
to include other changes to bring the regulations into line with 
current national nursing standards for education and practice.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            07/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Marla E. Salmon, ScD. RN, Director, Division of 
Nursing, Bureau of Health Professions, Department of Health and Human 
Services, Health Resources and Services Administration, 9-35, Parklawn 
Building, 5600 Fishers Lane, Rockville, MD 20857, 301 443-5786

RIN: 0905-AE11
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
  
_______________________________________________________________________
 
1277. GRANTS FOR FACULTY TRAINING PROJECTS IN GERIATRIC MEDICINE AND 
DENTISTRY

Significance:
Subject to OMB review: Yes

Legal Authority:  42 USC 216; 42 USC 294o

CFR Citation:  42 CFR 57, subpart PP

Legal Deadline: None

Abstract: This Notice of Proposed Rulemaking 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

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
  
_______________________________________________________________________
 
1278.  MEDICAL FACILITY CONSTRUCTION AND MODERNIZATION 
REQUIREMENTS FOR PROVISION OF SERVICES TO PERSONS UNABLE TO PAY

Significance:
Subject to OMB review: Yes

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

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
_______________________________________________________________________
  

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
  
_______________________________________________________________________
 
1279. NATIONAL VACCINE INJURY COMPENSATION (NVIC) PROGRAM: REVISIONS TO 
THE VACCINE INJURY TABLE

Significance:
Subject to OMB review: Yes

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 (NVIC) Program, 
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                    04/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
  
_______________________________________________________________________
 
1280. MATERNAL AND CHILD HEALTH (MCH) PROJECT GRANTS

Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Undetermined

Legal Authority:  42 USC 702(a)

CFR Citation:  42 CFR 51a

Legal Deadline: None

Abstract: This proposed rule revises existing regulations governing the 
Maternal and Child Health (MCH) Federal Set-Aside programs to 
accommodate changing policy concerns, implement data collection 
requirements established under the Omnibus Budget Reconciliation Act 
(OBRA) of 1989 (Pub. L. 101-239), and make other technical or 
clarifying changes. This proposed rule will bring the existing 
regulations up-to-date with current Department policy and statutory 
amendments to these programs.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            07/21/93                    58 FR 38995
NPRM Comment Period End         09/20/93                    58 FR 38995
Final Action                    04/00/94

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Federal

Agency Contact: Lynn Squire, Reports Clearance Officer/Office of 
Program Development, Maternal & Child Health Bureau, Department of 
Health and Human Services, Health Services Administration, 5600 Fishers 
Lane, Parklawn Building, Room 18-20, Rockville, Maryland 20857, 301 
443-2778

RIN: 0905-AD88
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
  
_______________________________________________________________________
 
1281. MEDICAL FACILITY CONSTRUCTION AND MODERNIZATION; REQUIREMENTS FOR 
PROVISION OF SERVICES TO PERSONS UNABLE TO PAY

Significance:
Subject to OMB review: Yes

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

CFR Citation:  42 CFR 124 subpart F

Legal Deadline: None

Abstract: The proposed rule would revise the rules currently governing 
how certain health care facilities, assisted under titles VI and XVI of 
the Public Health Service Act, fulfill the assurance given in their 
applications for assistance that they would provide a reasonable volume 
of services to persons unable to pay. Public comment on the current 
rules and operational experience with them has indicated the need to 
revise the current requirements with respect to nonprofit facilities 
that provide substantial amounts of free or below-cost care under their 
own programs but are unable, under current requirements, to credit such 
care toward fulfillment of their assurance. The intended effect of 
these proposed rules is to allow qualified facilities to satisfy their 
uncompensated services assurance through their continued provision of 
free or below-cost health services.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            11/04/93                    58 FR 58828
NPRM Comment Period End         01/03/94
Final Action                    08/00/94

Small Entities Affected: Organizations

Government Levels Affected: None

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

RIN: 0905-AE06
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
  
_______________________________________________________________________
 
1282. GRANTS FOR THE ESTABLISHMENT OF DEPARTMENTS OF FAMILY MEDICINE

Significance:
Subject to OMB review: Yes

Legal Authority:  42 USC 216; 42 USC 293k

CFR Citation:  42 CFR 57, subpart R

Legal Deadline: None

Abstract: This Notice of Proposed Rulemaking 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

_________________________________________________________________________

Final Action                    05/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
  
_______________________________________________________________________
 
1283.  NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON 
PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: AMENDMENT TO DATA BANK 
REGULATIONS TO COMPLY WITH COURT ORDER

Significance:
Subject to OMB review: Yes

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                    06/00/94

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
_______________________________________________________________________
  

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
  
_______________________________________________________________________
 
1284. HEALTH EDUCATION ASSISTANCE LOAN (HEAL) PROGRAM: SCHOOL COLLECTION 
ASSISTANCE

Significance:
Subject to OMB review: Yes

CFR Citation:  42 CFR 60

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    12/21/93                    58 FR 67346

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: James W. Farrington, D.M.D., 301 443-1173

RIN: 0905-AC87
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
  
_______________________________________________________________________
 
1285. HEALTH EDUCATION ASSISTANCE LOAN (HEAL) PROGRAM: POSTJUDGMENT 
COLLECTIONS

CFR Citation:  42 CFR 60

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn - Recent program 
development obviates need for 
regulation.                     02/04/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Michael Heningburg, 301 443-1173

RIN: 0905-AD11
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
  
_______________________________________________________________________
 
1286. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON 
PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: AUTHORIZED AGENTS

CFR Citation:  45 CFR 60

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn - Recent program 
development obviates need for 
regulation.                     02/07/94

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AE10
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
  
_______________________________________________________________________
 
1287. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON 
PHYSICIANS AND OTHER HEALTH PRACTITIONERS: AMENDMENTS TO COLLECTION OF 
USER FEES

CFR Citation:  45 CFR 60

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn -Action to be 
incorporated into more 
comprehensive package.          02/04/94

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AE15
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Public Health Service (PHS)--Health Resources and Services 
Administration (HRSA)
  
_______________________________________________________________________
 
1288. GRANTS FOR HEALTH PROFESSIONS PROJECTS IN GERIATRICS

Significance:
Subject to OMB review: Yes

CFR Citation:  42 CFR 57, subpart OO

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    12/20/93                    58 FR 66297

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AE16
_______________________________________________________________________
  

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Indian Health Service (IHS)
  
_______________________________________________________________________
 
1289. INDIAN HEALTH SERVICE LOAN REPAYMENT PROGRAM REGULATIONS

Significance:
Subject to OMB review: Undetermined

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                            04/00/94
NPRM Comment Period End         06/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Indian Health Service (IHS)
  
_______________________________________________________________________
 
1290. INDIAN HEALTH SERVICE CATASTROPHIC HEALTH EMERGENCY FUND PROGRAM

Significance:
Subject to OMB review: Undetermined

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                            06/00/94
NPRM Comment Period End         08/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Richard J. McCloskey, Dir., Div. of Legislation and 
Regulations, 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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Indian Health Service (IHS)
  
_______________________________________________________________________
 
1291. REVISION OF INDIAN SELF-DETERMINATION REGULATIONS

Significance:
Subject to OMB review: Undetermined

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

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

Legal Deadline:  NPRM, Statutory, May 5, 1989. Final, Statutory, August 
5, 1989.

Abstract: Public Law 93-638 passed in 1975, requires the IHS to turn 
over administrative responsibility for services delivery programs to 
tribes so requesting, using the mechanism of contracting. Public Law 
93-638 also authorizes the IHS to make grants to tribe(s) for the 
planning, development, and or operations of health programs. Public Law 
100-472, enacted October 5, 1988, made significant changes to the 
statute and required that regulations implementing the amendments be 
promulgated in final within ten months of enactment. The law provides 
for tribal consultation and participation in the development of the 
regulations.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            01/20/94                     59 FR 3166
NPRM Comment Period End         05/20/94
Final Action                    11/00/94

Small Entities Affected: None

Government Levels Affected: Tribal

Procurement: This is a procurement-related action for which there is a 
statutory requirement. There is a paperwork burden associated with this 
action.
Additional Information: The Act (P.L. 100-472) provides that except for 
construction contracts, the Office of Federal Procurement Policy Act 
and Federal Acquisition Regulations shall not apply to self-
determination contracts. Therefore, implementing regulations for the 
Indian Self-Determination Act amendments will include a subpart on 
construction contracts which, unlike other self-determination awards, 
will be made subject to certain procurement rules (e.g., FARS, HSARS, 
FSARS).

Agency Contact: Richard J. McCloskey, Dir., Div. of Legislation and 
Regulations, 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-AC98
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Indian Health Service (IHS)
  
_______________________________________________________________________
 
1292. REVISION OF URBAN INDIAN HEALTH REGULATIONS

Significance:
Subject to OMB review: Undetermined

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                            06/00/94
NPRM Comment Period End         08/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Richard J. McCloskey, Dir., Div. of Legislation and 
Regulations, 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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--Indian Health Service (IHS)
  
_______________________________________________________________________
 
1293. ACQUISITION UNDER THE BUY INDIAN ACT

Significance:
Subject to OMB review: Undetermined

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                            00/00/00
NPRM Comment Period End         00/00/00

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)
  
_______________________________________________________________________
 
1294. REVIEW OF THE DETERMINATION OF AN INDIAN TRIBE'S RESOURCE 
DEFICIENCY LEVEL

Significance:
Subject to OMB review: Undetermined

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: Richard J. McCloskey, Dir., Div. of Legislation and 
Regulations, 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)
  
_______________________________________________________________________
 
1295. GRANTS FOR RESEARCH PROJECTS

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined

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                            06/00/94

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, 31/3B07, Bethesda, MD 20892, 301 496-4606

RIN: 0905-AC02
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
  
_______________________________________________________________________
 
1296. NATIONAL INSTITUTES OF HEALTH AIDS RESEARCH LOAN REPAYMENT PROGRAM

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined

Legal Authority:  42 USC 216; 42 USC 288-1

CFR Citation:  42 CFR 68

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            06/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
  
_______________________________________________________________________
 
1297. HAZARDOUS SUBSTANCES BASIC RESEARCH AND TRAINING GRANTS

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined

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                            06/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
  
_______________________________________________________________________
 
1298. NATIONAL INSTITUTES OF HEALTH CONSTRUCTION GRANTS

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined

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

CFR Citation:  42 CFR 52b

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            06/00/94

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 3B11, Bethesda, 
Maryland 20892, 301 496-4606

RIN: 0905-AD49
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
  
_______________________________________________________________________
 
1299. TRAINING GRANTS

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined

Legal Authority:  42 USC 216; 42 USC 285a-2(b)(3); 42 USC 285b; 42 USC 
285c; 42 USC 285c-2; 42 USC 285c-8; 42 USC 285d; 42 USC 285d-2; 42 USC 
285e,; 42 USC 285e-1; 42 USC 285f to 285g; 42 USC 285g-4(b)(1); 42 USC 
285h to 285i; 42 USC 285j-1; 42 USC 285i; ...

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                            07/00/94

Small Entities Affected: None

Government Levels Affected: None

Additional Information: 42 USC 285m 42 USC 287c 42 USC 287c-1 42 USC 
300cc-15(b)(1) 42 USC 300cc-41(a)(5)(C) 42 USC 740(h)(2)

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 3B-11, 
Bethesda, MD 20892, 301 496-4606

RIN: 0905-AD56
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
  
_______________________________________________________________________
 
1300. NATIONAL INSTITUTES OF HEALTH CENTER GRANTS

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined

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

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                            07/00/94

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, Building 31, Room 
3B-11, 9000 Rockville Pike, Bethesda, MD 20892, 301 496-4606

RIN: 0905-AE00
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
  
_______________________________________________________________________
 
1301. RESPONSIBILITIES OF PUBLIC HEALTH SERVICE FUNDED INSTITUTIONS FOR 
PROMOTING OBJECTIVITY IN RESEARCH

Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Yes

Legal Authority:  42 USC 216; 42 USC 289b-1

CFR Citation:  42 CFR 50, subpart F; 42 CFR 309

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

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            04/00/94

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

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

RIN: 0905-AE01
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
  
_______________________________________________________________________
 
1302. GRANTS FOR NATIONAL ALCOHOL RESEARCH CENTERS

Significance:
Subject to OMB review: Undetermined

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                            04/00/94

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
_______________________________________________________________________
  

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
  
_______________________________________________________________________
 
1303. TRAINEESHIPS

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined

Legal Authority:  42 USC 216; 42 USC 284(b)(1)(C); 42 USC 285c-8; 42 
USC 286b-3; 42 USC 287c; 42 USC 287c-1

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 the authority provided in 
PHS Act sections 405(b)(1)(C), 421, 434, 474, 484, and 485B.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            08/06/93                    58 FR 42039
NPRM Comment Period End         10/05/93
Final Action                    07/00/94

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. 3B11, Bethesda, MD 20892, 
301 496-4606

RIN: 0905-AD28
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
  
_______________________________________________________________________
 
1304. STANDARDS FOR BONE MARROW REGISTRIES AND CENTERS

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined

Legal Authority:  42 USC 216; 42 USC 274k

CFR Citation:  42 CFR 122

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

Abstract: Regulations will be promulgated 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

_________________________________________________________________________

Interim Final Rule              06/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
  
_______________________________________________________________________
 
1305. NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES HAZARDOUS WASTE 
WORKER TRAINING

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined

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                    07/00/94

