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


_______________________________________________________________________

Part VIII





Department of Health and Human Services





_______________________________________________________________________



Semiannual Regulatory Agenda

[[Page 21932]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)                          


  



_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

21 CFR Ch. I

42 CFR Chs. I-V

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

Unified Agenda of Federal Regulatory and Deregulatory Actions

AGENCY: Office of the Secretary, HHS.

ACTION: Semiannual regulatory agenda.

_______________________________________________________________________

SUMMARY: The President's Executive Order 12866 and the Regulatory 
Flexibility Act of 1980 require the semiannual publication of an agenda 
which summarizes all current, projected, and recently completed 
rulemakings of the Department. The agenda enables the public to know 
about and to participate in the Department's regulations development 
work. The last such agenda was published on October 29, 1997.

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

SUPPLEMENTARY INFORMATION: The agenda of regulatory actions set out 
below continues to reflect the Department's efforts to exemplify in its 
rulemaking the President's initiative to streamline the Federal 
regulatory system so that it affords important benefits to the American 
people while creating fewer burdens. The agenda also reflects emerging 
policy mandates for HHS, stemming from several major new pieces of 
legislation, broadly ranging over child health; welfare reform; health 
insurance reform; food safety; improved regulation of drugs and medical 
products; the combating of waste, fraud, and abuse in the health care 
system; and the restructuring of the Medicare and Medicaid financing 
systems.

    For example, the Balanced Budget Act of 1997 (BBA) includes 
numerous provisions requiring regulatory actions substantially 
affecting the characteristics and administration of the Medicare 
Program. These actions will affect areas such as changes in 
Medicare reimbursement rules for graduate medical education; 
revisions to payment procedures for hospice and home health 
services; and solvency standards for provider-sponsored 
organizations.

    Also, the Health Insurance Portability and Accountability Act 
of 1996, along with its health insurance reforms, gives the 
Department major new responsibilities concerning health data 
standards and health record privacy. These provisions require the 
Secretary to adopt a series of data standards to support electronic 
data interchange for health insurance and related transactions, 
such as claims processing and enrollment. The standards will apply 
to the entire health industry, not just Federal programs.

    And, the FDA Modernization Act put into law many of the 
initiatives undertaken under the Vice President's Reinventing 
Government program. In addition, the Act requires, among many other 
things, regulations to codify FDA's existing practices of 
increasing patient access to experimental drugs and of accelerating 
review of important new medications. The Act also requires 
regulations facilitating dissemination by manufacturers of peer-
reviewed journal articles about unapproved uses of drugs and 
medical devices, in exchange for commitments by the manufacturers 
to submit research data to FDA regarding safety and effectiveness 
of these products.

    Underlying these initiatives, there endures the focus and 
discipline which the principles articulated in the President's 
Executive Order 12866 and the many subsequent regulatory reform 
initiatives of the Administration have brought to the Department's 
regulatory program. Public comments are invited to assist the 
Department in continuing to pursue the President's purposes. 
Comments should be sent to the addresses listed below, depending on 
the specific agenda entry that is of interest. Comments may be sent 
to the Office of the Secretary if the responsible component of the 
Department is not apparent or if a comment covers subjects crossing 
agency lines.

    Health Care Financing Administration: Sue Brown, Director, 
Division of Regulations and Issuances, 7500 Security Boulevard, C5-
09-27, Baltimore, Maryland 21244; phone 410-786-4473.

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

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

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

    Agency for Health Care Policy and Research: Peggy Washburn, 
2101 East Jefferson Street, Suite 603, Rockville, Maryland 20852; 
phone 301-594-1455.

    Centers for Disease Control: Dana Weller, Policy Analyst, 
Office of Program and Planning and Evaluation, Office of the 
Director, 1600 Clifton Road, Building 16, Mail Stop D23, Atlanta, 
Georgia 30333; phone 404-639-7077.

    Health Resource Services Administration: Dolores R. Etherith, 
5600 Fishers Lane, Room 14-A-08, Rockville, Maryland 20857; phone 
301-443-1786.

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

    National Institutes of Health: Jerry Moore, 6011 Executive 
Boulevard, Room 601, Mail Stop 7669, Rockville, Maryland 20852; 
phone 301-496-4606.

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

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

LaVarne Burton,

Executive Secretary to the Department.

[[Page 21933]]



                                  Office of the Secretary--Proposed Rule Stage                                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
921          Revised OIG Sanction Authorities Resulting From Public Law 105-33....................    0991-AA95 
----------------------------------------------------------------------------------------------------------------


                                    Office of the Secretary--Final Rule Stage                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
922          Clarification of the Initial OIG Safe Harbor Provisions and Establishment of                       
            Additional Safe Harbor Provisions Under the Anti-Kickback Statute.....................    0991-AA66 
923          Reproduction and Sale of Official Forms and Publications.............................    0991-AA83 
924          Revised OIG Exclusion Authorities Resulting From Public Law 104-191..................    0991-AA87 
925          Revised OIG Civil Money Penalties Resulting From Public Law 104-191..................    0991-AA90 
926          Shared Risk Exception to the Safe Harbor Provisions..................................    0991-AA91 
927          Issuance of Advisory Opinions by the Inspector General...............................    0991-AA94 
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                                   Office of the Secretary--Long-Term Actions                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
928          Civil Money Penalties (CMPs) for Certain Hospital Physician Incentive Plans..........    0991-AA45 
929          Civil Money Penalties (CMPs) for Certain Practices Relating to Medicare Supplemental               
            Policies..............................................................................    0991-AA53 
930          Civil Money Penalties for Notifying a Home Health Agency, or a Home or Community-                  
            Based Health Care Center or Provider, of a Standard Survey............................    0991-AA79 
931          Civil Money Penalties for False Information on Drug Manufacturer Price Surveys and                 
            Rebate Agreements.....................................................................    0991-AA80 
932          Senior Biomedical Research Services..................................................    0991-AA82 
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                                   Office of the Secretary--Completed Actions                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
933          Civil Money Penalties for Referrals to Entities and for Prohibited Arrangements and                
            Schemes...............................................................................    0991-AA65 
934          Administrative Requirements for Grantees To Reflect Single Audit Act Amendments......    0991-AA92 
----------------------------------------------------------------------------------------------------------------


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


                  Substance Abuse and Mental Health Services Administration--Completed Actions                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
936          Protection and Advocacy for Individuals With Mental Illness..........................    0930-AA02 
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[[Page 21934]]


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


                                   Food and Drug Administration--Prerule Stage                                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
938          Animal Drug Approvals for Minor Species and Minor Usage..............................    0910-AB07 
939          Shell Eggs: Warning, Notice and Safe Handling Labeling Statements and Refrigeration                
            Requirements..........................................................................    0910-AB30 
940          Electronic Submission of Adverse Drug Reaction Reports...............................    0910-AB42 
941          Supplemental Manufacturing Changes for New Animal Drugs..............................    0910-AB49 
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                                Food and Drug Administration--Proposed Rule Stage                               
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
942          Over-the-Counter (OTC) Drug Review...................................................    0910-AA01 
943          Fees for Certification Services; Insulin and Color Additive Certification Programs...    0910-AA07 
944          Review of Warnings, Use Instructions, and Precautionary Information Under Section 314              
            of the National Childhood Vaccine Injury Act of 1986..................................    0910-AA14 
945          Hearing Aids; Professional and Patient Labeling; Conditions for Sale.................    0910-AA39 
946          Fruit and Vegetable Juices: Development of HACCP and Label Warning Statements for                  
            Juices................................................................................    0910-AA43 
947          Bioavailability and Bioequivalence Requirements......................................    0910-AA51 
948          Drugs Used for Treatment of Narcotic Addicts.........................................    0910-AA52 
949          Dietary Supplement Regulations in Response to DSHEA..................................    0910-AA59 
950          Investigational New Drugs: Export Requirements for Unapproved New Drug Products......    0910-AA61 
951          Adverse Drug Reaction Reporting, Recordkeeping, and Records Access Requirements for                
            Marketed OTC Drugs....................................................................    0910-AA86 
952          Informed Consent for Human Drugs and Biologics; Determination That Informed Consent                
            Is Not Feasible.......................................................................    0910-AA89 
953          Direct-to-Consumer Promotion Regulations.............................................    0910-AA90 
954          Labeling for Human Prescription Drugs; Revised Format................................    0910-AA94 
955          Adverse Drug Reaction Reporting Requirements for Human Drug and Biological Products..    0910-AA97 
956          Chlorofluorocarbon Propellants in Self-Pressurized Containers; Determinations That                 
            Uses Are No Longer Essential..........................................................    0910-AA99 
957          Radioactive Drugs for Basic Research.................................................    0910-AB00 
958          Establishment Registration and Listing of Human Cellular and Tissue-Based Products...    0910-AB05 
959          Veterinary Feed Directives: Distributor Notification.................................    0910-AB09 
960          Use of Ozone-Depleting Substances in Aerosol Products or Other Pressurized Dispensers    0910-AB10 
961          Exports; Reporting and Recordkeeping Requirements....................................    0910-AB16 
962          Requirements Pertaining to the Sale and Distribution of Cigarettes and Smokeless                   
            Tobacco To Protect Children and Adolescents; Use of Nontobacco Trade or Brand Names...    0910-AB17 
963          Exemption From Preemption of State and Local Cigarette and Smokeless Tobacco                       
            Requirements; Applications for Exemption Submitted by Various State Governments; Group              
            1; Group 2............................................................................    0910-AB19 
964          Registration of Foreign Establishments and Product Listing...........................    0910-AB21 
965          Public Information; Communications with State and Foreign Government Officials.......    0910-AB22 
966          Dissemination of Treatment Information on Unapproved Uses for Marketed Drugs and                   
            Devices...............................................................................    0910-AB23 
967          FDA Export Reform and Enhancement Act of 1996; Reporting and Recordkeeping                         
            Requirements for Unapproved or Violative Products Imported for Further Processing or                
            Incorporation and Later Export........................................................    0910-AB24 
968          Blood Initiative.....................................................................    0910-AB26 
969          Suitability Determination for Donors of Human Cellular and Tissue-Based Products.....    0910-AB27 
970          Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based                  
            Products..............................................................................    0910-AB28 
971          Biological Products Regulated Under Section 351 of the Public Health Services Act;                 
            Implementation of Biologics License; Elimination of Establishment License and Product               
            License...............................................................................    0910-AB29 
972          Antibiotic Drug Approval and Exclusivity.............................................    0910-AB33 
973          Applications for FDA Approval to Market a New Drug or Antibiotic Drug; Complete                    
            Review Letter; Amendments to Unapproved Applications..................................    0910-AB34 
974          Expanded Access to Investigational Therapies.........................................    0910-AB37 
975          Distinguishing Marks for Drug Products Containing Insulin............................    0910-AB43 

[[Page 21935]]

                                                                                                                
976          Progestational Drug Products for Human Use; Requirements for Labeling Directed to the              
            Patient...............................................................................    0910-AB45 
977          Requirements for Liquid Medicated Feed and Free Choice Medicated Feed................    0910-AB50 
978          Revisions to the General Safety Requirements for Biological Products; Direct Final                 
            Rule..................................................................................    0910-AB51 
979          Radiopharmaceuticals Used for In Vivo Diagnosis and Monitoring.......................    0910-AB52 
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                                 Food and Drug Administration--Final Rule Stage                                 
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
980          New Animal Drug Approval Process; Implementation of Title I of the Generic Animal                  
            Drug and Patent Term Restoration Act (GADPTRA)........................................    0910-AA02 
981          Prescription Drug Marketing Act of 1987; Policy Information, Guidance, and                         
            Clarifications........................................................................    0910-AA08 
982          Biological Products: Reporting of Errors and Accidents in Manufacturing..............    0910-AA12 
983          Tamper-Evident Packaging Requirements for Over-the-Counter Human Drug Products.......    0910-AA26 
984          Prescription Drug Product Labeling; Medication Guide.................................    0910-AA37 
985          Current Good Manufacturing Practice; Amendment of Certain Requirements for Finished                
            Pharmaceuticals.......................................................................    0910-AA45 
986          Parenteral Drug Products Containing Aluminum as an Ingredient or Contaminant;                      
            Labeling Requirements; Warning Statement..............................................    0910-AA74 
987          New Drug Applications; Drug Master File..............................................    0910-AA78 
988          Over-the-Counter Human Drugs; Labeling Requirements..................................    0910-AA79 
989          Investigational New Drug Applications; Clinical Holds for Drugs for Life-Threatening               
            Illnesses.............................................................................    0910-AA84 
990          Sterility Requirements for Inhalation Solution Products..............................    0910-AA88 
991          Current Good Manufacturing Practice; Revision of Certain Labeling Controls...........    0910-AA98 
992          Definition of Substantial Evidence...................................................    0910-AB08 
993          Medicated Feed Mill Licenses.........................................................    0910-AB18 
994          Regulations Requiring Manufacturers To Assess the Safety and Effectiveness of New                  
            Drugs and Biological Products in Pediatric Patients...................................    0910-AB20 
995          Revocation of Lather Brushes Regulation..............................................    0910-AB25 
996          Removal of Regulations Regarding Certification of Antibiotic Drugs...................    0910-AB31 
997          Revocation of Antibiotic Certification Requirements; Conforming Revisions to                       
            Regulations...........................................................................    0910-AB32 
998          Removal of Regulations Regarding Certification of Drugs Composed Wholly or Partly of               
            Insulin...............................................................................    0910-AB38 
999          Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs....    0910-AB39 
1000         List of Drugs That Have Been Withdrawn or Removed from the Market for Reasons of                   
            Safety and Effectiveness..............................................................    0910-AB40 
1001         Streamlining Clinical Research.......................................................    0910-AB41 
1002         Medical Devices; IDE Modifications...................................................    0910-AB53 
1003         Dispute Resolution...................................................................    0910-AB54 
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Long-Term Actions                                
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1004         Infant Formula: Good Manufacturing Practice, Quality Control Procedures, Quality                   
            Factors, Notification Requirements, and Records and Reports...........................    0910-AA04 
1005         Food Labeling Review.................................................................    0910-AA19 
1006         Medical Foods........................................................................    0910-AA20 
1007         Amalgam Ingredient Labeling..........................................................    0910-AA33 
1008         Classification of Computer Software Programs That Are Medical Devices................    0910-AA41 
1009         Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution...    0910-AA49 
1010         Reinventing FDA Food Regulations.....................................................    0910-AA58 
1011         Reinvention of Administrative Procedures Regulations.................................    0910-AA69 
1012         Long-Term Contraceptive Drug Products and Medical Devices; Informed Consent                        
            Requirements..........................................................................    0910-AA75 
1013         Debarment Certification Regulations for Drug Applications............................    0910-AA76 
1014         Investigational New Drug Applications; Request for Information and Comments..........    0910-AA83 
1015         Investigational New Animal Drug Regulations..........................................    0910-AB02 
1016         New Drugs for Human Use; Clarification of Requirements for Patent Holder Notification    0910-AB12 

[[Page 21936]]

                                                                                                                
1017         Administrative Practices and Procedures; Advisory Opinions and Guidelines............    0910-AB14 
1018         Pregnancy Labeling Revision..........................................................    0910-AB44 
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Completed Actions                                
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1019         Implementation of the Safe Medical Devices Act of 1990...............................    0910-AA09 
1020         Mammography Quality Standards Act of 1992............................................    0910-AA24 
1021         Financial Disclosure by Clinical Investigators.......................................    0910-AA30 
1022         Habit-Forming Drugs..................................................................    0910-AA50 
1023         Revocation of Certain Regulations....................................................    0910-AA54 
1024         Investigational New Drug Applications; Clinical Holds................................    0910-AA73 
1025         Certification of Drugs Composed Wholly or Partly of Insulin..........................    0910-AA77 
1026         Investigational New Drug Applications and New Drug Applications......................    0910-AA82 
1027         Postmarketing Periodic Adverse Experience Reporting Requirements for Human Drug and                
            Licensed Biological Products..........................................................    0910-AA85 
1028         New Drugs for Human Use; Clarification of Requirements for Application Supplements...    0910-AA87 
1029         Definition of Adequate and Well-Controlled Studies...................................    0910-AB01 
1030         FDA Export Reform and Enhancement Act of 1996; Reporting and Recordkeeping                         
            Requirements for Unapproved or Violative Products Imported for Further Processing or                
            Incorporation and Later Export........................................................    0910-AB06 
1031         Clarification of the Scope of Treatment Uses With Investigational New Drugs That Can               
            Be Authorized Under INDs and the Criteria for Charging for Investigational New Drugs                
            Under INDs............................................................................    0910-AB11 
1032         Prescription Drug Compounding........................................................    0910-AB13 
1033         Revocation of Regulation on Positron Emission Tomography Drug Products...............    0910-AB46 
----------------------------------------------------------------------------------------------------------------


                        Health Resources and Services Administration--Proposed Rule Stage                       
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1034         National Practitioner Data Bank for Adverse Information on Physicians and Other                    
            Health Care Practitioners: Corporate Shield...........................................    0906-AA41 
1035         National Practitioner Data Bank for Adverse Information on Physicians and Other                    
            Health Care Practitioners: Reporting Adverse and Negative Actions.....................    0906-AA43 
1036         Designation of Medically Underserved Populations and Health Professional Shortage                  
            Areas.................................................................................    0906-AA44 
1037         Health Care Fraud and Abuse Data Collection Program..................................    0906-AA46 
1038         National Practitioner Data Bank for Adverse Information on Physicians and Other                    
            Health Care Providers: Clarification and Modernization of Regulatory Terms............    0906-AA48 
----------------------------------------------------------------------------------------------------------------


                         Health Resources and Services Administration--Final Rule Stage                         
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1039         Organ Procurement and Transplantation Network Rules..................................    0906-AA32 
1040         National Vaccine Injury Compensation Program: Effective Date Provisions of Coverage                
            of Certain Vaccines to the Vaccine Injury Table.......................................    0906-AA49 
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[[Page 21937]]


                         Health Resources and Services Administration--Long-Term Actions                        
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1041         Drug Pricing Program: Prime Vendor User Charge.......................................    0906-AA45 
----------------------------------------------------------------------------------------------------------------


                         Health Resources and Services Administration--Completed Actions                        
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1042         National Practitioner Data Bank for Adverse Information on Physicians and Other                    
            Health Care Practitioners: Charge for Self-Queries....................................    0906-AA42 
1043         Grants for Residency Training and Advanced Education in the General Practice of                    
            Dentistry; Technical Amendments.......................................................    0906-AA47 
----------------------------------------------------------------------------------------------------------------


                                   Indian Health Service--Proposed Rule Stage                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1044         Acquisition Under the Buy Indian Act.................................................    0917-AA00 
1045         Indian Child Protection and Family Violence Prevention Act Minimum Standards of                    
            Character.............................................................................    0917-AA02 
----------------------------------------------------------------------------------------------------------------


                               National Institutes of Health--Proposed Rule Stage                               
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1046         National Institutes of Health AIDS Research Loan Repayment Program...................    0925-AA02 
1047         Undergraduate Scholarship Program Regarding Professions Needed by the NIH............    0925-AA10 
1048         Traineeships.........................................................................    0925-AA11 
1049         Additional DHHS Protections for Pregnant Women and Human Fetuses Involved as Subjects              
            in Research, and Pertaining to Human In Vitro Fertilization...........................    0925-AA14 
1050         National Research Service Awards.....................................................    0925-AA16 
1051         Removal of National Cancer Institute Clinical Cancer Education Program...............    0925-AA17 
1052         National Institutes of Health Loan Repayment Program for Research....................    0925-AA18 
1053         National Institute of Child Health and Human Development Contraception and                         
            Infertility Research Loan Repayment Program...........................................    0925-AA19 
1054         Scientific Peer Review of Research Grant Applications and Research and Development                 
            Contract Projects.....................................................................    0925-AA20 
1055         Federal Policy (Common Rule) for the Protection of Human Subjects....................    0925-AA21 
----------------------------------------------------------------------------------------------------------------


                                 National Institutes of Health--Final Rule Stage                                
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1056         National Institutes of Health Construction Grants....................................    0925-AA04 
1057         National Institutes of Health Clinical Research Loan Repayment Program for                         
            Individuals From Disadvantaged Backgrounds............................................    0925-AA09 
1058         Service Fellowship...................................................................    0925-AA22 
----------------------------------------------------------------------------------------------------------------


[[Page 21938]]


                           Office of Assistant Secretary for Health--Long-Term Actions                          
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1059         Standards of Compliance for Abortion-Related Services in Family Planning Service                   
            Projects..............................................................................    0937-AA00 
----------------------------------------------------------------------------------------------------------------


                                   Public Health Service--Proposed Rule Stage                                   
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1060         Public Health Service Standards for the Protection of Research Misconduct                          
            Whistleblowers........................................................................    0905-AE71 
----------------------------------------------------------------------------------------------------------------


                               Health Care Financing Administration--Prerule Stage                              
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1061         Prospective Fee Schedule for Ambulance Services (HCFA-1002-NR).......................    0938-AI72 
----------------------------------------------------------------------------------------------------------------


                            Health Care Financing Administration--Proposed Rule Stage                           
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1062         ``Without Fault'' and Beneficiary Waiver of Recovery As It Applies to Medicare                     
            Overpayment Liability (HCFA-1719-P)...................................................    0938-AD95 
1063         Provider Reimbursement Determinations and Appeals (HCFA-1727-P)......................    0938-AF28 
1064         Revisions to Rules on Health Care Prepayment Plans (HCFA-1016-P).....................    0938-AF97 
1065         Conditions of Participation for Rural Health Clinics (HCFA-1764-P)...................    0938-AG05 
1066         Alternative Sanctions for Renal Dialysis Facilities (HCFA-3204-P)....................    0938-AG31 
1067         Effect of Change of Ownership on Provider and Supplier Penalties, Sanctions,                       
            Underpayments and Overpayments (HCFA-2215-P)..........................................    0938-AG59 
1068         Medicaid: Optional Coverage of TB-Related Services for Individuals Infected With                   
            Tuberculosis (HCFA-2082-P)............................................................    0938-AG72 
1069         Physicians' Referrals to Health Care Entities With Which They Have Financial                       
            Relationships--Expanded to Designated Health Services (HCFA-1809-F)...................    0938-AG80 
1070         End Stage Renal Disease (ESRD) Conditions for Coverage (HCFA-3818-P).................    0938-AG82 
1071         Liability for Third Parties To Pay for Care and Services (MB-080-P)..................    0938-AH01 
1072         Definition of Skilled Nursing Facility (SNF) for Coverage of Durable Medical                       
            Equipment (DME) (BPD-834-P)...........................................................    0938-AH16 
1073         Medicare Coverage of Organ Transplantation (HCFA-3835-PN)............................    0938-AH17 
1074         State Plan Amendment (SPA) Reconsideration Process (HCFA-2096-P).....................    0938-AH24 
1075         Hospice Care--Conditions of Participation (HCFA-3844-P)..............................    0938-AH27 
1076         Medicare Coverage of Services of Speech-Language Pathologists and Audiologists (HCFA-              
            1843-P)...............................................................................    0938-AH37 
1077         Payment Amount If Customary Charges Are Less Than Reasonable Costs (HCFA-1860-FC)....    0938-AH49 
1078         Supplier Participation Agreements and Limits on Actual Charges of Nonparticipating                 
            Physicians (HCFA-1862-P)..............................................................    0938-AH50 
1079         Revision to Accrual Basis of Accounting Policy (HCFA-1876-P).........................    0938-AH61 
1080         Medicaid; Estate Recoveries (HCFA-2083-P)............................................    0938-AH63 
1081         Provider and Supplier Billing When Medicare Is Secondary Payor to Liability Insurance              
            (HCFA-1848-P).........................................................................    0938-AH66 
1082         Medicare Technical Conforming Amendments (HCFA-1858-FC)..............................    0938-AH67 
1083         Elimination of Certain Requirements for Peer Review Organizations in the Utilization               
            and Quality Review Process and a Change in the Length of Peer Review Organization                   
            Contracts (HCFA-3235-FC)..............................................................    0938-AH68 
1084         Determination of Substandard Care in SNFs and NFs (HCFA-2240-P)......................    0938-AH69 
1085         Update of Ratesetting Methodology, Payment Rates and the List of Covered Surgical                  
            Procedures for Ambulatory Surgical Centers Effective for Calendar Year 1998 (HCFA-1885-             
            P)....................................................................................    0938-AH81 
1086         Revisions to Conditions for Coverage for Ambulatory Surgical Centers (HCFA-3887-P)...    0938-AH83 
1087         Disclosure of Peer Review Organization Information in Response to Beneficiary                      
            Complaints (HCFA-3241-P)..............................................................    0938-AH85 
1088         Medicare Program; Beneficiary Incentives Programs (HCFA-6144-P)......................    0938-AH86 
1089         National Standard for Identifiers of Health Plans (HCFA-4145-P)......................    0938-AH87 
1090         Medicaid Program; Amendment to the Preadmission Screening and Annual Resident Review               
            Program (HCFA-2107-P).................................................................    0938-AH89 

[[Page 21939]]

                                                                                                                
1091         Medicaid Program; Coverage and Payment for Federally Qualified Health Center Services              
            (HCFA-2043-P).........................................................................    0938-AH95 
1092         Medicare Coverage of Certified Nurse-Midwife Services (HCFA-1496-P)..................    0938-AH96 
1093         National Standard Health Care Provider Identifier (HCFA-0045-P)......................    0938-AH99 
1094         Medicare Program; Improvements to the Appeals Process for Medicare Beneficiaries                   
            Enrolled in HMOs, CMPs, and HCPPs (HCFA-4024-P).......................................    0938-AI11 
1095         Newborns' and Mothers' Health Protection.............................................    0938-AI13 
1096         Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 1999                 
            Rates (HCFA-1003-P)...................................................................    0938-AI22 
1097         Children's Health Insurance: Program Implementations; State Plan Approval; State                   
            Payment; Coordination With State Medicaid Program (HCFA-2006-P).......................    0938-AI28 
1098         Standards for Electronic Transactions (HCFA-0149-P)..................................    0938-AI58 
1099         National Standard Employer Identifier (HCFA-0047-P)..................................    0938-AI59 
----------------------------------------------------------------------------------------------------------------


                             Health Care Financing Administration--Final Rule Stage                             
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1100         Deduction of Incurred Medical Expenses (Spenddown) (HCFA-2020-F).....................    0938-AB07 
1101         Payment for Clinical Diagnostic Laboratory Tests (HCFA-1309-F).......................    0938-AB50 
1102         Participation in CHAMPUS and CHAMPVA, Hospital Admissions for Veterans, Discharge                  
            Rights Notice, and Hospital Responsibility for Emergency Care (HCFA-1393-IFC).........    0938-AC58 
1103         Medicare Secondary Payer for Disabled Individuals (HCFA-1482-F)......................    0938-AD73 
1104         Omnibus Nursing Home Reform Requirements (HCFA-3488-F)...............................    0938-AD81 
1105         Coverage of Screening Pap Smears (BPD-705-F).........................................    0938-AE98 
1106         Case Management (HCFA-2027-F)........................................................    0938-AF07 
1107         Medicaid Payment for Covered Outpatient Drugs Under Rebate Agreements (HCFA-2046-FC).    0938-AF42 
1108         Medicaid: Outstationed Intake Locations for Certain Low-Income Pregnant Women,                     
            Infants, and Children Under Age 19 (HCFA-2052-F)......................................    0938-AF69 
1109         Retroactive Enrollment and Disenrollment in Risk Health Maintenance Organizations and              
            Competitive Medical Plans (HCFA-1015-F)...............................................    0938-AF98 
1110         Payment for Preadmission Services (HCFA-1731-F)......................................    0938-AG00 
1111         Change in Provider Agreement Regulations Related to Federal Employee Health Benefits               
            (HCFA-1748-F).........................................................................    0938-AG03 
1112         Revised Medicaid Management Information Systems (MB-38-FN)...........................    0938-AG10 
1113         Noncoverage of Electrostimulation of Salivary Glands for the Treatment of Xerostomia               
            (Dry Mouth) (HCFA-3782-FN)............................................................    0938-AG45 
1114         Telephone Requests for Review of Part B Initial Claim Determinations (HCFA-4121-F)...    0938-AG48 
1115         Home Health Agency (HHA) Conditions of Participation (HCFA-3819-F)...................    0938-AG81 
1116         CLIA Program: Categorization of Waived Tests (HCFA-2225-FC)..........................    0938-AG99 
1117         Ambulance Services (HCFA-1813-F).....................................................    0938-AH13 
1118         Adjustment in Payment Amounts for New Technology Intraocular Lenses (HCFA-3831-F)....    0938-AH15 
1119         CLIA Program: Cytology Proficiency Testing (HCFA-2233-N).............................    0938-AH35 
1120         Requirements for Enrollment of Medicaid Recipients Under Cost Effective Employer-                  
            Based Group Health Plans (HCFA-2047-FC)...............................................    0938-AH48 
1121         Limitations on Liability (HCFA-4859-FC)..............................................    0938-AH51 
1122         Terms, Definitions, and Addresses: Technical Amendments (HCFA-9877-FC)...............    0938-AH53 
1123         Changes to the Hospital Inpatient Prospective Payment System and Fiscal Year 1998                  
            Rates (HCFA-1878-F)...................................................................    0938-AH55 
1124         Utilization Control and Discontinued Review Activities; Medicaid (MB-101-FC).........    0938-AH64 
1125         Individual Market Health Ins. Reform Portability from Group to Indiv. Coverage;                    
            Federal Rules for Access in the Indiv. Market; State Alternative Mechanisms to Federal              
            Rules (HCFA-2882-F)...................................................................    0938-AH75 
1126         Medicaid Program; Redeterminations of Medicaid Eligibility Due to Welfare Reform                   
            (HCFA-2105-IFC).......................................................................    0938-AH76 
1127         CLIA Program; Simplifying CLIA Regulations to Accreditation Exemption of Laboratories              
            Under a State Licensure Program, and Proficiency Testing and Inspection (HCFA-2239-FC)    0938-AH82 
1128         Allocation of Enhanced Federal Matching Funds for Increased Administrative Costs (MB-              
            103-N)................................................................................    0938-AH90 
1129         Medically Needy Determinations Under Welfare Reform (HCFA-2109-IFC)..................    0938-AH92 
1130         Final Limitations on Aggregate Payments to Disproportionate Share Hospitals: Federal               
            Fiscal Year 1998 (HCFA-2110-N)........................................................    0938-AH93 
1131         Revision to the Definition of an Unemployed Parent (HCFA-2106-FC)....................    0938-AH98 
1132         Health Insurance Reform: Parity in the Application of Certain Limits to Mental Health              
            Benefits (HCFA-2891-IFC)..............................................................    0938-AI05 

[[Page 21940]]

                                                                                                                
1133         Portability and Nondiscrimination in the Group Health Insurance Market (HCFA-2890-F).    0938-AI08 
1134         Part A Premium for 1998 for the Uninsured Aged and for Certain Disabled Individuals                
            Who Have Exhausted Other Entitlement (HCFA-5056-N)....................................    0938-AI10 
1135         Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance                  
            Amounts for 1998 (HCFA-5057-N)........................................................    0938-AI12 
1136         Health Insurance Portability: Newborns' and Mothers' Health Protection (HCFA-2892-                 
            IFC)..................................................................................    0938-AI17 
1137         Medicare Program: Update of Ambulatory Surgical Center Payment Rates Effective for                 
            Services On or Before October 1, 1997 (HCFA-1897-N)...................................    0938-AI18 
1138         Medicaid Program: Charges for Vaccine Administration Under the Vaccines for Children               
            (VCF) Program (HCFA-2084-FNC).........................................................    0938-AI20 
1139         Solvency Standards for Provider-Sponsored Organizations (HCFA-1011-IFC)..............    0938-AI25 
1140         Medicare Program; Notice for the Solicitation for Proposals for a Demonstration                    
            Project for Congestive Heart Failure Case Management HCFA-1104-N).....................    0938-AI26 
1141         GME: Incentive Payments under Plans for Voluntary Reduction in Number of Residents                 
            (HCFA-1001-IFC).......................................................................    0938-AI27 
1142         Medicare + Choice Program; Regulatory Program to Implement Certain Medicare                        
            Provisions of the Balanced Budget Act of 1997 (OMC-030-IFC)...........................    0938-AI29 
1143         Medicare Program; Prospective Payment System and Consolidated Billing for Skilled                  
            Nursing Facilities. (HCFA-1913-IFC)...................................................    0938-AI47 
1144         Resource Based Practice Expense Payments and Revisions to Payment Policies for CY                  
            1999 (HCFA-1006-P)....................................................................    0938-AI52 
1145         Medicare Program; Definition of Provider-Sponsored Organization and Related                        
            Requirements (HCFA-1027-IFC)..........................................................    0938-AI60 
----------------------------------------------------------------------------------------------------------------


                             Health Care Financing Administration--Long-Term Actions                            
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1146         Criteria and Procedures for Developing Medical Services Coverage Policy (HCFA-3546-F)    0938-AD07 
1147         Medicare Coverage of Outpatient Occupational Therapy Services (HCFA-1425-P)..........    0938-AD32 
1148         Changes to Peer Review Organization Regulations (HCFA-3135-F)........................    0938-AD38 
1149         Protection of Income and Resources for Community Spouses of Institutionalized                      
            Individuals (HCFA-2023-P).............................................................    0938-AE12 
1150         Survey Requirements and Alternative Sanctions for Home Health Agencies (HCFA-2169-F).    0938-AE39 
1151         Revisions to Regulations Implementing CLIA (HCFA-2226-F).............................    0938-AE47 
1152         Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Services (MB-28-F)...    0938-AE72 
1153         Payment for Nursing and Allied Health Science Education (HCFA-1685-F)................    0938-AE79 
1154         Medicare Coverage of, and Application of the Outpatient Mental Health Treatment                    
            Limitation to, Clinical Psychologist and Clinical Social Worker Services (HCFA-3706-F)    0938-AE99 
1155         Changes to the Long-Term Care Facility Survey Process (HCFA-3175-FC).................    0938-AF02 
1156         Requirements for Certain Health Insuring Organizations and OBRA'90 Technical                       
            Amendments (HCFA-1018-F)..............................................................    0938-AF15 
1157         Alternative Sanctions for Psychiatric Hospitals (HCFA-2191-P)........................    0938-AF32 
1158         Referral to Child Support Enforcement Agencies of Medicaid Families (HCFA-2051-F)....    0938-AF68 
1159         Assessing Interest Against Medicare Secondary Payer (MSP) Debts (HCFA-6108-P)........    0938-AF87 
1160         Description of HCFA's Evaluation Methodology for the Peer Review Organizations Fifth               
            Scope of Work Contracts (HCFA-3207-N).................................................    0938-AG32 
1161         Disclosure of Confidential PRO and ESRD Network Organization Information for Research              
            Purposes (HCFA-3208-P)................................................................    0938-AG33 
1162         Medicare Program: Limitations on Medicare Coverage of Intermittent Positive Pressure               
            Breathing Machine Therapy (HCFA-3781-FN)..............................................    0938-AG44 
1163         Revision of Medicare Hospital Conditions of Participation (HCFA-3745-F)..............    0938-AG79 
1164         Distinct Part Requirements for Nursing Homes and Prohibition of Financial Screening                
            of Applicants for Nursing Home Admission (BPD-815-P)..................................    0938-AG84 
1165         Clinical Laboratory Improvement Amendment (CLIA) Fee Schedule Revision (HCFA-3219-                 
            GNC)..................................................................................    0938-AG87 
1166         Categorization and Certification Requirements for a New Subcategory of Moderate                    
            Complexity Testing (HCFA-2222-F)......................................................    0938-AG98 
1167         Additional Supplier Standards (HCFA-1864-P)..........................................    0938-AH19 
1168         Criteria and Procedures for Extending Coverage to Certain Devices and Related                      
            Services (HCFA-3841-F)................................................................    0938-AH21 
1169         Delegation of Civil Money Penalties (HCFA-6135-FC)...................................    0938-AH22 
1170         Medicare Secondary Payer Clarifications and Amendments (HCFA-1865-P).................    0938-AH52 

[[Page 21941]]

                                                                                                                
1171         Conditions for Certification of Community Mental Health Centers and Coverage                       
            Requirements for Partial Hospitalization Services (HCFA-1871-P).......................    0938-AH58 
1172         Medicaid Hospice Care (HCFA-2016-P)..................................................    0938-AH65 
1173         Waiver of Staffing Requirements for End Stage Renal Disease (ESRD) Facilities                      
            Participating in an Experiment (HCFA-2236-GNC)........................................    0938-AH72 
1174         Provider and Supplier Enrollment and Re-enrollment Requirements (HCFA-1023-P)........    0938-AH73 
1175         Medicare Program; Medicare Integrity Program (HCFA-7020-P)...........................    0938-AI09 
1176         Medicare Program; Physician Fee Schedule Conversion Factor for Calendar Year 1998 and              
            Sustainable Growth Rate For Fiscal Year 1998 (HCFA-1893-FN)...........................    0938-AI16 
1177         Medicaid: Medical Child Support (HCFA-2081-P)........................................    0938-AI21 
1178         Collection of User Fees From Medicare+Choice Plans and Risk-Sharing Contractors (HCFA-             
            1911-IFC).............................................................................    0938-AI35 
1179         Medicare Program: Physicians' Referrals; Issuance of Advisory Opinions (HCFA-1902-F).    0938-AI38 
1180         Medicaid Program; State Allotments for Payment of Medicare Part B Premiums for                     
            Qualified Individuals: Federal Fiscal Year 1998 (HCFA-2005-NC)........................    0938-AI39 
1181         Medicare Program: Payments for Teleconsultations in Rural Health Professional                      
            Shortage Areas (HCFA-1906-P)..........................................................    0938-AI44 
1182         Medicare Program: User Fees (HCFA-6021-P)............................................    0938-AI46 
1183         Surety Bond Requirements for Comprehensive Outpatient Rehab. Facilities, Rehab.                    
            Agencies, Community Mental Health Centers, and Independent Diagnostic Testing                       
            Facilities (HCFA-1026-P)..............................................................    0938-AI48 
1184         Administrative Appeals Process for Suppliers Seeking To Enroll in Medicare Program                 
            (HCFA-1907-FC)........................................................................    0938-AI49 
1185         Medicare Program; Prospective Payment System for Hospital Outpatient (HCFA-1005-P)...    0938-AI56 
1186         Security and Electronic Signature Standards (HCFA-0049-P)............................    0938-AI57 
1187         Surety Bond for Suppliers of Medical Equipment (HCFA-2007-P).........................    0938-AI63 
1188         Child Health Insurance Allotments FY 1999 (HCFA-2014-N)..............................    0938-AI64 
1189         State Children Health Plan Allotments and Payments to States (HCFA-2114-FC)..........    0938-AI65 
1190         DSH Payments - Institution for Mental Disease (HCFA-2007-P)..........................    0938-AI66 
1191         Medicaid Program; Home and Community-Based Services (HCFA-2010-FC)...................    0938-AI67 
1192         Revisions to Payment Policies Under the Physician Fee Schedule and Other Part B                    
            Payment Policies for Calendar Year 1999 and the Rebasing of the Medicare Economic                   
            Index (HCFA-1006-P)...................................................................    0938-AI69 
1193         Managed Care: Global Medicaid Managed Care Provisions in the Balanced Budget Act of                
            1997 (HCFA-2001-P)....................................................................    0938-AI70 
1194         New and Pending Demonstration Project Proposals Submitted Pursuant to Section 1115(a)              
            of the Social Security Act July, August, September, October, and November 1997........    0938-AI71 
1195         Elimination of Application of Federal Financial Participation Limits (HCFA-2111-IFC).    0938-AI73 
1196         Medicaid Program; Changes to Eligibility of Non-U.S. Citizens (HCFA-2108-P)..........    0938-AI74 
1197         Medicare Program; Advance Refunding of Debt and Methodology for Repayment of Loan                  
            (HCFA-1777-P).........................................................................    0938-AI75 
1198         Medicare Program; Advertising Costs (HCFA-1880-P)....................................    0938-AI76 
1199         Medicare Hospice Care (HCFA-1022-P)..................................................    0938-AI77 
1200         State Allotments for Additional Federal Funding of Emergency Health Services                       
            Furnished to Undocumented Aliens: Federal Fiscal Years 1998 Through 2001..............    0938-AI78 
1201         Medicaid Program; Extension of Waiver To Extend Medicaid Eligibility Timeframes (HCFA-             
            2009-N)...............................................................................    0938-AI79 
1202         Revision of Procedures for Requesting Exceptions to Cost Limits for SNFs and                       
            Elimination of Reclassifications (HCFA-1883-P)........................................    0938-AI80 
1203         Medicare and Medicaid Programs; Surety Bond and Capitalization Requirements for Home               
            Health Agencies (HCFA-1038-NC)........................................................    0938-AI82 
1204         Solvency Standards for Provider-Sponsored Organizations (HCFA-1011-IFC)..............    0938-AI83 
1205         Schedule of Per-Beneficiary Limitations on Home Health Agency Costs for Cost                       
            Reporting Periods Begining On or After October 1, 1997 (HCFA-1905-FC).................    0938-AI84 
1206         Expanded Coverage of Blood Glucose Monitors and Test Strips (HCFA-3003-IFC)..........    0938-AI85 
1207         Surety Bond Requirements for Home Health Agencies (HCFA-1152.1-F)....................    0938-AI86 
1208         Hospice Wage Index Notice (HCFA-1039-N)..............................................    0938-AI87 
1209         Medicare Program; Standardization of Medicare Coverage for Bone Mass Measurements                  
            (HCFA-3004-IFC).......................................................................    0938-AI89 
1210         Recognition of the American Association for Accreditation of Ambulatory Surgery                    
            Facilities Inc., for Ambulatory Surgical Centers Program (HCFA-2008-PN)...............    0938-AI90 
----------------------------------------------------------------------------------------------------------------


[[Page 21942]]


                             Health Care Financing Administration--Completed Actions                            
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1211         Effective Dates for Provider Agreements and Supplier Approvals (HCFA-3139-F).........    0938-AC88 
1212         Prohibition on Unbundling of Hospital Outpatient Services (HCFA-1426-F)..............    0938-AD33 
1213         Resident Assessment in Long-Term Care Facilities (HCFA-2180-F).......................    0938-AE61 
1214         Post-Contract Beneficiary Protections and Other Provisions (OMC-003-F)...............    0938-AE63 
1215         Salary Equivalency Guidelines for Physical Therapy, Respiratory Therapy, Speech                    
            Pathology, and Occupational Therapy (HCFA-1808-F).....................................    0938-AG70 
1216         Home Health Agency Physician Certification Regulations (BPD-875-NC)..................    0938-AH59 
1217         Medicare Program; Establishment of an Expedited Review Process for Medicare                        
            Beneficiaries Enrolled in HMOs, CMPs, and HCPPs (HCFA-1025-FC)........................    0938-AH62 
1218         Use of the OASIS as Part of the Conditions of Participation for Home Health Agencies               
            (HCFA-3238-F).........................................................................    0938-AH74 
1219         Medicare Program; Revisions to Payment Policies and Adjustments to the Relative Value              
            Units Under the Physician Fee Schedule, Other Part B Payment Policies for Calendar YR               
            1998 (HCFA-1884-FC)...................................................................    0938-AH94 
1220         Medicare Program: Monthly Actuarial Rates and Monthly Supplementary Medicare                       
            Insurance Premium Rate Beginning January 1, 1998 (OACT-055-N).........................    0938-AI03 
1221         Schedule of Limits on Home Health Agency Cost Per Visit for Cost Reporting Periods                 
            Beginning On or After October 1, 1997 (BPD-904-FC)....................................    0938-AI24 
1222         Surety Bond and Capitalization Requirements for Home Health Agencies (HCFA-1152-FC)..    0938-AI31 
1223         Health Insurance Portability and Accountability Act (HIPPA) of 1996: Administrative                
            Simplification........................................................................    0938-AI32 
1224         Medicare Program: Delay in Implementing Adjustments to Practice Expense Relative                   
            Value Units Under the Physician Fee Schedule For Calendar Year 1998 (HCFA-1901-NC)....    0938-AI33 
1225         Medicare Program; Limit on the Valuation of Depreciable Asset Recognized as an                     
            Allowance for Depreciation and Interest on Capital Indebtedness After a Change of                   
            Ownership (HCFA-1004-FC)..............................................................    0938-AI34 
1226         Application of Inherent Reasonableness to All Medicare Part B Services (Other than                 
            Physician Services) (HCFA-1908-IFC)...................................................    0938-AI37 
1227         Medicare Program: Request for Public Comments on Implementation of the                             
            Medicare+Choice Program and Notice of Timeframes for Submission of Applications for                 
            Contracts (HCFA-1014-N)...............................................................    0938-AI45 
----------------------------------------------------------------------------------------------------------------


                          Administration for Children and Families--Proposed Rule Stage                         
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1228         Title IV-E Foster Care Eligibility Reviews and Child and Family Services State Plan                
            Reviews, MEPA Implementation, and ASFA Implementation.................................    0970-AA97 
1229         Construction of Head Start Facilities................................................    0970-AB54 
1230         Methodology for Determining Child Poverty Rates......................................    0970-AB65 
1231         Bonus to Reward High Performance States Under the Temporary Assistance for Needy                   
            Families Block Grant..................................................................    0970-AB66 
1232         Child Support Enforcement for Indian Tribes..........................................    0970-AB73 
1233         Requirements for the Tribal Programs.................................................    0970-AB78 
1234         Refugee Resettlement Program: Responding to TANF Replacing AFDC......................    0970-AB83 
1235         Child Support Non-Performance Penalty................................................    0970-AB85 
1236         Child Abuse and Neglect Prevention and Treatment.....................................    0970-AB86 
1237         Head Start Appeal Timelines..........................................................    0970-AB87 
1238         Title IV-E Training..................................................................    0970-AB89 
1239         Family Child Care Program Option for Head Start Programs.............................    0970-AB90 
1240         Implementation of Adoption & Safe Families Act of Remaining Provisions of the 1997                 
            and Other Title IV-B/IV-E Regulatory Amendments.......................................    0970-AB94 
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Final Rule Stage                           
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1241         Standards for Safe Transportation....................................................    0970-AB24 
1242         Standards for Purchase of Facilities.................................................    0970-AB31 
1243         Designation of Alternative Agency To Serve Indian Tribal Children....................    0970-AB52 
1244         Quarterly Wage and Unemployment Compensation Claims Reporting to the National                      
            Directory of New Hires................................................................    0970-AB67 

[[Page 21943]]

                                                                                                                
1245         State Law Concerning Paternity Establishment.........................................    0970-AB69 
1246         Automated Data Processing Requirements/State Case Registry...........................    0970-AB70 
1247         Automated Data Processing Funding Limitation.........................................    0970-AB71 
1248         Grants to States for Access and Visitation Programs..................................    0970-AB72 
1249         Child Care and Development Fund......................................................    0970-AB74 
1250         Temporary Assistance for Needy Families (TANF).......................................    0970-AB77 
1251         Bonus to Reward Decrease in Illegitimacy.............................................    0970-AB79 
1252         Child Support Enforcement Program Omnibus Conforming Regulation......................    0970-AB81 
1253         Case Closure.........................................................................    0970-AB82 
1254         Data Collection and Elements for the Welfare to Work Program.........................    0970-AB92 
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Completed Actions                          
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1255         Income Eligibility Criteria for Indian Tribes........................................    0970-AB53 
1256         Income and Resource Disregards Related to Interests of Individual Indians in Trust or              
            Restricted Lands......................................................................    0970-AB59 
1257         State Case Registry and Expansion of the Federal Parent Locator Service (FPLS).......    0970-AB68 
1258         Personal Responsibility and Work Opportunity Reconciliation Act of 1996 Conforming                 
            Regulation............................................................................    0970-AB84 
1259         Title IV-B Planning Requirements for Tribes..........................................    0970-AB88 
----------------------------------------------------------------------------------------------------------------


                                  Administration on Aging--Proposed Rule Stage                                  
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation 
 Sequence                                           Title                                            Identifier 
  Number                                                                                               Number   
----------------------------------------------------------------------------------------------------------------
1260         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)



_______________________________________________________________________




921.  REVISED OIG SANCTION AUTHORITIES RESULTING FROM PUBLIC LAW 
105-33

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 105-33, sec 4301; PL 105-33, sec 4303; PL 105-33, 
sec 4304; PL 105-33, sec 4331(c); PL 105-33, sec 4331(d)

CFR Citation:  42 CFR 1001; 42 CFR 1002; 42 CFR 1003

Legal Deadline: None

Abstract: This proposed rule would revise the OIG's exclusion and civil 
money penalty (CMP) authorities resulting from the Balanced Budget Act 
of 1997, Public Law 105-33. These proposed revisions would protect and 
strengthen Medicare and other Federal health care programs by 
increasing the OIG's anti-fraud and abuse authorities through new or 
revised exclusion and CMP provisions, including new CMPs (1) against 
institutional health care provider that employ, or enter into contracts 
for medical services with, excluded individuals; (2) for failure to 
report information to the Healthcare Integrity and Protection Data 
Bank; and (3) for health care providers who violate the anti-kickback 
statute.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/98
NPRM Comment Period End         08/00/98

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, 330 Independence 
Avenue, OCIG, Washington, DC 20201
Phone: 202 619-0089

RIN: 0991-AA95

[[Page 21944]]

_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




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

Priority:  Other Significant

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

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

CFR Citation:  42 CFR 1001

Legal Deadline: None

Abstract: This final rule serves both to clarify various aspects of the 
original safe harbor provisions and to add new safe harbors as 
authorized under section 14 of PL 100-93. Specifically, this rule 
modifies the original set of final safe harbor provisions (56 FR 35952, 
7/29/91) to give greater clarity to the rulemaking's original intent. 
In addition, this rule sets forth an expanded listing of safe harbor 
provisions designed to protect additional payment and business 
practices from criminal prosecution and civil sanctions under the anti-
kickback statute.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/21/93                    58 FR 49008
NPRM Comment Period End         11/22/93
Final Action                    11/00/98

Small Entities Affected: None

Government Levels Affected: None

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

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

RIN: 0991-AA66
_______________________________________________________________________




923. REPRODUCTION AND SALE OF OFFICIAL FORMS AND PUBLICATIONS

Priority:  Info./Admin./Other

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

CFR Citation:  45 CFR 101

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              06/00/98

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0991-AA83
_______________________________________________________________________




924. REVISED OIG EXCLUSION AUTHORITIES RESULTING FROM PUBLIC LAW 104-191

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 104-191, sec 211; PL 104-191, sec 212; PL 104-191, 
sec 213

CFR Citation:  42 CFR 1000; 42 CFR 1001; 42 CFR 1002; 42 CFR 1005

Legal Deadline: None

Abstract: This final rule addresses revisions to the OIG's sanction 
authorities in conjunction with sections 211, 212, and 213 resulting 
from the Health Insurance Portability and Accountability Act of 1996, 
along with other technical and conforming changes to the OIG exclusion 
authorities. The revisions are specifically designed to expand the 
protection of certain basic fraud authorities and revise and strengthen 
the current legal authorities pertaining to exclusions from Medicare 
and and other Federal health care programs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/08/97                    62 FR 47182
NPRM Comment Period End         11/07/97
Final Action                    08/00/98

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

RIN: 0991-AA87
_______________________________________________________________________




925. REVISED OIG CIVIL MONEY PENALTIES RESULTING FROM PUBLIC LAW 104-191

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 104-191, sec 231(a); PL 104-191, sec 231(b); PL 
104-191, sec 231(c); PL 104-191, sec 231(d); PL 104-191, sec 231(e); PL 
104-191, sec 231(h); PL 104-191, sec 232

CFR Citation:  42 CFR 1003; 42 CFR 1005; 42 CFR 1006

Legal Deadline: None

Abstract: This final rule will revise the OIG's civil money penalty 
provisions in conjunction with new and revised authorities set forth in 
the Health Insurance Portability and Accountability Act of 1996. Among 
other provisions, this final rulemaking would codify new civil money 
penalties for (1) excluded individuals retaining ownership or control 
interest in an entity; (2) upcoding and claims for medically 
unnecessary services; (3) offering inducements to beneficiaries; and 
(4) false certification of eligibility for home health services.

[[Page 21945]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/25/98                    63 FR 14393
NPRM Comment Period End         05/26/98
Final Action                    12/00/98

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

RIN: 0991-AA90
_______________________________________________________________________




926. SHARED RISK EXCEPTION TO THE SAFE HARBOR PROVISIONS

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1302 sec 216; 42 USC 1320a-7b; 42 USC 1395hh

CFR Citation:  41 CFR 1001

Legal Deadline:  Final, Statutory, January 1, 1997.

Abstract: This interim final rule would establish a new statutory 
exception for risk-sharing arrangements under the Federal health care 
programs anti-kickback provisions. The rule would set forth an 
exception from liability for remuneration between an eligible 
organization under section 1876 of the Social Security Act and an 
individual or entity providing items or services in accordance with a 
written agreement between these parties. The rule would also allow 
remuneration between an organization and an individual or entity if a 
written agreement places the individual or entity at ``substantial 
financial risk'' for the cost or utilization of the items or services 
which the individual or entity is obligated to provide.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           05/23/97                    62 FR 28410
ANPRM Comment Period End        06/09/97
Interim Final Rule              10/00/98

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

RIN: 0991-AA91
_______________________________________________________________________




927. ISSUANCE OF ADVISORY OPINIONS BY THE INSPECTOR GENERAL

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1320a-7d(b)

CFR Citation:  42 CFR 1008

Legal Deadline:  Final, Statutory, February 21, 1997.

Abstract: This final rule sets forth the specific procedures by which 
the OIG, in consultation with the Department of Justice, will issue 
advisory opinions to outside parties regarding the interpretation and 
applicability of certain statutes relating to the Medicare and State 
health care programs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              02/19/97                     62 FR 7350
Final Action                    07/00/98

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0991-AA94
_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




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

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 1001; 42 CFR 1003

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

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

RIN: 0991-AA45
_______________________________________________________________________




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

Priority:  Substantive, Nonsignificant

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

[[Page 21946]]

101-508, Sec 4351; PL 101-508, Sec 4354(a)(1)(E); PL 101-508, Sec 
4354(a)(2); PL 101-508, Sec 4355(a); PL 101-508, Sec 4357

CFR Citation:  42 CFR 1003

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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

RIN: 0991-AA53
_______________________________________________________________________




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

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395bbb; 42 USC 1396t

CFR Citation:  42 CFR 1003

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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

RIN: 0991-AA79
_______________________________________________________________________




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

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302; 42 USC 1396r-8

CFR Citation:  42 CFR 1003

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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

RIN: 0991-AA80
_______________________________________________________________________




932. SENIOR BIOMEDICAL RESEARCH SERVICES

Priority:  Info./Admin./Other

Legal Authority:  42 USC 228

CFR Citation:  42 CFR 24

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: Federal

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

RIN: 0991-AA82

[[Page 21947]]

_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Office of the Secretary (OS)



_______________________________________________________________________




933. CIVIL MONEY PENALTIES FOR REFERRALS TO ENTITIES AND FOR PROHIBITED 
ARRANGEMENTS AND SCHEMES

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 1001; 42 CFR 1003

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/20/93                    58 FR 54096

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Joel Jay Schaer
Phone: 202 619-0089

RIN: 0991-AA65
_______________________________________________________________________




934. ADMINISTRATIVE REQUIREMENTS FOR GRANTEES TO REFLECT SINGLE AUDIT 
ACT AMENDMENTS

Priority:  Info./Admin./Other

Unfunded Mandates: This action may affect State, local or tribal 
governments and the private sector.

CFR Citation:  45 CFR 74; 45 CFR 92; 45 CFR 96

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

No Further Action Required      10/28/97

Small Entities Affected: None

Government Levels Affected: State, Local, Tribal

Agency Contact: Charles Gale
Phone: 202 690-6377
TDD: 202 690-6902
Fax: 202 690-6415

RIN: 0991-AA92
_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




935. BLOCK GRANTS FOR PREVENTION AND TREATMENT OF SUBSTANCE ABUSE

Priority:  Other Significant

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

CFR Citation:  45 CFR 96

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Tribal

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

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

RIN: 0930-AA01
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




936. PROTECTION AND ADVOCACY FOR INDIVIDUALS WITH MENTAL ILLNESS

Priority:  Substantive, Nonsignificant

CFR Citation:  45 CFR 51

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/15/97                    62 FR 53548

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Local

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

RIN: 0930-AA02

[[Page 21948]]

_______________________________________________________________________


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


Departmental Management (HHSDM)



_______________________________________________________________________




937. IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT IN AGENCY 
PROCEEDINGS

Priority:  Substantive, Nonsignificant

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

CFR Citation:  45 CFR 13

Legal Deadline: None

Abstract: The Equal Access to Justice Act requires agencies to pay fees 
to parties prevailing against the government in certain administrative 
proceedings. The Act has been amended several times since its 1980 
enactment, most recently by the Contract with America Advancement Act 
of 1996, which increased the amount of the hourly fees payable. The 
proposed rule revises 45 CFR Part 13 (HHS' regulation implementing the 
Equal Access to Justice Act) to conform with statutory changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/19/87                    52 FR 23311
NPRM Comment Period End         08/17/87
Second NPRM                     06/00/98
Final Action                    08/00/98

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0990-AA02
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)             Prerule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________




938. ANIMAL DRUG APPROVALS FOR MINOR SPECIES AND MINOR USAGE

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

Legal Authority:  PL 104-250

CFR Citation:  Not yet determined

Legal Deadline:  Other, Statutory, April 9, 1998.
Animal Drug Availability Act of 1996.

Abstract: The Animal Drug Availability Act of 1996 (ADAA) requires FDA 
to consider legislative and regulatory options for facilitating 
approval of new animal drugs intended for use in minor species and for 
minor uses, and to announce no later than April 9, 1998, proposals for 
legislative or regulatory change to the approval process for such 
drugs. Because the markets are small for approved new animal drugs 
intended for minor species or for minor uses, there are often 
insufficient economic incentives to motivate sponsors to develop the 
data necessary to support approvals. Manufacturers have not, in many 
cases, been willing to fund research to obtain these data, so only 
small numbers of new animal drugs intended for minor species or for 
minor uses have been approved and are legally marketed. Facilitating 
approvals for minor uses and minor species will bring about an increase 
in approvals of new animal drugs intended for these uses, which would 
be desirable to address the scarcity of approved, legally marketed new 
animal drugs intended for minor species or minor uses.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           06/23/97                    62 FR 33781
Notice of Availability          04/00/98

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: Request for Comments 62 FR 33789, 6/23/97.