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. 3B11, 
Bethesda, MD 20892, 301 496-4606

RIN: 0905-AD69
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--National Institutes of Health (NIH)
  
_______________________________________________________________________
 
1306.  NATIONAL HEART, LUNG, AND BLOOD INSTITUTE GRANTS FOR 
PREVENTION AND CONTROL PROJECTS

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined

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                    07/00/94

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, NIH, Building 31, 
Room 3B11, 9000 Rockville Pike, Bethesda, MD 20892, 301 496-2832

RIN: 0905-AE25
_______________________________________________________________________
  

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Public Health Service (PHS)--National Institutes of Health (NIH)
  
_______________________________________________________________________
 
1307. SPECIAL VOLUNTEER SERVICES AT THE NATIONAL INSTITUTES OF HEALTH

Significance:
Subject to OMB review: Yes

CFR Citation:  45 CFR 57a

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn - No compelling public 
need under E.O. 12866.          04/01/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Stephen C. Benowitz, 301 496-3592

RIN: 0905-AC95
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Public Health Service (PHS)--National Institutes of Health (NIH)
  
_______________________________________________________________________
 
1308. MINORITY BIOMEDICAL RESEARCH SUPPORT PROGRAM

Significance:
Subject to OMB review: Yes

CFR Citation:  42 CFR 52c

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    11/19/93                    58 FR 61029
Final Action Effective          12/20/93                    58 FR 61029

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AD47
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Public Health Service (PHS)--National Institutes of Health (NIH)
  
_______________________________________________________________________
 
1309. NATIONAL HEART, LUNG, AND BLOOD INSTITUTE GRANTS FOR PREVENTION AND 
CONTROL PROJECTS

Significance:
Subject to OMB review: Yes
Economically significant: Undetermined

CFR Citation:  42 CFR 52e

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    10/21/93                    58 FR 54297
Final Action Effective          11/22/93                    58 FR 54297

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0905-AD48
_______________________________________________________________________
  

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Public Health Service (PHS)--Agency for Health Care Policy and Research 
(AHCPR)
  
_______________________________________________________________________
 
1310. HEALTH SERVICES RESEARCH, EVALUATION, DEMONSTRATION, AND 
DISSEMINATION PROJECTS; PEER REVIEW OF GRANTS AND CONTRACTS

Significance:
Subject to OMB review: Undetermined

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                    08/00/94

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)
  
_______________________________________________________________________
 
1311. HOSPICE SERVICES (MB-7-P)

Significance:
Subject to OMB review: Undetermined

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                            08/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1312. OPTIONAL PAYMENT SYSTEM FOR LOW MEDICARE VOLUME SKILLED NURSING 
FACILITIES (BPD-409-P)

Significance:
Subject to OMB review: Yes

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 proposes to 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 would also specify that the return on equity provision 
for proprietary SNFs is eliminated effective October 1, 1993.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            04/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1313. MEDICAID ELIGIBILITY OF POVERTY LEVEL GROUPS AND EXTENDED COVERAGE 
OF SERVICES (MB-13-F)

Significance:
Subject to OMB review: Yes

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 amends 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), the Omnibus Budget Reconciliation Acts of 1990, 1989, 1987, 
and 1986, (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 adds 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                    00/00/00

Small Entities Affected: None

Government Levels Affected: State, Local

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

RIN: 0938-AD17
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1314. TRANSFER OF RESOURCES FOR LESS THAN FAIR MARKET VALUE (MB-10-P)

Significance:
Subject to OMB review: Undetermined

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                            06/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1315. MEDICARE COVERAGE OF OUTPATIENT OCCUPATIONAL THERAPY SERVICES (BPD-
425-P)

Significance:
Subject to OMB review: Undetermined

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                            06/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Marsha Klamner, Program Analyst, Alternative Delivery 
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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1316. REVISIONS TO THE FREEDOM OF INFORMATION REGULATIONS (OPA-1-P)

Significance:
Subject to OMB review: Yes

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                            06/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1317. NEW MINIMUM STANDARDS FOR MEDICARE SUPPLEMENTAL (MEDIGAP) POLICIES 
(BPD-491-P)

Significance:
Subject to OMB review: Undetermined

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                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: 
TIMETABLE: Under development.

Agency Contact: Thomas E. Hoyer, Director, 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, 410 966-4607

RIN: 0938-AD82
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1318. CLARIFICATION OF ``WITHOUT FAULT'' AS IT APPLIES TO PHYSICIAN 
PROVIDER AND SUPPLIER LIABILITY (BPD-719-P)

Significance:
Subject to OMB review: Undetermined

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                            07/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1319. PROTECTION OF INCOME AND RESOURCES FOR COMMUNITY SPOUSE (MB-23-P)

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined

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                            07/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1320. PHYSICIAN CERTIFICATION AND PLAN OF CARE REQUIREMENTS AND 
INSPECTION OF CARE REVIEWS (HSQ-178-P)

Significance:
Subject to OMB review: Undetermined

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                            09/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1321. 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)

Significance:
Subject to OMB review: Yes

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                            06/00/94

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 Blvd., Baltimore, MD 
21207, 410 966-4451

RIN: 0938-AE38
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1322. POST-CONTRACT BENEFICIARY PROTECTIONS AND OTHER PROVISIONS (OCC-
011-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 HMO or 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                    00/00/00

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Tracy Jensen, Office of Coordinated Care Policy and 
Planning, 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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1323. COVERAGE OF PHYSICIAN ASSISTANT, NURSE PRACTITIONER, AND CLINICAL 
NURSE SPECIALIST SERVICES (BPD-708-P)

Significance:
Subject to OMB review: Undetermined

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1324. UTILIZATION AND QUALITY CONTROL PEER REVIEW ORGANIZATIONS (PRO): 
CONFIDENTIAL INFORMATION (HSQ-190-P)

Significance:
Subject to OMB review: Undetermined

Legal Authority:  42 USC 1320c-9

CFR Citation:  42 CFR 476

Legal Deadline: None

Abstract: This rule would revise existing regulations to clarify which 
PRO information is considered confidential, to whom confidential 
information may be disclosed, and the conditions for disclosure.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            01/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Harvey Brook, Office of Peer Review, Department of 
Health and Human Services, Health Care Financing Administration, Room 
2-D-2, ME Bldg., 6325 Security Blvd., Baltimore, MD 21207, 410 966-6853

RIN: 0938-AF03
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1325. DAY HABILITATION AND RELATED SERVICES (MB-37-P)

Significance:
Subject to OMB review: Undetermined

Legal Authority:  PL 101-239, Sec 6411(g)

CFR Citation:  42 CFR 440

Legal Deadline: None

Abstract: Section 6411(g) of OBRA '89 prohibits disallowance on day 
habilitation services included in State plans which were approved on or 
before June 30, 1989. This prohibition will continue until clarifying 
regulations are promulgated. This rule would specify the types of day 
habilitation and related services that a State may cover under 
paragraph (9) or (13) of section 1905(a) of the Social Security Act on 
behalf of persons with mental retardation or with related conditions.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0938-AF10
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1326. MEDICAID THIRD PARTY LIABILITY: COST EFFECTIVENESS WAIVERS (MB-39-
F)

Significance:
Subject to OMB review: Yes

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

CFR Citation:  42 CFR 433.138; 42 CFR 433.139

Legal Deadline: None

Abstract: This rule would 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 
would 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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1327. OBRA '90 AND MISCELLANEOUS MANAGED CARE TECHNICAL AMENDMENTS (MB-
044-P)

Significance:
Subject to OMB review: Yes

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 would require certain health insuring organizations 
to be subject to the regulations governing prepaid health plans. This 
proposed rule would also allow State-only funds to be paid to Medicaid 
contracting entities. These funds would not be considered when 
computing the rate at which Federal financial participation is made. 
This rule would also incorporate several technical amendments from 
section 4732 of OBRA '90.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            04/00/94

Small Entities Affected: Businesses, Organizations

Government Levels Affected: State, Local

Agency Contact: Mike Fiore, Deputy Director, Medicaid Coordinated Care 
Office, Department of Health and Human Services, Health Care Financing 
Administration, Room 233, ELR, 6325 Security Blvd., Baltimore, MD 
21207, 410 966-4460

RIN: 0938-AF15
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1328. CRITERIA FOR THE DETERMINATION OF REASONABLE COSTS FOR MEDICARE --
CONTRACTING PREPAID HEALTH PLANS (OCC-018-F)

Significance:
Subject to OMB review: Yes
Economically significant: Undetermined

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' 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: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Jennifer Messersmith, Program Analyst, Office of 
Coordinated Care Policy and Planning, Department of Health and Human 
Services, Health Care Financing Administration, 4360 Cohen Bldg., 330 
Independence Ave. SW., Washington, DC 20201, 202 401-2325

RIN: 0938-AF16
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1329. PROVIDER REIMBURSEMENT DETERMINATIONS AND APPEALS REVISIONS (BPD-
727-P)

Significance:
Subject to OMB review: Undetermined

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                            08/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1330. ALTERNATIVE SANCTIONS FOR PSYCHIATRIC HOSPITALS (HSQ-191-P)

Significance:
Subject to OMB review: Undetermined

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                            12/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1331. MEDICARE, MEDICAID, AND CLIA PROGRAMS: INSPECTION AND CERTIFICATION 
PROCEDURES FOR LABORATORIES (HSQ-193-P)

Significance:
Subject to OMB review: Undetermined

Legal Authority:  42 USC 1395w-2; 42 USC 263a

CFR Citation:  42 CFR 493

Legal Deadline: None

Abstract: This rule would implement procedures for States to follow in 
inspecting and certifying laboratories under CLIA '88 (PL 100-578). 
This rule is needed to carry out the authority of the Department of 
Health and Human Services to inspect laboratories, as mandated by 
section 353(g) of the Public Health Service Act, and to take 
enforcement actions as authorized by section 353(h) and (i) of the 
Public Health Services Act and section 1846 of the Social Security Act.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            08/00/94

Small Entities Affected: Businesses, Governmental Jurisdictions

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-AF33
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1332. MEDICAID PAYMENT FOR OBSTETRICAL AND PEDIATRIC SERVICES--ADEQUATE 
PAYMENT LEVEL PROVISION (MB-036-P)

Significance:
Subject to OMB review: Undetermined

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1333. REQUIREMENTS FOR ENROLLMENT OF MEDICAID RECIPIENTS UNDER COST 
EFFECTIVE EMPLOYER BASED GROUP HEALTH PLANS (MB-047-P)

Significance:
Subject to OMB review: Yes

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 would 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                            05/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1334. CLARIFICATION OF COVERAGE OF INPATIENT PSYCHIATRIC SERVICES (MB-
060-P)

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined

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                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: State

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

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1335. NATIONAL COVERAGE DECISIONS: RULES FOR RISK CONTRACTING HMOS AND 
CMPS (BPD-732-F)

Significance:
Subject to OMB review: Yes

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 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
NPRM Comment Period End         04/25/94                     59 FR 8429
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Joanne Sinsheimer, Chief, Long Term Care Branch, 
Department of Health and Human Services, Health Care Financing 
Administration, Room 401, EHR, 6325 Security Boulevard, Baltimore, 
Maryland 21207, 410 966-4620

RIN: 0938-AF76
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1336. PART B ADVANCE PAYMENTS TO PHYSICIANS/SUPPLIERS OR OTHER ENTITIES 
FURNISHING ITEMS OR SERVICES UNDER MEDICARE PART B (BPO-105-P)

Significance:
Subject to OMB review: Yes

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                            06/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1337. FEDERALLY QUALIFIED HEALTH CENTER SERVICES (MEDICAID) (MB-043-P)

Significance:
Subject to OMB review: Undetermined

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                            00/00/00

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1338. REVISIONS TO RULES ON HEALTH CARE PREPAYMENT PLANS (OCC-032-P)

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined

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 (HCPPs) 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                            01/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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

RIN: 0938-AF97
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1339. 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: Tom Hoyer, Director, Division of Provider Services 
Coverage Policy, Department of Health and Human Services, Health Care 
Financing Administration, 401 EHR, 6325 Security Boulevard, Baltimore, 
MD 21207, 410 966-4607

RIN: 0938-AG03
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1340. CONDITIONS OF PARTICIPATION FOR RURAL HEALTH CLINICS (BPD-764-P)

Significance:
Subject to OMB review: Undetermined

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.)