Agency Contact: Linda Wilmot, Veterinary Medical Officer, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Veterinary Medicine (HFV-112), 7500 Standish Place, Rockville, MD 20855
Phone: 301 594-0614

RIN: 0910-AB07
_______________________________________________________________________




939.  SHELL EGGS: WARNING, NOTICE AND SAFE HANDLING LABELING 
STATEMENTS AND REFRIGERATION REQUIREMENTS

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

Legal Authority:  21 USC 321; 42 USC 264

CFR Citation:  21 CFR 101.17(g); 21 CFR 1240.63

Legal Deadline: None

Abstract: There have been numerous foodborne outbreaks of 
Salmonellosis, principally due to Salmonella Enteritidis, that have 
been traced to the consumption of temperature abused and/or undercooked 
shell eggs. The Food and Drug Administration has received petitions 
from Rose Acres Farm, Inc., and the Center for Science in the Public 
Interest that request, in part, that FDA establish safe handling 
statements for shell eggs. FDA intends to propose to require safe 
handling statements on labeling of shell eggs that have not been 
treated to destroy Salmonella microorganisms that may be present. In 
accordance with amendments to the Egg Products Inspection Act, USDA 
proposed on October 27, 1992, to require that shell eggs be stored at 
an ambient temperature of 7 degrees celcius (45 degrees farenheit). 
USDA intends to finalize that requirement shortly. However, the USDA 
rulemaking does not include refrigeration at retail. As part of 
separate rulemaking, FDA intends to propose regulations, based on 
recommended provisions of the Retail Food Code, to mandate that shell 
eggs be stored for retail sale at 5 degrees celsius (41 degrees 
fahrenheit) or less. FDA is proposing this measure to ensure that shell 
eggs are handled in a manner to decrease the possible growth of any SE 
that may be present in shell eggs. All of these actions are intended to 
reduce the occurrence of illnesses and deaths associated with the 
consumption of improperly cooked shell eggs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           09/00/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Geraldine A. June, Consumer Safety Officer, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Food

[[Page 21949]]

Safety and Applied Nutrition, (HFS-158), 200 C Street SW., Washington, 
DC 20204
Phone: 202 205-5099
Fax: 202 205-4594
Email: [email protected]

RIN: 0910-AB30
_______________________________________________________________________




940.  ELECTRONIC SUBMISSION OF ADVERSE DRUG REACTION REPORTS

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

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 216; 21 USC 262; 21 USC 263; 21 USC 263a; 21 
USC 264; 21 USC 300aa; 21 USC 321; 21 USC 331; 21 USC 251 to 353; 21 
USC 355 to 357; 21 USC 371; 21 USC 374

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

Legal Deadline: None

Abstract: This advance notice of proposed rulemaking will discuss and 
request comments on the electronic submission of adverse drug reaction 
reports using international medical terminology, electronic data 
format, and electronic transmission standards.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           07/00/98
ANPRM Comment Period End        10/00/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Thomas Kuchenberg, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB42
_______________________________________________________________________




941.  SUPPLEMENTAL MANUFACTURING CHANGES FOR NEW ANIMAL DRUGS

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 105-115, sec 116

CFR Citation:  21 CFR 514.8

Legal Deadline: None

Abstract: Section 116 of the Food and Drug Administration Modernization 
Act of 1997 added a new section to the Federal Food, Drug, and Cosmetic 
Act that requires the agency to distinguish between moderate and 
minimal manufacturing changes and to establish systems for determining 
what information the agency would require before drugs manufactured 
subject to these changes may be distributed. The Center for Veterinary 
Medicine is proposing to amend the regulations regarding supplementary 
new animal drug regulations to incorporate the requirements of section 
116.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           05/00/98
NPRM                            12/00/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: William Marnane, Department of Health and Human 
Services, Food and Drug Administration, Center for Veterinary Medicine 
(HFV-200), 7500 Standish Place, Rockville, MD 20855
Phone: 301 594-0678

RIN: 0910-AB49
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




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

Priority:  Routine and Frequent

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

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

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

Legal Deadline: None

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

[[Page 21950]]



Timetable:

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

Alcohol (Oral) in OTC Drug Products  NPRM 10/21/93 (58 FR 54466)  Final 
Action 03/13/95 (60 FR 13590)  NPRM (Amendment) 05/10/96 (61 FR 
21392)  Final Action (Amendment) 11/18/96 (61 FR 58629)

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

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

Antacid Drug Products  ANPRM 04/05/73 (38 FR 8714)  NPRM 11/12/73 (38 
FR 31260)  Final Action 06/04/74 (39 FR 9862)  NPRM (Amendment) 
(Overindulgence) 12/24/91 (56 FR 66754)  Final Action (Amendment) 
(Warning) 08/26/93 (58 FR 45204)  NPRM (Amendment) (Testing) 09/23/93 
(58 FR 49826)  NPRM (Amendment)(Sodium Bicarb.) 02/02/94 (59 FR 
5060)  Final Action (Technical Amendment) 11/25/94 (59 FR 60555)  Final 
Action (Amendment) (Testing) 02/08/96 (61 FR 4822)  Final Action 
(Amendment)(Sodium B.) 08/00/98

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

Antibiotic First Aid Products  ANPRM 04/01/77 (42 FR 17642)  NPRM 07/
09/82 (47 FR 29986)  Final Action 12/11/87 (52 FR 47312)  NPRM 
(Amendment) 08/18/89 (54 FR 34188)  Final Action 03/15/90 (55 FR 
9721)  NPRM (Amendment) 05/11/90 (55 FR 19868)  NPRM (Amendment) 06/08/
90 (55 FR 23450)  Final Action (Amendment) 10/03/90 (55 FR 
40379)  Final Action (Amendment) 12/05/90 (55 FR 50171)  NPRM 
(Amendment) (Warning) 02/14/96 (61 FR 5918)  Final Action 
(Amendment)(Warning) 11/15/96 (61 FR 58471)

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

Antidiarrheal Products  ANPRM 03/21/75 (40 FR 12924)  NPRM 04/30/86 (51 
FR 16138)  NPRM (Amendment)(Trav. Diar.) 06/00/99  Final Action 06/00/
99

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

Antiemetic Products  ANPRM 03/21/75 (40 FR 12934)  NPRM 07/13/79 (44 FR 
41064)  Final Action 04/30/87 (52 FR 15886)  NPRM (Amendment) 08/26/93 
(58 FR 45216)  Final Action 04/11/94 (59 FR 16981)  NPRM 
(Amendment)(Warning) 08/29/97 (62 FR 45767)

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

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

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

Antiperspirant Products  ANPRM 10/10/78 (43 FR 46694)  NPRM 08/20/82 
(47 FR 36492)  Final Action 12/00/98

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

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

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

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

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

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

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

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

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

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

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

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

Cough/Cold (Antihistamine) Products  ANPRM 09/09/76 (41 FR 38312)  NPRM 
01/15/85 (50 FR 2200)  NPRM (Amendment) 08/24/87 (52 FR 31892)  Final 
Action 12/09/92 (57 FR 58356)  Final Action (Amendment)(Warning) 01/28/
94 (59 FR 4216)  NPRM (Amendment)(Warning) 08/29/97 (62 FR 45767)

Cough/Cold (Antitussive) Products  ANPRM 09/09/76 (41 FR 38312)  NPRM 
10/19/83 (48 FR 48576)  Final Action 08/12/87 (52 FR 30042)  NPRM 
(Amendment) 07/06/89 (54 FR 28442)  NPRM (Amendment) 10/02/89 (54 FR 
40412)  Final Action (Amendment) 07/06/90 (55 FR 27806)  Final Action 
(Amendment) 10/03/90 (55 FR 40381)  NPRM (Amendment)(Warning) 06/19/92 
(57 FR 27666)  NPRM (Amendment)(Ingredients) 12/09/92 (57 FR 
58378)  Final Action (Amendment)(Warning) 10/20/93 (58 FR 54232)  Final 
Action (Amdt.)(Ingredients) 06/03/94 (59 FR 29172)  NPRM 
(Amendment)(Warning) 08/29/97 (62 FR 45767)  NPRM (Amendment)(Warning) 
08/00/98

[[Page 21951]]

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

Cough/Cold (Combination) Products  ANPRM 09/09/76 (41 FR 38312)  NPRM 
08/12/88 (53 FR 30522)  NPRM (Amendment)(DPH Combinations) 02/23/95 (60 
FR 10286)  Final Action (Theophylline) 07/27/95 (60 FR 38636)  Final 
Action 03/00/99

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

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

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

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

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

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

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

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

Eligibility Criteria for Additional Conditions  ANPRM 10/03/96 (61 FR 
51625)  NPRM 10/00/98

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

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

External Analgesic Products  ANPRM 12/04/79 (44 FR 69768)  NPRM 02/08/
83 (48 FR 5852)  NPRM (Amendment) (Dandruff) 07/30/86 (51 FR 
27360)  NPRM (Amendment) (Anorectal) 08/25/88 (53 FR 32592)  NPRM 
(Amendment) (Poison Ivy) 10/03/89 (54 FR 40818)  NPRM (Amendment) (Fvr 
Blister/Ext) 01/31/90 (55 FR 3370)  NPRM (Amendment) (1%Hydrocortisone) 
02/27/90 (55 FR 6932)  NPRM (Amendment) (Diaper Rash) 06/20/90 (55 FR 
25234)  Final Action (Diaper Rash) 12/18/92 (57 FR 60426)  NPRM 
(Amendment)(Warning) 08/29/97 (62 FR 45767)  Final Action 00/00/00

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

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

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

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

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

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

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

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

Internal Analgesic Products  ANPRM 07/08/77 (42 FR 35346)  NPRM 11/16/
88 (53 FR 46204)  NPRM (Amendment) (Overindulgence) 12/24/91 (56 FR 
66762)  NPRM (Amdt.)(Sodium Bicarbonate) 02/02/94 (59 FR 5068)  NPRM 
(Prof. Labeling)(Acute MI) 06/13/96 (61 FR 30002)  NPRM 
(Amendment)(Alcohol Warning) 11/14/97 (62 FR 61041)  Final Action 
(ProfessionalLabeling) 06/00/98  Final Action 06/00/98  NPRM (Labeling-
revised indications) 10/00/99

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 Human Use  NPRM 04/05/93 (58 FR 
17553)  Final Action 01/28/94 (59 FR 3998)  NPRM (Do not mix drugs) 08/
03/94 (59 FR 39499)  NPRM (Amendment) (Do not mix drugs) 10/04/95 (60 
FR 52058)  NPRM (Unless a doctor tells you) 03/04/96 (61 FR 8450)  NPRM 
(Calcium/Magnesium/Potassium) 04/22/96 (61 FR 17807)  NPRM (Unless a 
doc. tells you)(Wi.) 02/27/97 (62 FR 9024)  Final Action (Format/
Examples) 07/00/98  Final Action (Ca/Mg/K) 12/00/98

Laxative Products  ANPRM 03/21/75 (40 FR 12902)  NPRM 01/15/85 (50 FR 
2124)  NPRM (Amendment) (Directions/Bulk) 10/01/86 (51 FR 35136)  NPRM 
(Amendment) (Docusate Salts) 09/02/93 (58 FR 46589)  NPRM 
(Amendment)(Sodium Phosphates) 03/31/94 (59 FR 15139)  NPRM 
(Phenolphthalein) 09/02/97 (62 FR 46223)  Final Action (Sodium 
Phosphates) 04/00/98  NPRM (Amendment)(Phosphates Label) 04/00/
98  Final Action 09/00/98

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

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

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

Mercurial (Active/Inactive)  NPRM 00/00/00

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

[[Page 21952]]

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

Nighttime Sleep Aid Products  ANPRM 12/08/75 (40 FR 57292)  NPRM 06/13/
78 (43 FR 25544)  Final Action 02/14/89 (54 FR 6814)  NPRM (Amendment) 
08/26/93 (58 FR 45217)  Final Action (Amendment) 04/11/94 (59 FR 
16982)  NPRM (Amendment) (Warning) 08/29/97 (62 FR 45767)

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

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

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

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

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

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

Otic Products (Dry Water-Clogged Ears)  NPRM (Amendment) 12/00/98

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

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

Overindulgence Remedies  ANPRM 10/01/82 (47 FR 43540)  NPRM 12/24/91 
(56 FR 66742)  NPRM (Amendment) (Warning) 05/05/93 (58 FR 26886)  Final 
Action (Amendment) (Warning) 08/00/98

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

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

Phenylpropanolamine Products (Labeling)  NPRM 02/14/96 (61 FR 
3912)  Final Action 00/00/00

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

Poison Treatment Products  NPRM 01/15/85 (50 FR 2244)  NPRM (Amendment) 
12/00/98  Final Action 06/00/99

Quinine for Malaria  NPRM 04/19/95 (60 FR 19650)  Final Action 07/00/98

Reporting of Adverse Reactions  NPRM 12/00/98

Skin Bleaching Products  ANPRM 11/03/78 (43 FR 51546)  NPRM 09/03/82 
(47 FR 39108)  NPRM (Reproposed) 12/00/98

Skin Protectant Products  ANPRM 08/04/78 (43 FR 34628)  NPRM 02/15/83 
(48 FR 6820)  NPRM (Amendment) (Astringent) 04/03/89 (54 FR 
13490)  NPRM (Amendment) (Poison Ivy) 10/03/89 (54 FR 40808)  NPRM 
(Amendment) (Fvr Blister/Ext) 01/31/90 (55 FR 3362)  NPRM (Amendment) 
(Diaper Rash) 06/20/90 (55 FR 25204)  Final Action (Astringent) 10/21/
93 (58 FR 54466)  Final Action (Witch Hazel) 06/03/94 (59 FR 
28767)  Final Action (Poison Ivy) 06/00/98  Final Action 06/00/98

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

Sodium Labeling  NPRM 04/25/91 (56 FR 19222)  Final Action 04/22/96 (61 
FR 17798)  Final Action (Technical Amendment) 12/00/98

Status of Certain Category II and III Ingredients  NPRM 05/16/90 (55 FR 
20434)  Final Action 11/07/90 (55 FR 46914)  NPRM 08/25/92 (57 FR 
38568)  Final Action 05/10/93 (58 FR 27636)  NPRM 08/00/98

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

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

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

Sunscreen Products  ANPRM 08/25/78 (43 FR 38206)  NPRM 05/12/93 (58 FR 
28194)  NPRM (Amendment) 06/08/94 (59 FR 29706)  NPRM 
(Amendment)(Avobenzone) 09/16/96 (61 FR 48645)  Final Action 
(Avobenzone Enf. Pol.) 04/30/97 (62 FR 23350)  Final Action 03/00/99

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

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

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

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

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

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

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

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

Small Entities Affected: None

Government Levels Affected: None

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

Agency Contact: Rosemary Cook, Supervisor, Project Management Staff, 
Office of Drug Evaluation V, Department of Health and Human Services, 
Food and Drug Administration, Center for Drug Evaluation and Research 
(HFD-105), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2222

RIN: 0910-AA01
_______________________________________________________________________




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

Priority:  Routine and Frequent

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

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

CFR Citation:  21 CFR 80; 21 CFR 429

[[Page 21953]]

Legal Deadline: None

Abstract: Insulin Certification Program:
Section 506 of the Federal Food, Drug, and Cosmetic Act, which 
authorized the certification of drugs containing insulin, was repealed 
by section 125 of the Food and Drug Administration Modernization Act of 
1997. The repeal was effective on November 21, 1997.
Color Certification Program:
In the Federal Register of November 29, 1994, FDA issued an interim 
rule effective December 29, 1994, which amended the color additive 
regulations by increasing the fees for certification services. In the 
Federal Register of February 1, 1996 (61 FR 3571), FDA issued a final 
rule, effective March 4, 1996, which incorporated comments FDA received 
from the International Association of Color Manufacturers (IACM) on the 
interim rule. FDA received an objection from IACM to an annual 
escalator provision which would have allowed FDA to increase the fees 
for color certification services by a rate proportional with Federal 
salary increases. After considering the objection, FDA decided not to 
implement this provision. The FDA's Office of Financial Management 
completed a fee study of the color certification program in May 1997 
which supports the maintenance of the existing fee schedule.

Timetable:

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

Insulin  Interim Final Rule 10/04/91 (56 FR 50248)  Interim Final Rule 
11/09/95 (60 FR 56515)  Removal of 21 CFR 429 04/00/98

Small Entities Affected: Undetermined

Government Levels Affected: None

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

Agency Contact: David R. Petak, Director, Division of Accounting, 
Department of Health and Human Services, Food and Drug Administration, 
Office of Financial Management (HFA-120), 5600 Fishers Lane, Rockville, 
MD 20857
Phone: 301 827-5004
Fax: 301 443-6242

RIN: 0910-AA07
_______________________________________________________________________




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

Priority:  Other Significant

Legal Authority:  PL 99-660, sec 314

CFR Citation:  21 CFR 601

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

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                            09/00/98

Small Entities Affected: None

Government Levels Affected: State

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

Agency Contact: Dano B. Murphy, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Biologics Evaluation and Research (HFM-17), 1401 Rockville Pike, Suite 
200N, Rockville, MD 20852-1448
Phone: 301 827-6210

RIN: 0910-AA14
_______________________________________________________________________




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

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

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

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

CFR Citation:  21 CFR 801.420; 21 CFR 801.421

Legal Deadline: None

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

Statement of Need: FDA has become aware of changes in the nature of the 
causes of hearing loss and the technology of hearing aids that 
necessitate reconsideration of the regulations governing the types of 
testing needed before a hearing aid purchase and the labeling for 
health professionals and patients. In the past, hearing loss often was 
caused by medically treatable conditions: because

[[Page 21954]]

of advances in health care, this is less common. Therefore, there may 
be less need for medical evaluation. On the other hand, advances in 
hearing aid technology necessitate proper testing in order for a 
hearing aid to be effective.

Summary of the Legal Basis: Under 21 USC 360j(e), FDA has the authority 
to restrict the sale, distribution, or use of a medical device, if FDA 
determines that, without such restrictions, there cannot be reasonable 
assurance of its safety and effectiveness. Under 21 USC 352, FDA has 
the authority to require that the labeling of a medical device include 
adequate directions for use.

Alternatives: FDA considered applying the rule only to first time 
purchasers of hearing aids. FDA believes, however, that this would not 
adequately protect present users of inappropriate or unneeded hearing 
aids. FDA also considered requiring additional tests, but has 
preliminarily determined to list these tests as recommended only in 
order to provide additional flexibility.

Anticipated Costs and Benefits: FDA has estimated the costs of the 
mandatory testing required by the rule would add an additional $24.8 
million to $51.7 million depending upon the assumptions concerning 
present practices. On the average, FDA estimates that this would add 
about $24 to the cost of a hearing aid. FDA expects that the benefits 
from the rule would include: (1) Improving the quality of life of 
hearing aid users; (2) avoiding the cost of inappropriate hearing aid 
purchase; (3) reducing doctor visits for hearing aid evaluations; (4) 
lowering treatment costs due to early detection of serious conditions; 
and (5) encouraging the dissemination of accurate information 
concerning the benefits and limitations of hearing aids.

Risks: If the hearing aid purchaser inappropriately waives the medical 
evaluation requirement under the existing rule, treatable causes of 
hearing loss may go undetected. Many purchasers who have not had proper 
testing before a hearing aid purchase will forego the use of a hearing 
aid because the one purchased does not adequately improve their hearing 
ability. At this time, FDA believes that many hearing impaired people 
who may benefit from a hearing aid do not purchase one because they 
fear that they will not benefit from one due to inaccurate information.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           11/10/93                    58 FR 59695
ANPRM Comment Period End        01/10/94
NPRM                            06/00/98

Small Entities Affected: Businesses

Government Levels Affected: State

Additional Information: Previously reported under RIN 0905-AE46.

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

RIN: 0910-AA39
_______________________________________________________________________




946. FRUIT AND VEGETABLE JUICES: DEVELOPMENT OF HACCP AND LABEL WARNING 
STATEMENTS FOR JUICES

Priority:  Economically Significant. Major under 5 USC 801.

Legal Authority:  21 USC 321 et seq; 42 USC 264

CFR Citation:  21 CFR 120

Legal Deadline: None

Abstract: FDA announced in an advance notice of proposed rulemaking of 
August 4, 1994, its plans to consider the development of regulations 
establishing requirements for a new comprehensive food safety assurance 
program for both domestically produced and imported foods that would be 
based on the principles of Hazard Analysis Critical Control Points 
(HACCP). The new food safety program would respond to new challenges, 
such as new food processing and packaging technologies, new food 
distribution and consumption patterns, exposure to industrial chemicals 
and chemical waste, the increasing importation of foods, new microbial 
pathogens, and resource constraints. Current information shows that the 
most serious of these challenges is presented by food-borne pathogens. 
The number of recognized food-borne pathogens has broadened 
considerably, as has the awareness of long-term complications from 
certain food-borne illnesses--such as arthritis, heart disease, and 
kidney and neurological damage. To meet such challenges, FDA intends to 
shift the focus of its food safety assurance program away from periodic 
visual inspection and end-product testing and toward prevention of food 
safety risks and problems, utilizing the state-of-the-art HACCP 
preventive approach. A first step was taken when FDA published a HACCP 
regulation for fish and fishery products on December 18, 1995. 
Consistent with FDA's HACCP efforts, USDA published a HACCP regulation 
for meat and poultry on July 25, 1996. As a next step in this food 
safety program, FDA will propose a HACCP regulation for the processing 
of juice. As part of the development of this document, FDA is 
considering information obtained during agency HACCP pilot activities, 
and comments and scientific and technological information relating to 
fresh juices provided during and after an agency public meeting on 
juice held on December 16 and 17, 1996. As a separate rulemaking, the 
agency intends to propose to require warning statements on the labels 
or in labeling for juice products that have not been processed to 
reduce, control, or eliminate the presence of harmful bacteria. Such 
labeling will serve to reduce the risk of foodborne illness.

Statement of Need: In this proposed rule, the Food and Drug 
Administration (FDA) is proposing to adopt regulations that would 
establish requirements for a new comprehensive food safety assurance 
program for both domestically produced and imported fruit and vegetable 
juices that would be based on the principles of Hazard Analysis 
Critical control Points (HACCP). FDA intends to propose a juice HACCP 
regulation because there have been a number of outbreaks of illnesses 
associated with juice products, including some directly affecting 
children, and because the agency believes that a system of preventive 
controls is the most effective and efficient way to ensure that these 
products will be safe.

Summary of the Legal Basis: Failure of a processor to have and 
implement a HACCP system will render the food products of that 
processor adulterated under section 402(a)(4) of the Federal Food, 
Drug, and Cosmetic Act. Whether a processor's actions are consistent 
with ensuring the safety of food will be determined through an 
evaluation of the overall implementation of the firm's HACCP system.

[[Page 21955]]

Alternatives: The two principal alternatives to HACCP are end-product 
testing and comprehensive current good manufacturing practices (CGMPs). 
FDA has concluded, based on information available at this time, that 
these alternatives lack the distinct advantages of a HACCP-based 
approach. End-product testing does not address the root causes of food 
safety problems, is not preventive by design, and requires that a large 
number of samples be analyzed to ensure product integrity. CGMPs are 
not practical because they are plant-wide operating procedures and do 
not concentrate on the identification and prevention of food hazards.

Anticipated Costs and Benefits: In general terms, HACCP focuses on 
prevention and is designed to prevent the occurrence of hazards 
affecting food; HACCP permits more effective and efficient oversight by 
Federal, State, and local governments; and HACCP appropriately places 
primary responsibility for ensuring food safety on the food 
manufacturer/distributor to analyze, in a rational, scientific manner, 
its production processes in order to identify critical control points 
and establish critical limits and monitoring procedures. FDA 
anticipates that costs to industry generated by implementation of HACCP 
would be offset in four ways: (1) by reducing the amount of food-borne 
illnesses (for example, total illness reduction benefits estimated to 
result from FDA's HACCP-based requirements for seafood regulation are 
between $15 and $75 million per year); (2) by increasing public 
confidence in the Nation's food supply; (3) by enabling U.S. food 
companies to compete more effectively in the world market (for example, 
current recommendations of the Codex Alimentarius Commission's 
Committee on Food Hygiene encourage the use of the HACCP system, and 
the European Community (EC) has begun to require that foods produced 
within the EC be processed under HACCP requirements); and (4) by 
decreasing the number of future product recalls.

Risks: Any potential for contamination of the food supply with 
industrial chemicals or microbial pathogens must be considered a very 
serious risk because of the possibility that such contamination could 
be widespread, affecting whole segments of the population, causing some 
severe long-term effects and even loss of life. FDA made a decision to 
adopt a HACCP-based approach to regulation of seafood, based on a 
considerable body of literature and expertise in this area. Likewise, 
FDA has reviewed current information on hazards associated with 
unprocessed juice, and intends to propose that processors use HACCP in 
the manufacture of certain juice products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           08/04/94                    59 FR 39888
ANPRM Comment Period End        12/02/94
Economic Analysis for Juice HACCP and Labeling  PRIA 04/00/98

HACCP for Juice  NPRM 04/00/98

Label Warning Statements for Juice  NPRM 04/00/98

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Additional Information: Previously reported under RIN 0905-AE60.

Agency Contact: John E. Kvenberg, Strategic Manager, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Food Safety and Applied Nutrition (HFS-10), 200 C Street SW., 
Washington, DC 20204
Phone: 202 205-4020
Fax: 202 205-4018
Email: [email protected]

RIN: 0910-AA43
_______________________________________________________________________




947. BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

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

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

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

CFR Citation:  21 CFR 320

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/98
NPRM Comment Period End         09/00/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Christine Rogers, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research (HFD-7), 1451 Rockville Pike, Suite 3047, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA51
_______________________________________________________________________




948. DRUGS USED FOR TREATMENT OF NARCOTIC ADDICTS

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

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

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

CFR Citation:  21 CFR 291

Legal Deadline: None

Abstract: The proposed rule will revise the regulations under part 291 
and title 42 to provide for the certification of narcotic treatment 
programs as a basis for fulfilling the Department's requirements of the 
Narcotic Addict Treatment Act of 1974. Certification will be based on 
accreditation by non-profit accrediting bodies. This new system will 
replace the current system which relies solely on direct FDA approval 
and inspection for determining whether narcotic treatment programs 
comply with Federal treatment standards. The proposed rule will provide 
for a transition period for programs operating under the existing 
regulatory system.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/98

Small Entities Affected: Undetermined

[[Page 21956]]

Government Levels Affected: Undetermined

Agency Contact: Nicholas Reuter, Associate Director for International 
and Domestic Drug Control, Department of Health and Human Services, 
Food and Drug Administration, Office of Health Affairs (HFY-20), 5600 
Fishers Lane, Rockville, MD 20857
Phone: 301 827-1696
Fax: 301 443-0232
Email: [email protected]

RIN: 0910-AA52
_______________________________________________________________________




949. DIETARY SUPPLEMENT REGULATIONS IN RESPONSE TO DSHEA

Priority:  Other Significant

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

CFR Citation:  21 CFR 101

Legal Deadline: None

Abstract: On January 4, 1994, FDA published final rules relative to 
nutrition labeling, nutrient content claims and health claims for 
dietary supplements. The Dietary Supplement Health and Education Act 
(DSHEA) was enacted on October 25, 1994, modifying the provisions for 
labeling of dietary supplements. FDA has initiated rulemaking to modify 
its regulations for dietary supplements accordingly. One proposal would 
modify the nutrition labeling and ingredient declaration requirements. 
A second proposal would provide for the use of nutrient content claims 
and health claims on dietary supplements and establish procedures for 
the use of a disclaimer to accompany statements of nutritional support. 
A third proposal would define the terms ``high potency'' and 
``antioxidant.'' These three proposals were published in the Federal 
Register on December 28, 1995. An ANPRM was published in February 1997 
seeking public comments on issues related to the establishment of 
current good manufacturing practices for dietary supplements. FDA 
published three final rules on September 23, 1997, responding to the 
proposals of December 28, 1995, and entitled: (1) ``Food Labeling; 
Statement of Identity, Nutrition Labeling and Ingredient Labeling of 
Dietary Supplements; Compliance Policy Guide, Revocation;'' (2) ``Food 
Labeling; Requirements for Nutrient Content Claims, Health Claims, and 
Statements of Nutritional Support for Dietary Supplements;'' and (3) 
``Food Labeling; Nutrient Content Claims: Definition for ``High 
Potency'' and Definition for ``Antioxident'' for Use in Nutrient 
Content Claims for Dietary Supplements and Conventional Foods.'' The 
agency received several petitions for reconsideration of aspects of the 
final rule on nutrition labeling and ingredient declaration for dietary 
supplements.
DHSEA also established an independent agency within the Executive 
Branch known as the Commission on Dietary Supplement Labels. The 
Commission was charged with conducting a study on, and providing 
recommendations for regulating label claims and statements for dietary 
supplement, including using literature in connection with the sale of 
dietary supplements and procedures for evaluating such claims. On 
November 24, 1997, the Commission's final report was released. FDA is 
issuing a notice on its views on the Commission's report and a proposed 
rule that responds to guidance in the report concerning statements 
about the effect of dietary supplements on structure or function of the 
body.

Timetable:

Comments on Report of the Commission on Dietary Supp. Labels  Notice 
04/00/98

CGMPs in the Manufacturing, Packing, or Holding of Dietary 
Supps.  ANPRM 02/06/97 (62 FR 5700)  Comment Period End 06/06/97  NPRM 
00/00/00

High Potency and Antioxidant Terms; Dietary Supplements  NPRM 12/28/95 
(60 FR 67184)  Comment Period End 06/10/96  Final Action 09/23/97 (62 
FR 49808)

Nutrient Content and Health Claims; Dietary Supplements  NPRM 12/28/95 
(60 FR 67176)  Comment Period End 06/10/96  Final Action 09/23/97 (62 
FR 49859)

Nutrient Labeling and Ingredient Labeling; Dietary Supplements  NPRM 
12/28/95 (60 FR 67194)  Comment Period End 06/10/96  Final Action 09/
23/97 (62 FR 49826)

Regs on Statements Made for Diet. Supps re Effect of Product  NPRM 04/
00/98

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Agency Contact: Elizabeth A. Yetley, Director, Office of Special 
Nutritionals, Department of Health and Human Services, Food and Drug 
Administration, Center for Food Safety and Applied Nutrition (HFS-450), 
200 C Street SW. Washington, DC 20204
Phone: 202 205-4168
Fax: 202 205-5295

RIN: 0910-AA59
_______________________________________________________________________




950. INVESTIGATIONAL NEW DRUGS: EXPORT REQUIREMENTS FOR UNAPPROVED NEW 
DRUG PRODUCTS

Priority:  Routine and Frequent

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 381; 21 
USC 382; 21 USC 393; 42 USC 241; 42 USC 243; 42 USC 262

CFR Citation:  21 CFR 312.110

Legal Deadline: None

Abstract: The proposed rule would amend the regulations on the 
exportation of unapproved new drug products, including biological 
products, for investigational use. The proposed rule would create four 
different routes for exporting an unapproved new drug product for 
investigational use. One route would permit exportation if the drug is 
the subject of an investigational new drug application (IND). A second 
route would permit exportation, without prior Food and Drug 
Administration (FDA) approval and without an IND, if the product is to 
be exported for use in a clinical investigation and has received 
marketing authorization in certain developed countries. The third route 
would permit exportation, without prior FDA approval and without an 
IND, if the product is to be exported for use in a clinical 
investigation in certain developed countries specified in the rule. The 
fourth route would permit exportation only if FDA authorized shipment 
of the investigational drug; such authorization would be obtained 
through submission of a written request to export the drug. Drugs 
exported under any of the first three routes would, however, be subject 
to certain statutory requirements, such as not conflicting with the 
foreign country's laws and not being sold or offered for sale in the 
United States. Drugs exported under either second or third routes would 
be subject to additional

[[Page 21957]]

statutory requirements, such as being in substantial conformity with 
the current good manufacturing practices and certain labeling 
requirements. These provisions would implement recent changes in FDA's 
export authority resulting from the FDA Export Reform and Enhancement 
Act of 1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/98

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Office of 
Policy (HF-23), 5600 Fishers Lane, Room 15-74, Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 443-6906
Email: [email protected]

RIN: 0910-AA61
_______________________________________________________________________




951. ADVERSE DRUG REACTION REPORTING, RECORDKEEPING, AND RECORDS ACCESS 
REQUIREMENTS FOR MARKETED OTC DRUGS

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

Unfunded Mandates: Undetermined

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

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

Legal Deadline: None

Abstract: The proposed rule would require manufacturers of marketed 
nonprescription human drug products to report to FDA information they 
receive about adverse drug reactions, maintain records of adverse drug 
reactions, and permit access by FDA to adverse drug reaction records.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/98
NPRM Comment Period End         01/00/99

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Audrey Thomas, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research (HFD-7), 1451 Rockville Pike, Suite 3047, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA86
_______________________________________________________________________




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

Priority:  Other Significant

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

CFR Citation:  21 CFR 50; 21 CFR 314; 21 CFR 601

Legal Deadline: None

Abstract: The Food and Drug Administration is proposing to revoke the 
interim final rule which permited the Commissioner to determine, based 
on a request by the Department of Defense, that obtaining informed 
consent from military personnel for the use of investigational products 
is not feasible in certain military combat situations. The rule was 
used to permit a waiver from the informed consent requirements for 
pyridostigmine bromide and the botulinum toxoid vaccine during the Gulf 
War. The agency is proposing this action after reviewing comments it 
received in response to a July 1997 Request for Comment as to whether 
the agency should revise or revoke the rule.
At the same time, it will propose to amend its new drug and biological 
product regulations to identify the kind of evidence needed to 
demonstrate the efficacy of drug and biological products used to treat 
or prevent the toxicity of potentially devastating chemical or 
biological substances when efficacy studies in humans ethically cannot 
be conducted because they would involve administering a lethal or 
permanently disabling toxic substance to healthy human volunteers 
without a proven treatment.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/98

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Bonnie M. Lee, Senior Policy Analyst, Office of the 
Executive Secretariat (HF-40), Department of Health and Human Services, 
Food and Drug Administration, Office of the Commissioner, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 827-4433
Fax: 301 443-1863

RIN: 0910-AA89
_______________________________________________________________________




953. DIRECT-TO-CONSUMER PROMOTION REGULATIONS

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

Unfunded Mandates: Undetermined

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

CFR Citation:  21 CFR 200; 21 CFR 800

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/99
NPRM Comment Period End         03/00/99

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Nancy Ostrove, Division of Drug Marketing, Advertising, 
and Communications, Department of Health and Human Services, Food and 
Drug Administration, Center for Drug Evaluation and Research (HFD-40), 
Room 17B-04, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2828

RIN: 0910-AA90

[[Page 21958]]

_______________________________________________________________________




954. LABELING FOR HUMAN PRESCRIPTION DRUGS; REVISED FORMAT

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

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

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

CFR Citation:  21 CFR 201

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/98
NPRM Comment Period End         12/00/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Nancy Ostrove, Division of Drug Marketing, Advertising 
and Communications, Department of Health and Human Services, Food and 
Drug Administration, Center for Drug Evaluation and Research (HFD-40), 
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2828
Fax: 301 594-6759

RIN: 0910-AA94
_______________________________________________________________________




955. ADVERSE DRUG REACTION REPORTING REQUIREMENTS FOR HUMAN DRUG AND 
BIOLOGICAL PRODUCTS

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

Unfunded Mandates: Undetermined

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

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

Legal Deadline: None

Abstract: The proposed rule would amend the expedited and periodic 
safety reporting regulations for human drugs and biological products to 
revise certain definitions and reporting formats as recommended by the 
International Conference on Harmonization and to define new terms; to 
add to or revise current reporting requirements; to revise certain 
reporting time frames; and to make other revisions to these regulations 
to enhance the quality of adverse drug reaction reports received by 
FDA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/98
NPRM Comment Period End         01/00/99

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Audrey Thomas, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research (HFD-7), 1451 Rockville Pike, Suite 3047, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA97
_______________________________________________________________________




956. CHLOROFLUOROCARBON PROPELLANTS IN SELF-PRESSURIZED CONTAINERS; 
DETERMINATIONS THAT USES ARE NO LONGER ESSENTIAL

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

Unfunded Mandates: Undetermined

Legal Authority:  15 USC 402; 15 USC 409; 21 USC 321; 21 USC 331; 21 
USC 335; 21 USC 342; 21 USC 346a; 21 USC 348; 21 USC 351; 21 USC 352; 
21 USC 355; 21 USC 357; 21 USC 360b; 21 USC 361; 21 USC 371; ...