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            11/00/94

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Jacqueline Sheridan, Chief, Alternative Delivery 
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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1341. INTERMEDIARY AND CARRIER FUNCTIONS (BPO-111-F)

Significance:
Subject to OMB review: Yes

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 will change 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
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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1342. INCOME AND ELIGIBILITY VERIFICATION SYSTEM (MB-66-P)

Significance:
Subject to OMB review: Undetermined

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 the 
Health Care Financing Administration. 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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1343. MEDICARE APPEALS OF INDIVIDUAL CLAIMS (BPD-453-P)

Significance:
Subject to OMB review: Undetermined

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                            09/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1344. CRITERIA FOR APPROVAL OF END-STAGE RENAL DISEASE (ESRD) PAYMENT 
EXCEPTION REQUESTS (BPD-763-P)

Significance:
Subject to OMB review: Undetermined

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.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            05/00/94

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Mike Powell, Program Analyst, Division of Special 
Payment Policy, 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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1345. 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)

Significance:
Subject to OMB review: Yes

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 will also 
update 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, Alternative Delivery 
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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1346. APPOINTMENT OF REPRESENTATIVES FOR APPEAL (BPO-120-P)

Significance:
Subject to OMB review: Undetermined

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                            01/00/95

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Lisa Vriezen, 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, 410 966-6477

RIN: 0938-AG30
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1347. ENFORCEMENT REQUIREMENTS FOR RENAL DIALYSIS FACILITIES (HSQ-204-P)

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined

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 ESRD 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                            12/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1348. DISCLOSURE OF CONFIDENTIAL PRO INFORMATION FOR RESEARCH PURPOSES 
(HSQ-208-P)

Significance:
Subject to OMB review: Undetermined

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1349. COMMUNITY SUPPORTED LIVING ARRANGEMENTS SERVICES (MB-070-P)

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined

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                            00/00/00

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1350. MEDICARE PROGRAM: LIMITATIONS ON MEDICARE COVERAGE OF INTERMITTENT 
POSITIVE PRESSURE BREATHING MACHINE THERAPY (BPD-781-PN)

Significance:
Subject to OMB review: Undetermined

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                 08/00/94

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Jacqueline Sheridan, Acting Director, Division of 
Medical Services Coverage Policy, BPD, Department of Health and Human 
Services, Health Care Financing Administration, Room 401, EHR Building, 
6325 Security Boulevard, Baltimore, Maryland 21207, 410 966-4637

RIN: 0938-AG44
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1351. NONCOVERAGE OF ELECTROSTIMULATION OF SALIVARY GLANDS FOR THE 
TREATMENT OF XEROSTOMIA (DRY MOUTH) (BPD-782-PN)

Significance:
Subject to OMB review: Undetermined

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                 06/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1352. MEDICARE PROGRAM: CHANGES TO THE INPATIENT HOSPITAL PROSPECTIVE 
PAYMENT SYSTEMS AND FISCAL YEAR 1995 RATES (BPD-802-P)

Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Yes

Legal Authority:  42 USC 1395ww

CFR Citation:  42 CFR 412; 42 CFR 413

Legal Deadline:  NPRM, Statutory, May 1, 1994. Final, Statutory, 
September 1, 1994.

Abstract: This rule will make revisions to the inpatient hospital 
prospective payment systems for operating costs and capital- related 
costs. It also will include changes in the methods, amounts, and 
factors used to determine the prospective payment rates applicable to 
discharges occurring during FY 1995. In addition, the final rule sets 
forth the rate-of-increase limits for hospitals and hospital units 
excluded from the prospective payment systems.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            05/00/94

Small Entities Affected: Businesses, Organizations

Government Levels Affected: State, Federal

Agency Contact: Nancy Drucker, Acting Director, Division of Hospital 
Payment Policy, BPD, Department of Health and Human Services, Health 
Care Financing Administration, Room 1-H-1, ELR Building, 6325 Security 
Boulevard, Baltimore, Maryland 21207, 410 966-4529

RIN: 0938-AG46
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1353. TELEPHONE REQUESTS FOR REVIEW OF INITIAL DETERMINATIONS (BPO-121-P)

Significance:
Subject to OMB review: Undetermined

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                            07/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1354. REFINEMENTS TO THE PHYSICIAN FEE SCHEDULE GEOGRAPHIC ADJUSTMENT 
FACTOR VALUES AND OTHER CHANGES (BPD-789-P)

Significance:
Subject to OMB review: Undetermined

Legal Authority:  42 USC 1395w-4

CFR Citation:  42 CFR 414

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

Abstract: This proposed rule discusses changes to the geographic 
practice cost indices, fee schedule payment areas, proposed relative 
value units for certain physician services, and revisions to payment 
policies for specific physician services and supplies. It also 
discusses implementation of the OBRA '93 provision regarding payment 
for antigens, which places antigens under the physician fee schedule 
and subjects them to charge limits.
In addition, the notice will announce policy changes that HCFA proposes 
to make to the physician fee schedule.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            05/00/94

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Elizabeth Holland, Health Insurance Specialist, Office 
of Payment Policy, BPD, Department of Health and Human Services, Health 
Care Financing Administration, 1-H-5, ELR Building, 6325 Security 
Boulevard, Baltimore, Maryland, 410 966-1309

RIN: 0938-AG52
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1355. CONDITIONS FOR PAYMENT FOR PHYSICIANS' SERVICES IN TEACHING 
SETTINGS (BPD-792-P)

Significance:
Subject to OMB review: Undetermined

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 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                            07/00/94

Small Entities Affected: Undetermined

Government Levels Affected: None

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1356. DATE FOR FILING MEDICARE COST REPORTS (BPD-794-P)

Significance:
Subject to OMB review: Undetermined

Legal Authority:  42 USC 1395g

CFR Citation:  42 CFR 405.376; 42 CFR 413.24

Legal Deadline: None

Abstract: This rule would 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                            06/00/94

Small Entities Affected: None

Government Levels Affected: None

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 Boulevard, 
Baltimore, Maryland 21207, 410 966-4513

RIN: 0938-AG55
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1357. LIMITATIONS ON REVISIONS TO FINAL ADMINISTRATIVE COST PROPOSALS 
(BPO-122-P)

Significance:
Subject to OMB review: Undetermined

Legal Authority:  42 USC 1395g; 42 USC 1395h; 42 USC 1395u; 42 USC 
1395kk

CFR Citation:  42 CFR 421.10

Legal Deadline: None

Abstract: This rule would establish a time limit beyond which fiscal 
intermediaries and carriers may not claim reimbursement for incurred 
administrative costs. Under current procedures, these costs are claimed 
on an intermediary's or carrier's final administrative cost proposed 
report submitted shortly after the close of the fiscal year but open to 
revision. We propose to no longer accept revisions to that report 
submitted significantly after the report's due date.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Don Posen, Health Insurance Specialist, Bureau of 
Program Operations, Department of Health and Human Services, Health 
Care Financing Administration, Room 343, ME Building, 6325 Security 
Boulevard, Baltimore, Maryland 21207, 410 966-7533

RIN: 0938-AG57
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1358. NEW LOOK BEHIND FOR INTERMEDIATE CARE FACILITIES FOR THE MENTALLY 
RETARDED (ICFS/MR) (HSQ-214-P)

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined

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                            10/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1359. EFFECT OF CHANGE OF OWNERSHIP ON PROVIDER AND SUPPLIER PENALTIES, 
SANCTIONS, AND OVERPAYMENTS (HSQ-215-P)

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined

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                            08/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1360. INSTITUTIONAL PLAN AMENDMENT FINDINGS (MB-078-P)

Significance:
Subject to OMB review: Yes

Legal Authority:  42 USC 1396a(a)(13)(A); PL 97-35, Sec 2173

CFR Citation:  42 CFR 430; 42 CFR 447

Legal Deadline: None

Abstract: This rule would provide guidance to States on institutional 
plan amendment findings and clarify the provisions of the regulations 
governing effective dates of plan amendments for Medicaid payments of 
hospital and long term care services. This proposed rule would promote 
increased economy in the administration of the Medicaid program while 
retaining State flexibility to the maximum extent possible.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            05/00/94

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Bernie Truffer, Director, Division of Payment Policy, 
Department of Health and Human Services, Health Care Financing 
Administration, Room 233, EHR, 6325 Security Boulevard, Baltimore, 
Maryland 21207, 410 966-1357

RIN: 0938-AG60
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1361.  MEDICARE PROGRAM: LIMITATIONS ON MEDICARE COVERAGE OF 
CATARACT SURGERY (BPD-797-PN)

Significance:
Subject to OMB review: Undetermined

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

CFR Citation:  None

Legal Deadline: None

Abstract: This notice announces 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                 08/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1362.  EFFECTS OF GENERALLY ACCEPTED ACCOUNTING PRINCIPLES (GAAP) 
ON REASONABLE COSTS DETERMINATIONS (BPD-800-P)

Significance:
Subject to OMB review: Undetermined

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                            01/00/95

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Janet Wellham, Chief, Payment Policy Branch, Department 
of Health and Human Services, Health Care Financing Administration, 
Room 1-F-5, ELR, 6325 Security Boulevard, Baltimore, Maryland 21207, 
410 966-4510

RIN: 0938-AG66
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1363.  EXPANSION OF THE DEFINITION OF EYE AND EAR SPECIALTY 
HOSPITALS (BPD-804-P)

Significance:
Subject to OMB review: Undetermined

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 (ASC) 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                            12/00/94

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Bill 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 Boulevard, 
Baltimore, Maryland 21207, 410 966-4513

RIN: 0938-AG67
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1364.  SALARY EQUIVALENCY GUIDELINES FOR PHYSICAL AND RESPIRATORY 
THERAPY SERVICES FURNISHED UNDER ARRANGEMENTS (BPD-808-PN)

Significance:
Subject to OMB review: Undetermined

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

CFR Citation:  None

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 furnished under agreements by 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                 10/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1365.  MEDICAID: OPTIONAL COVERAGE OF TB-RELATED SERVICES FOR 
INDIVIDUALS INFECTED WITH TUBERCULOSIS (MB-082-P)

Significance:
Subject to OMB review: Undetermined

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                            08/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1366.  MEDICAID PROGRAM: NURSE-MIDWIFE SERVICES (MB-085-P)

Significance:
Subject to OMB review: Undetermined

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                            09/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1367.  PROPOSED PAYMENTS TO DISPROPORTIONATE SHARE HOSPITALS FOR 
FY 1995 (MB-089-N)

Significance:
Subject to OMB review: Yes
Economically significant: Undetermined
Regulatory Plan entry: Undetermined

Legal Authority:  42 USC 1396r-4(f)

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

Legal Deadline: None

Abstract: This notice 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
_______________________________________________________________________
  

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1368. MEDICAID ELIGIBILITY AND COVERAGE REQUIREMENTS (MB-001-F)

Significance:
Subject to OMB review: Undetermined
Economically significant: Yes
Regulatory Plan entry: Yes

Legal Authority:  42 USC 1396a(a)(10); 42 USC 1396a(f); 42 USC 
1396a(a)(17); 42 USC 1396b(f)(1); 42 USC 1396d(a)

CFR Citation:  42 CFR 435; 42 CFR 436

Legal Deadline: None

Abstract: This final rule amends the regulations for determining 
Medicaid eligibility. The amendments implement or conform the 
regulations to various statutes, including TEFRA '82 (PL 97-248), OBRA 
'87 (PL 100-203), MCCA '88 (PL 100-360), OBRA '89 (PL 101-239) and OBRA 
'90 (PL 101-508). The amendments also make some administrative changes 
to clarify policy and enhance the efficient operation of the Medicaid 
program.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            09/26/89                    54 FR 39421
NPRM Comment Period End         11/27/89                    54 FR 39421
Final Rule With Comment Period  01/19/93                     58 FR 4908
Public Comment Period End       02/16/93                     58 FR 4908
Effective Date Generally        08/18/94                     59 FR 8138
Effective Date for Secs. 
435.604, 435.606, 436.604, and 
436.606                         10/19/94                     59 FR 8138
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: State, Local

Additional Information: 
TIMETABLE: Pending review of complex policy 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 Boulevard, Baltimore, MD 
21207, 410 966-4451

RIN: 0938-AA58
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1369. DEDUCTION OF INCURRED MEDICAL EXPENSES (SPENDDOWN) (MB-020-F)

Significance:
Subject to OMB review: Yes
Economically significant: Yes

Legal Authority:  42 USC 1396a(a)(10); 42 USC 1396a(a)(17)

CFR Citation:  42 CFR 435.732; 42 CFR 435.831; 42 CFR 436.831

Legal Deadline: None

Abstract: These regulations will permit States to revise the process by 
which medical expenses are considered in determining Medicaid 
eligibility. This process applies when an individual's income level 
during a budget period would ordinarily preclude eligibility except 
that incurred medical expenses reduce income to the eligibility level.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            09/02/83                    48 FR 39959
NPRM Comment Period End         11/01/83                    48 FR 39959
Final Rule With Comment Period  01/12/94                     59 FR 1659
Comment Period End              03/14/94
Final Rule Effective            03/14/94
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Marinos Svolos, Director, Division of Eligibility 
Policy, Department of Health and Human Services, Health Care Financing 
Administration, Room 323 East High Rise Bldg., 6325 Security Boulevard, 
Baltimore, MD 21207, 410 966-4451

RIN: 0938-AB07
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1370. PAYMENT FOR CLINICAL DIAGNOSTIC LABORATORY SERVICES (BPD-309-F)

Significance:
Subject to OMB review: Undetermined

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

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 Blvd., 
Baltimore, MD 21207, 410 966-4497

RIN: 0938-AB50
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1371. HOME AND COMMUNITY-BASED SERVICES AND RESPIRATORY CARE FOR 
VENTILATOR-DEPENDENT INDIVIDUALS (MB-8-FC)

Significance:
Subject to OMB review: Undetermined

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 Action                    06/00/94

Small Entities Affected: None

Government Levels Affected: State, Local

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

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1372. PARTICIPATION IN CHAMPUS AND CHAMPVA, HOSPITAL ADMISSIONS FOR 
VETERANS, DISCHARGE RIGHTS NOTICE, AND HOSPITAL RESPONSIBILITY FOR 
EMERGENCY CARE (BPD-393-FC)

Significance:
Subject to OMB review: Yes

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 with comment period will formally implement 
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 will 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  04/00/94

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Thomas Hoyer, Director, Division of Provider Services 
Coverage Policy, Department of Health and Human Services, Health Care 
Financing Administration, Room 401 EHR Bldg., 6325 Security Blvd., 
Baltimore, MD 21207, 410 966-4607

RIN: 0938-AC58
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1373. DENIAL OF PAYMENT FOR SUBSTANDARD QUALITY CARE (HSQ-132-F)

Significance:
Subject to OMB review: Undetermined

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: Undetermined

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1374. REVISED EFFECTIVE DATE OF MEDICARE/MEDICAID PROVIDER AGREEMENT AND 
SUPPLIER PARTICIPATION (HSQ-139-F)

Significance:
Subject to OMB review: Undetermined

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                    08/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1375. CHANGES CONCERNING SUSPENSION OF MEDICARE PAYMENTS AND 
DETERMINATIONS OF ALLOWABLE INTEREST EXPENSE (BPO-118-FC)

Significance:
Subject to OMB review: Undetermined

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 OIG 
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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1376. CHANGES CONCERNING THE DEFINITION OF ACCRUAL BASIS OF ACCOUNTING 
(BPD-366-F)

Significance:
Subject to OMB review: Undetermined

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

CFR Citation:  42 CFR 413.24

Legal Deadline: None

Abstract: This rule revises 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                    09/00/94

Small Entities Affected: None

Government Levels Affected: None

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-AD01
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1377. CRITERIA AND PROCEDURES FOR MAKING MEDICAL SERVICES COVERAGE 
DECISIONS THAT RELATE TO HEALTH CARE TECHNOLOGY (BPD-432-F)

Significance:
Subject to OMB review: Undetermined

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 rule will establish in regulations generally applicable 
standards and procedures for determinations as to whether and under 
what circumstances specific medical items and services should be paid 
for under Medicare. It establishes and explains the criteria relied 
upon for determining whether an item or service is ``reasonable and 
necessary.'' 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 properly covered under the Medicare program.

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: Jacqueline Sheridan, Acting Director, Division of 
Medical Services Coverage Policy, Department of Health and Human 
Services, Health Care Financing Administration, 401 East High Rise 
Bldg., 6325 Security Blvd., Baltimore, MD 21207, 410 966-4637

RIN: 0938-AD07
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1378. REVISIONS TO CONDITIONS OF PARTICIPATION FOR HOSPITALS AND 
CONDITIONS FOR COVERAGE OF SUPPLIERS OF END-STAGE RENAL DISEASE SERVICES 
(BPD-421-F)

Significance:
Subject to OMB review: Undetermined

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 Medicare 
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                    04/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Thomas Hoyer, Director, Division of Provider Services 
Coverage Policy, Department of Health and Human Services, Health Care 
Financing Administration, Room 401 EHR, 6325 Security Blvd., Baltimore, 
MD 21207, 410 966-4607

RIN: 0938-AD11
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1379. PROHIBITION ON UNBUNDLING OF HOSPITAL OUTPATIENT SERVICES (BPD-426-
F)

Significance:
Subject to OMB review: Undetermined

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

CFR Citation:  42 CFR 405; 42 CFR 409; 42 CFR 410; 42 CFR 411; 42 CFR 
412; 42 CFR 489; 42 CFR 1003

Legal Deadline: None

Abstract: These regulations will implement sections 9343(c)(1), (c)(2), 
and (c)(3) of OBRA '86, as amended by section 4157 of OBRA '90. This 
rule, issued jointly by HCFA and OIG, will prohibit Medicare payment 
for most nonphysician services furnished to a hospital outpatient by a 
provider or supplier other than the hospital, unless the services are 
furnished under an arrangement with the hospital. The hospital will be 
obligated by its provider agreement to furnish the services directly or 
under an arrangement. These regulations will also authorize OIG to 
impose a civil money penalty, not to exceed $2,000, against any 
individual who knowingly and willfully presents, or causes to be 
presented, a bill or request for payment for a hospital outpatient 
service under Part B of Medicare in violation of an arrangement.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: Businesses

Government Levels Affected: None

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

Agency Contact: Thomas Hoyer, Director, Div. of Provider Services 
Coverage Policy, Department of Health and Human Services, Health Care 
Financing Administration, Rm. 401 EHR, 6325 Security Blvd., Baltimore, 
MD 21207, 410 966-4607

RIN: 0938-AD33
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1380. CHANGES TO PEER REVIEW ORGANIZATION REGULATIONS (HSQ-135-F)

Significance:
Subject to OMB review: Undetermined

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 sets forth several changes to regulations that 
govern Peer Review Organizations (PROs) and is based on legislative 
changes contained in COBRA '85 (PL 99-272) and OBRA '86 (PL 99-503). In 
addition, several technical changes have been proposed, as a result of 
experience gained with the PRO program by HCFA. This rule also 
implements the new quality review requirements for certain Medicaid 
Health Maintenance Organization contracts.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            03/16/88                     53 FR 8654
NPRM Comment Period End         05/16/88                     53 FR 8654
Final Action                    12/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1381. HOME AND COMMUNITY-BASED SERVICES FOR THE ELDERLY (MB-019-F)

Significance:
Subject to OMB review: Undetermined

Legal Authority:  42 USC 1396n(d)

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

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

Abstract: This regulation implements section 1915(d) of the Social 
Security Act, which allows a State to obtain a waiver of certain 
Medicaid requirements to permit Federal financial participation for 
home and community based services provided to individuals age 65 or 
older who are shown by an evaluation to be likely to require the level 
of care provided in a skilled nursing facility (SNF), intermediate care 
facility (ICF), a nursing facility (NF) effective October 1, 1990, the 
cost for which could be paid by Medicaid. The statute allows for 
waivers of statewideness, comparability, and income deeming. Under the 
waiver provisions, the total amount expended by the State for home and 
community based services, SNF services, and ICF services (NF effective 
October 1, 1990) for individuals over age 65 may not exceed a 
``projected amount,'' determined under the methodology provided in 
these regulations. For States electing this option the waiver would 
replace home and community based waivers available under section 
1915(c) of the Act, for individuals in this age category.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Interim Final Rule With Comment 
Period                          06/30/92                    57 FR 29142
Effective Date                  08/30/92                    57 FR 29142
Public Comment Period End       08/31/92                    57 FR 29142
Final Action                    00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: State, Local

Additional Information: 
TIMETABLE: Pending analysis of public comments.

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-AD55
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1382. PAYMENT FOR DURABLE MEDICAL EQUIPMENT AND ORTHOTIC AND PROSTHETIC 
DEVICES (BPD-494-F)

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined

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                    02/00/95

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1383. MEDICARE SECONDARY PAYER FOR DISABLED ACTIVE INDIVIDUALS (BPD-482-
FC)

Significance:
Subject to OMB review: Undetermined

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 ``active Individuals'' who are also covered 
under large group health plans (LGHP) and prohibits discrimination by 
LGHPs against such individuals. It will contain procedures under which 
a plan can appeal a determination of noncompliance which leads to a tax 
penalty. It will also reflect statutory revisions mandated by OBRA '93, 
some of which also affect the MSP provisions for those 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                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

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

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1384. MEDICARE COVERAGE OF HOME HEALTH SERVICES, MEDICARE CONDITIONS OF 
PARTICIPATION AND HOME HEALTH AIDE SUPERVISION (BPD-469-F)

Significance:
Subject to OMB review: Yes

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                    09/00/94

Small Entities Affected: Undetermined

Government Levels Affected: None

Agency Contact: Thomas Hoyer, Director, 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, 410 966-4607

RIN: 0938-AD78
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1385. APPEALS FOR ENROLLEES OF PREPAID HEALTH CARE PLANS (OCC-020-F)

Significance:
Subject to OMB review: Undetermined

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                    09/00/94

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Maureen Miller, Program Analyst, Office of Coordinated 
Care Policy and Planning, 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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1386. OMNIBUS NURSING HOME REFORM REQUIREMENTS (BPD-488-FC)

Significance:
Subject to OMB review: Undetermined

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  01/00/95

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Agency Contact: Bill Ullman, Program Analyst, 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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1387. FEE SCHEDULE FOR PAYMENT OF THERAPEUTIC AND DIAGNOSTIC SERVICES 
OTHER THAN PSYCHOLOGICAL TESTING PROVIDED BY CLINICAL PSYCHOLOGISTS AND 
CLINICAL SOCIAL WORKERS (BPD-495-IFC)

Significance:
Subject to OMB review: Undetermined

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, and a clinical 
social worker. It implements a portion of section 4077(b) of OBRA '87 
as amended. It will also reflect statutory revisions mandated by OBRA 
'93.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Interim Final Rule With Comment 
Period                          08/00/94

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Bernard Patashnik, Director, 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, 410 966-4497

RIN: 0938-AD84
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1388. SURVEY AND CERTIFICATION OF SKILLED NURSING FACILITIES AND NURSING 
FACILITIES AND ENFORCEMENT PROCEDURES (HSQ-156-F)

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Regulatory Plan entry: Yes

Legal Authority:  42 USC 1395aa; 42 USC 1395i-3(g); 42 USC 1396r(g)

CFR Citation:  42 CFR 488; 42 CFR 431; 42 CFR 442; 42 CFR 489

Legal Deadline:  Final, Statutory, January 1, 1988.

Abstract: This rule would implement sections 4202, 4203, 4212, and 4213 
of OBRA '87 (PL 100-203) which govern the process used by HCFA to 
survey long-term care facilities, and to certify that the facilities 
meet the participation requirements for the Medicare and Medicaid 
programs. The rule would also specify a number of sanctions or remedies 
that could be used when a skilled nursing facility or nursing facility 
is out of compliance with Federal requirements as an alternative to or 
in addition to termination.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            08/28/92                    57 FR 39278
NPRM Comment Period End         10/27/92                    57 FR 39278
Final Action                    05/00/94

Small Entities Affected: Undetermined

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, ME 
Building, 6325 Security Boulevard, Baltimore, Maryland 21207, 410 966-
7089

RIN: 0938-AD94
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1389. HMO ORGANIZATIONAL STRUCTURE AND SERVICES (OCC-019-F)

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Regulatory Plan entry: Yes

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 would 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                    01/00/95

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0938-AE25
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1390. ``CONFINED TO THE HOME'' REQUIREMENTS FOR HOME HEALTH SERVICES 
(BPD-626-F)

Significance:
Subject to OMB review: Undetermined

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: Thomas Hoyer, Director, Division of Provider Services 
Coverage Policy, Department of Health and Human Services, Health Care 
Financing Administration, Room 401 EHR, 6325 Security Blvd., Baltimore, 
MD 21207, 410 966-4607

RIN: 0938-AE34
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1391. PAYMENT ADJUSTMENTS FOR HOSPITALS THAT SERVE A DISPROPORTIONATE 
NUMBER OF LOW-INCOME PATIENTS (MB-017-IFC)

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined

Legal Authority:  42 USC 1396a(a)(13)(A); 42 USC 1396r-4

CFR Citation:  42 CFR 412; 42 CFR 440; 42 CFR 447

Legal Deadline: None

Abstract: This rule establishes the requirements and options for 
Medicaid payments to hospitals that serve a disproportionate number of 
low-income patients with special needs. The Medicaid agency will be 
required to make payment adjustments to these hospitals when such 
hospitals have met specified conditions.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            03/19/90                    55 FR 10077
NPRM Comment Period End         05/18/90                    55 FR 10077
Interim Final Rule              00/00/00

Small Entities Affected: Businesses

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, MD 
21207, 410 966-1357

RIN: 0938-AE35
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1392. SURVEY REQUIREMENTS AND ALTERNATIVE SANCTIONS FOR HOME HEALTH 
AGENCIES (HSQ-169-F)

Significance:
Subject to OMB review: Undetermined

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 would establish periodic, unannounced surveys of 
home health agencies and other survey requirements and also would 
specify a number of sanctions that could be used, when a home health 
agency is out of compliance with Federal requirements, as an 
alternative or in addition to terminating its 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                    07/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1393. HOSPITAL STANDARD FOR HIV INFECTIOUS BLOOD (BPD-633-F)

Significance:
Subject to OMB review: Undetermined

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

CFR Citation:  42 CFR 482

Legal Deadline: None

Abstract: This final rule will require hospitals or blood banks 
providing services to hospitals to notify either each recipient or each 
recipient's physician when potentially HIV infectious blood has been 
administered, and to offer each recipient counseling and testing. 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: Joyce Eng, Program Analyst, Division of Provider 
Services Coverage Policy, Department of Health and Human Services, 
Health Care Financing Administration, Room 401, EHR, 6325 Security 
Blvd, Baltimore, MD 21207, 410 966-4619

RIN: 0938-AE40
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1394. MEDICARE, MEDICAID, AND CLIA PROGRAMS: REGULATIONS IMPLEMENTING THE 
CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 (CLIA '88) (HSQ-202-F)

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined

Legal Authority:  42 USC 263a

CFR Citation:  42 CFR 493

Legal Deadline: None

Abstract: Historically the Department regulated laboratories by 
``location,'' rather than by types of tests they perform. CLIA '88 
changed this approach. CLIA requires that the Department ``regulate by 
test,'' using what is commonly referred to as the ``complexity model.'' 
A final rule with comment period was published February 28, 1992, that 
set forth standards for all laboratories based on complexity and 
responds to public comments on the proposed standards. The regulation 
was revised by a rule with comment period published on January 19, 
1993, 56 FR 5215. The comment period for this rule ended March 22, 
1993. A final rule, which will respond to public comments on the 
February 28, 1992 rule and the January 19, 1993 rule, will also be 
issued.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            05/21/90                    55 FR 20896
NPRM Comment Period End         09/21/90                    55 FR 34289
Final Rule With Comment Period  02/28/92                     57 FR 7002
Public Comment Period End       04/28/92                     57 FR 7002
Effective Date                  09/01/92                     57 FR 7002
Effective Date                  01/19/93                     58 FR 5215
Final Rule With Comment Period  01/19/93                     58 FR 5215
Comment Period End              03/22/93                     58 FR 6215
Final Action                    02/00/95

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Additional Information: 
TIMETABLE: Pending analysis of public comments.