CFR Citation:  21 CFR 2

Legal Deadline: None

Abstract: The proposed rule presents the policy FDA is proposing to 
adopt on making and implementing determinations that uses of 
chlorofluorocarbons (CFCs) currently designated essential will no 
longer be deemed essential under section 610 of the Clean Air Act due 
to the availability of safe and effective medical product technology 
that does not use CFCs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           03/06/97                    62 FR 10242
ANPRM Comment Period End        05/05/97
NPRM                            12/00/98
NPRM Comment Period End         03/00/99

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Leanne Cusumano, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA99
_______________________________________________________________________




957. RADIOACTIVE DRUGS FOR BASIC RESEARCH

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

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

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

CFR Citation:  21 CFR 361

Legal Deadline: None

Abstract: The proposed rule would update FDA's regulations on the use 
of

[[Page 21959]]

radioactive drugs for basic research to reflect technological changes 
in the field of radiopharmaceuticals. The proposed rule would also 
clarify and correct certain provisions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/98
NPRM Comment Period End         01/00/99

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Brian L. Pendleton, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB00
_______________________________________________________________________




958. ESTABLISHMENT REGISTRATION AND LISTING OF HUMAN CELLULAR AND 
TISSUE-BASED PRODUCTS

Priority:  Other Significant

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

Legal Authority:  42 USC 264

CFR Citation:  21 CFR 1271

Legal Deadline: None

Abstract: This action is a continuation of FDA's approach for the 
regulation of human tissues and is part of FDA's reinventing government 
initiative. The proposed rule would require manufacturers of human 
cellular and tissue-based products to register with the agency and 
submit a list of all such products produced. Future regulations would 
include the promulgation of good tissue practices (GTP) that will 
provide good manufacturing standards and regulations for donor 
screening and testing, promotion and labeling, and compliance and 
procedural issues. The proposed approach would provide a rational, 
comprehensive, and clear framework under which tissue processors can 
develop and market their products without being subjected to 
unnecessary regulation and without sacrificing the protection of the 
public health.

Statement of Need: Presently, FDA can only approximate the numbers of 
manufacturers involved in the production of human cellular and tissue-
based products. Recent innovations in the methods of manipulating human 
cells and tissues for therapeutic purposes has resulted in the rapid 
growth of the industry producing human cellular and tissue-based 
products. The growth has occurred in industry segments that normally 
communicate with the agency as well as in segments that have not 
previously had any contact with FDA. In order to characterize the 
industry and establish a basis for communication with that industry, 
FDA is proposing that all manufacturers of human cellular and tissue-
based products register with FDA and submit lists of all their products 
to the agency.

Summary of the Legal Basis: The Public Health Service Act (42 USC 216 
et seq.) and the Federal Food, Drug, and Cosmetic Act (21 USC 321 et 
seq.) authorize FDA to regulate biological products and to ensure that 
the products are safe, pure, potent, and effective. The Public Health 
Service Act also contains the authority under which FDA can promulgate 
regulations designed to prevent the spread of communicable diseases. In 
order to meet these objectives, FDA must be able to identify those 
manufacturers participating in activities that may be subject to 
regulation. FDA proposes the registration and listing as a simple and 
efficient means of acquiring the needed information.

Alternatives: FDA has considered two alternatives. The first 
alternative would be an information collection undertaken by the agency 
that would be entirely dependent on voluntary compliance. FDA considers 
this alternative inefficient and lacking in any compliance inducements.
The second alternative is to compel the registration of manufacturers 
and require registrants to list their products with the agency. Such a 
system has been proposed to industry and gained general acceptance. 
Manufacturers would simply fill out an electronically available, 
registration and listing form and fax or mail the completed form to the 
agency with periodic updates. No other paperwork should be required.

Anticipated Costs and Benefits: Registration and listing will enable 
FDA to characterize the industry without imposing any significant 
procedural or monetary burdens. Registration and listing would provide 
effective means by which FDA can monitor the production of human 
cellular and tissue-based products. The costs of registration and 
listing are expected to be minimal because, as stated above, the 
process would require only the information necessary for FDA to 
identify the affected industry.

Risks: FDA believes that the risks posed by requiring registration and 
listing of human cellular and tissue-based products are minimal. In 
contrast, failure to identify manufacturers involved in the production 
of human cellular and tissue-based products would subject the public to 
the great and avoidable risk of contracting debilitating communicable 
diseases. Without any mechanism to target regulations intended to 
ensure the safety, purity and potency of human cellular and tissue-
based products, FDA's oversight of the industry would be severely 
hindered and the protection of the public health jeopardized.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/98
NPRM Comment Period End         09/00/98

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Dano B. Murphy, Regulatory Counsel, Regulations and 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Biologics Evaluation and Research (HFM-17), 
1401 Rockville Pike, Suite 200N, Rockville MD 20852
Phone: 301 827-6210

RIN: 0910-AB05
_______________________________________________________________________




959. VETERINARY FEED DIRECTIVES: DISTRIBUTOR NOTIFICATION

Priority:  Other Significant

Legal Authority:  PL 104-250

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: The Animal Drug Availability Act (ADAA) amended the Federal 
Food, Drug, and Cosmetic Act (the act)

[[Page 21960]]

to create a new section 504, Veterinary Feed Directive Drugs (VFD 
Drugs). VFD drugs are animal drugs intended for use in or on animal 
feed which are limited by an approved application filed pursuant to 
section 512(b) of the act to use under the professional supervision of 
a licensed veterinarian in the course of the veterinarian's 
professional practice. This section requires, among other things, that 
the labeling, distribution and use of a VFD drug be consistent with its 
approval; that persons involved in the distribution and use of a VFD 
drug maintain copies of the VFD; and, that persons distributing animal 
feed provide a one time notice upon first engaging in the distribution 
of VFD drugs. The proposed rule will provide guidance to the industry 
about how to comply with section 504 of the act and will serve as a 
basis for enforcement action.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: George Graber, Department of Health and Human Services, 
Food and Drug Administration, Center for Veterinary Medicine (HFV-228), 
7500 Standish Place, Rockville, MD 20855
Phone: 301 594-1733
Fax: 301 594-1512

RIN: 0910-AB09
_______________________________________________________________________




960. USE OF OZONE-DEPLETING SUBSTANCES IN AEROSOL PRODUCTS OR OTHER 
PRESSURIZED DISPENSERS

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

Unfunded Mandates: Undetermined

Legal Authority:  15 USC 402; 15 USC 409; 21 USC 321; 21 USC 331; 21 
USC 335; 21 USC 342; 21 USC 346a; 21 USC 348; 21 USC 351; 21 USC 352; 
21 USC 355; 21 USC 357; 21 USC 360b; 21 USC 361; 21 USC 371; ...

CFR Citation:  21 CFR 2

Legal Deadline: None

Abstract: FDA is proposing to amend its essential-use regulations to 
provide stricter scrutiny of proposed exemptions from the general ban 
on the use of ozone-depleting substances for new uses of ozone-
depleting substances. FDA is also proposing to amend the regulations to 
better conform to other statutes and regulations relating to ozone-
depleting substances to eliminate potential confusion and conflicts. 
FDA is also proposing to eliminate out-of-date transitional provisions 
and make other nonsubstantive housekeeping changes to its regulations 
on ozone-depleting substances.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/98
NPRM Comment Period End         10/00/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Leanne Cusumano, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB10
_______________________________________________________________________




961. EXPORTS; REPORTING AND RECORDKEEPING REQUIREMENTS

Priority:  Routine and Frequent

Legal Authority:  15 USC 1453 to 1455; 21 USC 321; 21 USC 343; 21 USC 
352; 21 USC 355; 21 USC 360b; 21 USC 362; 21 USC 371; 21 USC 381; 21 
USC 382; 21 USC 393; 42 USC 216; 42 USC 241; 42 USC 243; 42 USC 262

CFR Citation:  21 CFR 1

Legal Deadline: None

Abstract: The proposed rule would establish the recordkeeping and 
notification requirements for persons exporting human drugs, animal 
drugs, biologics, and devices under the FDA Export Reform and 
Enhancement Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/98

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Office of 
Policy (HF-23), 5600 Fishers Lane, Room 15-74, Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 443-6906
Email: [email protected]

RIN: 0910-AB16
_______________________________________________________________________




962. REQUIREMENTS PERTAINING TO THE SALE AND DISTRIBUTION OF CIGARETTES 
AND SMOKELESS TOBACCO TO PROTECT CHILDREN AND ADOLESCENTS; USE OF 
NONTOBACCO TRADE OR BRAND NAMES

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 352; 21 USC 360; 21 USC 360(j); 21 USC 371; 21 
USC 372

CFR Citation:  21 CFR 897

Legal Deadline: None

Abstract: The proposed rule would clarify the restrictions on the use 
of nontobacco product names and other identification on tobacco 
products and would modify the list of established names for smokeless 
tobacco products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/98

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Office of 
Policy (HF-23), 5600 Fishers Lane, Room 15-74, Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 443-6906
Email: [email protected]

RIN: 0910-AB17
_______________________________________________________________________




963. EXEMPTION FROM PREEMPTION OF STATE AND LOCAL CIGARETTE AND 
SMOKELESS TOBACCO REQUIREMENTS; APPLICATIONS FOR EXEMPTION SUBMITTED BY 
VARIOUS STATE GOVERNMENTS; GROUP 1; GROUP 2

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 360k; 21 USC 371

CFR Citation:  21 CFR 808

Legal Deadline: None

[[Page 21961]]

Abstract: FDA published a notice of proposed rulemaking on November 7, 
1996, announcing that the agency would be accepting applications for 
exemption from Federal preemption for State and local cigarette and 
smokeless tobacco requirements. The notice explained that FDA would 
consider the applications in two groups and set deadlines for 
submitting applications. Group 1 applications, due December 9, 1996, 
pertain to State and local requirements governing the sale and 
distribution of cigarettes and smokeless tobacco that are different 
from, or in addition to, FDA requirements under section 897.14(a) and 
section 897.14(b) of the final tobacco rule (the age and identification 
requirements). Group 2 applications, due May 6, 1997, pertain to State 
and local requirements governing the sale and distribution of 
cigarettes and smokeless tobacco that are different from, or in 
addition to, all other requirements under the final tobacco rule.

Timetable:

Group 1  NPRM 02/19/97 (62 FR 7390)  NPRM Comment Period End 06/23/
97  Final Action 11/28/97 (62 FR 63271)

Group 2  NPRM 05/00/98

Groups 1 and 2  Notice 11/07/96 (61 FR 57685)

Small Entities Affected: None

Government Levels Affected: State, Local

Additional Information: Formerly listed under RIN 0910-AB03.

Agency Contact: Anne M. Kirchner, Policy Analyst, Department of Health 
and Human Services, Food and Drug Administration, Office of Policy 
(HFD-11), 5600 Fishers Lane, Room 14-72, Rockville, MD 20857
Phone: 301 827-5321
Fax: 301 443-5169

RIN: 0910-AB19
_______________________________________________________________________




964.  REGISTRATION OF FOREIGN ESTABLISHMENTS AND PRODUCT LISTING

Priority:  Routine and Frequent

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 352; 21 USC 355; 21 
USC 360; 21 USC 360b to 360c; 21 USC 360e; 21 USC 360i to 360j; 21 USC 
371; 21 USC 374; 42 USC 216; 42 USC 262

CFR Citation:  21 CFR 207; 21 CFR 607; 21 CFR 807

Legal Deadline: None

Abstract: The proposal would amend the establishment registration and 
product listing regulations for human drugs, biologics, animal drugs, 
and devices to require foreign manufacturers importing such products 
into the United States to register and to list their products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/98

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Office of 
Policy (HF-23), 5600 Fishers Lane, Room 15-74, Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 443-6906
Email: [email protected]

RIN: 0910-AB21
_______________________________________________________________________




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

Priority:  Info./Admin./Other

Legal Authority:  18 USC 552; 18 USC 1905; 19 USC 2531 to 2582; 21 USC 
321 to 393; 21 USC 1401 to 1403; 42 USC 241; 42 USC 242; 42 USC 242a; 
42 USC 242e; 42 USC 242l; 42 USC 242n; 42 USC 243; 42 USC 262; 42 USC 
263; 42 USC 263b to 263n; ...

CFR Citation:  21 CFR 20.88; 21 CFR 20.89

Legal Deadline: None

Abstract: The proposed rule would amend the regulations governing 
communications with State and foreign government officials. The 
proposed rule would permit the Food and Drug Administration (FDA) to 
disclose confidential commercial information to international 
organizations having responsibility to facilitate global or regional 
harmonization of standards and requirements. These disclosures would, 
in almost all instances, occur only with the consent of the person 
providing the confidential commercial information to FDA. The proposed 
rule would also eliminate the need for a written statement by a State 
or foreign government official establishing that government's ability 
to protect from public disclosure nonpublic, predecisional documents 
(such as draft rules and guidance documents) provided by FDA that do 
not include confidential commercial information. These changes are 
intended to facilitate information exchanges with State and foreign 
governments.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/98

Small Entities Affected: None

Government Levels Affected: None

Additional Information: 5 USC 552

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Office of 
Policy (HF-23), 5600 Fishers Lane, Room 15-74, Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 443-6906
Email: [email protected]

RIN: 0910-AB22
_______________________________________________________________________




966.  DISSEMINATION OF TREATMENT INFORMATION ON UNAPPROVED USES 
FOR MARKETED DRUGS AND DEVICES

Priority:  Other Significant

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 
USC 355; 21 USC 360b; 21 USC 360c; 21 USC 360e; 21 USC 371; 21 USC 374; 
PL 105-115 sec. 401

CFR Citation:  21 CFR 99

Legal Deadline: None

Abstract: The proposal would establish the procedures and requirements 
for the dissemination of information on unapproved new uses of marketed 
drugs, biologics, and devices. The proposal would include requirements 
concerning submissions to the Food and Drug Administration, requests to 
extend the time period for completing studies needed to submit a 
supplemental application for a new use, applications for an exemption 
from the requirement to conduct studies, recordkeeping, and reporting. 
The proposal would also cover agency actions on such submissions, 
requests, and applications, as well as orders to cease or to terminate 
dissemination of information.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/98

[[Page 21962]]

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Peggy Dotzel, Senior Science Policy Advisor, Department 
of Health and Human Services, Food and Drug Administration, Office of 
Policy (HF-13), 5600 Fishers Lane, Room 14-72, Rockville, MD 20857
Phone: 301 827-5321
Fax: 301 443-5169

RIN: 0910-AB23
_______________________________________________________________________




967.  FDA EXPORT REFORM AND ENHANCEMENT ACT OF 1996; REPORTING 
AND RECORDKEEPING REQUIREMENTS FOR UNAPPROVED OR VIOLATIVE PRODUCTS 
IMPORTED FOR FURTHER PROCESSING OR INCORPORATION AND LATER EXPORT

Priority:  Substantive, Nonsignificant

Legal Authority:  15 USC 1453 to 1455; 21 USC 321; 21 USC 343; 21 USC 
352; 21 USC 355; 21 USC 360b; 21 USC 362; 21 USC 371; 21 USC 374; 21 
USC 381; 21 USC 382; 21 USC 393; 42 USC 216

CFR Citation:  21 CFR 1.84

Legal Deadline: None

Abstract: The proposed rule would establish reporting and recordkeeping 
requirements to implement sections 801(d)(3) and 801 (d)(4) of the 
Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food 
and Drug Administration (FDA) Export Reform and Enhancement Act of 
1996. Section 801(d)(3) of the act provides that, under prescribed 
conditions, drug and device components, food and color additives, and 
dietary supplements may be imported if they are to be further processed 
or incorporated into products that are to be exported from the United 
States in accordance with sections 801(e) or 802 of the act or section 
351(h) of the Public Health Service (PHS) Act. Section 801(d)(4) of the 
act provides that blood, blood components, source plasma, or source 
leukocytes, or a component, accessory, or part thereof, may not be 
imported under section 801(d)(3) of the act unless the importation 
complies with section 351(a) of the PHS Act or FDA permits the 
importation under FDA-determined appropriate circumstances and 
conditions. Additionally, section 801(d)(4) of the act prohibits the 
importation of tissue or a component or part of tissue under section 
801(d)(3) of the act unless the importation complies with section 361 
of the PHS Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/98

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Office of 
Policy (HF-23), 5600 Fishers Lane, Room 15-74, Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 443-6906
Email: [email protected]

RIN: 0910-AB24
_______________________________________________________________________




968.  BLOOD INITIATIVE

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

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 
USC 353; 21 USC 355; 21 USC 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; 21 CFR 601; 21 CFR 606; 21 CFR 607; 21 CFR 
610; 21 CFR 640; 21 CFR 660; 21 CFR 680

Legal Deadline: None

Abstract: In multiple rulemakings, the Food and Drug Administration is 
proposing to amend the biologics regulations by removing, revising, or 
updating specific regulations applicable to blood derivative products 
to be more consistent with current practices and to remove unnecessary 
or outdated requirements. This action is based on a comprehensive 
review of the regulations that has been performed. It is also based on 
reports by the U.S. House of Representatives Committee on Government 
Reform and Oversight, Subcommittee on House Resources and 
Intergovernmental Relations; the General Accounting Office; the 
Institute of Medicine; as well as public comments received in response 
to the comprehensive review. Some of the subjects to be addressed in 
the rulemakings include: ``Lookback'' requirements for hepatitis C 
virus; notification of consignees and end users of product safety 
information for plasma derivative products; notification of permanently 
deferred donors; requirements for donor suitability and testing; viral 
inactivation; and definitions for ``analogous products.'' These actions 
are intended to help ensure the continued safety of the nation's blood 
supply.

Timetable:

CGMPs for Blood and Blood Components  NPRM 10/00/98

Definition for ``Analogous Products''  NPRM 01/00/99

Minor Changes to Reqs. for CGMP for Blood and Blood Components  Direct 
Final Rule 10/00/98

Notification of End Users of Plasma Derivative Products  NPRM 10/00/98

Notification of Permanently Deferred Donors  NPRM 01/00/99

Reqs. Applicable to Albumin (Human), Plasma Protein Fraction  Direct 
Final Rule 10/00/98

Requirements for Donor Testing  NPRM 01/00/99

Suitability Reqs. for Whole Blood and Source Plasma Donors  NPRM 01/00/
99

Viral Inactivation  NPRM 01/00/99

Small Entities Affected: Undetermined

Government Levels Affected: None

Agency Contact: Steven F. Falter, Director, Regulations and Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Biologics Evaluation and Research (HFM-17), 
1401 Rockville Pike, Suite 200N, Rockville, MD 20852
Phone: 301 827-6210

RIN: 0910-AB26
_______________________________________________________________________




969.  SUITABILITY DETERMINATION FOR DONORS OF HUMAN CELLULAR AND 
TISSUE-BASED PRODUCTS

Priority:  Other Significant

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

Legal Authority:  42 USC 216; 42 USC 243; 42 USC 262; 42 USC 263a; 42 
USC 264; 42 USC 271

CFR Citation:  21 CFR 210.1(c); 21 CFR 210.2(a); 21 CFR 210.2(b); 21 
CFR 311.1(b); 21 CFR 820.1(a)(1); 21 CFR 820.1(c); 21 CFR 1271

Legal Deadline: None

[[Page 21963]]

Abstract: As part of implementing the proposed regulatory approach to 
human cellular and tissue-based products, the Food and Drug 
Administration is proposing to require manufacturers of human cellular 
and tissue-based products to screen and test the donors of cells and 
tissues used in those products for evidence of or risk factors for 
relevant communicable disease. As part of this action, the agency is 
proposing to amend the current good manufacturing practice regulations 
that apply to human cellular and tissue-based products regulated as 
drugs, medical devices, and/or biological products in order to 
incorporate the new donor suitability requirements into existing good 
manufacturing practice regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/98

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Paula S. McKeever, Consumer Safety Officer, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Biologics Evaluation and Research (HFM-17), 1401 Rockville Pike, Suite 
200N, Rockville, MD 20852
Phone: 301 827-6210

RIN: 0910-AB27
_______________________________________________________________________




970.  CURRENT GOOD TISSUE PRACTICE FOR MANUFACTURERS OF HUMAN 
CELLULAR AND TISSUE-BASED PRODUCTS

Priority:  Other Significant

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

Legal Authority:  42 USC 216; 42 USC 243; 42 USC 262; 42 USC 263a; 42 
USC 264; 42 USC 271

CFR Citation:  21 CFR 1271

Legal Deadline: None

Abstract: As part of implementing the proposed regulatory approach to 
human cellular and tissue-based products, the Food and Drug 
Administration (FDA) is proposing to require manufacturers of human 
cellular and tissue-based products to follow current good tissue 
practice (GTP), which includes proper handling, processing, and storage 
of human cellular and tissue-based products, recordkeeping, and the 
maintenance of a quality program. FDA is also proposing to amend the 
current good manufacturing practice regulations that apply to human 
cellular and tissue-based products regulated as drugs, medical devices, 
and/or biological products in order to incorporate the new GTP 
requirements into existing good manufacturing practice regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/98

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Paula S. McKeever, Consumer Safety Officer, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Biologics Evaluation and Research (HFM-17), 1401 Rockville Pike, Suite 
200N, Rockville, MD 20852
Phone: 301 827-6210

RIN: 0910-AB28
_______________________________________________________________________




971.  BIOLOGICAL PRODUCTS REGULATED UNDER SECTION 351 OF THE 
PUBLIC HEALTH SERVICES ACT; IMPLEMENTATION OF BIOLOGICS LICENSE; 
ELIMINATION OF ESTABLISHMENT LICENSE AND PRODUCT LICENSE

Priority:  Other Significant

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

Legal Authority:  42 USC 262; PL 105-115

CFR Citation:  21 CFR 3; 21 CFR 5; 21 CFR 10; 21 CFR 20; 21 CFR 207; 21 
CFR 310; 21 CFR 312; 21 CFR 316; 21 CFR 600; 21 CFR 601; 21 CFR 607; 21 
CFR 610; 21 CFR 640; 21 CFR 660

Legal Deadline: None

Abstract: As a ``Reinventing Government'' initiative and to amend 
regulations to implement section 123 of the Food and Drug 
Administration Modernization Act of 1997; FDA is proposing to eliminate 
the requirement and use of establishment licenses and product licenses 
for biological products regulated under section 351 of the Public 
Health Service Act. In lieu of product licenses and establishment 
licenses, FDA will require submission and approval of a biologics 
license application in order to market these biologic products in 
interstate commerce.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/98

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Timothy W. Beth, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Biologics Evaluation and Research (HFM-17), 1401 Rockville Pike, Suite 
200N, Rockville, MD 20852
Phone: 301 827-6333
Email: [email protected]

RIN: 0910-AB29
_______________________________________________________________________




972.  ANTIBIOTIC DRUG APPROVAL AND EXCLUSIVITY

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

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

Legal Authority:  PL 105-115, sec 125

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: This proposed rule will implement the incorporation of 
antibiotics, which were formerly regulated under authority of section 
507 of the Federal Food, Drug, and Cosmetic Act, into the new drug 
regulatory scheme under section 505 of the Act. The regulation will 
describe which antibiotics will be eligible for exclusivity under 
sections 505(c)(3)(D) and 505 (j)(4)(D) of the Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/98
NPRM Comment Period End         11/00/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Wayne Mitchell, Regulatory Counsel, Department of

[[Page 21964]]

Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research (HFD-7), 1451 Rockville Pike, Suite 3047, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB33
_______________________________________________________________________




973.  APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG OR 
ANTIBIOTIC DRUG; COMPLETE REVIEW LETTER; AMENDMENTS TO UNAPPROVED 
APPLICATIONS

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

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

Legal Authority:  21 USC 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 379e

CFR Citation:  21 CFR 312; 21 CFR 314

Legal Deadline: None

Abstract: This proposed rule will amend the regulations on marketing 
approval of new drugs to discontinue the use of approvable and not 
approvable letters when taking action on a marketing application and 
instead use complete review letters.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/98
NPRM Comment Period End         10/00/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Brian L. Pendleton, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB34
_______________________________________________________________________




974.  EXPANDED ACCESS TO INVESTIGATIONAL THERAPIES

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

Unfunded Mandates: Undetermined

Legal Authority:  PL 105-115, sec 402

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: This proposed rule will revise the investigational new drug 
regulations to clarify the conditions under which individual patients 
may receive investigational drugs for treatment use; to clarify the 
conditions under which a small group of patients may receive 
investigational drugs for treatment use under an expanded access 
protocol; and to clarify the criteria under which sponsors can recover 
costs for providing investigational drugs to patients for certain 
treatment uses.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/98
NPRM Comment Period End         11/00/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Joseph Griffin, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB37
_______________________________________________________________________




975.  DISTINGUISHING MARKS FOR DRUG PRODUCTS CONTAINING INSULIN

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

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 
USC 353; 21 USC 355; 21 USC 357; 21 USC 358; 21 USC 360; 21 USC 360b; 
21 USC 360gg to 360ss; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216; 
...

CFR Citation:  21 CFR 201

Legal Deadline: None

Abstract: This proposed rule will set forth a new system of distinctive 
colors and marks to identify different types of insulin-containing drug 
products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/98
NPRM Comment Period End         01/00/99

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB43
_______________________________________________________________________




976.  PROGESTATIONAL DRUG PRODUCTS FOR HUMAN USE; REQUIREMENTS 
FOR LABELING DIRECTED TO THE PATIENT

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

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 
USC 353; 21 USC 355; 21 USC 356; 21 USC 357; 21 USC 360b to 360f; 21 
USC 360j; 21 USC 361(a); 21 USC 371; 21 USC 374; 21 USC 375; 21 USC 
379e; ...

CFR Citation:  21 CFR 310

Legal Deadline: None

Abstract: This proposed rule will revoke 21 CFR 310.516 which requires 
that progestational drug products be dispensed with a patient package 
insert containing a discussion of the risks of birth defects resulting 
from the use of these drugs during the first four months of pregnancy. 
The Food and Drug Administration is proposing to revoke this labeling 
requirement because of changes in the currently available scientific 
information.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/98
NPRM Comment Period End         10/00/98

Small Entities Affected: Undetermined

[[Page 21965]]

Government Levels Affected: Undetermined

Agency Contact: Christine Rogers, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB45
_______________________________________________________________________




977.  REQUIREMENTS FOR LIQUID MEDICATED FEED AND FREE CHOICE 
MEDICATED FEED

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 104-25; 21 USC 360(b)

CFR Citation:  21 CFR 558.5; 21 CFR 510.455

Legal Deadline: None

Abstract: In response to a citizen petition filed by the American Feed 
Industry Association, the Food and Drug Administration (FDA) is 
proposing to amend the requirements for liquid medicated animal feed to 
clarify what information and data are required to demonstrate chemical 
and positional stability. The amended regulations would also clarify 
the provisions for the submission of such data through a master file 
and the reference to master files by subsequent applicants. 
Additionally, FDA is proposing to amend the regulations for free-choice 
medicated feed in order to ensure consistency with the requirements for 
liquid medicated feed. Finally, FDA is proposing to amend the 
regulations for free choice medicated feed and liquid medicated feed so 
that these provisions comply with the terms of the Animal Drug 
Availability Act of 1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/99

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: William Price, Department of Health and Human Services, 
Food and Drug Administration, Center for Veterinary Medicine (HFV-200), 
7500 Standish Place, Rockville, MD 20855
Phone: 301 594-1725

RIN: 0910-AB50
_______________________________________________________________________




978.  REVISIONS TO THE GENERAL SAFETY REQUIREMENTS FOR 
BIOLOGICAL PRODUCTS; DIRECT FINAL RULE

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 351

CFR Citation:  21 CFR 610.11(g)

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is amending the 
biologics regulations by adding ``cellular therapy products'' to the 
list of products excepted from the general safety test (GST), and by 
adding an administrative procedure for obtaining exemptions from the 
GST requirements for other biological products. FDA is taking this 
action because the GST may not be relevant or necessary for all 
biological products, including cellular therapy products, currently in 
various stages of development. This direct final rule is part of FDA's 
continuing effort to achieve the objectives of the President's 
``Reinventing Government'' initiative, and is intended to reduce the 
burden of unnecessary regulations on biological products without 
diminishing the protection of the public health. FDA is publishing a 
companion proposed rule under FDA's usual procedures for notice and 
comment to provide a procedural framework to finalize the rule in the 
event the agency receives any significant adverse comment and withdraws 
this direct final rule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Direct Final Rule               04/00/98
Companion Document to Direct Final Rule  Proposed Rule 04/00/98

Small Entities Affected: None

Government Levels Affected: None

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

Agency Contact: Dano B. Murphy, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Biologics Evaluation and Research (HFM-617), 1401 Rockville Pike, Suite 
200N, Rockville, MD 20852-1448
Phone: 301 827-6210

RIN: 0910-AB51
_______________________________________________________________________




979.  RADIOPHARMACEUTICALS USED FOR IN VIVO DIAGNOSIS AND 
MONITORING

Priority:  Substantive, Nonsignificant

Unfunded Mandates: Undetermined

Legal Authority:  PL 105-115, sec 122

CFR Citation:  21 CFR 315; 21 CFR 601

Legal Deadline:  NPRM, Statutory, May 20, 1998. Final, Statutory, May 
20, 1999.