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

RIN: 0938-AE47
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1395. CONDITIONS OF COVERAGE FOR ORGAN PROCUREMENT ORGANIZATIONS (BPD-
646-FC)

Significance:
Subject to OMB review: Yes

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 Action                    06/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Claude Mone, Program Analyst, Alternative Delivery 
Organizations Branch, Department of Health and Human Services, Health 
Care Financing Administration, 401, EHR, 6325 Security Boulevard, 
Baltimore, Maryland 21207, 410 966-5666

RIN: 0938-AE48
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1396. PREADMISSION SCREENING AND ANNUAL RESIDENT REVIEW (BPD-661-F)

Significance:
Subject to OMB review: Undetermined
Regulatory Plan entry: Yes

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1397. EXTENDED MEDICAID ELIGIBILITY FOR CERTAIN INDIVIDUALS (MB-026-F)

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined

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 would 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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1398. RESIDENT ASSESSMENT IN LONG-TERM CARE FACILITIES (HSQ-180-F)

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined

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                    09/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1399. CONFORMING PROVISIONS FOR 1988 HMO AMENDMENTS (OCC-012-F)

Significance:
Subject to OMB review: Undetermined

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. It would also eliminate the requirement that one-third 
of a HMO's policymaking body be HMO enrollees.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            07/05/91                    56 FR 30723
Public Comment Period End       09/03/91                    56 FR 30723
Final Action                    09/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Marty Abeln, Office of Coordinated Care Policy and 
Planning, 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-AE64
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1400. EARLY AND PERIODIC SCREENING, DIAGNOSTIC, AND TREATMENT (EPSDT) 
SERVICES (MB-28-F)

Significance:
Subject to OMB review: Undetermined
Regulatory Plan entry: Yes

Legal Authority:  42 USC 1396a(a)(43); 42 USC 1396d(r)

CFR Citation:  42 CFR 441.50; 42 CFR 440.40

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

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

Small Entities Affected: Undetermined

Government Levels Affected: State, Local

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

RIN: 0938-AE72
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1401. PAYMENT FOR NURSING AND ALLIED HEALTH SCIENCE EDUCATION (BPD-685-F)

Significance:
Subject to OMB review: Undetermined

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                    07/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1402. 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
NPRM Comment Period End         10/18/91                    56 FR 41110
Final Action                    05/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1403. MEDICARE COVERAGE OF PRESCRIPTION DRUGS USED IN IMMUNOSUPPRESSIVE 
THERAPY (BPD-424-F)

Significance:
Subject to OMB review: Undetermined

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                    06/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Walter Rutemueller, Chief, Special Cvoverage 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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1404. FIRE SAFETY STANDARDS FOR HOSPITALS, LONG-TERM CARE FACILITIES, AND 
INTERMEDIATE CARE FACILITIES FOR THE MENTALLY RETARDED (BPD-650-F)

Significance:
Subject to OMB review: Undetermined

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: Thomas E. Hoyer, Director, Division of Provider 
Services Coverage Policy, Department of Health and Human Services, 
Health Care Financing Administration, Room 401, EHR, 6325 Security 
Blvd., Baltimore, MD 21207, 410 966-4607

RIN: 0938-AE97
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1405. COVERAGE OF SCREENING PAP SMEARS (BPD-705-F)

Significance:
Subject to OMB review: Undetermined

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                    00/00/00

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1406. MEDICARE COVERAGE OF CLINICAL PSYCHOLOGIST, OTHER PSYCHOLOGIST, AND 
CLINICAL SOCIAL WORKER SERVICES--MEDICARE (BPD-706-F)

Significance:
Subject to OMB review: Yes
Economically significant: Yes

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                    00/00/00

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1407. ALLOWING CERTIFICATIONS AND RECERTIFICATIONS BY NURSE PRACTITIONERS 
AND CLINICAL NURSE SPECIALISTS FOR CERTAIN SERVICES (BPD-709-F)

Significance:
Subject to OMB review: Undetermined

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                    06/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Thomas Hoyer, Director, 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, 410 966-4607

RIN: 0938-AF01
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1408. CHANGES TO THE LONG-TERM CARE FACILITY SURVEY PROCESS (HSQ-175-FC)

Significance:
Subject to OMB review: Undetermined

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1409. CASE MANAGEMENT (MB-27-F)

Significance:
Subject to OMB review: Undetermined

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 would place in 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                     54 FR 4045
NPRM Comment Period End         12/14/93                     54 FR 4045
Final Action                    00/00/00

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Local

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

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1410. REQUIRED COVERAGE OF NURSE PRACTITIONER SERVICES--MEDICAID (MB-41-
F)

Significance:
Subject to OMB review: Undetermined

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

CFR Citation:  42 CFR 440

Legal Deadline: None

Abstract: This regulation would 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                    00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1411. PAYMENT FOR FEDERALLY QUALIFIED HEALTH CENTER (FQHC) SERVICES (BPD-
728-F)

Significance:
Subject to OMB review: Undetermined

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

CFR Citation:  42 CFR 405; 42 CFR 491

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Effective Date                  06/12/92                    57 FR 24961
Final Rule with Comment Period  06/12/92                    57 FR 24961
Public Comment Period End       08/11/92                    57 FR 24961
Final Action                    08/00/94

Small Entities Affected: Undetermined

Government Levels Affected: State

Agency Contact: Jackie Sheridan, Chief, Alternative Delivery 
Organization 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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1412. MEDICARE COVERAGE OF SCREENING MAMMOGRAPHY (BPD-724-F)

Significance:
Subject to OMB review: Undetermined

Legal Authority:  42 USC 1395aa(a); 42 USC 1395bb(a); 42 USC 
1395l(a)(2)(E); 42 USC 1395y(a)(1)(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

Legal Deadline: None

Abstract: This final rule will respond to public comments on the 
interim final rule published on December 31, 1990, and adopt 
requirements set forth in the Food and Drug Administration (FDA) 
regulations published December 21, 1993 (58 FR 67558 and 58 FR 67565). 
The FDA regulations implement the Mammography Quality Standards Act of 
1992. (HCFA also intends to publish a separate notice to give the 
public constructive notice of the interim requirements for Medicare 
coverage of screening mammography.)

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Interim Final Rule              12/31/90                    55 FR 53510
Effective Date                  01/01/91                    55 FR 53510
Public Comment Period End       03/01/91                    55 FR 53510
Final Action                    00/00/00

Small Entities Affected: Businesses

Government Levels Affected: None

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

Agency Contact: William Larson, Program Analyst, Office of Coverage and 
Eligibility Policy, Department of Health and Human Services, Health 
Care Financing Administration, Room 401, EHR, 6325 Security Boulevard, 
Baltimore, Maryland 21207, 410 966-4639

RIN: 0938-AF26
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1413. PHYSICIAN OWNERSHIP OF AND REFERRALS TO HEALTH CARE FACILITIES THAT 
FURNISH CLINICAL LABORATORY SERVICES AND FINANCIAL RELATIONSHIP REPORTING 
REQUIREMENTS (BPD-674-F)

Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Yes

Legal Authority:  42 USC 1395nn

CFR Citation:  42 CFR 411

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

Abstract: This rule will incorporate into regulations the provisions of 
section 6204 of OBRA '89. It will prohibit a physician from making a 
referral for the provision of clinical laboratory services to an entity 
with which the physician has a financial relationship. It will also 
reflect statutory revisions mandated by OBRA '93.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            03/11/92                     57 FR 8588
NPRM Comment Period End         05/11/92                     57 FR 8588
Final Action                    10/00/94

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Betty Burrier, Program Analyst, Medical Services 
Branch, Department of Health and Human Services, Health Care Financing 
Administration, Room 401, EHR, 6325 Security Boulevard, Baltimore, 
Maryland 21207, 410 966-4649

RIN: 0938-AF40
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1414. MEDICAID PAYMENT FOR COVERED OUTPATIENT DRUGS UNDER REBATE 
AGREEMENTS (MB-046-IFC)

Significance:
Subject to OMB review: Yes
Economically significant: Yes

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 would 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              06/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1415. MEDICARE AND MEDICAID PROGRAMS; ADVANCE DIRECTIVES (BPD-718-F)

Significance:
Subject to OMB review: Undetermined

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                    09/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Thomas Hoyer, Director, Division of Provider Services 
Coverage Policy, Department of Health and Human Services, Health Care 
Financing Administration, Room 401, EHR, 6325 Security Boulevard, 
Baltimore, Maryland 21207, 410 966-4607

RIN: 0938-AF50
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1416. PARTIAL HOSPITALIZATION SERVICES IN COMMUNITY MENTAL HEALTH CENTERS 
(BPD-736-F)

Significance:
Subject to OMB review: Undetermined

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 Effective    02/11/94                     59 FR 6570
Interim Final Rule With Comment 
Period                          02/11/94                     59 FR 6570
Interim Final Rule Comment 
Period End                      04/11/94                     59 FR 6570
Final Action                    00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Regina Walker, Program Analyst, Medical Services 
Branch, Department of Health and Human Services, Health Care Financing 
Administration, Room 401, EHR, 6325 Security Boulevard, Baltimore, 
Maryland 21207, 410 966-6735

RIN: 0938-AF53
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1417. MEDICAID DRUG USE REVIEW PROGRAM AND ELECTRONIC CLAIMS MANAGEMENT 
SYSTEM FOR OUTPATIENT DRUG CLAIMS (MB-050-F)

Significance:
Subject to OMB review: Undetermined

Legal Authority:  42 USC 1396r-8(g)(h)

CFR Citation:  42 CFR 456

Legal Deadline: None

Abstract: An interim final rule with comment period (57 FR 49397) 
implemented sections 1927(g) and (h) of the Social Security Act as 
established by OBRA '90 (PL 101-508). It prescribed requirements for an 
outpatient drug use review program that includes both prospective drug 
review and retrospective drug use review. It also contained 
requirements for State drug use review boards and requirements of a 
point-of-sale electronic claims management system for processing claims 
for outpatient drugs. Following analysis of public comments, a final 
rulemaking document will be published.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Interim Final Rule With Comment 
Period                          11/02/92                    57 FR 49397
Effective Date                  01/01/93                    57 FR 49397
Public Comment Period End       01/04/93                    57 FR 49397
Final Action                    07/00/94

Small Entities Affected: Businesses

Government Levels Affected: State

Agency Contact: Al Beachley, Branch Chief, Drug Rebate Operations 
Branch, Department of Health and Human Services, Health Care Financing 
Administration, Room 273 EHR, 6325 Security Boulevard, Baltimore, 
Maryland 21207, 410 966-3325

RIN: 0938-AF67
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1418. REFERRAL TO CHILD SUPPORT ENFORCEMENT AGENCIES OF MEDICAID FAMILIES 
WITH AN ABSENT PARENT (MB-051-F)

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined
Regulatory Plan entry: Undetermined

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                    00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: MB-041-F will incorporate response to public 
comments made on 0938-AF65, MB-048-F.