Abstract: Section 122 of FDAMA, Requirements for Radiopharmaceuticals, 
requires the Secretary, HHS, after consultation with patient advisory 
groups, associations, physicians licensed to use radiopharmaceuticals, 
and the regulated industry, to issue proposed regulations governing the 
approval of radiopharmaceuticals. The regulations shall provide that 
the determination of safety and effectiveness of a radiopharmaceutical 
under section 505 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355) or section 351 of the Public Health Service Act (42 U.S.C. 
262) shall include consideraton of the proposed use of the 
radiopharmaceutical in the practice of medicine, the pharmacological 
and toxicological activity of the radiopharmaceutical (including any 
carrier or ligand component of the radiopharmaceutical), and the 
estimated radiation dose of the radiopharmaceutical. In addition, the 
indication for which a radiopharmaceutical is approved for marketing 
may, in appropriate cases, refer to manifestations of disease (such as 
biochemical, physiological, anatomical, or pathological processes) 
common to, or present in, one or more disease states.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/98
Final Action                    05/00/99

Small Entities Affected: Undetermined

Government Levels Affected: None

[[Page 21966]]

Agency Contact: Dano B. Murphy, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Biologics Evaluation and Research (HFM-617), 1401 Rockville Pike, Suite 
200N, Rockville, MD 20852-1448
Phone: 301 827-6210

RIN: 0910-AB52
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




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

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

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

Legal Authority:  21 USC 321; 21 USC 351; 21 USC 352; 21 USC 360b; 21 
USC 371; 21 USC 379e; 21 USC 381

CFR Citation:  21 CFR 514

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

Abstract: On December 17, 1991, the Agency published a proposed 
revision of the existing regulations that is consistent with the 
current procedural regulations for human drugs, where appropriate. The 
New Animal Drug Application (NADA) revisions articulate general 
requirements in regulations containing performance standards and would 
complement these regulations through detailed guidelines on, among 
other matters, appropriate ways of meeting requirements for submission 
of chemistry, pharmacology, and statistical data that would better 
address the intricate scientific issues involved. A separate proposed 
rule for reporting requirements for marketed animal drugs also was 
published on that date. The agency intends to repropose the NADA 
proposed rule to incorporate some recent changes in procedure. The NADA 
revisions are expected to include regulations to implement the 
provisions of the Animal Drug Availability Act of 1996, specifically 
the definition of flexible labeling, and implement parts of the 
President's National Performance Report ``Reinventing the Regulation of 
Animal Drugs,'' May 1996. In the reinventing regulations report, FDA 
proposed to revise its regulations to reflect numerous new process 
changes and programs that will maintain safety and effectiveness of new 
animal drugs and enable a more streamlined animal drug application 
review and approval process which will result in less regulatory burden 
upon industry and FDA. The Agency also proposes to amend its 
regulations to implement title I of the Generic Animal Drug and Patent 
Term Restoration Act, which established new standards for marketing 
approval of generic copies of animal drugs approved after 1962.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           11/21/96                    61 FR 59209
ANPRM Comment Period End        01/21/97
New Animal Drug Approval Process  NPRM 12/17/91 (56 FR 65544)  NPRM 00/
00/00

Reporting Requirements for Marketed Animal Drugs  NPRM 12/17/91 (56 FR 
65581)  Final Action 12/00/98

Small Entities Affected: Businesses

Government Levels Affected: None

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

Agency Contact: Margaret Miller, Deputy Director, Office of New Animal 
Drug Evaluation, Department of Health and Human Services, Food and Drug 
Administration, Center for Veterinary Medicine (HFV-100), 7500 Standish 
Place, Rockville, MD 20855
Phone: 301 594-1620

RIN: 0910-AA02
_______________________________________________________________________




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

Priority:  Other Significant

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

CFR Citation:  21 CFR 203

Legal Deadline: None

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

[[Page 21967]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/14/94                    59 FR 11842
NPRM Comment Period End         08/01/94
Final Action                    07/00/98

Small Entities Affected: Businesses, Organizations

Government Levels Affected: State, Federal

Additional Information: Previously reported under RIN 0905-AD44.

Agency Contact: Lee D. Korb, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA08
_______________________________________________________________________




982. BIOLOGICAL PRODUCTS: REPORTING OF ERRORS AND ACCIDENTS IN 
MANUFACTURING

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 
355; 21 USC 360; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC 374; 42 
USC 216; 42 USC 262 to 264; 42 USC 300aa-25

CFR Citation:  21 CFR 600; 21 CFR 606

Legal Deadline: None

Abstract: FDA is amending the regulations that require licensed 
manufacturers of biological products to report errors and accidents in 
manufacturing that may affect the safety, purity, or potency of a 
product. FDA defines terms used; establishes a reporting period for all 
licensed biological products; and amends the current good manufacturing 
practice (CGMP) regulations for blood and blood components to require 
error and accident reporting by unlicensed registered blood 
establishments and transfusion services currently reporting on a 
voluntary basis. The reporting requirements will expedite reporting of 
errors and accidents in manufacturing of biological products; provides 
FDA with a more accurate surveillance of the Nation's blood supply, 
enabling FDA to monitor actions taken in response to the errors and 
accidents detected for all establishments involved in the manufacture 
of blood and blood components; and facilitate a rapid response where 
public health may be at risk. The cost to licensed establishments would 
be minimal, since they already are required to report. Unlicensed 
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 final rule they 
would have to establish reporting procedures and report to FDA. The 
transfusion services would have to assure that their recordkeeping and 
investigation procedures are sufficient, and establish reporting 
procedures.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/23/97                    62 FR 49642
NPRM Comment Period End         12/22/97
Final Action                    12/00/98

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD67.

Agency Contact: Valerie A. Butler, Consumer Safety Officer, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Biologics Evaluation and Research (HFM-17), 1401 Rockville Pike, Suite 
200N, Rockville, MD 20852-1448
Phone: 301 827-6210

RIN: 0910-AA12
_______________________________________________________________________




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

Priority:  Substantive, Nonsignificant

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

CFR Citation:  21 CFR 211

Legal Deadline: None

Abstract: FDA has required tamper-resistant packaging features for OTC 
drug products since 1982. The tamper-resistant packaging regulations 
were revised in 1989 in response to continuing tampering incidents. 
Despite the regulatory protection provided by the regulations, two-
piece, hard gelatin capsules remain vulnerable to malicious tampering 
and were implicated in tampering incidents in 1991. This action is in 
response to the 1991 tampering incidents and requires use of the term 
``tamper-evident'' instead of ``tamper-resistant'', and that all OTC 
human drug products marketed in two-piece, hard gelatin capsules be 
sealed.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/18/94                     59 FR 2542
NPRM Comment Period End         03/21/94
Final Action                    06/00/98
Final Action Effective          06/00/99

Small Entities Affected: Businesses

Government Levels Affected: Federal

Additional Information: Previously reported under RIN 0905-AE27.

Agency Contact: Thomas Kuchenberg, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA26
_______________________________________________________________________




984. PRESCRIPTION DRUG PRODUCT LABELING; MEDICATION GUIDE

Priority:  Other Significant

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

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

Legal Deadline: None

Abstract: In August, 1995 the Food and Drug Administration (FDA) 
published a proposed rule that specified standards for the distribution 
and quality of useful prescription medication information, designed for 
patients, that voluntary, private-sector efforts should supply to 
patients receiving new prescriptions. On August 6, 1996, section 601 of 
the Agriculture Rural Development, Food and Drug Administration, and 
Related Agencies Appropriations Act, 1997 was enacted which places the 
proposed rule as it relates to a voluntary program in abeyance. The 
legislation did not address the provisions that would have required 
mandatory Medication Guides in relatively rare instances (approximately 
5 products annually)

[[Page 21968]]

where a product poses a serious and significant public health concern 
requiring immediate distribution of FDA-approved patient information. 
FDA is in the process of finalizing the requirement for mandatory 
Medication Guides for these rare products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/24/95                    60 FR 44182
Final Action                    07/00/98

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Additional Information: Previously reported under RIN 0905-AE43.

Agency Contact: Nancy M. Ostrove, Division of Drug Marketing, 
Advertising, and Communications, Department of Health and Human 
Services, Food and Drug Administration, Center for Drug Evaluation and 
Research (HFD-240), 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 594-6828

RIN: 0910-AA37
_______________________________________________________________________




985. CURRENT GOOD MANUFACTURING PRACTICE; AMENDMENT OF CERTAIN 
REQUIREMENTS FOR FINISHED PHARMACEUTICALS

Priority:  Other Significant

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/03/96                    61 FR 20104
NPRM Comment Period End         09/30/96
Final Action                    12/00/98
Final Action Effective          03/00/99

Small Entities Affected: Businesses

Government Levels Affected: Federal

Additional Information: Previously reported under RIN 0905-AE63.

Agency Contact: Thomas Kuchenberg, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA45
_______________________________________________________________________




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

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

Unfunded Mandates: Undetermined

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

CFR Citation:  21 CFR 201

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/05/98                      63 FR 176
NPRM Comment Period End         04/06/98
Final Action                    11/00/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Leanne Cusumano, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA74
_______________________________________________________________________




987. NEW DRUG APPLICATIONS; DRUG MASTER FILE

Priority:  Substantive, Nonsignificant

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

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

CFR Citation:  21 CFR 314

Legal Deadline: None

Abstract: The final rule eliminates Type I Drug Master Files, which 
contain information about manufacturing sites, facilities, operating 
procedures, and personnel, because these files contain outdated 
information, duplicate information contained in marketing applications, 
and are not used by application review divisions or field inspectors.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/03/95                    60 FR 34486
NPRM Comment Period End         10/02/95
Final Action                    06/00/98
Final Action Effective          12/00/98

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Thomas Kuchenburg, Regulatory Counsel, Department of

[[Page 21969]]

Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research, (HFD-7), 1451 Rockville Pike, Suite 3047, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA78
_______________________________________________________________________




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

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

Unfunded Mandates: Undetermined

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

CFR Citation:  21 CFR 201; 21 CFR 330

Legal Deadline: None

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

Statement of Need: Currently, the design, format, and placement of 
required labeling information varies considerably among OTC products. 
As a result, consumers often have difficulty finding, reading, and 
understanding this labeling information. Modifying and simplifying the 
manner in which the information is presented can improve the legibility 
and understandability of OTC drug product labeling. Therefore, this 
final rule will establish a standardized format for the labeling of all 
marketed OTC drug products. This action is intended to enable consumers 
to better read and understand OTC drug product labeling and to apply 
this information to the safe and effective use of OTC drug products.

Summary of the Legal Basis: FDA's legal authority to modify and 
simplify the manner in which certain information is presented in OTC 
drug product labeling derives from sections 201, 502, 505, and 701 of 
the Federal Food, Drug, and Cosmetic Act (the act). Regulating the 
order, appearance, and format of OTC drug product labeling is 
consistent with the agency's authority to ensure that drug labeling 
convey all material information to the consumer (21 USC 321(n) and 
352(a)), and that the labeling communicates this information in a 
manner that is ``likely to be read and understood by the ordinary 
individual under customary conditions of purchase and use.'' (21 USC 
352(c)). Regulating the content of OTC drug product labeling is 
consistent with FDA's authority to ensure that the products are safe 
and effective for use (sections 201(n) and (p), 502, and 505 of the 
act).

Alternatives: FDA considered several alternatives. First, the agency 
considered but rejected a voluntary labeling scheme, as previous 
industry efforts have been unsuccessful in achieving both a uniform 
format and an acceptable minimum print size for a majority of the 
products on the market. Second, the agency considered but rejected 
revising all OTC monographs on an individual basis because this 
approach would not achieve a standardized labeling format for a 
majority of the marketed products in a timely manner. Third, the agency 
considered alternative implementation periods but chose the option 
proposed because it believed that the chosen approach provides 
significant reduction in cost while meeting the agency objective of 
achieving a standardized labeling format for a majority of the products 
in a timely manner.

Anticipated Costs and Benefits: The final rule is expected to cost a 
total of $14 million when implemented. This cost includes a 1-year 
extension for implementation time of individual OTC drug products 
having sales of less than $25,000 per year.
In general, the rule will benefit consumers by allowing them to make 
more appropriate choices for self-treatment, and to reduce trial and 
error approaches to self-medication. Consequently, this could lead to 
decreased overall health care costs resulting from reduced visits to 
the doctor or hospital for treatment. Additionally, the easy to read, 
standardized format will directly benefit consumers by helping ensure 
the safe and effective use of the product.

Risks: None.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/27/97                     62 FR 9024
NPRM Comment Period End         10/06/97                    62 FR 33379
Final Action                    08/00/98

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Cazemiro Martin, Division of OTC Drug Evaluation, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Drug Evaluation and Research (HFD-560), 9201 Corporate 
Blvd., Rockville, MD 20850
Phone: 301 827-2222

RIN: 0910-AA79
_______________________________________________________________________




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

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

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

CFR Citation:  21 CFR 312

Legal Deadline: None

Abstract: The final rule amends the provisions governing 
investigational new drug applications to permit FDA to place a clinical 
hold on one or more studies under an IND involving a drug that is 
intended to treat a life-threatening disease affecting both genders if 
men or women with reproductive potential who have the disease are 
excluded from eligibility in any phase of the investigation because of 
a risk or potential risk of reproductive or developmental toxicity from 
use of the investigational drug.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/24/97                    62 FR 49946
NPRM Comment Period End         12/23/97
Final Action                    10/00/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Andrea Masciale, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research (HFD-5), 1451

[[Page 21970]]

Rockville Pike, Suite 6027, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA84
_______________________________________________________________________




990. STERILITY REQUIREMENTS FOR INHALATION SOLUTION PRODUCTS

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

Unfunded Mandates: Undetermined

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

CFR Citation:  21 CFR 200

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/23/97                    62 FR 49638
NPRM Comment Period End         12/22/97
Final Action                    09/00/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Carol Drew, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA88
_______________________________________________________________________




991. CURRENT GOOD MANUFACTURING PRACTICE; REVISION OF CERTAIN LABELING 
CONTROLS

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

Unfunded Mandates: Undetermined

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

CFR Citation:  21 CFR 210; 21 CFR 211

Legal Deadline: None

Abstract: The final rule amends the labeling control provisions in the 
current good manufacturing practice regulations to make the provisions 
less burdensome while still reducing the frequency of drug product 
mislabeling and associated drug product recalls associated with cut 
labeling.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/29/97                    62 FR 40489
NPRM Comment Period End         10/27/97
Final Action                    11/00/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Thomas Kuchenberg, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA98
_______________________________________________________________________




992. DEFINITION OF SUBSTANTIAL EVIDENCE

Priority:  Other Significant

Legal Authority:  21 USC 360(b); PL 104-250

CFR Citation:  21 CFR 514.4

Legal Deadline:  NPRM, Statutory, October 9, 1997. Final, Statutory, 
October 9, 1998.

Abstract: The ADAA requires FDA to issue within 24 months after the 
date of its enactment final proposed regulations to encourage dose 
range labeling and to further define the term ``substantial evidence,'' 
as the term is defined in section 512(d)(3) of the Federal Food, Drug, 
and Cosmetic Act, as amended by the ADAA, in a manner that encourages 
the submission of applications and supplemental applications.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           11/21/96                    61 FR 59209
NPRM                            11/05/97                    62 FR 59830
Final Action                    10/00/98

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Gail Schmerfeld, Special Assistant, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Veterinary Medicine (HFV-100), 7500 Standish Place, Rockville, MD 20855
Phone: 301 827-0205
Fax: 301 594-2297

RIN: 0910-AB08
_______________________________________________________________________




993. MEDICATED FEED MILL LICENSES

Priority:  Substantive, Nonsignificant

Legal Authority:  PL 104-250

CFR Citation:  21 CFR 5; 21 CFR 207; 21 CFR 225; 21 CFR 510; 21 CFR 
514; 21 CFR 515; 21 CFR 558

Legal Deadline: None

Abstract: The Animal Drug Availability Act of 1996 (ADAA) amends 
sections 512(a) and 512(m) of the Federal Food, Drug, and Cosmetic Act 
(the act) to require a single facility license for the manufacture of 
feeds containing approved new animal drugs, rather than multiple 
medicated feed applications (MFAs) for each feed mill, as previously 
required by the act. Prior to the passage of the ADAA, an approved 
medicated feed application was required by the act for the manufacture 
of medicated feed. The ADAA eliminates the requirement that a feed mill 
submit a separate medicated feed application for the manufacture of 
each type of medicated feed and instead provides for feed mills to be 
licensed and allows a licensed facility to manufacture any feed 
containing an approved new animal drug. Additionally, the act, as 
amended by the ADAA, provides the agency with the authority to exempt 
facilities that manufacture certain types of medicated feed from the 
requirement of a medicated feed mill license.
The Food and Drug Administration published on July 30, 1997, a proposed 
rule to amend the animal drug regulations and add a new part (21 CFR 
515) to provide for feed mill licensing in accordance with the ADAA. 
The proposed regulation implements the requirements for feed mill 
licensing set forth in the ADAA. Under this proposal, those medicated 
feeds exempted from the MFA requirement under 21 CFR 558.4 will also be

[[Page 21971]]

exempt from the requirement of a medicated feed mill license.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/30/97                    62 FR 40765
NPRM Comment Period End         10/28/97
Final Action                    12/00/98

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: William D. Price, Special Assistant, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Veterinary Medicine (HFV-200), 7500 Standish Place, Rockville, MD 20855
Phone: 301 594-1724

RIN: 0910-AB18
_______________________________________________________________________




994. REGULATIONS REQUIRING MANUFACTURERS TO ASSESS THE SAFETY AND 
EFFECTIVENESS OF NEW DRUGS AND BIOLOGICAL PRODUCTS IN PEDIATRIC PATIENTS

Priority:  Other Significant

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 352; 21 USC 355; 21 
USC 371; 21 USC 502; 42 USC 262

CFR Citation:  21 CFR 200; 21 CFR 312; 21 CFR 314; 21 CFR 601

Legal Deadline: None

Abstract: The final rule, if promulgated, would require pediatric 
studies of a limited class of new drug and biological products so that 
the products will have sufficient data and information to support 
directions for pediatric use for the claimed indications.

Statement of Need: Many new drugs and biological products represent 
treatments that are, at least at times, the best available treatment 
for children, but most of them have not been adequately tested in the 
pediatric population. As a result, product labeling frequently fails to 
provide directions for safe and effective use in pediatric patients. 
The absence of pediatric labeling information poses a number of 
disadvantages to pediatric patients, including the potential for under- 
or over-dosing leading to ineffective treatment or excessive or 
unanticipated side effects. It may also result in the failure to 
provide optimal treatment to children because of the lack of 
appropriate scientific data.
Despite previous efforts to increase the amount of pediatric use 
information in drug labeling, the majority of new drugs and biological 
products are still insufficiently tested in the pediatric population 
and their labeling carries little or no information on pediatric safety 
and effectiveness. The final rule would help address this lack of 
pediatric information.

Summary of the Legal Basis: Under 502(a), 502(f), 505(d)(7), and 201(n) 
of the Federal Food, Drug, and Cosmetic Act (the act), FDA may require 
a product to carry labeling that provides safety and effectiveness 
information on use in subpopulations in which the product is 
customarily or commonly used. Section 505(i) of the act authorizes the 
issuance of regulations governing the use of investigational drugs, and 
provision 505(k) of the act, which requires regulations issued under 
505(i) to have ``due regard * * * for the interests of patients,'' 
together authorize FDA to impose conditions on the investigation of new 
drugs, including conditions related to the interests of patients. 
Section 351 of the Public Health Service Act (42 USC 262) provides 
authority to regulate the labeling and shipment of biological products.

Alternatives: With OMB's concurrence FDA previously published proposed 
and final rules in an attempt to encourage manufacturers to include 
pediatric labeling on drug products for which there was existing safety 
and effectiveness data on pediatric patients. These previous attempts, 
which included a NPRM published on October 16, 1992 (57 FR 47423), and 
a final rule published on December 13, 1994 (59 FR 64240), stopped 
short of requiring studies and have not produced a significant increase 
in pediatric labeling. This final rule will be a step towards 
addressing the current absence of adequate pediatric labeling.

Anticipated Costs and Benefits: Estimated costs will range from $13.5 
million to $20.9 million when implemented. The rule will result in 
fewer adverse reactions in children (i.e., drug reactions that occur 
because of the use of inadvertent drug overdoses or other drug 
administration problems that can be avoided with better information on 
appropriate pediatric use); and will help prevent the under treatment 
of children with potentially safe and effective drug products because 
the physician either prescribed an inadequate dosage regimen, 
prescribed a less effective drug, or did not prescribe a drug, due to 
the physician's uncertainty about whether the drug or the dose was safe 
and effective in children. Approved pediatric indications should 
therefore increase sales of affected products to pediatric patients.

Risks: None.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/15/97                    62 FR 43899
NPRM Comment Period End         11/13/97
Final Action                    10/00/98

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Paula Botstein, Director, Office of Drug Evaluation 
III, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-103), 5600 
Fishers Lane, Room 13B-45, Rockville, MD 20857
Phone: 301 827-3144
Fax: 301 480-3761
Email: botstein@[email protected]

RIN: 0910-AB20
_______________________________________________________________________




995.  REVOCATION OF LATHER BRUSHES REGULATION

Priority:  Info./Admin./Other

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

CFR Citation:  21 CFR 1240.70

Legal Deadline: None

Abstract: The final rule would revoke the regulation pertaining to the 
treatment, sterilization, handling, storage, marking, and inspection of 
lather brushes. The Food and Drug Administration is revoking this 
regulation because the regulation is no longer necessary to protect the 
public health.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/20/97                    62 FR 54398
NPRM Comment Period End         01/05/98
Final Action                    06/00/98

Small Entities Affected: None

Government Levels Affected: None

[[Page 21972]]

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Office of 
Policy (HF-23), 5600 Fishers Lane, Room 15-74, Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 443-6906
Email: [email protected]

RIN: 0910-AB25
_______________________________________________________________________




996.  REMOVAL OF REGULATIONS REGARDING CERTIFICATION OF 
ANTIBIOTIC DRUGS

Priority:  Other Significant

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

Legal Authority:  PL 105-115, sec 125

CFR Citation:  21 CFR 430; 21 CFR 431; 21 CFR 432; 21 CFR 433; 21 CFR 
436; 21 CFR 440; 21 CFR 441; 21 CFR 442; 21 CFR 443; 21 CFR 444; 21 CFR 
446; 21 CFR 448; 21 CFR 450; 21 CFR 452; 21 CFR 453; ...

Legal Deadline: None

Abstract: This direct final rule will remove 21 CFR parts 430 through 
460 (antibiotic monographs and antibiotic certification program 
regulations).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Direct Final Rule               04/00/98

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Christine Rogers, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research (HFD-7), 1451 Rockville Pike, Suite 3047, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB31
_______________________________________________________________________




997.  REVOCATION OF ANTIBIOTIC CERTIFICATION REQUIREMENTS; 
CONFORMING REVISIONS TO REGULATIONS

Priority:  Other Significant

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

Legal Authority:  PL 105-115, sec 125

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: This direct final rule will make conforming changes to 21 CFR 
to remove references to section 507 of the Federal Food, Drug, and 
Cosmetic Act, and references to deleted monograph sections.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Direct Final Rule               06/00/98

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Christine Rogers, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Center for 
Drug Evaluation and Research (HFD-7), 1451 Rockville Pike, Suite 3047, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB32
_______________________________________________________________________




998.  REMOVAL OF REGULATIONS REGARDING CERTIFICATION OF DRUGS 
COMPOSED WHOLLY OR PARTLY OF INSULIN

Priority:  Other Significant

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

Legal Authority:  PL 105-115, sec 125

CFR Citation:  21 CFR 3; 21 CFR 5; 21 CFR 10; 21 CFR 16; 21 CFR 25; 21 
CFR 50; 21 CFR 56; 21 CFR 58; 21 CFR 71; 21 CFR 200; 21 CFR 201; 21 CFR 
210; 21 CFR 211; 21 CFR 310

Legal Deadline: None

Abstract: This direct final rule will remove all regulations dealing 
with the certification of insulin, remove citations to section 506 in 
various authority sections in title 21 of the Code of Federal 
Regulations, eliminate citations to section 506 in regulations that do 
not deal primarily with the certification of insulin, and eliminate 
out-of-date provisions dealing with labeling and testing of insulin.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Direct Final Rule               04/00/98

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB38
_______________________________________________________________________




999.  AMENDMENT OF REGULATIONS REGARDING CERTAIN LABEL 
STATEMENTS ON PRESCRIPTION DRUGS

Priority:  Other Significant

Legal Authority:  PL 105-115, sec 126

CFR Citation:  21 CFR 201; 21 CFR 250; 21 CFR 310; 21 CFR 329; 21 CFR 
361; 21 CFR 369

Legal Deadline: None

Abstract: This direct final rule will revise 21 CFR parts 201, 250, 
310, and 361 by removing the requirement that prescription drugs be 
labeled ``Caution: Federal law prohibits the dispensing without 
prescription'' and substituting a requirement that prescription drugs 
be labeled ``Rx only''. The rule will also revise parts 201, 329, and 
369 by removing the requirement that certain habit-forming narcotics or 
hypnotics bear the statement ``Warning--May be habit forming.''

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Direct Final Rule               07/00/98

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Christine Rogers, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB39

[[Page 21973]]

_______________________________________________________________________




1000.  LIST OF DRUGS THAT HAVE BEEN WITHDRAWN OR REMOVED FROM 
THE MARKET FOR REASONS OF SAFETY AND EFFECTIVENESS

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

Unfunded Mandates: Undetermined

Legal Authority:  PL 105-115

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: Section 127 of the Food and Drug Administration Modernization 
Act of 1997 (Pub. L. 105-115) added section 503A to the Food, Drug and 
Cosmetic Act (21 U.S.C 353a). Section 503A governs the application of 
Federal law to the practice of pharmacy compounding. Section 
503A(b)(1)(C) directs FDA to publish a list of drug products that have 
been withdrawn or removed from the market for reasons of safety or 
effectiveness. Section 503A(d)(1) directs that the list be issued as a 
regulation. Drugs on the list may not be compounded by pharmacists or 
licensed practioners.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/00/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB40
_______________________________________________________________________




1001.  STREAMLINING CLINICAL RESEARCH

Priority:  Other Significant

Legal Authority:  PL 105-115, sec 117

CFR Citation:  21 CFR 312

Legal Deadline: None

Abstract: This direct final rule will amend the clinical hold 
regulations to require the Food and Drug Administration (FDA), in 
situations in which FDA has placed a clinical investigation on clinical 
hold, to respond in writing to a sponsor's written request to lift the 
clinical hold within 30 days of receipt of the request.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Direct Final Rule               06/00/98

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Andrea Masciale, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB41
_______________________________________________________________________




1002.  MEDICAL DEVICES; IDE MODIFICATIONS

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 360j(g)

CFR Citation:  21 CFR 812

Legal Deadline:  Final, Statutory, November 21, 1998.

Abstract: Under the Food and Drug Administration Modernization Act of 
1997 (Pub. L. 105-15). FDA must publish a regulation under which the 
sponsor of a device with an investigational device exemption that is in 
effect may make developmental changes to the device that do not 
constitute a significant change in design or basic principles of 
operation and that are made in response to information gathered during 
the course of the investigation, and changes that do not affect the 
validity of the data, the scientific soundness of the investigational 
plan or the rights, safety or welfare of the human subjects.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Direct Final Rule               11/00/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Devices and Radiological Health (HFZ-215), 1350 Piccard Drive, 
Rockville, MD 20850
Phone: 301 827-2974

RIN: 0910-AB53
_______________________________________________________________________




1003.  DISPUTE RESOLUTION

Priority:  Substantive, Nonsignificant

Unfunded Mandates: Undetermined

Legal Authority:  PL 105-115, sec 404

CFR Citation:  21 CFR 10

Legal Deadline:  Final, Statutory, November 21, 1998.

Abstract: The Food and Drug Administration (FDA) is amending its 
regulations governing the review of agency decisions by inserting a 
statement that a sponsor, applicant, or manufacturer of a drug or 
device may request the review of a scientific controversy by an FDA 
advisory panel or committee. This action is being taken to clarify that 
review of scientific disputes by outside experts and advisory 
committees is available.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Direct Final Rule               11/00/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Suzanne O'Shea, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Office of the 
Commissioner (HF-7), 5600 Fishers Lane, Suite 13C-26, Rockville, MD 
20857
Phone: 301 827-3390

RIN: 0910-AB54

[[Page 21974]]

_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




1004. INFANT FORMULA: GOOD MANUFACTURING PRACTICE, QUALITY CONTROL 
PROCEDURES, QUALITY FACTORS, NOTIFICATION REQUIREMENTS, AND RECORDS AND 
REPORTS

Priority:  Other Significant

Legal Authority:  21 USC 350a

CFR Citation:  21 CFR 107; 21 CFR 106

Legal Deadline: None

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

Timetable:

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

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

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AC46.

Agency Contact: Carolyn W. Miles, Nutritionist, Department of Health 
and Human Services, Food and Drug Administration, Center for Food 
Safety and Applied Nutrition (HFS-456), 200 C Street SW., Washington, 
DC 20204
Phone: 202 401-9858

RIN: 0910-AA04
_______________________________________________________________________




1005. FOOD LABELING REVIEW

Priority:  Routine and Frequent

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

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

Legal Deadline: None

Abstract: The Nutrition Labeling and Education Act of 1990 (NLEA) 
requires that most foods bear nutrition labeling. The agency issued 
final rules implementing most of the provisions contained in the NLEA 
on January 6, 1993. Subsequently, however, the agency has identified 
additional areas that should be the subject of rulemaking. FDA issued a 
proposal on January 6, 1993, to establish requirements for the 
identification of certain ingredients on food labels. FDA proposed on 
June 15, 1993, to amend its January 6, 1993, final rules on nutrient 
content and health claims to remove the provisions that exempted 
restaurant menus from the requirements for how nutrient content claims 
and health claims are to be made. The agency proposed January 4, 1994, 
to establish reference daily intakes based on the 9th and 10th editions 
of the National Research Council's Recommended Dietary Allowances. On 
March 14, 1994, FDA published a proposal describing the provisions for 
exemptions for low-volume food products of small businesses that were 
established by the Nutrition Labeling and Education Act Amendments of 
1993. On August 18, 1993, FDA published a proposal concerning the 
placement of the nutrition facts panel on food labels. Finally, on July 
18, 1994, FDA published proposed revised guidelines for the voluntary 
declaration of nutrition labeling for raw produce and fish. A final 
rule concerning the placement of the nutrition facts panel was 
published on April 5, 1995. A final rule establishing reference daily 
intakes based on the 9th and 10th editions of Recommended Dietary 
Allowances was published on December 28, 1995.
FDA published a final rule on August 2, 1996, on nutrient content 
claims and health claims to remove the provisions that exempted 
restaurant menus from the requirements for how nutrient content claims 
and health claims are to be made. FDA published a final rule on August 
7, 1996, describing provisions for an exemption for small businesses 
from the requirements for nutrition labeling and providing instructions 
on how to file a notice claiming the exemption. FDA published on August 
16, 1996, final guidelines in the voluntary declaration of nutrition 
labeling for raw produce and fish.

Timetable:

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

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

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

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

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

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

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

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

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

Voluntary Guidelines for Nutrition Labeling Produce  NPRM 07/18/94 (59 
FR 36379)  Final Action 08/16/96 (61 FR 42742)

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Additional Information: Previously reported under RIN 0905-AD89.

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

RIN: 0910-AA19
_______________________________________________________________________




1006. MEDICAL FOODS

Priority:  Other Significant

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

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: The Food and Drug Administration is considering development 
of regulations for medical foods, as defined by the Orphan Drug Act 
Amendments of 1988 (21 USC

[[Page 21975]]

360ee(b)(3)) to assure, among other things, the safety and 
effectiveness of these products, proper labeling of the nutrient 
content and purported uses, including adequate and appropriate 
directions for use, and quality control and good manufacturing 
practices.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           11/29/96                    61 FR 60661
ANPRM Comment Period End        04/28/97
NPRM                            00/00/00

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Additional Information: Previously reported under RIN 0905-AD91.

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

RIN: 0910-AA20
_______________________________________________________________________




1007. AMALGAM INGREDIENT LABELING

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 352

CFR Citation:  21 CFR 801

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE39.

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

RIN: 0910-AA33
_______________________________________________________________________




1008. CLASSIFICATION OF COMPUTER SOFTWARE PROGRAMS THAT ARE MEDICAL 
DEVICES

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

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 321(h); 21 USC 351; 21 USC 352; 21 USC 360; 21 
USC 360c to 360l; 21 USC 371 to 374

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: FDA is considering whether to classify stand-alone computer 
software products that fit the definition of a medical device under the 
Federal Food, Drug, and Cosmetic Act. Although the Secretary has not 
made a final decision to initiate such a program, the Agency is 
considering classifying these devices by using a risk-based approach as 
required under the Medical Device Amendments to the act. In addition, 
the agency would use existing exemptions from regulation where 
appropriate. Under this approach, low risk medical software devices 
would be subject only to the adulteration and misbranding provisions of 
the act. Moderate risk devices would additionally be subject to the 
registration, listing, good manufacturing practice requirements, and 
reporting and recordkeeping requirements. High risk devices would be 
the only products to require premarket submissions. FDA is also seeking 
comment on potential criteria related to the intended uses of medical 
software devices that might be used in determining the level of risk.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE58.