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

RIN: 0938-AF68
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1419. MEDICAID: OUTSTATIONED INTAKE LOCATIONS FOR CERTAIN LOW-INCOME 
PREGNANT WOMEN, INFANTS AND CHILDREN (MB-052-IFC)

Significance:
Subject to OMB review: Yes

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                          04/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1420. OPTIONAL SPENDDOWN (MB-055-IFC)

Significance:
Subject to OMB review: Undetermined
Economically significant: Yes

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                          07/00/94

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-AF72
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1421. MEDICARE AND MEDICAID PROGRAMS: REQUIREMENTS FOR PHYSICIAN 
INCENTIVE PLANS IN PREPAID HEALTH CARE ORGANIZATIONS (OCC-024-F)

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined

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

CFR Citation:  42 CFR 417.01; 42 CFR 417.409; 42 CFR 417.495; 42 CFR 
434.67; 42 CFR 1003.100; 42 CFR 1003.101; 42 CFR 1003.102; 42 CFR 
1003.103

Legal Deadline: None

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

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            12/14/92                    57 FR 59024
Public Comment Period End       04/13/93                     58 FR 8568
Final Action                    07/00/94

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Tony Hausner, Program Analyst, Office of Coordinated 
Care, Department of Health and Human Services, Health Care Financing 
Administration, Room 4360 Cohen Building, 330 Independence Avenue SW., 
Washington, DC 20201, 202 619-2755

RIN: 0938-AF74
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1422. APPLICATION OF INTEREST CHARGES TO MEDICARE SECONDARY PAYER 
RECOVERIES (BPO-108-GN)

Significance:
Subject to OMB review: Undetermined

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                          10/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1423. MINIMUM PHYSICIAN QUALIFICATIONS FOR CERTAIN SERVICES (MB-059-P)

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined

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
Final Action                    00/00/00

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1424. RETROACTIVE ENROLLMENT (OCC-031-F)

Significance:
Subject to OMB review: Undetermined

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                    00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Tracy Jensen, Office of Coordinated Care Policy & 
Planning, 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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1425. PAYMENT FOR PREADMISSION SERVICES (BPD-731-F)

Significance:
Subject to OMB review: Undetermined

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: Thomas Hoyer, Director, Division 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, 410 966-4607

RIN: 0938-AG00
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1426. PAYMENT FOR EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY SERVICES 
FURNISHED BY AMBULATORY SURGICAL CENTERS (BPD-762-FN)

Significance:
Subject to OMB review: Undetermined

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: Bernadette Schumaker, Director, 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, 410 966-4568

RIN: 0938-AG04
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1427. REVISED MEDICAID MANAGEMENT INFORMATION SYSTEMS (MB-38-FN)

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1428. INTERMEDIARY AND CARRIER CHECKS THAT ARE LOST, STOLEN, DEFACED, 
MUTILATED, DESTROYED, OR PAID ON FORGED ENDORSEMENTS (BPO-114-FC)

Significance:
Subject to OMB review: Yes

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 424.350; 42 CFR 424.352; 42 CFR 424.354

Legal Deadline: None

Abstract: This rule revises the Medicare regulations governing the 
procedures for replacing checks issued by our fiscal intermediaries and 
carriers that are lost, stolen, defaced, mutilated, destroyed, or paid 
on forged endorsements. Since States have established legal processes 
for pursuing claims for check replacement and recovery under these 
circumstances, it is inefficient to maintain duplicative Federal 
requirements. Our revised regulations would provide that any 
replacement or reclamation proceedings will be carried out in 
accordance with applicable State banking laws. We will continue to 
reissue only checks that have not been negotiated.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Rule With Comment Period  12/13/93                    58 FR 65126
Effective Date                  01/12/94                    58 FR 65126
Public Comment Period End       02/11/94                    58 FR 65126
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Samuel Guida, Director, Div. of Acct Managemt & 
Collection, Bureau of Program Operations, Department of Health and 
Human Services, Health Care Financing Administration, Room 1-E-6 
Meadows East Bldg., 6325 Security Boulevard, Baltimore, MD 21207, 410 
966-7495

RIN: 0938-AG16
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1429. REVISIONS TO THE DEFINITION OF END-STAGE RENAL DISEASE AND 
RESUMPTION OF ENTITLEMENT (BPD-738-F)

Significance:
Subject to OMB review: Undetermined

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1430. MEDICARE PROGRAM: PROPOSED ADDITIONS TO AND DELETIONS FROM THE 
CURRENT LIST OF COVERED SURGICAL PROCEDURES FOR AMBULATORY SURGICAL 
CENTERS (BPD-776-FN)

Significance:
Subject to OMB review: Yes

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                    00/00/00

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Jacqueline Sheridan, Chief, Alternative Delivery 
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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1431. MEDICARE PROGRAM: SPECIAL PAYMENT LIMITS FOR HOME BLOOD GLUCOSE 
MONITORS (BPD-778-FN)

Significance:
Subject to OMB review: Yes

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                    00/00/00

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Joel Kaiser, Program Analyst, 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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1432. GENERAL EVALUATION CRITERIA AND STANDARDS FOR EVALUATING 
PERFORMANCE OF CONTRACT (HSQ-207-GNC)

Significance:
Subject to OMB review: Undetermined

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      07/00/94

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1433. CHANGES IN PHYSICIAN ATTESTATION REQUIREMENTS (BPD-769-F)

Significance:
Subject to OMB review: Yes

Legal Authority:  42 USC 1395ww

CFR Citation:  42 CFR 412.46(c)

Legal Deadline: None

Abstract: This final rule period will revise the Medicare regulations 
that require a hospital to obtain on an annual basis, from each 
physician who has admitting privileges, a signed acknowledgement that 
the physician understands the penalty for misrepresenting the 
information on an attestation statement relating to principal and 
secondary diagnoses and major procedures performed on patients. These 
regulations will eliminate the requirement for an annual 
acknowledgement statement and instead require that a physician sign an 
acknowledgement statement only upon being granted admitting privileges 
at a hospital. The purpose of this change is to reduce the paperwork 
burden associated with processing claims under Medicare.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Rule With Comment Period  03/09/94                    59 FR 11000
Comment Period End              05/09/94
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Thomas Hoyer, Director, Division of Provider Services 
Coverage Policy, BPD, Department of Health and Human Services, Health 
Care Financing Administration, 401, EHR, 6325 Security Boulevard, 
Baltimore, Maryland 21207, 410 966-4607

RIN: 0938-AG34
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1434. 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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1435. PART A PREMIUM FOR 1995 FOR THE UNINSURED AGED AND FOR CERTAIN 
DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER ENTITLEMENT (OACT-046-N)

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined

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                          09/00/94

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1436. MEDICARE PROGRAM: MONTHLY ACTUARIAL RATES AND MONTHLY SUPPLEMENTARY 
MEDICAL INSURANCE PREMIUM RATES BEGINNING JANUARY 1, 1995 (OACT-047-N)

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined

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                          09/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1437. INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED CARE 
SERVICES COINSURANCE AMOUNTS FOR 1995 (OACT-048-N)

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined

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                          09/00/94

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1438. REDUCTIONS IN PAYMENTS FOR HHA SERVICES (BPD-793-NC)

Significance:
Subject to OMB review: Undetermined

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      06/00/94

Small Entities Affected: Undetermined

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1439. REDUCTIONS IN PAYMENTS FOR SNF SERVICES (BPD-795-NC)

Significance:
Subject to OMB review: Undetermined

Legal Authority:  42 USC 1395x; 42 USC 1395yy; PL 103-66, Sec 13503

CFR Citation:  42 CFR 413.30

Legal Deadline: None

Abstract: This notice, in accordance with PL 103-66, provides that 
there be no changes in skilled nursing facility cost limits during 
Federal fiscal years 1994 and 1995. The notice also requires the 
Secretary, when granting or extending exceptions to the cost limits, to 
limit any exception to the amount that would have been granted if there 
were no restrictions or changes in the cost limits. In addition, this 
notice also eliminates additional payments for excess overhead costs 
allocated to hospital-based facilities, effective for cost reporting 
periods beginning on or after October 1, 1993.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Effective Date                  10/01/93                      59 FR 762
Notice With Comment Period      01/06/94                      59 FR 762
Public Comment Period End       03/07/94                      59 FR 762
Final Action                    00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: None

Agency Contact: Robert Kuhl, Chief, Cost Control Policy Branch, 
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-AG56
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1440. REQUIRED LABORATORY PROCEDURES FOR RURAL HEALTH CLINICS (BPD-783-
FC)

Significance:
Subject to OMB review: Undetermined

Legal Authority:  42 USC 1302; 42 USC 263a

CFR Citation:  42 CFR 491.9

Legal Deadline: None

Abstract: This rule revises the range of laboratory tests rural health 
clinics (RHCs) are required to provide in order to meet the Medicare 
conditions of participation. We eliminate certain tests not classified 
as waived under the Clinical Laboratory Improvement Amendments of 1988 
(CLIA). These changes are being made because the CLIA program 
introduced participation requirements that may cause some RHCs to 
withdraw from the program, creating a shortage of available medical 
care in some areas.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Rule With Comment Period  12/02/93                    58 FR 63533
Effective Date                  01/03/94                    58 FR 63533
Public Comment Period End       01/31/94                    58 FR 63533
Final Action                    00/00/00

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Agency Contact: Jacqueline Sheridan, Chief, Alternative Delivery 
Organizations, Branch, BPD, Department of Health and Human Services, 
Health Care Financing Administration, 6325 Security Boulevard, 
Baltimore, MD 21207, 410 966-4635

RIN: 0938-AG62
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1441. FREEDOM OF CHOICE WAIVER; CONFORMING CHANGES (MB-68-IFC)

Legal Authority:  42 USC 1302

CFR Citation:  42 CFR 431.55; 42 CFR 431.57

Legal Deadline: None

Abstract: This interim final rule with comment period 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: Mike Fiore, Deputy Director, Medicaid Coordinated Care 
Office, Department of Health and Human Services, Health Care Financing 
Administration, Room 233, East High Rise Building, 6325 Security 
Boulevard, Baltimore, MD 21207, 410 966-4460

RIN: 0938-AG63
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1442.  SELF-IMPLEMENTING COVERAGE AND PAYMENT PROVISIONS: 1993 
LEGISLATION (BPD-791-FC)

Significance:
Subject to OMB review: Undetermined

Legal Authority:  42 USC 1395x(v); 42 USC 1395f(i); 42 USC 1395i-2(d); 
42 USC 1395l(i); 42 USC 1395l(g); 42 USC 1395x(aa); 42 USC 1395rr(b); 
42 USC 1395r(e); PL 103-66, sec 13541

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

Legal Deadline: None

Abstract: This rule places in regulations self-implementing provisions 
of OBRA '93 and also explains other self-implementing provisions of 
that law. These provisions are already effective under the terms of the 
statute. This regulation assures that our rules conform to the 
requirements of OBRA '93 and are up-to-date with respect to these 
provisions.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final With Comment Period       06/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Matt Plonski, Chief, Special Issues Branch, Regulations 
Branch, BPD, Department of Health and Human Services, Health Care 
Financing Administration, Room 132, EHR, 6325 Security Boulevard, 
Baltimore, Maryland 21207, 410 966-4662

RIN: 0938-AG64
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1443.  PAYMENT TO SWING BED HOSPITALS (BPD-805-FC)

Significance:
Subject to OMB review: Undetermined

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 
reasonable cost per patient day (for routine extended care services 
provided in free standing skilled nursing facilities in the region in 
which the hospital is located) during the most recent year for which 
cost reporting data are available. In accordance with PL 101-508, this 
rule also provides that the reasonable cost for these services will be 
the higher of the reasonable cost rates in effect for the current 
calendar year or for the previous calendar year. Finally, this rule 
would implement the statutory requirement that the reasonable cost of 
ancillary services furnished as extended care services be determined in 
the same manner as the reasonable cost of ancillary services provided 
for inpatient hospital services.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Rule With Comment Period  10/00/94

Small Entities Affected: Undetermined

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 Boulevard, 
Baltimore, Maryland 21207, 410 966-4513

RIN: 0938-AG68
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1444.  PHYSICIAN PERFORMANCE STANDARD RATES OF INCREASE FOR FY 
1995 AND PHYSICIAN FEE SCHEDULE UPDATE FOR CY 1995 (BPD-807-FNC)

Significance:
Subject to OMB review: Yes

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1445.  CATEGORIZATION OF CLIA TESTS AND PERSONNEL MODIFICATIONS 
(HSQ-216-FC)

Significance:
Subject to OMB review: Undetermined

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. This rule also expands the criteria used to determine whether 
a test may be waived from meeting CLIA requirements. It also creates a 
new subcategory of moderate complexity testing called accurate and 
precise technology tests.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Rule With Comment Period  05/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1446.  FINAL LIMITATIONS ON AGGREGATE PAYMENTS TO 
DISPROPORTIONATE SHARE HOSPITALS: FEDERAL FISCAL YEAR 1994 (MB-088-N)

Significance:
Subject to OMB review: Undetermined
Economically significant: Undetermined

Legal Authority:  PL 103-234, Sec 3; 42 USC 1923(f)

CFR Citation:  42 CFR 447.297; 42 CFR 447.298

Legal Deadline: None

Abstract: This notice announces the final Federal Fiscal Year 1994 
national target and individual State allotments for Medicaid payments 
made to hospitals that serve a disproportionate number of Medicaid 
recipients and other low-income individuals with special needs. This 
notice is a follow-up to a notice published at the beginning of the 
Federal Fiscal Year that announces preliminary amounts. Publication of 
this notice is required by Medicaid regulations.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Notice                          04/00/94

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State

Agency Contact: Richard Strauss, Health Insurance Analyst, Medicaid 
Bureau, Department of Health and Human Services, Health Care Financing 
Administration, Room 273, EHR, 6325 Security Boulevard, Baltimore, 
Maryland 21207, 410 966-2019

RIN: 0938-AG74
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1447.  SMALL BUSINESS INNOVATION RESEARCH GRANTS FOR FY 95 (ORD-
068-N)

Significance:
Subject to OMB review: Undetermined

Legal Authority:  PL 97-219; PL 99-443; PL 102-564

CFR Citation:  None

Legal Deadline: None

Abstract: This notice announces the availability of grants to small 
businesses for the development of innovative techniques and products. 
The grants involve two phases: (1) concept development, and (2) product 
development and preparation for marketing. This program is limited to 
small for-profit businesses.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Notice                    09/00/94

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Carl Hackerman, Director, Division of Program Support, 
Office of Research & Demonstrations, Department of Health and Human 
Services, Health Care Financing Administration, 2-C-Oak Meadows 
Building, 6325 Security Boulevard, Baltimore, Maryland 21207, 410 966-
6644

RIN: 0938-AG76
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1448.  MEDICAID PROGRAM: FEES FOR VACCINE ADMINISTRATION UNDER 
PEDIATRIC IMMUNIZATION PROGRAM (MB-084-N)