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

RIN: 0910-AA41
_______________________________________________________________________




1009. REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN 
COMMERCIAL DISTRIBUTION

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

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

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

CFR Citation:  21 CFR 207

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Lee D. Korb, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Center for Drug 
Evaluation and Research (HFD-7), 1451 Rockville Pike, Suite 3047, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA49
_______________________________________________________________________




1010. REINVENTING FDA FOOD REGULATIONS

Priority:  Substantive, Nonsignificant

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

[[Page 21976]]

Legal Authority:  15 USC 1453; 15 USC 1454; 15 USC 1455; 21 USC 321 et 
seq

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

Legal Deadline: None

Abstract: In response to President Clinton's memorandum to heads of 
departments and agencies entitled ``Regulatory Reinvention 
Initiative,'' FDA has initiated rulemaking to retain, revise, or revoke 
certain of its regulations for food. FDA published an advance notice of 
proposed rulemaking (ANPR) on December 29, 1995, requesting information 
on the need to retain, revise, or revoke its food standards of identity 
regulations and its common or usual name regulations. In the same issue 
of the Federal Register FDA proposed to improve the coordination of the 
food additive, GRAS, and color additive approval process with USDA for 
substances used in meat and poultry products. FDA proposed to revoke 
several lower fat milk standards on November 9, 1995. On June 12, 1996, 
FDA published an ANPR announcing its intention to review (1) its human 
food labeling regulations pertaining to the exemption for soft drinks 
from requirements for the type size and placement of certain 
information on the information panel, requirements for listing 
``statements of identity,'' and requirements for flavor labeling; (2) 
its infant formula regulations to ensure that they fully reflect the 
Federal Food, Drug, and Cosmetic Act; (3) its regulations pertaining to 
the discharge of waste aboard casino ships, passenger ships, and 
ferries; and (4) its food additive regulations to consolidate certain 
existing regulations. In the same June 12 issue of the Federal 
Register, FDA published a second ANPR seeking public comment on 
possible ways to streamline various food additive regulations. FDA also 
proposed on June 12, 1996, to revoke certain food labeling regulations 
pertaining to labeling of food with number of servings and labeling 
Kosher and Kosher-style foods and to revoke the agency's voluntary 
filing of cosmetic product experiences. The latter was published August 
12, 1997.
On October 13, 1995, FDA proposed to revoke certain agency regulations 
that were obsolete or no longer necessary to achieve public health 
goals. The final rule (pertaining to food regulations only) published 
on June 3, 1996. A confirmation of effective date (CED) on those 
regulations promulgated under the formal rulemaking procedures of 
section 701(e) of the Federal Food, Drug, and Cosmetic Act (21 USC 
371(e)) pertaining to diabetic labeling (21 CFR 105.67) and sodium 
intake (cont)

Timetable:

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

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

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

Food, Color, and GRAS; Simult. Pet. Rev. by USDA (Meat/Poultry)  NPRM 
12/29/95 (60 FR 67490)  Comment Period End 03/14/96  Extension of 
Comment Period 06/03/96  Final Action 00/00/00

Notification Procedures for Independent GRAS Determinations  NPRM 04/
17/97 (62 FR 18938)  NPRM Comment Period End 07/16/97  Final Action 00/
00/00

Revocation of Certain Food Labeling and Cosmetic Regulations  NPRM 06/
12/96 (61 FR 29708)  Comment Period Ends 08/26/96  Final Action 08/12/
97 (62 FR 43071)

Revocation of Lower Fat Milk Standards  NPRM 11/09/95 (60 FR 
56541)  Comment Period Ends 01/23/96  Partial Final 11/20/96 (61 FR 
58991)  Confirmation of Effective Date 02/24/97 (62 FR 8163)

Revocation of Lower Fat Yogurt Standards  NPRM 11/09/95 (60 FR 
56541)  Confirmation of Effective Date 00/00/00  Final Action (Yogurt) 
00/00/00

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

Small Entities Affected: Businesses

Government Levels Affected: State

Additional Information: ABSTRACT CONT: labeling (21 CFR 105.69) was 
published on August 27, 1996.
In the Federal Register of April 17, 1997 (62 FR 18938), FDA proposed 
to establish a notification procedure for companies to use inform FDA 
of a company's determination that use of a substance in food is 
generally recognized as safe (GRAS).

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

RIN: 0910-AA58
_______________________________________________________________________




1011. REINVENTION OF ADMINISTRATIVE PROCEDURES REGULATIONS

Priority:  Other Significant

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

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

[[Page 21977]]

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Tribal, Federal

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

RIN: 0910-AA69
_______________________________________________________________________




1012. LONG-TERM CONTRACEPTIVE DRUG PRODUCTS AND MEDICAL DEVICES; 
INFORMED CONSENT REQUIREMENTS

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

Unfunded Mandates: Undetermined

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

CFR Citation:  21 CFR 201; 21 CFR 801

Legal Deadline: None

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

Timetable: Next Action Undetermined

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Carol Drew, Regulatory Counsel, Department of Health 
and Human Services, Food and Drug Administration, Center for Drug 
Evaluation and Research (HFD-7), 1451 Rockville Pike, Suite 3047, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA75
_______________________________________________________________________




1013. DEBARMENT CERTIFICATION REGULATIONS FOR DRUG APPLICATIONS

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

Unfunded Mandates: Undetermined

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

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

Legal Deadline: None

Abstract: The proposed rule would amend the regulations to require 
applicants to submit a debarment certification statement in accordance 
with 21 U.S.C. 335a(k).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Leanne Cusumano, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA76
_______________________________________________________________________




1014. INVESTIGATIONAL NEW DRUG APPLICATIONS; REQUEST FOR INFORMATION AND 
COMMENTS

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

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

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

CFR Citation:  21 CFR 56; 21 CFR 312

Legal Deadline: None

Abstract: This rulemaking would permit certain uses of investigational 
new drugs by individual investigators who are not included in a 
commercial sponsor's application provided that, among other things, the 
drugs are in Phase 2 of commercial development.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Joseph Griffin, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 594-5562

RIN: 0910-AA83
_______________________________________________________________________




1015. INVESTIGATIONAL NEW ANIMAL DRUG REGULATIONS

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

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

Legal Authority:  21 USC 321; 21 USC 351; 21 USC 353; 21 USC 360b; 21 
USC 371; 21 USC 381

CFR Citation:  21 CFR 511; 21 CFR 512

Legal Deadline: None

Abstract: FDA is proposing to revise its regulations governing 
investigational use of new animal drugs by proposing to delete 21 CFR 
511 and establish in 21 CFR part 512 revised investigational use new 
animal drug regulations. The investigational use new animal drug 
regulations are expected to include regulations to implement provisions 
of the Animal Drug Availability Act of 1996, specifically presubmission 
conferences, and implement parts of the President's National 
Performance Report ``Reinventing the Regulation of Animal Drugs,'' May 
1996. In the reinventing regulations report, FDA

[[Page 21978]]

proposed to revise its regulations to reflect numerous new process 
changes and programs that will enable a more streamlined animal drug 
application review and approval process, and which would result in less 
regulatory burden upon industry and FDA while maintaining safety and 
effectiveness of new animal drugs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           11/21/96                    61 FR 59209
ANPRM Comment Period End        01/21/97
NPRM                            12/00/99

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Marty Schoenemann, Department of Health and Human 
Services, Food and Drug Administration, Center for Veterinary Medicine 
(HFV-120), 7500 Standish Place, Rockville, MD 20855
Phone: 301 827-0220

RIN: 0910-AB02
_______________________________________________________________________




1016. NEW DRUGS FOR HUMAN USE; CLARIFICATION OF REQUIREMENTS FOR PATENT 
HOLDER NOTIFICATION

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

Unfunded Mandates: Undetermined

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

CFR Citation:  21 CFR 314

Legal Deadline: None

Abstract: This proposed rule would clarify the methods by which 
application holders may provide notice to patent holders.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/06/98                    63 FR 11174
NPRM Comment Period End         06/04/98
Final Action                    00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Leanne Cusumano, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB12
_______________________________________________________________________




1017. ADMINISTRATIVE PRACTICES AND PROCEDURES; ADVISORY OPINIONS AND 
GUIDELINES

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

Unfunded Mandates: Undetermined

Legal Authority:  15 USC 1451 to 1461; 21 USC 41 to 50; 21 USC 141 to 
149; 21 USC 321 to 394; 21 USC 467f; 21 USC 679; 21 USC 821; 21 USC 
1034; 42 USC 201; 42 USC 262; 42 USC 263b; 42 USC 264

CFR Citation:  21 CFR 10; 21 CFR 808

Legal Deadline: None

Abstract: This proposed rule would amend FDA regulations in 21 CFR part 
10 concerning advisory opinions and guidelines to provide consistency 
with the agency's Good Guidance Practices and applicable case law.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Andrea Masciale, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB14
_______________________________________________________________________




1018.  PREGNANCY LABELING REVISION

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

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 
USC 353; 21 USC 355; 21 USC 357; 21 USC 358; 21 USC 360; 21 USC 360b; 
21 USC 360gg to 360ss; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216; 
...

CFR Citation:  21 CFR 201

Legal Deadline: None

Abstract: This advance notice of proposed rulemaking will announce that 
the Food and Drug Administration is considering ways to revise the 
regulatory requirements for the pregnancy labeling subsection of the 
labeling requirements for human drugs and biologics. The notice will 
make available preliminary proposals for changing the current 
requirements and will invite comments on all aspects of the notice.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Joseph Griffin, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB44

[[Page 21979]]

_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Food and Drug Administration (FDA)



_______________________________________________________________________




1019. IMPLEMENTATION OF THE SAFE MEDICAL DEVICES ACT OF 1990

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

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Replaced by Food and 
Drug Administration 
Modernization Act               01/28/98

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Federal

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

RIN: 0910-AA09
_______________________________________________________________________




1020. MAMMOGRAPHY QUALITY STANDARDS ACT OF 1992

Priority:  Other Significant. Major under 5 USC 801.

Unfunded Mandates: This action may affect State, local or tribal 
governments and the private sector.

CFR Citation:  21 CFR 900

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/28/97                    62 FR 55852
Final Action Effective          04/28/99

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Local, Federal

Agency Contact: Ruth Fischer
Phone: 301 594-3311

RIN: 0910-AA24
_______________________________________________________________________




1021. FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS

Priority:  Other Significant

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; ...

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    02/02/98                     63 FR 5233

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Mary Gross
Phone: 301 827-3440
Fax: 301 594-0113

RIN: 0910-AA30
_______________________________________________________________________




1022. HABIT-FORMING DRUGS

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

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

CFR Citation:  21 CFR 329

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Replaced by FDAMA   01/30/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Wayne H. Mitchell
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA50
_______________________________________________________________________




1023. REVOCATION OF CERTAIN REGULATIONS

Priority:  Other Significant

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

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/23/97                    62 FR 39439

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: Lisa M. Helmanis
Phone: 301 443-3480
Fax: 301 443-2946

RIN: 0910-AA54
_______________________________________________________________________




1024. INVESTIGATIONAL NEW DRUG APPLICATIONS; CLINICAL HOLDS

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

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

CFR Citation:  21 CFR 312

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Replaced by FDAMA 
sec 117 Regulations             01/30/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Joseph Griffin
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA73
_______________________________________________________________________




1025. CERTIFICATION OF DRUGS COMPOSED WHOLLY OR PARTLY OF INSULIN

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

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

CFR Citation:  21 CFR 200; 21 CFR 429

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Replaced by FDAMA 
sec 125.                        01/30/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Wayne Mitchell
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA77

[[Page 21980]]

_______________________________________________________________________




1026. INVESTIGATIONAL NEW DRUG APPLICATIONS AND NEW DRUG APPLICATIONS

Priority:  Other Significant

CFR Citation:  21 CFR 312; 21 CFR 314

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    02/11/98                     63 FR 6854

Small Entities Affected: Businesses, Organizations

Government Levels Affected: Federal

Agency Contact: Nancy E. Derr
Phone: 301 594-5408
Fax: 301 594-6197

RIN: 0910-AA82
_______________________________________________________________________




1027. POSTMARKETING PERIODIC ADVERSE EXPERIENCE REPORTING REQUIREMENTS 
FOR HUMAN DRUG AND LICENSED BIOLOGICAL PRODUCTS

Priority:  Other Significant

CFR Citation:  21 CFR 314; 21 CFR 600

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Merged With RIN 0910-AA97       01/30/98

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Audrey Thomas
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA85
_______________________________________________________________________




1028. NEW DRUGS FOR HUMAN USE; CLARIFICATION OF REQUIREMENTS FOR 
APPLICATION SUPPLEMENTS

Priority:  Substantive, Nonsignificant

CFR Citation:  21 CFR 314

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Replaced by FDAMA 
sec 116                         01/30/98

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Thomas Kuchenberg
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA87
_______________________________________________________________________




1029. DEFINITION OF ADEQUATE AND WELL-CONTROLLED STUDIES

Priority:  Substantive, Nonsignificant

CFR Citation:  21 CFR 514.117

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/05/98                    63 FR 10765

Small Entities Affected: None

Government Levels Affected: Undetermined

Agency Contact: Marty Schoenemann
Phone: 301 827-0220

RIN: 0910-AB01
_______________________________________________________________________




1030. FDA EXPORT REFORM AND ENHANCEMENT ACT OF 1996; REPORTING AND 
RECORDKEEPING REQUIREMENTS FOR UNAPPROVED OR VIOLATIVE PRODUCTS IMPORTED 
FOR FURTHER PROCESSING OR INCORPORATION AND LATER EXPORT

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Duplicate of 0910-
AB24                            02/26/98

RIN: 0910-AB06
_______________________________________________________________________




1031. CLARIFICATION OF THE SCOPE OF TREATMENT USES WITH INVESTIGATIONAL 
NEW DRUGS THAT CAN BE AUTHORIZED UNDER INDS AND THE CRITERIA FOR 
CHARGING FOR INVESTIGATIONAL NEW DRUGS UNDER INDS

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

Unfunded Mandates: Undetermined

CFR Citation:  21 CFR 312

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Replaced by FDAMA 
sec 402                         01/30/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Joseph Griffin
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB11
_______________________________________________________________________




1032. PRESCRIPTION DRUG COMPOUNDING

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

Unfunded Mandates: Undetermined

CFR Citation:  21 CFR 201; 21 CFR 207; 21 CFR 211; 21 CFR 310; 21 CFR 
314

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Replaced by FDAMA 
sec 127                         01/30/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Richard Schwartzbard
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB13
_______________________________________________________________________




1033.  REVOCATION OF REGULATION ON POSITRON EMISSION TOMOGRAPHY 
DRUG PRODUCTS

Priority:  Other Significant

Legal Authority:  PL 105-115, sec 121

CFR Citation:  21 CFR 211

Legal Deadline:  Final, Statutory, December 21, 1997.

Abstract: This final rule revokes a regulation on positron emission 
tomography (PET) radiopharmaceutical drug products. The regulation 
permitted the Food and Drug Administration to approve requests from 
manufacturers of PET drugs for exceptions or alternatives to provisions 
of the current good manufacturing practice regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action Mandated by the 
Food and Drug Modernization Act.12/19/97                    62 FR 66522
Final Action Effective          12/21/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Brian L. Pendleton, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-7), 1451 
Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041

[[Page 21981]]

Fax: 301 827-5562

RIN: 0910-AB46
_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1034. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON 
PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: CORPORATE SHIELD

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 11131

CFR Citation:  45 CFR 60

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/98

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0906-AA41
_______________________________________________________________________




1035. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON 
PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: REPORTING ADVERSE AND 
NEGATIVE ACTIONS

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396r-2, note

CFR Citation:  45 CFR 60

Legal Deadline: None

Abstract: Public Law 100-93 amended section 1921 of the Social Security 
Act to require that each State have in effect a system of reporting 
disciplinary licensure actions taken against all licensed health care 
practitioners and entities. It also requires States to report any 
negative action or finding which a peer review organization, private 
accreditation entity or a State has concluded against a health care 
practitioner or entity. Section 1921 directs the Secretary to provide 
for maximum appropriate coordination in the implementation of these 
reporting requirements with those of the Health Care Quality 
Improvement Act of 1986 (title IV of Public Law 99-660).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/98

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, Parklawn 
Building, Room 8A-55, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 443-2300

RIN: 0906-AA43
_______________________________________________________________________




1036. DESIGNATION OF MEDICALLY UNDERSERVED POPULATIONS AND HEALTH 
PROFESSIONAL SHORTAGE AREAS

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 254b; 42 USC 254e

CFR Citation:  42 CFR 5; 42 CFR 51c

Legal Deadline: None

Abstract: This rule would consolidate the process for designating areas 
of health professional shortage and medical underservice that apply in 
several department programs, and would improve the criteria for 
designating medically underserved populations (MUPs) and Primary Care 
Health Professional Shortage Areas (HPSAs).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/98
NPRM Comment Period End         07/00/98

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Richard Lee, Public Health Analyst, Bureau of Primary 
Health Care, Department of Health and Human Services, Health Resources 
and Services Administration, 4350 East-West Highway, Bethesda, MD 20814
Phone: 301 594-4280

RIN: 0906-AA44
_______________________________________________________________________




1037. HEALTH CARE FRAUD AND ABUSE DATA COLLECTION PROGRAM

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1320a-7e

[[Page 21982]]

CFR Citation:  42 CFR 61 (New)

Legal Deadline:  Final, Statutory, January 1, 1997.

Abstract: This proposed rule would implement the requirements of 
section 1128E of the Social Security Act, as added by section 221(a) of 
the Health Insurance Portability and Accountability Act of 1996. 
Section 1128E of the Act directs the Department to establish a national 
health care fraud and abuse data collection program for the reporting 
and disclosure of certain final adverse actions taken against health 
care providers, suppliers and practitioners. The statute also requires 
the Department to implement the national health care fraud and abuse 
data collection program in such a manner as to avoid with reporting 
requirements established for the National Practitioner Data Bank under 
the Health Care Quality Improvement Act of 1986.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/98
NPRM Comment Period End         10/00/98

Small Entities Affected: None

Government Levels Affected: Undetermined

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

RIN: 0906-AA46
_______________________________________________________________________




1038. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON 
PHYSICIANS AND OTHER HEALTH CARE PROVIDERS: CLARIFICATION AND 
MODERNIZATION OF REGULATORY TERMS

Priority:  Substantive, Nonsignificant

Legal Authority:  45 USC 11101 to 11152

CFR Citation:  45 CFR 60

Legal Deadline: None

Abstract: Since the opening of the Data Bank, the Department has 
received feedback that several terms defined in the regulations have 
caused confusion. These items include ``health care entity'', ``formal 
peer review process'', and ``clinical privileges''. Based on this 
feedback, the Department reviewed the Health Care Quality Improvement 
Act of 1986 and its regulations. Through this review, the Department 
recognizes the need to clarify and/or broaden certain definitions due 
to the rapid evolution of the health care system in order to fully 
implement Congressional intent, which was to give access to Data Bank 
information to those health care organizations reviewing the quality of 
physician care in order to protect patients from incompetent 
practitioners with previous damaging or incompetent performance.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/98

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, Parklawn 
Building, Room 8-A55, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 443-2300

RIN: 0906-AA48
_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1039. ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK RULES

Priority:  Other Significant. Major under 5 USC 801.

Legal Authority:  42 USC 1320b-8 sec 1138 of the Social Security Act; 
42 USC 274 sec 372 of the Public Health Service Act; 42 USC 274b sec 
374 of the Public Health Service Act; 42 USC 216 sec 215 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.

Statement of Need: These regulations are needed to establish a legally 
binding framework for the operation of the OPTN and for participation 
in the OPTN by transplant hospitals and OPOs.

Summary of the Legal Basis: Section 215 of the Public Health Service 
Act, along with the provision of sections 372 and 374 of the Act (42 
USC 216, 274 and 274, respectively) provide authority to issue OPTN 
regulations. In addition section 1138 of the Social Security Act (42 
USC 1320b-8) 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 
(42 USC 274).

Alternatives: The alternative was to continue without codifying 
existing policies.

Anticipated Costs and Benefits: There are no anticipated costs beyond 
the cost

[[Page 21983]]

of preparing the regulations (approximately $100,000.00). The 
anticipated benefit is that the regulations will make mandatory 
adherence to the policies set forth in the regulations.

Risks: None known.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/08/94                    59 FR 46482
NPRM Comment Period End         12/07/94
Final with Comment Period       04/02/98                    63 FR 16296
Comment Period End              06/01/98

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD26.
Sections 215, 372, and 374 of the PHS Act provide general authority to 
regulate the activities of the Organ Procurement and Transplantation 
Network (OPTN) established under section 372.

Agency Contact: Jon Nelson, Acting Director, Division of 
Transplantation, Office of Special Programs, Department of Health and 
Human Services, Health Resources and Services Administration, Room 7-29 
Parklawn Bldg., 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 443-7577

RIN: 0906-AA32
_______________________________________________________________________




1040.  NATIONAL VACCINE INJURY COMPENSATION PROGRAM: EFFECTIVE 
DATE PROVISIONS OF COVERAGE OF CERTAIN VACCINES TO THE VACCINE INJURY 
TABLE

Priority:  Info./Admin./Other

Legal Authority:  42 USC 300aa.15(a)(3)(B)

CFR Citation:  42 CFR 100

Legal Deadline: None

Abstract: Section 904(b) of the Taxpayer Relief Act of 1997 provides 
for an excise tax for three new vaccines, effective August 6, 1997, and 
petitions for compensation for injuries or deaths related to hepatitis 
B, Hib, and varicella vaccines may now be filed under the VICP. This 
technical amendment (final rule) will amend the CFR to include a date 
certain (August 6, 1997) in section 100.3(c), so that there will be no 
uncertainty as to the coverage of these three vaccines.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/00/98

Small Entities Affected: Undetermined

Government Levels Affected: None

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

RIN: 0906-AA49
_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1041. DRUG PRICING PROGRAM: PRIME VENDOR USER CHARGE

Priority:  Routine and Frequent

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

Legal Authority:  PL 102-585

CFR Citation:  45 CFR 8

Legal Deadline: None

Abstract: This rule proposes to include a user charge (not over 1/2 of 
1% of total drug sale revenue) to be paid by the prime vendor to HRSA. 
It is intended to cover costs that HRSA incurs in providing information 
and services essential to prime vendor operations.

Timetable: Next Action Undetermined

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jimmy Mitchell, Acting Director, Office of Drug 
Pricing, Department of Health and Human Services, Health Resources and 
Services Administration, 4350 East/West Highway, Bethesda, MD 20814
Phone: 301 594-4353
Fax: 301 594-4992

RIN: 0906-AA45
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1042. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON 
PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: CHARGE FOR SELF-QUERIES

Priority:  Info./Admin./Other

CFR Citation:  45 CFR 60

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/24/98                    63 FR 14059

Small Entities Affected: None

Government Levels Affected: None

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

RIN: 0906-AA42
_______________________________________________________________________




1043. GRANTS FOR RESIDENCY TRAINING AND ADVANCED EDUCATION IN THE 
GENERAL PRACTICE OF DENTISTRY; TECHNICAL AMENDMENTS

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 57 subpart L

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/01/97                    62 FR 51373

Small Entities Affected: None

[[Page 21984]]

Government Levels Affected: None

Agency Contact: Bernice Parlak
Phone: 301 443-6853
Fax: 301 443-1164

RIN: 0906-AA47
  
_______________________________________________________________________


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


Indian Health Service (IHS)



_______________________________________________________________________




1044. ACQUISITION UNDER THE BUY INDIAN ACT

Priority:  Substantive, Nonsignificant

Legal Authority:  25 USC 47

CFR Citation:  48 CFR ch 3, app A

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/98

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: Previously reported under RIN 0905-AE09.

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

RIN: 0917-AA00
_______________________________________________________________________




1045. INDIAN CHILD PROTECTION AND FAMILY VIOLENCE PREVENTION ACT MINIMUM 
STANDARDS OF CHARACTER

Priority:  Info./Admin./Other

Legal Authority:  25 USC 3201 et seq

CFR Citation:  42 CFR 36

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/98
NPRM Comment Period End         09/00/98

Small Entities Affected: None

Government Levels Affected: Tribal

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

RIN: 0917-AA02
_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




1046. NATIONAL INSTITUTES OF HEALTH AIDS RESEARCH LOAN REPAYMENT PROGRAM

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 68

Legal Deadline: None

Abstract: Section 487A of the Public Health Service Act creates a 
program through which appropriately qualified health professionals may 
obtain federally funded repayment of educational loans by conducting 
AIDS research as NIH employees.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: Previously reported under RIN 0905-AD18.

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Blvd., Room 601, MSC 7669, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA02
_______________________________________________________________________




1047. UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING PROFESSIONS NEEDED BY 
THE NIH

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 68b

Legal Deadline: None

Abstract: Section 487D of the Public Health Service Act, as added by 
the National Institutes of Health Revitalization Act of 1993, creates a 
program offering scholarships, in an amount not to exceed $20,000 per 
year of academic study, to individuals from disadvantaged backgrounds 
who are enrolled as full-time students at accredited institutions 
pursuing academic programs appropriate for careers in professions 
needed by the

[[Page 21985]]

NIH. For each year of scholarship support, the recipient agrees to 
service (employment) after graduation, at the NIH, for one year. 
Additionally, the individual agrees to at least ten consecutive weeks 
of service (employment) a the NIH during which the individual is 
attending the institution and receiving the NIH scholarship. The 
proposed new regulations will cover this program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/98

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE57.

Agency Contact: Jerry Moore, NIH Regulations Officer Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Blvd., Room 601, MSC 7669, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169

RIN: 0925-AA10
_______________________________________________________________________




1048. TRAINEESHIPS

Priority:  Info./Admin./Other

Legal Authority:  42 USC 216; 42 USC 283g(d)(2); 42 USC 284(b)(1)(C); 
42 USC 286b-3

CFR Citation:  42 CFR 63

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/98

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE62.

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Blvd., Room 601, MSC 7669, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA11
_______________________________________________________________________




1049. ADDITIONAL DHHS PROTECTIONS FOR PREGNANT WOMEN AND HUMAN FETUSES 
INVOLVED AS SUBJECTS IN RESEARCH, AND PERTAINING TO HUMAN IN VITRO 
FERTILIZATION

Priority:  Other Significant

Legal Authority:  5 USC 301; 42 USC 289

CFR Citation:  45 CFR 46, subpart B

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Michele Russell-Einhorn, J.P., Director of Regulatory 
Affairs, Department of Health and Human Services, National Institutes 
of Health, Office for Protection from Research Risks, 6100 Executive 
Blvd., Ste. 3B01, MSC 7507, Rockville, MD 20892-7507
Phone: 301 435-5649
Fax: 301 402-2071

RIN: 0925-AA14
_______________________________________________________________________




1050. NATIONAL RESEARCH SERVICE AWARDS

Priority:  Info./Admin./Other

Legal Authority:  42 USC 216; 42 USC 288

CFR Citation:  42 CFR 66

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/98

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6100 
Executive Blvd., Room 601, MSC 7669, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA16
_______________________________________________________________________




1051. REMOVAL OF NATIONAL CANCER INSTITUTE CLINICAL CANCER EDUCATION 
PROGRAM

Priority:  Info./Admin./Other

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

Legal Authority:  42 USC 216

CFR Citation:  42 CFR 52d

Legal Deadline: None

Abstract: Current regulations relating to the National Cancer Institute 
Clinical Cancer Education Program will be rescinded because the 
regulations are obsolete. Current guidelines communicated by NCI with 
respect to the care of cancer patients no longer reflect the type of 
program described in the current regulations. This action will not 
affect the authority of the Director, NCI, to support appropriate 
programs of education and training, including clinical research 
training set forth in section 414 of the Public Health Service Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/98

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Blvd., Room 601, MSC 7669, Rockville, MD 20852
Phone: 301 496-4606

[[Page 21986]]

Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA17
_______________________________________________________________________




1052. NATIONAL INSTITUTES OF HEALTH LOAN REPAYMENT PROGRAM FOR RESEARCH

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 216; 42 USC 288-3

CFR Citation:  42 CFR 68d

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/98

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Blvd., Room 601, MSC 7669, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 496-0125
Email: [email protected]

RIN: 0925-AA18
_______________________________________________________________________




1053. NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT 
CONTRACEPTION AND INFERTILITY RESEARCH LOAN REPAYMENT PROGRAM

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 216; 42 USC 288-2

CFR Citation:  42 CFR 68c

Legal Deadline: None

Abstract: Section 487B of the Public Health Service Act creates a 
program through which appropriately qualified health professionals may 
obtain federally funded repayment of education loans by conducting 
research with respect to contraception and/or infertility. The initial 
implementation of the program will be limited to employees of the three 
NICHD Contraception Research Centers and two NICHD Infertility Research 
Centers due to limited availability of funds.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/98

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Blvd., Room 601, MSC 7669, Rockville, MD 20852
Phone: 301 496-4607
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA19
_______________________________________________________________________




1054. SCIENTIFIC PEER REVIEW OF RESEARCH GRANT APPLICATIONS AND RESEARCH 
AND DEVELOPMENT CONTRACT PROJECTS

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 216; 42 USC 282(b)(6); 42 USC 284(c)(3); 42 
USC 289a; 42 USC 290aa-3

CFR Citation:  42 CFR 52h

Legal Deadline: None

Abstract: NIH staff have been reexamining the peer review process as 
part of its reinvention initiatives and have found ambiguities, 
misstatements, and voids in the existing regulations governing peer 
review in NIH, SAMHSA, and HRSA. These regulations, which govern the 
first level of review, would be amended to reflect current policies and 
procedures.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/98

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Blvd., Room 601, MSC 7669, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA20
_______________________________________________________________________




1055.  FEDERAL POLICY (COMMON RULE) FOR THE PROTECTION OF HUMAN 
SUBJECTS

Priority:  Other Significant

Legal Authority:  5 USC 301; 42 USC 289; 42 USC 300v-1(b)

CFR Citation:  45 CFR 46

Legal Deadline: None
The President's Memorandum prohibits agencies fromconducting or 
supporting classified human subject research without having proposed 
and promulaged the Common Rule and the changes.

Abstract: In compliance with the President's Memorandum of March 27, 
1997, this proposed rule would amend the Federal Policy (Common Rule) 
for the Protection of Human Subjects to add a new section that applies 
only to classified research involving human subjects. The new section 
would modify the Federal Policy by (1) prohibiting any executive branch 
agency from engaging in classified research involving human subjects 
unless the agency has adopted the Federal Policy and the proposed rule; 
(2) eliminating the availability of waiver of informed consent and 
expedited review for classified research involving human subjects; (3) 
enhancing the informed consent requirements and allowing for disclosure 
of classified information if necessary; and (4) changing the 
composition of the institutional review board (IRB) and establishing a 
process for individual IRM members to appeal from any IRB approvals of 
classified research.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/98

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Michele Russell-Einhorn, J.D., Director of Regulatory 
Affairs, Department of Health and Human Services, National Institutes 
of Health, Office for Protection from Research Risks, 6100 Executive 
Blvd., Room 3B01, MSC 7505, Rockville, MD 29852
Phone: 301 496-7005

[[Page 21987]]

Fax: 301 402-2071

RIN: 0925-AA21
_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




1056. NATIONAL INSTITUTES OF HEALTH CONSTRUCTION GRANTS

Priority:  Other Significant

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

Legal Authority:  42 USC 216; 42 USC 285a-2; 42 USC 285a-3; 42 USC 
285b-3; 42 USC 285b-4; 42 USC 285d-6; 42 USC 285i; 42 USC 285m-3; 42 
USC 285o-4; 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 make them generally applicable 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 Public 
Health Service Act section numbers, and update the listing of other HHS 
regulations relevant to contruction grants.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/06/95                    60 FR 35266
NPRM Comment Period End         09/05/95
Final Action                    09/00/98

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD49.

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Blvd., Room 601, MSC 7669, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA04
_______________________________________________________________________




1057. NATIONAL INSTITUTES OF HEALTH CLINICAL RESEARCH LOAN REPAYMENT 
PROGRAM FOR INDIVIDUALS FROM DISADVANTAGED BACKGROUNDS

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 68a

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/10/97                     62 FR 5953
NPRM Comment Period End         04/11/97
Final Action                    09/00/98

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE56.

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Blvd., Room 601, MSC 7669, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA09
_______________________________________________________________________




1058.  SERVICE FELLOWSHIP

Priority:  Other Significant

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

Legal Authority:  42 USC 209; 42 USC 210; 42 USC 216

CFR Citation:  42 CFR 61, subpart B

Legal Deadline: None

Abstract: This interim final rule amends the regulations governing 
service fellowships by revising the current authority citation, 
extending the time limitation on initial appointments from 2 to 5 
years, permitting extensions of appointments for up to 5 years rather 
than year-to-year, and removing obsolete references to the Surgeon 
General and obsolete requirements regarding the qualifications of 
applicants. These changes are being made to provide HHS health agencies 
with greater flexibility to recruit and retain their talented 
scientists and to update obsolete references.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/00/98
Final Action                    06/00/98

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Jerry Moore, NIH Regulations Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Blvd., Room 601, MSC 7669, Rockville, MD 20852
Phone: 301 496-4606
Fax: 301 402-0169
Email: [email protected]

RIN: 0925-AA22

[[Page 21988]]

_______________________________________________________________________


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


Office of Assistant Secretary for Health (OASH)



_______________________________________________________________________




1059. STANDARDS OF COMPLIANCE FOR ABORTION-RELATED SERVICES IN FAMILY 
PLANNING SERVICE PROJECTS

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 300a-4

CFR Citation:  42 CFR 59

Legal Deadline: None

Abstract: This rule would return the Family Planning Service Program, 
funded under title X of the Public Health Service Act, to the 
regulatory standard operative prior to February 2, 1988, with regard to 
the statutory provision prohibiting abortion as a method of family 
planning in projects funded under that title.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: State

Additional Information: Previously reported under RIN 0905-AE03.

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

RIN: 0937-AA00
_______________________________________________________________________


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


Public Health Service (PHS)



_______________________________________________________________________




1060. PUBLIC HEALTH SERVICE STANDARDS FOR THE PROTECTION OF RESEARCH 
MISCONDUCT WHISTLEBLOWERS

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 216; 42 USC 241; 42 USC 289b

CFR Citation:  42 CFR 94

Legal Deadline: None

Abstract: To implement section 493(e) of the Public Health Service Act 
(added by section 163 of the National Institutes of Health 
Revitalization Act of 1993, Public Law 103-43), the Department is 
proposing to add new part 94 to title 42 of the Code of Federal 
Regulations. Under this proposed regulation, covered institutions must 
follow certain requirements for preventing and responding to 
occurrences of retaliation against whistleblowers. The purpose of this 
part is to protect: (1) persons who make a good faith allegation that a 
covered institution or member thereof engaged in, or failed to (2) 
persons who cooperate in good faith with an investigation of research 
misconduct.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/98
NPRM Comment Period End         09/00/98

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State

Agency Contact: Barbara Bullman, Policy Analyst, OPHS, Office of 
Research Integrity, Department of Health and Human Services, Public 
Health Service, 5515 Security Lane, Suite 700, Rockville, MD 20852
Phone: 301 443-5300
Fax: 301 443-5351

RIN: 0905-AE71
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)             Prerule Stage


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1061.  PROSPECTIVE FEE SCHEDULE FOR AMBULANCE SERVICES (HCFA-
1002-NR)

Priority:  Other Significant

Unfunded Mandates: Undetermined

Legal Authority:  PL 105-33, sec 4531(b)

CFR Citation:  42 CFR 410

Legal Deadline:  Final, Statutory, January 1, 2020.

Abstract: The Balanced Budget Act of 1997 requires that the Secretary 
establish a fee schedule for ambulance services through negotiated 
rulemaking. The fee schedule is to be effective beginning with services 
furnished on or after January 1, 2000. In addition to setting the 
payment rates, the Secretary is to ensure that the aggregate amount of 
payment made for ambulance services in 2000 may not exceed the amount 
of payment that would have been made absent the fee schedule. This is a 
cap on payment, not a budget neutrality adjustment. The Secretary is to 
consult with national organizations representing individuals and 
entities that furnish and regulate ambulance services and share 
relevant data with these organizations. This provision will be met 
through the negotiated rulemaking process.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice of Intent to Negotiate   04/00/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Nancy Edwards, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-4531
Email: [email protected]

RIN: 0938-AI72

[[Page 21989]]

_______________________________________________________________________


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


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1062. ``WITHOUT FAULT'' AND BENEFICIARY WAIVER OF RECOVERY AS IT APPLIES 
TO MEDICARE OVERPAYMENT LIABILITY (HCFA-1719-P)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1395gg

CFR Citation:  42 CFR 401; 42 CFR 403.310; 42 CFR 405; 42 CFR 410.1; 42 
CFR 411.23; 42 CFR 411.28; 42 CFR 413.20; 42 CFR 413.153; 42 CFR 
447.31; 42 CFR 466.86; 42 CFR 466.94; 42 CFR 473.14; 42 CFR 493.1834

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 rule would amend the 
Medicare regulations governing liability for overpayments to eliminate 
application of certain regulations of the Social Security 
Administration and to replace them with HCFA regulations more specific 
to circumstances involving Medicare overpayments.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/98

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-719

Agency Contact: David Walczak, Center for Health Plans and Providers, 
Plan & Provider Purchasing Policy Group, Department of Health and Human 
Services, Health Care Financing Administration, C4-07-07, 7500 Security 
Blvd., Baltimore, MD 21244
Phone: 410 786-4475

RIN: 0938-AD95
_______________________________________________________________________




1063. PROVIDER REIMBURSEMENT DETERMINATIONS AND APPEALS (HCFA-1727-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302; 42 USC 1395f(b); 42 USC 1395g(A); 42 USC 
1395l; 42 USC 1395x(v); 42 USC 1395x(v)(1)(a); 42 USC 1395hh; 42 USC 
1395ii; 42 USC 1395oo; 42 USC 1395ww; 42 USC 405; 42 USC 300e; 42 USC 
300e-5; 42 USC 300e-9; 31 USC 9701

CFR Citation:  42 CFR 405.1801 to 405.1889; 42 CFR 413.30 to 413.64; 42 
CFR 417.576; 42 CFR 417.810

Legal Deadline: None

Abstract: Section 1878 of the Social Security Act and 42 CFR part 405, 
subpart R provide for administrative and judicial review in accordance 
with prescribed requirements, of certain disputes regarding Medicare 
reimbursement for participating providers of services. This proposed 
rule would revise, update, and clarify various provisions of the 
regulations pertaining to provider appeals and make conforming changes 
to other regulations

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/98

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-727

Agency Contact: Morty Marcus, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-07-07, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4477

RIN: 0938-AF28
_______________________________________________________________________




1064. REVISIONS TO RULES ON HEALTH CARE PREPAYMENT PLANS (HCFA-1016-P)

Priority:  Other Significant

Legal Authority:  42 USC 1302; 42 USC 1395hh; 42 USC 13951; 42 USC 
300e; 42 USC 300e-5; 42 USC 300e-9; 31 USC 9701

CFR Citation:  42 CFR 471.800; 42 CFR 417.801; 42 CFR 417.806; 42 CFR 
417.812; 42 CFR 417.814; 42 CFR 417.816; 42 CFR 417.818; 42 CFR 
417.820; 42 CFR 417.822; 42 CFR 417.824

Legal Deadline: None

Abstract: This regulation would impose a range of requirements on 
health care prepayment plans (HCPP) 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 HCPP program. We 
will also address related requirements of the Balanced Budget Act of 
1997.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/98

Small Entities Affected: None

Government Levels Affected: None

Additional Information: OMC-016

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

RIN: 0938-AF97
_______________________________________________________________________




1065. CONDITIONS OF PARTICIPATION FOR RURAL HEALTH CLINICS (HCFA-1764-P)

Priority:  Other Significant

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

Legal Authority:  42 USC 1395l(a); 42 USC 1395x(aa); 42 USC 
1395y(a)(14); 42 USC 1396a(a)(13)(E); 42 USC 263a; 42 USC 1302; 42 USC 
1395hh

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

Legal Deadline: None

Abstract: This rule would update our regulations to incorporate several 
health care coverage and payment provisions contained in OBRAs '86, 
'87, '89, and '90 and would propose administrative changes that clarify 
policy related to sharing space between rural health clinics and other 
entities, such as physician offices, the replacement of the provider-
based cost

[[Page 21990]]

basis system with the all-inclusive rate payment system, and the 
allowance of separate payment under part B for more complex laboratory 
services. Some changes pertain to federally qualified health centers as 
well as rural health clinics.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/98

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: BPD-764

Agency Contact: Helen Klein, Center for Health Plans and Providers, 
Division of Integrated Services, Department of Health and Human 
Services, Health Care Financing Administration, C4-06-07, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4641

RIN: 0938-AG05
_______________________________________________________________________




1066. ALTERNATIVE SANCTIONS FOR RENAL DIALYSIS FACILITIES (HCFA-3204-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395rr(c); 42 USC 1395rr(g)

CFR Citation:  42 CFR 405; 42 CFR 488; 42 CFR 498

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: HSQ-204

Agency Contact: Judith Kari, Center for Medicaid and State Operations, 
Division of Outcomes and Improvements, Department of Health and Human 
Services, Health Care Financing Administration, S2-19-26, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6829

RIN: 0938-AG31
_______________________________________________________________________




1067. EFFECT OF CHANGE OF OWNERSHIP ON PROVIDER AND SUPPLIER PENALTIES, 
SANCTIONS, UNDERPAYMENTS AND OVERPAYMENTS (HCFA-2215-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302; 42 USC 1395f(b); 42 USC 1395g(a); 42 USC 
1395hh; 42 USC 1395ii; 42 USC 1395oo; 42 USC 1395xx; 42 USC 1395x(v); 
42 USC 13951; 42 USC 405; 42 USC 1395ww

CFR Citation:  42 CFR 405.1803; 42 CFR 405.1811; 42 CFR 405.1835; 42 
CFR 405.1843; 42 CFR 405.1805; 42 CFR 489.2; 42 CFR 489.18

Legal Deadline: None

Abstract: This rule would amend the regulations on provider and certain 
supplier agreements by clarifying the effect a change of ownership has 
on penalties and sanctions incurred by the former provider or supplier. 
It also would clarify our policy on changes involving leased 
departments.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/98

Small Entities Affected: None

Government Levels Affected: Undetermined

Additional Information: HSQ-215

Agency Contact: Mike Goldman, Division of Integrated Health Systems, 
Department of Health and Human Services, Health Care Financing 
Administration, S2-14-27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6813

RIN: 0938-AG59
_______________________________________________________________________




1068. MEDICAID: OPTIONAL COVERAGE OF TB-RELATED SERVICES FOR INDIVIDUALS 
INFECTED WITH TUBERCULOSIS (HCFA-2082-P)

Priority:  Other Significant

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/98

Small Entities Affected: None

Government Levels Affected: State, Local

Additional Information: HCFA-2082-P

Agency Contact: Ingrid Osborne, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, C4-19-24, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4461

RIN: 0938-AG72
_______________________________________________________________________




1069. PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY HAVE 
FINANCIAL RELATIONSHIPS--EXPANDED TO DESIGNATED HEALTH SERVICES (HCFA-
1809-F)

Priority:  Other Significant

Legal Authority:  42 USC 1302; 42 USC 1395hh; 42 USC 1395nn; 42 USC 
1396b

CFR Citation:  42 CFR 411.350 to 411.361; 42 CFR 424.22; 42 CFR 
435.1012; 42 CFR 455.108; 42 CFR 455.109

Legal Deadline: None

Abstract: This rule provides that a physician who has (or whose 
immediate family member has) a

[[Page 21991]]

financial relationship with a health care entity may not make referrals 
to that entity for certain services (designated health services) under 
the Medicare program except under specified circumstances. In the 
Medicaid context, this rule would deny payment to a State for 
expenditures for designated health services furnished on the basis of a 
physician referral that, all things being equal, would result in denial 
of payment under Medicare. The provisions of the rule are based on 
sections 13562 and 13624 of OBRA '93 and section 152 of SSAA '94.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/09/98                     63 FR 1659
NPRM Comment Period End         05/11/98
Final Action                    00/00/00

Small Entities Affected: Businesses

Government Levels Affected: State

Additional Information: BPD-809

Agency Contact: Joanne Sinsheimer, Center for Health Plans and 
Providers, Department of Health and Human Services, Health Care 
Financing Administration, C4-11-23, 7500 Security Blvd., Baltimore, MD 
21244
Phone: 410 786-4620

RIN: 0938-AG80
_______________________________________________________________________




1070. END STAGE RENAL DISEASE (ESRD) CONDITIONS FOR COVERAGE (HCFA-3818-
P)

Priority:  Other Significant

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

Legal Authority:  42 USC 1395rr

CFR Citation:  42 CFR 400; 42 CFR 405; 42 CFR 406; 42 CFR 409; 42 CFR 
410; 42 CFR 412; 42 CFR 413; 42 CFR 414; 42 CFR 489; 42 CFR 492

Legal Deadline: None

Abstract: This proposed rule would revise the current conditions for 
coverage for end stage renal disease (ESRD) facilities approved to 
provide ESRD service under Medicare. It would update the conditions to 
reflect developments in technology and equipment, emphasize the total 
patient experience and develop performance expectations for the 
facility that result in quality, comprehensive care for the dialysis 
patient.

Statement of Need: Section 1881(b)(1) of the Social Security Act 
stipulates that payment is made to individuals, providers of services, 
and renal dialysis facilities that meet the requirements for 
institutional dialysis services and supplies that are determined by the 
Secretary. These requirements are the end-stage renal disease (ESRD) 
conditions for coverage.
Our decision to propose major changes to the existing conditions is 
based on several considerations. Revising the ESRD requirements is part 
of HCFA's effort to move toward a patient outcome-based system that 
focuses on quality assessment and performance improvement. We believe 
that revising the conditions will encourage improved outcomes of care 
for beneficiaries. The ESRD conditions for coverage have not been 
comprehensively revised since their inception in 1976. The existing 
requirements emphasize the policies and procedures that must be in 
place to support good patient care, and they focus on a facility's 
capacity to furnish care rather than on the actual provision of quality 
care to patients and the outcomes of that care.
During the 1980's and early 1990's major changes took place in the 
delivery of services to dialysis patients, and these advances are not 
reflected in the existing requirements. Thus we have concluded that 
significant revisions to the conditions for coverage for ESRD 
facilities are essential. The regulation would have an emphasis on the 
patient's total experience with dialysis. The proposed changes, which 
were undertaken in a collaborative effort with the renal community, 
reflect improvements in standard care practices, the use of more 
advanced technology and equipment, and, most notably, the adoption of 
quantifiable performance measures that are viewed in the renal 
community to be related, at least in part, to the quality of care 
provided to dialysis patients.
Following publication of the proposed rule, we will consult further 
with the industry.

Summary of the Legal Basis: Section 1881(b)(1) of the Act authorizes 
the Secretary to prescribe health and safety requirements (known as 
conditions for coverage) that a facility providing dialysis and 
transplantation services to dialysis patients must meet to qualify for 
Medicare reimbursement. In addition, section 1881(c) of the Act 
establishes ESRD network areas and network organizations to assure that 
dialysis patients are provided appropriate care. The requirements from 
section 1881(b) and (c) are implemented in regulations at 42 CFR part 
405, subpart U, Conditions for Coverage for ESRD Facilities.
Section 1138(b)(1)(D) of the Act requires hospitals to be members and 
abide by the rules and requirements of the Organ Procurement and 
Transplant Network. Section 1861(s)(2)(F) of the Act describes 
``medical and other health services'' covered under Medicare to include 
home dialysis supplies and equipment, self-care home dialysis support 
services, and institutional dialysis services and supplies, and section 
1862(a) of the Act specifies the exclusions from coverage.
Section 1869(e)(9) of the Act requires hospitals to meet such other 
requirements as the Secretary finds necessary in the interest of health 
and safety of individuals who are furnished services in the 
institution.

Alternatives: In the past, HCFA has revised sections of the ESRD 
regulations. However, we have determined that a complete and thorough 
revision would be a more effective mechanism for developing a 
comprehensive approach to quality care for the dialysis patient. In 
addition, this approach provides greater potential for successful 
implementation. Another option is to update the current regulations and 
maintain the process-oriented standards without focusing on patient 
outcome. However, for the reasons discussed, we believe it is important 
to move forward with a proposed regulation that is patient-centered and 
intended to stimulate improvements in processes and outcomes of care.

Anticipated Costs and Benefits: The purpose of this proposed rule is to 
ensure that ESRD beneficiaries are receiving quality care dialysis and 
transplantation. We believe that revised regulations are necessary to 
ensure that all facilities are using the most effective technology and 
equipment. The primary benefit of updating the conditions for coverage 
is the development of performance expectations for the facility that 
would result in the comprehensive, integrated care and outcomes the 
patient needs

[[Page 21992]]

and wants. As a result, the beneficiaries would receive an improved 
quality of care. The revised regulations would also address the issue 
of adequacy of dialysis, which would have a significant impact on 
ensuring that patients are not being under-dialysised.
Items that have the potential to affect the cost of the ESRD program 
include data gathering, infection control, and achieving the specified 
outcome measure. However, at this time the cost or savings to the 
Medicare program have not yet been established, but costs should not be 
significant.

Risks: If the ESRD conditions are not updated, our regulations will not 
reflect new developments in the industry, thereby denying the improved 
protections to patients' health care that would result from this 
proposed rule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/98

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: HCFA-3818-P

Agency Contact: Lynn Merritt-Nixon, Office of Clinical Standards and 
Quality, Department of Health and Human Services, Health Care Financing 
Administration, C5-05-15, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4652

RIN: 0938-AG82
_______________________________________________________________________




1071. LIABILITY FOR THIRD PARTIES TO PAY FOR CARE AND SERVICES (MB-080-
P)

Priority:  Other Significant

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

CFR Citation:  42 CFR 433.135 to 433.152

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/98

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Additional Information: MB-080

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

RIN: 0938-AH01
_______________________________________________________________________




1072. DEFINITION OF SKILLED NURSING FACILITY (SNF) FOR COVERAGE OF 
DURABLE MEDICAL EQUIPMENT (DME) (BPD-834-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395x(n); 42 USC 1395i-3(a)(1); 42 USC 
1396r(a)(1)

CFR Citation:  42 CFR 409; 42 CFR 410

Legal Deadline: None

Abstract: This proposed rule would define skilled nursing facilities 
(SNFs) under section 1819(A)(1) of the Social Security Act for purposes 
of Medicare coverage of durable medical equipment (DME) and home health 
services. A Medicare SNF (as defined under section 1819 of the Social 
Security Act) cannot be considered a home under Medicare part B for DME 
and home health coverage. This proposed rule would presume that all 
Medicare nursing facilities are section 1819(A)(1) facilities and thus 
would not be considered a Home for DME. This would define non-Medicare 
nursing homes as skilled facilities based upon the receipt of skilled 
care by at least once a week by a proportion of its residents 
population.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/98

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-834

Agency Contact: Thomas Hoyer, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-02-16, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4605

RIN: 0938-AH16
_______________________________________________________________________




1073. MEDICARE COVERAGE OF ORGAN TRANSPLANTATION (HCFA-3835-PN)

Priority:  Other Significant

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

CFR Citation:  None

Legal Deadline: None

Abstract: This proposed notice would announce changes in Medicare's 
national coverage policy for organ transplantations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Notice                 04/00/98

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: HCFA-3835-PN

Agency Contact: Jacqueline Sheridan, Office of Clinical Standards and 
Quality, Department of Health and Human Services, Health Care Financing 
Administration, C5-05-27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4653

RIN: 0938-AH17
_______________________________________________________________________




1074. STATE PLAN AMENDMENT (SPA) RECONSIDERATION PROCESS (HCFA-2096-P)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1316; 42 USC 1396a(a)

CFR Citation:  42 CFR 430.18; 42 CFR 430.60

Legal Deadline: None

Abstract: This proposed rule would revise and streamline the State Plan 
Amendment (SPA) reconsideration process. Currently, when a State

[[Page 21993]]

requests reconsideration of a denied SPA, a hearing is held in all 
cases, even when the only dispute is over the interpretation of the 
statute. Under the proposed regulation, the State and HCFA could avoid 
the cost and delay of the hearing process when the only issue is 
interpretation of the statute by permitting the State expedited 
judicial review, without a full administrative hearing, after HCFA has 
a brief opportunity to reconsider its decision.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: HCFA-2096-P

Agency Contact: Robert Tomlinson, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, C4-20-21, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4463

RIN: 0938-AH24
_______________________________________________________________________




1075. HOSPICE CARE--CONDITIONS OF PARTICIPATION (HCFA-3844-P)

Priority:  Other Significant

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

Legal Authority:  42 USC 1302; 42 USC 1395x(dd); 42 USC 1395hh

CFR Citation:  42 CFR 418

Legal Deadline: None

Abstract: This proposed rule would revise the Medicare conditions of 
participation for hospices to help ensure the provision of quality care 
through an emphasis on patient-centered outcomes. Areas of change would 
include, among others, assessment of patient needs, clarification of 
physician roles, coordination of care for hospice patients residing in 
nursing homes, clarification of nursing roles, patient rights, and 
provision of services.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/98

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: HCFA-3844

Agency Contact: Lynn Merritt-Nixon, Office of Standard & Quality, 
Department of Health and Human Services, Health Care Financing 
Administration, C5-05-15, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4652

RIN: 0938-AH27
_______________________________________________________________________




1076. MEDICARE COVERAGE OF SERVICES OF SPEECH-LANGUAGE PATHOLOGISTS AND 
AUDIOLOGISTS (HCFA-1843-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302; 42 USC 1395x; 42 USC 1395x(cc)(1); 42 
USC 1395x(ll)

CFR Citation:  42 CFR 484; 42 CFR 485

Legal Deadline: None

Abstract: This proposed rule would implement SSA '94 provisions to 
provide coverage for speech-language pathology services furnished by a 
qualified pathologist.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/98

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-843

Agency Contact: Jackie Gordon, Division of Cost Reporting, Department 
of Health and Human Services, Health Care Financing Administration, C4-
07-14, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4517

RIN: 0938-AH37
_______________________________________________________________________




1077. PAYMENT AMOUNT IF CUSTOMARY CHARGES ARE LESS THAN REASONABLE COSTS 
(HCFA-1860-FC)

Priority:  Other Significant

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

Legal Authority:  42 USC 1395f(b); 42 USC 1395l(a); 42 USC 1395m(a)

CFR Citation:  42 CFR 413.13

Legal Deadline: None

Abstract: A provider whose charges are lower than its reasonable costs 
for those services in any cost reporting period beginning January 1, 
1974, but before April 28, 1988, may carry forward costs that are 
unreimbursed for two succeeding cost reporting periods. Sufficient time 
has passed since the publication of this provision to warrant the 
deletion from the regulation text of any reference to the carryover 
provision. Since payment for durable medical equipment (DME) provided 
by home health agencies (HHAs) is no longer based on the lesser of the 
reasonable cost or reasonable charge but rather on 80% of the lesser of 
the actual charge for the item or the payment amount recognized under 
the DME fee schedule and, for nominal charge HHAs, on 80% of the DME 
fee schedule amount, the lesser of costs or charges provision no longer 
applies and should be deleted from the CFR.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: BPD-860

Agency Contact: Ward Pleines, Chronic Care Purchasing Policy Group, 
Division of Cost Reporting, Department of Health and Human Services, 
Health Care Financing Administration, C5-02-23, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4528

RIN: 0938-AH49
_______________________________________________________________________




1078. SUPPLIER PARTICIPATION AGREEMENTS AND LIMITS ON ACTUAL CHARGES OF 
NONPARTICIPATING PHYSICIANS (HCFA-1862-P)

Priority:  Other Significant

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

Legal Authority:  42 USC 1302; 42 USC 1395u(h); 42 USC 1395hh; 42 USC 
1395rr(b)(1)

CFR Citation:  42 CFR 400; 42 CFR 414

Legal Deadline: None

[[Page 21994]]

Abstract: The Deficit Reduction Act of 1984 established a voluntary 
participation program for physicians and suppliers under which 
physicians and suppliers enter into an agreement with Medicare that 
binds them to accept payment on an assignment-related basis for all 
services they furnish to Medicare beneficiaries. This proposed rule 
would set forth the terms and conditions of the participation 
agreements. This proposed rule would reflect provisions of OBRA '93 as 
to the suppliers subject to the charge limits, and provisions of SSA 
'94 as to administrative procedures for enforcing the charge limits. 
This rulemaking will revise text in the CFR to reduce burden or 
duplication, or streamline requirements. It will give beneficiaries the 
opportunity to make informed consumer decisions regarding the choice of 
Medicare Part B services.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/98

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-862

Agency Contact: Anita Heygster, Center for Health Plans & Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-04-27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4486

RIN: 0938-AH50
_______________________________________________________________________




1079. REVISION TO ACCRUAL BASIS OF ACCOUNTING POLICY (HCFA-1876-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395x(v); 42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 413.100

Legal Deadline: None

Abstract: The proposed rule would specify the providers' share of the 
costs of FICA and other employee payroll taxes that will be allowable 
under Medicare when the payroll period ends subsequent to the end of 
the reporting period. The proposed rule would provide that if payment 
would be made to an employee during a lost reporting period but for the 
fact that the regularly scheduled payment date is after the end of the 
period, that portion of employees FICA or other taxes that have accrued 
up to the end of the reporting period will be treated as allowable 
costs in the current reporting period.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/98

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: HCFA-1876-P

Agency Contact: John Eppinger, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, C5-03-18, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4518

RIN: 0938-AH61
_______________________________________________________________________




1080. MEDICAID; ESTATE RECOVERIES (HCFA-2083-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396a; 42 USC 1396p

CFR Citation:  42 CFR 433.36

Legal Deadline: None

Abstract: This proposed rule is being developed as a result of the OBRA 
1993 provisions that mandated States to seek adjustment or recovery 
from the estates of Medicaid beneficiaries for amounts correctly spent 
by Medicaid on permanently institutionalized individuals (any age) and 
individuals age 55 or older for certain services. The OBRA 1993 
provision also defines ``estate,'' and further requires States to 
establish hardship procedures, in accordance with standards specified 
by the Secretary for waiver of recovery in cases where undue hardship 
would result.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/98

Small Entities Affected: Undetermined

Government Levels Affected: State

Additional Information: HCFA-2083-P

Agency Contact: Ingrid Osborne, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, C4-22-06, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4461

RIN: 0938-AH63
_______________________________________________________________________




1081. PROVIDER AND SUPPLIER BILLING WHEN MEDICARE IS SECONDARY PAYOR TO 
LIABILITY INSURANCE (HCFA-1848-P)

Priority:  Other Significant

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

Legal Authority:  42 USC 1302; 42 USC 1395cc; 42 USC 1395dd; 42 USC 
1395hh; 42 USC 1395ww; 42 USC 1395x; 42 USC 1395aa

CFR Citation:  42 CFR part 411; 42 CFR part 489

Legal Deadline: None

Abstract: This proposed rule would revise current regulations to 
require that providers and suppliers attempt to collect payment from 
the proceeds of liability insurance during the ``promptly period.'' 
This rule would also permit providers and suppliers to choose either to 
pursue collection of payment from the proceeds of liability insurance 
after the ``promptly period'' has ended or to bill Medicare.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/98

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-848

Agency Contact: Anita Heygster, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-08-25, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4486

RIN: 0938-AH66
_______________________________________________________________________




1082. MEDICARE TECHNICAL CONFORMING AMENDMENTS (HCFA-1858-FC)

Priority:  Substantive, Nonsignificant

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

[[Page 21995]]

duplication, or streamline requirements.

Legal Authority:  42 USC 1302; 42 USC 1395k

CFR Citation:  42 CFR 409.50; 42 CFR 409.61; 42 CFR 410.152

Legal Deadline: None

Abstract: This final rule with comment period will update our 
regulations to reflect that payment for durable medical equipment is on 
the basis of a fee schedule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/98

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-858

Agency Contact: Martha Kuespert, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-02-16, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4605

RIN: 0938-AH67
_______________________________________________________________________




1083. ELIMINATION OF CERTAIN REQUIREMENTS FOR PEER REVIEW ORGANIZATIONS 
IN THE UTILIZATION AND QUALITY REVIEW PROCESS AND A CHANGE IN THE LENGTH 
OF PEER REVIEW ORGANIZATION CONTRACTS (HCFA-3235-FC)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 462.107; 42 CFR 466.71; 42 CFR 466.73

Legal Deadline: None

Abstract: This proposed rule would eliminate the requirement that Peer 
Review Organizations (PROs) conduct quarterly random sample reviews of 
hospital discharges. It would also change the period for PRO contracts 
from 2 years to 3 years and would eliminate certain notification 
requirements regarding contract awards.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/98

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: HSQ-235-FC

Agency Contact: Bill Roskey, Office of Clinical Standards and Quality, 
Department of Health and Human Services, Health Care Financing 
Administration, S1-09-18, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0433

RIN: 0938-AH68
_______________________________________________________________________




1084. DETERMINATION OF SUBSTANDARD CARE IN SNFS AND NFS (HCFA-2240-P)

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 488.301

Legal Deadline: None

Abstract: This proposed rule would revise the definition of 
``substandard quality of care'' as it applies to skilled nursing 
facilities, in the Medicare program, and nursing facilities, in the 
Medicaid program. ``Substandard quality of care'' is one type of 
noncompliance with Federal participation requirements that carries with 
it statutory consequences to facilities providing such care. The 
purpose of this proposed revision is to improve the definition of 
substandard quality of care so that the process can make a more 
meaningful distinction between facility noncompliance that warrants the 
consequences mandated by the statute for a finding of substandard 
quality of care and noncompliance that does not.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/98

Small Entities Affected: Businesses, Organizations

Government Levels Affected: State, Local, Federal

Additional Information: HSQ-240

Agency Contact: Pat Miller, Center for Medicaid and State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, S2-19-14, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6780

RIN: 0938-AH69
_______________________________________________________________________




1085. UPDATE OF RATESETTING METHODOLOGY, PAYMENT RATES AND THE LIST OF 
COVERED SURGICAL PROCEDURES FOR AMBULATORY SURGICAL CENTERS EFFECTIVE 
FOR CALENDAR YEAR 1998 (HCFA-1885-P)

Priority:  Economically Significant. Major under 5 USC 801.