Significance:
Subject to OMB review: Undetermined

Legal Authority:  PL 103-66, sec 13631; 42 USC 1396a(a)(62); 42 USC 
1396s

CFR Citation:  None

Legal Deadline: None

Abstract: This notice establishes a regional maximum fee that a 
Medicaid provider may charge for the administration of qualified 
pediatric vaccines under the Medicaid Pediatric Immunization Program. 
It also specifies the methodology used to develop this maximum fee and 
allows a State to pay a rate lower than the maximum fee if the State 
can ensure federally vaccine eligible children adequate access to the 
vaccines at the lower rate. This notice implements section 
1928(c)(2)(C)(ii) of the Social Security Act, as added by section 13631 
of OBRA '93.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Notice                          08/00/94

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State

Agency Contact: Marge Sciulli, Health Insurance Specialist, Medicaid 
Bureau, Department of Health and Human Services, Health Care Financing 
Administration, Room 349, EHR, 6325 Security Blvd., Baltimore, MD 
21207, 410 966-4513

RIN: 0938-AG77
_______________________________________________________________________
  

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1449. PAYMENT FOR THE COST OF MALPRACTICE INSURANCE FOR HOSPITALS 
EXCLUDED FROM THE PROSPECTIVE PAYMENT SYSTEM (BPD-437-P)

CFR Citation:  42 CFR 413.56

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn - no action 
anticipated in the next 12 
months                          02/25/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Paul Trimble, 410 966-4509

RIN: 0938-AC97
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1450. CHANGES CONCERNING THE INVESTMENT INCOME OFFSET POLICY (BPD-481-P)

CFR Citation:  42 CFR 413.153; 42 CFR 413.130

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn - no action 
anticipated in the next 12 
months                          02/25/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: William J. Goeller, 410 966-4513

RIN: 0938-AD72
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1451. DIAGNOSIS CODES ON PHYSICIAN BILLS (BPD-610-F)

Significance:
Subject to OMB review: Yes

CFR Citation:  42 CFR 405.512; 42 CFR 424.3; 42 CFR 424.32; 42 CFR 
424.34

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    03/04/94                    59 FR 10290
Final Action Effective          04/04/94                    59 FR 10290

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Pat Brooks, 410 966-5318

RIN: 0938-AE06
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1452. HMOS: GROUP SPECIFIC RATINGS (OCC-009-F)

CFR Citation:  42 CFR 417.104; 42 CFR 417.107

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn - No further action 
anticipated                     03/11/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Maureen Miller, 202 619-0129

RIN: 0938-AE24
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1453. AGGREGATION OF MEDICARE CLAIMS FOR ADMINISTRATIVE LAW JUDGE (ALJ) 
HEARINGS AND JUDICIAL REVIEW (BPD-694-F)

Significance:
Subject to OMB review: Yes

CFR Citation:  42 CFR 405.701; 42 CFR 405.740; 42 CFR 405.741; 42 CFR 
405.801; 42 CFR 405.802; 42 CFR 405.811; 42 CFR 405.815; 42 CFR 
405.817; 42 CFR 405.820; 42 CFR 405.821; 42 CFR 405.822 to 405.826; 42 
CFR 405.830

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    03/16/94                    59 FR 12172
Final Action Effective          04/15/94                    59 FR 12172

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Paul Olenick, 410 966-4472

RIN: 0938-AE93
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1454. GENERAL NOTICE ON MEDICARE SECONDARY PAYMENT (BPO-94-GN)

Significance:
Subject to OMB review: Yes

CFR Citation:  42 CFR 411.25

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    04/01/94

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Cathy Carter, 410 966-7449

RIN: 0938-AF05
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1455. GRANTING AND WITHDRAWAL OF DEEMING AUTHORITY TO NATIONAL 
ACCREDITATION ORGANIZATIONS (HSQ-159-F)

Significance:
Subject to OMB review: Yes
Economically significant: Undetermined

CFR Citation:  42 CFR 401.126b; 42 CFR 401.133; 42 CFR 488.9

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    11/23/93                    58 FR 61816
Final Action Effective          02/22/94                    58 FR 61816

Small Entities Affected: None

Government Levels Affected: State, Federal

Agency Contact: Pam Vocke, 410 966-7089

RIN: 0938-AF17
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1456. SELF-IMPLEMENTING COVERAGE AND PAYMENT PROVISIONS OF OMNIBUS BUDGET 
RECONCILIATION ACT OF 1990 (BPD-725-N)

Significance:
Subject to OMB review: Yes

CFR Citation:  42 CFR 405; 42 CFR 406; 42 CFR 410; 42 CFR 411; 42 CFR 
412; 42 CFR 413; 42 CFR 409; 42 CFR 418; 42 CFR 489

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    11/02/93                    58 FR 58502
Final Action Effective          09/11/92                    57 FR 36006

Small Entities Affected: Businesses, Organizations

Government Levels Affected: Federal

Agency Contact: Sue B. Brown, 410 966-4658

RIN: 0938-AF27
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1457. PREADMISSION REVIEW AND AUTHORIZATION, OUTPATIENT SURGERY, 
PREADMISSION DIAGNOSTIC TESTING, AND SAME DAY SURGERY UNDER MEDICAID (MB-
021P)

CFR Citation:  42 CFR 431

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn                       02/25/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Robert Wardwell, 410 966-5659

RIN: 0938-AF35
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1458. DURABLE MEDICAL EQUIPMENT (DME) MEDICAL NECESSITY FORMS (BPD-734-
FC)

CFR Citation:  42 CFR 410.38

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn - no action 
anticipated in the next 12 
months                          02/25/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Israel Brauner, 410 966-4640

RIN: 0938-AF51
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1459. INJECTABLES FOR OSTEOPOROSIS (BPD-735-FC)

CFR Citation:  42 CFR 410

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn - No action 
anticipated in the next 12 
months                          02/25/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: John Thomas, 410 966-4636

RIN: 0938-AF52
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1460. MEDICARE COVERAGE OF EPO FOR HOME USE BY HOME DIALYSIS PATIENTS 
(BPD-737-F)

Significance:
Subject to OMB review: Yes

CFR Citation:  42 CFR 405; 42 CFR 410; 42 CFR 413; 42 CFR 414

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    01/10/94                     59 FR 1278
Final Action Effective          02/09/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Bob Cereghino, 410 966-4637

RIN: 0938-AF54
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1461. DESIGNATION OF REGIONAL CARRIERS TO PROCESS CLAIMS FOR DURABLE 
MEDICAL EQUIPMENT, PROSTHETICS, ORTHOTICS, AND SUPPLIES (BPO-102-F)

Significance:
Subject to OMB review: Yes

CFR Citation:  42 CFR 400.202; 42 CFR 420.200; 42 CFR 420.201; 42 CFR 
420.204; 42 CFR 420.205; 42 CFR 421.210; 42 CFR 421.1; 42 CFR 421.200; 
42 CFR 421.202; 42 CFR 421.206

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    11/18/93                    58 FR 60789
Final Action Effective          12/17/93                    58 FR 60789

Small Entities Affected: Businesses, Organizations

Government Levels Affected: Federal

Agency Contact: Lisanne Bradley, 410 966-3359

RIN: 0938-AF59
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1462. UNIFORM PAYMENT MECHANISM FOR HOSPITALS UNDER PART A OF MEDICARE 
(BPO-104-FN)

CFR Citation:  None

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn                       01/24/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Craig Brewer, 410 966-7541

RIN: 0938-AF60
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1463. MEDICAID QUALIFYING TRUSTS (MB-011-P)

CFR Citation:  42 CFR 435; 42 CFR 436

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn - will be merged with 
RIN 0938-AD18, MB-011-P         02/08/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Marinos Svolos, 410 966-4451

RIN: 0938-AF61
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1464. EXEMPTION OF LOW-INCOME PREGNANT WOMEN FROM ELIGIBILITY CONDITION 
OF ESTABLISHING PATERNITY AND SEEKING SUPPORT (MB-048-F)

CFR Citation:  42 CFR 433.145; 42 CFR 433.147; 42 CFR 435.604; 42 CFR 
436.604

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn                       02/25/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Marinos Svolos, 410 966-4451

RIN: 0938-AF65
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1465. HOME AND COMMUNITY-BASED CARE AS AN OPTIONAL SERVICE (MB-053-IFC)

CFR Citation:  42 CFR 441

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn - no action 
anticipated in the next 12 
months                          02/25/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Robert Wardwell, 410 966-5659

RIN: 0938-AF70
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1466. REVISIONS TO CRITERIA AND STANDARDS FOR EVALUATING INTERMEDIARIES 
AND CARRIERS (BP0-083-F)

CFR Citation:  42 CFR 421

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    01/06/94                      59 FR 679
Final Action Effective          02/07/94                      59 FR 679

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Pat Hotkowski, 410 966-7143

RIN: 0938-AF84
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1467. MEDICARE PROGRAM: PEER REVIEW ORGANIZATION; GENERAL CRITERIA AND 
STANDARDS FOR EVALUATING PERFORMANCE OF CONTRACT OBLIGATIONS (HSQ-200-NC)

CFR Citation:  None

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

No further action to be taken   04/01/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Diane Maupai-Harrington, 410 966-7211

RIN: 0938-AF89
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1468. COMPUTER MATCHING AND PRIVACY PROTECTION FOR MEDICAID ELIGIBILITY 
(MB-057-F)

Significance:
Subject to OMB review: Yes
Economically significant: Yes

CFR Citation:  42 CFR 435.945; 42 CFR 435.952; 42 CFR 435.955

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    01/21/94                     59 FR 4252
Final Action Effective          04/01/94                     59 FR 4252

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Helaine Jeffers, 410 966-5920

RIN: 0938-AF91
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1469. MEDICARE PROGRAM: COVERAGE OF CERTIFIED NURSE-MIDWIFE SERVICES 
(BPD-496-P)

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

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn - no action 
anticipated in the next 12 
months                          02/25/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: David Higbee, 410 966-4636

RIN: 0938-AG02
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1470. MEDICAID PRESCRIPTION DRUG COVERAGE: SCOPE AND LIMITATIONS (MB-067-
P)

CFR Citation:  42 CFR 440.120; 42 CFR 441.25

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn - no action 
anticipated in the next 12 
months                          02/25/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Linda Sizelove, 410 966-4626

RIN: 0938-AG13
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1471. USE OF FEDERALLY STANDARDIZED CLAIMS PROCESSING FORMS AND 
PROCEDURES (MB-069-P)

CFR Citation:  Not applicable

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn - Obviated by Health 
Care Reform Initiative          03/11/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Richard Friedman, 410 966-3292

RIN: 0938-AG14
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1472. UPDATE OF EPO PAYMENT RATE FOR 1993 (BPD-768-PN)

CFR Citation:  42 CFR 413.70

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn - merged with RIN 
0938-AG64 (BPD-791-FC)          02/25/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Bernadette Schumaker, 410 966-4567

RIN: 0938-AG15
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1473. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE 
(BPD-770-FC)

Significance:
Subject to OMB review: Yes

CFR Citation:  42 CFR 405; 42 CFR 414

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    01/01/94
Final Action Effective          01/01/94

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Cindy Read, 410 966-4586

RIN: 0938-AG22
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1474. PHYSICIAN PERFORMANCE STANDARD RATES OF INCREASE FOR 1994 (BPD-774-
FC)

Significance:
Subject to OMB review: Yes

CFR Citation:  None

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    12/02/93                    58 FR 63856
Final Action Effective          01/01/94                    58 FR 63856

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Bernard Patashnik, 410 966-4497

RIN: 0938-AG25
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1475. MEDICAID COVERAGE OF PERSONAL CARE SERVICES OUTSIDE THE HOME (MB-
071-P)

CFR Citation:  42 CFR 440.70

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn - no action 
anticipated in the next 12 
months                          02/25/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Linda Sizelove, 410 966-4626

RIN: 0938-AG36
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1476. MEDICAID COVERED OUTPATIENT DRUGS UNDER DRUG REBATE (DVA LAW) (MB-
072-P)

CFR Citation:  42 CFR 447

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn - no action 
anticipated in the next 12 
months                          02/25/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Estelle Chisholm, 410 965-2048

RIN: 0938-AG37
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1477. PART A PREMIUM FOR 1994 FOR THE UNINSURED AGED AND FOR CERTAIN 
DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER ENTITLEMENT (OACT-043-N)

CFR Citation:  None

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    11/02/93                    58 FR 58555

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: John Wandishin, 410 966-6389

RIN: 0938-AG39
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1478. MONTHLY ACTUARIAL RATES AND MONTHLY SUPPLEMENTARY MEDICAL INSURANCE 
PREMIUM RATES BEGINNING JANUARY 1, 1994 (OACT-044-N)

Significance:
Subject to OMB review: Yes

CFR Citation:  None

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    01/01/94                    58 FR 59271
Final Action Effective          01/01/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Carter Warfield, 410 966-6396

RIN: 0938-AG40
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1479. INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED CARE 
SERVICES COINSURANCE AMOUNTS FOR 1994 (OACT-045-N)

Significance:
Subject to OMB review: Yes

CFR Citation:  None

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    01/01/94                    58 FR 58554
Final Action Effective          01/01/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: John Wandishin, 410 966-6389

RIN: 0938-AG41
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1480. SCHEDULE OF LIMITS ON HOME HEALTH AGENCY COSTS PER VISIT FOR COST 
REPORTING PERIODS BEGINNING ON OR AFTER JULY 1, L994 (BPD-786-NC)

CFR Citation:  42 CFR 413.30

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Withdrawn - Notice superseded by 
RIN 0938-AG54 (BPD-793-NC)      02/25/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: William Goeller, 410 966-4513

RIN: 0938-AG47
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Health Care Financing Administration (HCFA)
  
_______________________________________________________________________
 
1481. LIMITATIONS ON AGGREGATE PAYMENTS TO DISPROPORTIONATE SHARE 
HOSPITALS: FEDERAL FISCAL YEAR 1994 (MB-079-N)

Significance:
Subject to OMB review: Yes
Economically significant: Yes

CFR Citation:  42 CFR 447.297; 42 CFR 447.298

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    02/01/94                     59 FR 4717
Final Action Effective          10/01/93

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Richard Strauss, 410 966-6124

RIN: 0938-AG61
_______________________________________________________________________
  

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1482. FOSTER CARE, ADOPTION ASSISTANCE, AND CHILD WELFARE SERVICES

Significance:
Subject to OMB review: Undetermined

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                            00/00/00

Small Entities Affected: None

Government Levels Affected: State

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

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

RIN: 0970-AA97
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1483. 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. 103-218).

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            09/00/94

Small Entities Affected: None

Government Levels Affected: State

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

Agency Contact: John Doyle, Director, Administration and Planning 
Staff, Administration on Developmental Disabilities, Department of 
Health and Human Services, Administration for Children and Families, 
200 Independence Avenue, SW., Room 315D, Washington, DC 20201, 202 690-
5504

RIN: 0970-AB11
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1484. 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                            07/00/94
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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1485. 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                            09/00/94

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-AB24
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1486. TITLE IV-E TRAINING

Significance:
Subject to OMB review: Yes

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                            12/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1487. 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                            06/00/94
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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1488. 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
Final Action                    00/00/00

Small Entities Affected: Organizations

Government Levels Affected: None

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start Bureau, Department of Health and Human Services, Administration 
for Children and Families, P.O. Box 1182, Washington, DC 20013, 202 
205-8569

RIN: 0970-AB31
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1489. NATIONAL VOTER REGISTRATION ACT OF 1993 PROVISIONS AFFECTING PUBLIC 
ASSISTANCE AGENCIES

Significance:
Subject to OMB review: Yes

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                            08/00/94
NPRM Comment Period End         00/00/00

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1490. CHILD CARE--REVISED REGULATIONS

Significance:
Subject to OMB review: Yes

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                            04/00/94
NPRM Comment Period End         06/00/94
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: Undetermined

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

RIN: 0970-AB33
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1491.  FAMILY PRESERVATION AND SUPPORT

Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Undetermined

Legal Authority:  42 USC 430-435

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                            09/00/94
NPRM Comment Period End         11/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1492.  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                            10/00/94
Final Action                    10/00/95

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1493.  INTERSTATE CASE CLOSURE

Significance:
Subject to OMB review: Undetermined

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                            08/00/94
NPRM Comment Period End         10/00/94
Final Action                    08/00/95

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1494.  REFUGEE RESETTLEMENT PROGRAM: MISCELLANEOUS CHANGES

Significance:
Subject to OMB review: Undetermined

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                            08/00/94

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)       Proposed Rule Stage
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1495.  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                            07/00/94
NPRM Comment Period End         09/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1496.  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                            10/00/94
NPRM Comment Period End         12/00/94

Small Entities Affected: None

Government Levels Affected: Undetermined

Agency Contact: David B. Smith, Director, Division of State 
Legalization and, Repatriation, Department of Health and Human 
Services, Administration for Children and Families, 370 L'Enfant 
Promenade SW., Washington, DC 20447, 202 401-9255

RIN: 0970-AB45
_______________________________________________________________________
  

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1497. 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                    08/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1498. REVISIONS OF CHILD SUPPORT ENFORCEMENT PROGRAM AND AUDIT 
REGULATIONS

Significance:
Subject to OMB review: Yes

Legal Authority:  42 USC 603(h); 42 USC 604(d); 42 USC 652(a)(1); 42 
USC 652(a)(4); 42 USC 1302

CFR Citation:  45 CFR 301; 45 CFR 305

Legal Deadline: None

Abstract: This regulation revises existing audit procedures as a result 
of changes to program regulations to implement the child support 
provisions of the Family Support Act of 1988. These changes establish 
timeframes and standards for providing child support enforcement 
services, and require use of guidelines to establish support orders 
among other things. Audit regulations are being revised for consistency 
with new program requirements.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            09/09/93                    58 FR 47414
NPRM Comment Period End         11/08/93
Final Action                    10/00/94

Small Entities Affected: None

Government Levels Affected: State, Local, Federal

Agency Contact: Lourdes Henry, Program Specialist, Policy and Planning 
Div., Office of Child Support Enforcement, Department of Health and 
Human Services, Administration for Children and Families, 370 L'Enfant 
Promenade SW., Washington, DC 20447, 202 401-5440

RIN: 0970-AA74
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1499. HEAD START PERFORMANCE STANDARDS FOR INFANTS, TODDLERS, AND 
PREGNANT WOMEN

Significance:
Subject to OMB review: Yes

Legal Authority:  42 USC 9801 et seq

CFR Citation:  45 CFR 1307

Legal Deadline: None

Abstract: The final rule will establish a new part 1307 setting forth 
performance standards that must be used in providing Head Start 
services to infants, toddlers and pregnant women.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            06/19/90                    55 FR 24899
NPRM Comment Period End         08/20/90                    55 FR 24899
Final Action                    10/00/94

Small Entities Affected: Organizations

Government Levels Affected: None

Additional Information: This action was previously reported under RIN 
0980-AA33.

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-AB04
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1500. TECHNICAL CHANGES TO THE AFDC PROGRAM AS REQUIRED BY OBRA 90

Legal Authority:  42 USC 602

CFR Citation:  45 CFR 205; 45 CFR 233

Legal Deadline: None

Abstract: These interim final rules implement three minor changes to 
the AFDC program as required by the new statutory provisions in 
sections 5053, 5054, and 5055 of OBRA 90. They would eliminate deeming 
of income from legal guardians in minor parent cases, expand State 
agency responsibility for reporting child abuse and neglect, and 
authorize disclosure of information about AFDC cases to title IV-E 
programs.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Interim Final Rule              09/22/93                    58 FR 49218
Interim Final Rule Effective    09/22/93
Interim Final Rule Comment 
Period End                      10/22/93
Final Action                    05/00/94

Small Entities Affected: None

Government Levels Affected: State, Local, Federal

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-AB14
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1501. 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 implements 
changes to the LIHEAP statute which were made by the Augustus F. 
Hawkins Human Services Reauthorization Act of 1990 (Pub. L. 101-501) 
and which affect grantee administration of the LIHEAP program in fiscal 
years 1991 and 1992. 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 service under certain circumstances, and new 
leveraging incentive program. This final rule also implements a change 
regarding conditions for reallotment of LIHEAP funds.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Interim Final Rule              01/16/92                     57 FR 1960
Final Action                    10/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1502. 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: This notice of proposed rulemaking (NPRM) will amend the HHS 
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 are: -- Providing funding for the LIHEAP program on a new 
program year basis of July 1 - June 30 (forward funding) -- Ending of 
authority to transfer LIHEAP funds to other block grant programs. This 
NPRM also contains proposed requirements for an application completion 
date in order for Indian tribes and tribal organizations to receive 
Community Service Block Grant program. Finally, this NPRM, includes 
certain submission and completion dates for States and Territories 
applying for Community Services, Social Services and LIHEAP block grant 
funds to cover requirements under the Cash Management Improvement Act 
of 1990, P.L. 101-453.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            11/16/93                    58 FR 60498
Final Action                    11/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1503. 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                    11/00/94

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Local

Agency Contact: Margaret Washnitzer, Director, Division of State 
Assistance, Office of Community Services, Department of Health and 
Human Services, Administration for Children and Families, 370 L'Enfant 
Promenade SW., Washington, DC 20447, 202 401-2333

RIN: 0970-AB18
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1504.  STATEWIDE AUTOMATED CHILD WELFARE INFORMATION SYSTEM

Significance:
Subject to OMB review: Yes

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

_________________________________________________________________________

NPRM Comment Period End         12/22/93                    58 FR 67939
Final Action                    06/00/94

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
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1505.  AUTOMATIC DATA PROCESSING EQUIPMENT AND SERVICES; 
CONDITIONS FOR FEDERAL FINANCIAL PARTICIPATION AND GENERAL ADMINISTRATION 
- PUBLIC ASSISTANCE PROGRAMS

Legal Authority:  PL 103-66

CFR Citation:  45 CFR 95; 45 CFR 205

Legal Deadline: None

Abstract: The Final Rule will implement section 13741 of the Omnibus 
Budget Reconciliation Act of 1993 Public Law 103-66.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Interim Final Rule              05/00/94

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: William Davis, Management Analyst, Department of Health 
and Human Services, Administration for Children and Families, 326 F 
Hubert Humphrey Building, 200 Independence Ave. SW., Washington, DC 
20201, 202 401-6404

RIN: 0970-AB39
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)          Final Rule Stage
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1506.  PATERNITY ESTABLISHMENT PROVISIONS OF THE OMNIBUS BUDGET 
RECONCILIATION ACT OF 1993

Significance:
Subject to OMB review: Yes

Legal Authority:  42 USC 666(a); 42 USC 1302

CFR Citation:  45 CFR 302; 45 CFR 303; 45 CFR 304

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 regulation implements requirements of section 13721 of 
the Omnibus Budget Reconciliation Act of 1993 (Pub.L. 103-66) signed by 
the President on August 10, 1993 which amends title IV-D of the Social 
Security Act. The provisions require States to adopt procedures for a 
simple civil process for the voluntary acknowledgment of paternity, 
including early paternity establishment programs in hospitals. For 
paternity cases that remain contested, the provisions 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.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM                            11/29/93                    58 FR 62599
NPRM Comment Period End         01/28/94
Final Action                    10/00/94

Small Entities Affected: None

Government Levels Affected: State, Local, Federal

Agency Contact: Andrew Williams, Program Specialist, Policy and 
Planning Div., Office of Child Support Enforcement, Department of 
Health and Human Services, Administration for Children and Families, 
370 L'Enfant Promenade SW., Washington, DC 20447, 202 401-1467

RIN: 0970-AB40
_______________________________________________________________________
  

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1507. DISREGARDS OF INCOME AND RESOURCES

CFR Citation:  45 CFR 233.20(a)(3); 45 CFR 233.20(a)(4)

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    02/02/94                     59 FR 4835

Small Entities Affected: None

Government Levels Affected: State, Local, Federal

Agency Contact: Mack A. Storrs, 202 401-9289

RIN: 0970-AA70
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1508. ESSENTIAL PERSONS

Significance:
Subject to OMB review: Yes

CFR Citation:  45 CFR 233.20(a)(2)(vi), (vii)

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    12/28/93                    58 FR 60134

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Mack A. Storrs, 202 401-9289

RIN: 0970-AA93
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1509. ADOPTION AND FOSTER CARE ANALYSIS AND REPORTING SYSTEM

Significance:
Subject to OMB review: Yes

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

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    12/22/93                     45 FR 1355

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Daniel H. Lewis, 202 205-8618

RIN: 0970-AB05
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1510. SOCIAL SERVICES BLOCK GRANT INFORMATION COLLECTION

Significance:
Subject to OMB review: Yes

CFR Citation:  45 CFR 96

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    11/15/93

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State

Agency Contact: Bryant Tudor, 202 245-2874

RIN: 0970-AB06
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1511. REFUGEE CASH ASSISTANCE AND REFUGEE MEDICAL ASSISTANCE

CFR Citation:  45 CFR 400

Completed:
_________________________________________________________________________

Reason                            Date                      FR Cite

_________________________________________________________________________

Final Action                    12/08/93                    58 FR 64499

Small Entities Affected: None

Government Levels Affected: State, Local

Agency Contact: Toyo A. Biddle, 202 401-9250

RIN: 0970-AB27
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1512.  ELIMINATION OF ENHANCED FUNDING FOR AFDC

Legal Authority:  PL 103-66

CFR Citation:  45 CFR 235

Legal Deadline: None

Abstract: These final rules implement provisions of the Omnibus Budget 
Reconciliation Act of 1993 which eliminate enhanced funding rates for 
the optional fraud program conducted under the AFDC program and 
training activities conducted under the Adult Assistance Program.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Action Effective          03/18/94
Final Action                    04/01/94                    59 FR 12860

Small Entities Affected: None

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-AB35
_______________________________________________________________________


_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions
Administration for Children and Families (ACF)
  
_______________________________________________________________________
 
1513.  INCREASE IN STEPPARENT INCOME DISREGARD

Legal Authority:  PL 103-66

CFR Citation:  45 CFR 233

Legal Deadline: None

Abstract: This final rule implements the change in the stepparent 
earned income disregard for AFDC from $75 to $90, as provided under PL 
103-66.

Timetable:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

Final Action                    03/04/94                    59 FR 10299

Small Entities Affected: None

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-AB36
_______________________________________________________________________
  

_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Proposed Rule Stage
Administration on Aging (AOA)
  
_______________________________________________________________________
 
1514.  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

Significance:
Subject to OMB review: Yes
Regulatory Plan entry: Undetermined

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:
_________________________________________________________________________

Action                            Date                      FR Cite

_________________________________________________________________________

NPRM (Intrastate Funding 
Formulas)                       03/17/94                    59 FR 12728
NPRM Comment Period End 
(Intrastate Funding Formulas)   05/16/94
NPRM                            06/00/94
Final Action                    07/01/94

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. 94-6356 Filed 04-22-94; 8:45 am]
BILLING CODE 4150-04-F