Legal Authority:  42 USC 13951(i)(2)(A)

CFR Citation:  42 CFR 416.61(b); 42 CFR 416.65(a)(4); 42 CFR 416.65(c); 
42 CFR 416.120(c)(1); 42 CFR 416.125; 42 CFR 416.130; 42 CFR 
416.140(a); 42 CFR 416.140(b)

Legal Deadline: None

Abstract: This proposed rule discusses several policy changes affecting 
coverage of and payment for Ambulatory Surgical Center (ASC) facility 
services as provided under sections 1833(i)(1A) and (2A) of the Social 
Security Act. It would include the criteria for identifying procedures 
that are appropriate and safely performed in an ASC; the method used to 
set ASC payment rates; and the schedule for publishing and implementing 
payment and coverage updates.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/98

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-885-P

Agency Contact: Joan Sanow, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-5723

RIN: 0938-AH81
_______________________________________________________________________




1086. REVISIONS TO CONDITIONS FOR COVERAGE FOR AMBULATORY SURGICAL 
CENTERS (HCFA-3887-P)

Priority:  Other Significant

Legal Authority:  42 USC 1302; 42 USC 1395hh

[[Page 21996]]

CFR Citation:  42 CFR 416

Legal Deadline: None

Abstract: This proposed rule would revise the ambulatory surgical 
center conditions for coverage to reflect current innovations in 
healthcare delivery, quality assessment, and performance improvement. 
The focus would be to improve outcomes of health care and satisfaction 
for Medicare beneficiaries, while streamlining structural and 
procedural requirements where possible.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/98

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-887

Agency Contact: Judy Goldfarb, Office of Clinical Standards & Quality, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, S2-199.06, Baltiore, MD 21244
Phone: 410 786-6747

RIN: 0938-AH83
_______________________________________________________________________




1087. DISCLOSURE OF PEER REVIEW ORGANIZATION INFORMATION IN RESPONSE TO 
BENEFICIARY COMPLAINTS (HCFA-3241-P)

Priority:  Other Significant

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 466.70(a); 42 CFR 476.101; 42 CFR 476.107; 42 CFR 
476.132; 42 CFR 476.133(b)(4)

Legal Deadline: None

Abstract: This proposed rule would change our policy regarding the 
disclosure of peer review organization (PRO) information in responding 
to beneficiary complaints about physicians, other practitioners, and 
other institutional and non-institutional providers of health care, 
including Health Maintenance Organizations and Competitive Medical 
Plans. Under the proposal, we would permit the disclosure of PRO 
information about physicians and other individual practitioners without 
their permission to the extent necessary to comply with section 
1154(a)(14) of the Social Security Act. This section requires PROs to 
conduct reviews of beneficiary complaints about the quality of services 
that do not meet professionally recognized standards of health care and 
inform each beneficiary of the final disposition of his or her 
complaint.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/98

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: William Roskey, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd, S1-09-07, Baltimore, MD 
21244
Phone: 410 786-0433

RIN: 0938-AH85
_______________________________________________________________________




1088. MEDICARE PROGRAM; BENEFICIARY INCENTIVES PROGRAMS (HCFA-6144-P)

Priority:  Other Significant

Legal Authority:  PL 104-191, sec 203

CFR Citation:  42 CFR 420.400; 42 CFR 420.405; 42 CFR 420.410

Legal Deadline:  Final, Statutory, October 21, 1996.

Abstract: This proposed rule would establish a program for payment to 
individuals who provide information on Medicare fraud and abuse. It 
would also establish a program to collect suggestions to improve 
Medicare program efficiency and allow for payment to the individuals 
who provide the suggestions. Overall, it would implement sections 
203(b) and 203(c) of the Health Insurance Portability and 
Accountability Act of 1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: BPO-144-P

Agency Contact: Delilah Schmitt, Program Integrity Group, Office of 
Financial Management, Department of Health and Human Services, Health 
Care Financing Administration, 7500 Security Blvd, S3-08-05, Baltimore, 
MD 21244
Phone: 410 786-4300

RIN: 0938-AH86
_______________________________________________________________________




1089. NATIONAL STANDARD FOR IDENTIFIERS OF HEALTH PLANS (HCFA-4145-P)

Priority:  Other Significant. Major under 5 USC 801.

Legal Authority:  42 USC 1320d-2

CFR Citation:  45 CFR 142

Legal Deadline:  Final, Statutory, February 21, 1998.

Abstract: This rule would implement a standard identifier to identify 
health plans that process and pay certain electronic health care 
transactions. It would implement one of the requirements for 
administrative simplification in section 262 of the Health Insurance 
Portability and Accountability Act of 1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: BPO-145

Agency Contact: Faye Broseker, Center for Beneficiary Services, 
Department of Health and Human Services, Health Care Financing 
Administration, S3-04-05, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-3342

RIN: 0938-AH87
_______________________________________________________________________




1090. MEDICAID PROGRAM; AMENDMENT TO THE PREADMISSION SCREENING AND 
ANNUAL RESIDENT REVIEW PROGRAM (HCFA-2107-P)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1396r(e); 42 USC 1396r(b)

CFR Citation:  42 CFR 405; 42 CFR 431; 42 CFR 433; 42 CFR 441; 42 CFR 
483

Legal Deadline: None

Abstract: This proposed rule would make changes to the preadmission 
screening and annual resident review program in accordance with the 
provisions of Public Law 104-315, which were included in the

[[Page 21997]]

Reinventing Government effort. The rule would repeal the Medicaid 
program requirement for an annual review of nursing facility (NF) 
residents with mental illness or mental retardation. This proposed rule 
also would add the requirement for NFs to notify the State when there 
is a significant change in the physical or mental condition of a 
resident and add a statutory requirement that the State conduct a 
review promptly after notification of the resident's change in 
condition.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/98

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State

Additional Information: HCFA-2107-P

Agency Contact: Jan Earle, Center for Medicaid and State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, C4-12-23, Baltimore, MD 21244
Phone: 410 786-3326
Fax: 410 786-3262

RIN: 0938-AH89
_______________________________________________________________________




1091. MEDICAID PROGRAM; COVERAGE AND PAYMENT FOR FEDERALLY QUALIFIED 
HEALTH CENTER SERVICES (HCFA-2043-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396a(a)(13); 42 USC 1396d(a)

CFR Citation:  42 CFR 431; 42 CFR 440; 42 CFR 441; 42 CFR 447

Legal Deadline: None

Abstract: This proposed rule would incorporate and interpret in 
regulations coverage and payment requirements for services furnished by 
a federally qualified health center (FQHC) under the Medicaid program. 
This rule will include changes in the payment provisions to FQHCS made 
by section 4712 of the Balanced Budget Act of 1997 PL-105-33.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/98

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Tribal

Additional Information: MB-43

Agency Contact: David Worgo, Center for Medicaid and State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, C4-15-18, Baltimore, MD 21244
Phone: 410 786-5919

RIN: 0938-AH95
_______________________________________________________________________




1092. MEDICARE COVERAGE OF CERTIFIED NURSE-MIDWIFE SERVICES (HCFA-1496-
P)

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 405.2411; 42 CFR 405.2414; 42 CFR 405.2415; 42 
CFR 410.10; 42 CFR 410.77

Legal Deadline: None

Abstract: This proposed rule would implement section 4073 of OBRA 1987 
by amending Medicare regulations to reflect part B coverage of the 
services of certified nurse-midwives furnished without the supervision 
of a physician. It would define ``certified nurse-midwife'' and 
``certified nurse-midwife services.''

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/98

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-496-P

Agency Contact: Roberta Epps, Center for Health Plans and Providers, 
Division of Practitioner & Ambulatory Care, Department of Health and 
Human Services, Health Care Financing Administration, 7500 Security 
Blvd, C4-0516, Baltimore, MD 21244
Phone: 410 786-4475

RIN: 0938-AH96
_______________________________________________________________________




1093. NATIONAL STANDARD HEALTH CARE PROVIDER IDENTIFIER (HCFA-0045-P)

Priority:  Other Significant. Major under 5 USC 801.

Legal Authority:  42 USC 1320d-2

CFR Citation:  45 CFR 142

Legal Deadline:  Final, Statutory, February 21, 1998.

Abstract: This rule would address the health care industry's need for a 
standardized provider identifier. It would implement one of the 
requirements for administrative simplification in section 262 of the 
Health Insurance Portability and Accountability Act of 1996. A standard 
provider identifier would save the health insurance industry 
significant costs incurred in maintaining multiple identifier systems.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: HCFA-0045-P

Agency Contact: Karen Trudel, Office of Information Services, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., N3-06-13, Baltimore, MD 212244
Phone: 410 786-9937

RIN: 0938-AH99
_______________________________________________________________________




1094. MEDICARE PROGRAM; IMPROVEMENTS TO THE APPEALS PROCESS FOR MEDICARE 
BENEFICIARIES ENROLLED IN HMOS, CMPS, AND HCPPS (HCFA-4024-P)

Priority:  Other Significant

Legal Authority:  42 USC 1395mm(c)(5)

CFR Citation:  42 CFR 417

Legal Deadline: None

Abstract: This proposed rule would establish new administrative review 
requirements for Medicare beneficiaries enrolled in health maintenance 
organizations (HMOs), competitive medical plans (CMPs), and health care 
prepayment plans. This rule would implement section 1876(c)(5) of the 
Social Security Act, which specifies the appeal and grievance rights of 
Medicare enrollees in HMOs and CMPs. This rule would reduce time lines 
for nonurgent denials of care and make other improvements. We will also 
address related requirements of the Balanced Budget Act of 1997.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/98

Small Entities Affected: None

Government Levels Affected: None

[[Page 21998]]

Agency Contact: Cheryl Slay, Director, Division of Beneficiary 
Protections, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-6478

RIN: 0938-AI11
_______________________________________________________________________




1095. NEWBORNS' AND MOTHERS' HEALTH PROTECTION

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 100

CFR Citation:  45 CFR 300

Legal Deadline: None

Abstract: This needs information.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/98

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Ann White, Regulations Coordinator, Department of 
Health and Human Services, Health Care Financing Administration, 200 
Indepedendence Avenue, Washington, DC 20201
Phone: 202 690-6824

RIN: 0938-AI13
_______________________________________________________________________




1096. CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEMS AND 
FISCAL YEAR 1999 RATES (HCFA-1003-P)

Priority:  Other Significant. Major under 5 USC 801.

Legal Authority:  42 USC 1395ww

CFR Citation:  42 CFR 412; 42 CFR 413

Legal Deadline:  NPRM, Statutory, April 1, 1998. Final, Statutory, 
August 1, 1998.

Abstract: Medicare pays for hospital inpatient services under a 
prospective payment system (PPS) in which payment is made at a 
predetermined specific rate for the operating and capital-related costs 
associated with each discharge. These rules would announce the 
prospective payment rates for operating and capital-related costs for 
FY 1999 that reflect changes made by the Balanced Budget Act of 1997. 
We would also revise the Medicare hospital inpatient prospective 
payment systems for operating and capital-related costs to implement 
necessary changes arising from our continuing experience with the 
systems.

Statement of Need: Section 1886(e)(5) of the Social Security Act, as 
amended by section 4644(a)(1) and (b)(1) of the Balanced Budget Act of 
1997, requires the Secretary to publish a proposed rule on prospective 
payment system policies and payment rates in the Federal Register by 
April 1 and a final rule by August 1.

Summary of the Legal Basis: As noted above, publication of proposed and 
final rules concerning hospital prospective payment system policies and 
payment rates is required by law. The statute sets forth several 
specific requirements concerning what must be included in the 
prospective payment system proposed and final rules. (See sections 
1886(b)(3)(B), 1886(d)(1)(A), 1886(d)(2)(H), 1886(d)(3)(A), 
1886(d)(3)(E), 1886(d)(4)(C), 1886(e)(5), and 1886(G)(1)(A).)

Alternatives: Publication of these rules is not discretionary. Thus, no 
alternatives exits.

Anticipated Costs and Benefits: Estimates of the economic impact that 
will stem from these rules have not yet been completed.

Risks: Not applicable.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/98
Final Action                    08/00/98

Small Entities Affected: Businesses, Organizations

Government Levels Affected: Federal

Additional Information: HCFA-1003

Agency Contact: Tzvi Hefter, Director, Division of Acute Care, Center 
for Health Plans and Providers, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security 
Boulevard, C5-08-27, Baltimore, MD 21244
Phone: 410 786-4487

RIN: 0938-AI22
_______________________________________________________________________




1097. CHILDREN'S HEALTH INSURANCE: PROGRAM IMPLEMENTATIONS; STATE PLAN 
APPROVAL; STATE PAYMENT; COORDINATION WITH STATE MEDICAID PROGRAM (HCFA-
2006-P)

Priority:  Economically Significant

Legal Authority:  PL 105-33, sec 4901 to 4913

CFR Citation:  42 CFR ch IV

Legal Deadline: None

Abstract: Several proposed rules will include regulations for States on 
the implementation of the new State Children's Health Insurance Program 
(CHIP) under title XXI of the Social Security Act and corresponding 
changes to title XIX (Medicaid). The CHIP program was established to 
provide Federal funding to help States to initiate and expand child 
health assistance to uninsured, low-income children. The regulations 
will address a variety of aspects of CHIP, including but not limited to 
the procedure for approving state child health plans, policies on the 
issuance of grants and the distribution of payments to States with 
approved plans and the coordination of a State's approved child health 
plan with its Medicaid program. The following changes related to title 
XIX will be included among the regulations: (1) the Medicaid option for 
targeted low-income children; (2) Medicaid optional presumptive 
eligibility for children; and (3) the Medicaid option to accelerate 
phase in of poverty level group for children up to 19. The regulations 
will also establish financial rules that would apply to the treatment 
of various program expenditures.

Statement of Need: The new title XXI statutory authority implement and 
interpret necessitates the promulgation of regulations to complement 
the statute. Title XXI allows for States to submit state plans and, if 
approved, receive Federal matching funds each year up to the specified 
allotments for use by the States in the provision of insurance coverage 
and other child health assistance for targeted low- income children for 
periods beginning October 1, 1997. The Department of Health and Human 
Services must issue regulations on a timely basis in order for States 
to carry out the provisions of the statute to comply with plan approval 
requirements, requirements for State payment and requirements for

[[Page 21999]]

coordination of the child health plan with the State's Medicaid 
program. Absent such regulatory guidance, there is the potential that 
the intent of the legislation to provide health coverage for low-
income, uninsured children will not be realized.

Summary of the Legal Basis: Title XXI of the Social Security Act 
constitutes budget authority in advance of appropriations (section 
2101(c)) and represents the obligation of the Federal Government to 
provide for the payment to States of amounts provided under section 
2104 of the Act.

Alternatives: This is a new program for Federal oversight and is 
optional for States. Once States elect the option to establish a CHIP 
program under title XXI, there are no alternatives to providing Federal 
funding under approved State child health plans for approved program 
expenditures.

Anticipated Costs and Benefits: Section 2104 of the Social Security Act 
specifies the following Federal funding allotment amounts that are to 
be provided to States and Territories: $4.275 billion each for FY 1998, 
FY 1999, FY 2000, and FY 2001; $3.150 billion for FY 2002, FY 2003, and 
FY 2004; $4.050 billion for FY 2005 and FY 2006; and $5 billion for FY 
2007. Benefits: More low-income children will receive needed health 
coverage.

Risks: Unknown at this time.

Timetable:

Allotments and State Payment Policies  NPRM 04/00/98

Other CHIP Activities  NPRM 04/00/98

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Federal

Agency Contact: Rick Fenton, Center for Medical and State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5920

RIN: 0938-AI28
_______________________________________________________________________




1098.  STANDARDS FOR ELECTRONIC TRANSACTIONS (HCFA-0149-P)

Priority:  Other Significant. Major under 5 USC 801.

Legal Authority:  42 USC 1320d

CFR Citation:  45 CFR 142 subpart A; 45 CFR 142 subparts J-R

Legal Deadline:  Final, Statutory, April 1998.

Abstract: The rule proposes code set standards and standards for 8 
electronic transactions to be used by health plans, certain health care 
providers, and health care clearing houses. It would implement 
requirements for administrative simplification in section 262 of the 
Health Insurance Portability and Accountability Act of 1996. The 
standards would significantly reduce costs for processing health care 
transactions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Barbara Redding, Office of Information Services, 
Department of Health and Human Services, Health Care Financing 
Administration, S1-03-27, 7500 Security Blvd, Baltimore, MD 21228
Phone: 410 786-6165
Email: [email protected]

RIN: 0938-AI58
_______________________________________________________________________




1099.  NATIONAL STANDARD EMPLOYER IDENTIFIER (HCFA-0047-P)

Priority:  Other Significant. Major under 5 USC 801.

Legal Authority:  42 USC 1320d-2

CFR Citation:  45 CFR 142 subpart A; 45 CFR 142 subpart F

Legal Deadline:  Final, Statutory, February 21, 1998.

Abstract: This rule proposes the employer identification number as the 
standard for identifying employers for purposes of administrative 
simplification, as required by the Health Insurance Portability and 
Accountability Act of 1996. Use of one standard in the health care 
industry would reduce the cost of identifying employers in electronic 
health care transactions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Mary Emerson, Office of Information Services, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, Baltimore, MD 21228
Phone: 410 786-7065
Email: [email protected]

RIN: 0938-AI59
_______________________________________________________________________


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


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1100. DEDUCTION OF INCURRED MEDICAL EXPENSES (SPENDDOWN) (HCFA-2020-F)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1302

CFR Citation:  42 CFR 435.831; 42 CFR 436.831

Legal Deadline: None

Abstract: This final rule amends and responds to comments on a final 
rule with comment period published in the Federal Register on January 
12, 1994. That rule permits States flexibility to revise the process by 
which incurred medical expenses are considered to reduce an 
individual's or a family's income in order for the individual or family 
to become Medicaid eligible. The revisions permit States greater 
flexibility by offering options that will allow them to simplify the 
administration of their Medicaid programs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/02/83                    48 FR 39959

[[Page 22000]]

NPRM Comment Period End         11/16/83
Final Rule With Comment Period  01/12/94                     59 FR 1659
Interim Final Rule              03/04/94                     59 FR 1659
Comment Period End              03/14/94
Effective Date                  03/14/94
Final Action                    04/00/98

Small Entities Affected: None

Government Levels Affected: None

Additional Information: HCFA-2020

Agency Contact: Jackie Wilder, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, C4-23-07, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4579

RIN: 0938-AB07
_______________________________________________________________________




1101. PAYMENT FOR CLINICAL DIAGNOSTIC LABORATORY TESTS (HCFA-1309-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302; 42 USC 1395f(b); 42 USC 1395g; 42 USC 
1395k; 42 USC 1395l; 42 USC 1395x; 42 USC 1395hh; 42 USC 1395rr; 42 USC 
1395tt; 42 USC 1395ww; 42 USC 1396b

CFR Citation:  42 CFR 405; 42 CFR 413; 42 CFR 414; 42 CFR 424; 42 CFR 
431; 42 CFR 447

Legal Deadline: None

Abstract: This rule will incorporate provisions of the Deficit 
Reduction Act of 1984, COBRA '85, OBRA '86, OBRA '87, TMRA '88, OBRA 
'89, and OBRA '90 regarding payment and ``assignment'' for diagnostic 
clinical laboratory tests establishing in regulations the methods for 
implementing fee schedules. This rule will set forth the methods by 
which the fee schedules will be updated and will allow certain 
adjustments for exceptions to the fee schedule. It will also reflect a 
statutory revision mandated by OBRA '93.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/18/93                    58 FR 43156
NPRM Comment Period End         10/18/93
Final Action                    09/00/98

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-309

Agency Contact: Charles Spalding, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4496

RIN: 0938-AB50
_______________________________________________________________________




1102. PARTICIPATION IN CHAMPUS AND CHAMPVA, HOSPITAL ADMISSIONS FOR 
VETERANS, DISCHARGE RIGHTS NOTICE, AND HOSPITAL RESPONSIBILITY FOR 
EMERGENCY CARE (HCFA-1393-IFC)

Priority:  Other Significant

Legal Authority:  42 USC 1395x; 42 USC 1395cc; 42 USC 1395dd

CFR Citation:  42 CFR 488.18; 42 CFR 489.20; 42 CFR 489.24; 42 CFR 
489.25; 42 CFR 489.26; 42 CFR 489.27; 42 CFR 489.53; 42 CFR 1003

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/16/88                    53 FR 22513
NPRM Comment Period End         08/15/88
Final Rule With Comment Period  06/22/94                    59 FR 32086
Effective Date                  07/22/94
Comment Period End              08/22/94
Final Action                    04/00/98

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-393

Agency Contact: Tzvi Hefter, Center for Health Plans and providers, 
Department of Health and Human Services, Health Care Financing 
Administration, C5-08-27, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-1304

RIN: 0938-AC58
_______________________________________________________________________




1103. MEDICARE SECONDARY PAYER FOR DISABLED INDIVIDUALS (HCFA-1482-F)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1395y(b); 44 USC 3501 to 3511

CFR Citation:  42 CFR 400; 42 CFR 411

Legal Deadline: None

Abstract: This rule will codify in the CFR the Medicare secondary payer 
(MSP) provision, under the Social Security Act, for disabled 
individuals who are covered under large group health plans (LGHPs). 
Under this provision LGHPs may not take into account that such 
individuals are entitled to Medicare. The rule contains procedures 
under which a plan can appeal a determination of nonconformance which 
could lead to an excise tax. It reflects statutory revisions mandated 
by OBRA '86, OBRA '89, and OBRA '93, some of which also affect the MSP 
provisions for persons who are entitled on the basis of age or end-
stage renal disease.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/08/90                     55 FR 8491
Comment Period End              10/30/92
Final Rule                      08/31/95                    60 FR 45344
Effective Date                  10/02/95
Final Action                    10/00/98

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-482

[[Page 22001]]

Agency Contact: Herbert Pollock, Center for Health Plans and Providers, 
Division of Integrated Services, Department of Health and Human 
Services, Health Care Financing Administration, C4-08-14, 7500 Security 
Blvd., Baltimore, MD 21244
Phone: 410 786-4474

RIN: 0938-AD73
_______________________________________________________________________




1104. OMNIBUS NURSING HOME REFORM REQUIREMENTS (HCFA-3488-F)

Priority:  Other Significant. Major under 5 USC 801.

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

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

CFR Citation:  42 CFR 431; 42 CFR 482; 42 CFR 483; 42 CFR 488

Legal Deadline: None

Abstract: This final rule will implement several provisions of OBRA '87 
that concern services to residents of nursing homes. This rule will 
implement provisions that include Federal standards for evaluating 
State waivers of nursing facility nurse staffing requirements, use of 
physical and chemical restraints in nursing facilities, qualifications 
of facility administrators, notice of Medicaid rights to be given to 
persons admitted to nursing facilities, and other technical changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/05/92                     57 FR 4516
NPRM Comment Period End         04/06/92
Final Action                    06/00/98

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-488

Agency Contact: Bill Ullman, Office of Clinical Standards and Quality, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-11-06, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5667

RIN: 0938-AD81
_______________________________________________________________________




1105. COVERAGE OF SCREENING PAP SMEARS (BPD-705-F)

Priority:  Other Significant

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 410.10; 42 CFR 410.32; 42 CFR 410.56; 42 CFR 
411.15

Legal Deadline: None

Abstract: This rule establishes regulations under section 6115 of OBRA 
'89 to govern Medicare part B coverage of screening pap smears 
(including a physician's interpretation of the test results) provided 
to a woman for the early detection of cervical cancer.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/26/93                    58 FR 62312
NPRM Comment Period End         01/24/94
Final Action                    04/00/98

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-705

Agency Contact: Joyce Eng, Office of Clinical Standards and Quality, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-02-26, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4619

RIN: 0938-AE98
_______________________________________________________________________




1106. CASE MANAGEMENT (HCFA-2027-F)

Priority:  Other Significant

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/15/93                    58 FR 53481
NPRM Comment Period End         12/14/93
Final Action                    04/00/98

Small Entities Affected: None

Government Levels Affected: State, Local

Additional Information: HCFA-2027-F

Agency Contact: Pat Helphenstine, Disabled & Elderly Health Program 
Group, Center for Medicaid and State Operations, Department of Health 
and Human Services, Health Care Financing Administration, C4-13-13, 
7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-5900

RIN: 0938-AF07
_______________________________________________________________________




1107. MEDICAID PAYMENT FOR COVERED OUTPATIENT DRUGS UNDER REBATE 
AGREEMENTS (HCFA-2046-FC)

Priority:  Other Significant

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

Legal Authority:  42 USC 1396a(a); 42 USC 1396r-8; 42 USC 1396b(a); 42 
USC 1302

CFR Citation:  42 CFR 447; 42 CFR 441

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/19/95                    60 FR 48442

[[Page 22002]]

NPRM Comment Period End         11/20/95
Final Action                    08/00/98

Small Entities Affected: Businesses

Government Levels Affected: State

Additional Information: HCFA-2046-FC

Agency Contact: Sue Williams, Center for Medicaid and State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-15-26, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-3334

RIN: 0938-AF42
_______________________________________________________________________




1108. MEDICAID: OUTSTATIONED INTAKE LOCATIONS FOR CERTAIN LOW-INCOME 
PREGNANT WOMEN, INFANTS, AND CHILDREN UNDER AGE 19 (HCFA-2052-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396a(a)(55)

CFR Citation:  42 CFR 435.901; 42 CFR 435.902; 42 CFR 435.903; 42 CFR 
435.904; 42 CFR 435.907; 42 CFR 436.2; 42 CFR 436.3; 42 CFR 435.3

Legal Deadline: None

Abstract: This rule will finalize the interim final rule that requires 
State Medicaid agencies to provide for receipt and initial processing 
of Medicaid applications filed by certain low-income pregnant women, 
infants, and children under age 19, at locations which are other than 
those used for receipt and processing of applications for cash 
assistance under title IV-A of the Social Security Act. The rule is 
based on section 1902(a)(55) of the Social Security Act, as added by 
section 4602 of OBRA '90, PL 101-508.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule With Comment 
Period                          09/23/94                    59 FR 48805
Interim Final Rule Effective 
Date                            10/24/94
Interim Final Rule Comment 
Period End                      11/22/94
Final Action                    04/00/98

Small Entities Affected: None

Government Levels Affected: State

Additional Information: HCFA-2052-F

Agency Contact: Robert Tomlinson, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, C4-20-21, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4463

RIN: 0938-AF69
_______________________________________________________________________




1109. RETROACTIVE ENROLLMENT AND DISENROLLMENT IN RISK HEALTH 
MAINTENANCE ORGANIZATIONS AND COMPETITIVE MEDICAL PLANS (HCFA-1015-F)

Priority:  Other Significant

Legal Authority:  42 USC 1395mm; 43 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 417.448; 42 CFR 417.450; 42 CFR 417.456; 42 CFR 
417.460; 42 CFR 417.461; 42 CFR 417.462; 42 CFR 417.464; 42 CFR 
417.584; 42 CFR 417.436

Legal Deadline: None

Abstract: This rule implements section 4204(e) of OBRA '90. It permits 
HCFA to make retroactive payments for up to 90 days when there is a 
delay in notifying HCFA that a beneficiary has enrolled under a section 
1876 (of the Social Security Act) risk contract through an employer 
health plan. In addition, the rule will permit the Secretary to 
authorize retroactive disenrollment in specific cases. We will also 
address related requirements of the Balanced Budget Act of 1997.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/27/93                    58 FR 68366
NPRM Comment Period End         02/25/94
Final Action                    06/00/98

Small Entities Affected: None

Government Levels Affected: None

Additional Information: OMC-015

Agency Contact: Anne Manley, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1096

RIN: 0938-AF98
_______________________________________________________________________




1110. PAYMENT FOR PREADMISSION SERVICES (HCFA-1731-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395ww(a)(4)

CFR Citation:  42 CFR 412.2(c); 42 CFR 413.40

Legal Deadline: None

Abstract: This rule finalizes provisions published in an interim final 
rule with comment period on January 12, 1994, and responds to comments 
received on that rule. The interim final rule implemented section 4003 
of OBRA '90, entitled ``Expansion of DRG Payment Window,'' which 
amended the statutory definition of ``operating costs of inpatient 
hospital services'' to include certain preadmission services.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/12/94                     59 FR 1654
Interim Final Rule Effective 
Date                            01/12/94
Interim Final Rule Comment 
Period End                      03/14/94
Final Rule                      02/11/98                     63 FR 6864
Final Action                    04/00/98

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: HCFA-1731-F

Agency Contact: Nancy Edwards, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, C5-06-27, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4531

RIN: 0938-AG00
_______________________________________________________________________




1111. CHANGE IN PROVIDER AGREEMENT REGULATIONS RELATED TO FEDERAL 
EMPLOYEE HEALTH BENEFITS (HCFA-1748-F)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  5 USC 8904(b)

CFR Citation:  42 CFR 489

Legal Deadline: None

Abstract: This final rule will amend current Medicare regulations to 
require that payment limitations apply to hospitals that furnish 
inpatient hospital services to retired Federal workers, aged 65 or 
older, who are enrolled in a Federal Employee Health Benefits (FEHB) 
plan but not covered under

[[Page 22003]]

Medicare part A (Hospital Insurance). The payment amount will 
approximate the Medicare diagnosis-related group payment rates 
established under the inpatient hospital Medicare prospective payment 
rate. This rule will also amend current Medicare regulations to 
authorize HCFA to consider terminating or nonrenewing a hospital's 
Medicare provider agreement if the hospital repeatedly fails to accept 
the Medicare rate as payment in full for inpatient hospital services 
provided to retired Federal workers enrolled in a fee-for-service from 
a FEHB plan who do not have Medicare part A coverage. This rule will 
implement section 7002(f) of OBRA '90, enacted November 5, 1990. It 
will clarify that an institutional provider may not discriminate 
against Medicare patients in providing services because it is 
dissatisfied with the level of Medicare payment.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/10/94                     59 FR 6228
NPRM Comment Period End         04/11/94
Final Action                    04/00/98

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: BPD-748

Agency Contact: Bernadette Schumaker, Center for Health Plans and 
Providers, Department of Health and Human Services, Health Care 
Financing Administration, C4-02-26, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4568

RIN: 0938-AG03
_______________________________________________________________________




1112. REVISED MEDICAID MANAGEMENT INFORMATION SYSTEMS (MB-38-FN)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396b(r)

CFR Citation:  None

Legal Deadline: None

Abstract: This notice sets forth revised general functional 
requirements for the Medicaid Management Information System (MMIS). The 
MMIS consists of software and hardware used to process Medicaid claims 
and to retrieve and produce utilization and management information 
about services that are required by the Medicaid agency or Federal 
Government for administrative or audit purposes. The revised 
requirements allow States more flexibility to exercise variations in 
the implementation.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Notice                 11/22/93                    58 FR 61692
Comment Period End              01/21/94
Final Action                    04/00/98

Small Entities Affected: None

Government Levels Affected: State

Additional Information: MB-038

Agency Contact: Richard Friedman, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, C4-22-27, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4451

RIN: 0938-AG10
_______________________________________________________________________




1113. NONCOVERAGE OF ELECTROSTIMULATION OF SALIVARY GLANDS FOR THE 
TREATMENT OF XEROSTOMIA (DRY MOUTH) (HCFA-3782-FN)

Priority:  Substantive, Nonsignificant

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

CFR Citation:  45 CFR 300

Legal Deadline: None

Abstract: This notice announces the Medicare program's intent to 
exclude from coverage electrostimulation of the salivary glands in the 
treatment of xerostomia secondary to Sjogren's Syndrome. Public Health 
Service (PHS) studies show that there is insufficient data to establish 
the clinical utility of electrostimulation to evaluate its long-term 
effectiveness, or to identify those xerostomia patients who would 
benefit from this procedure. Also, PHS reports that electrostimulation 
is not widely accepted as a treatment for xerostomia secondary to 
Sjogren's Syndrome.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Notice                 05/23/94                    59 FR 26653
Comment Period End              07/22/94
Final Action                    06/00/98

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-782

Agency Contact: Francine Spencer, Office of Clinical Standards and 
Quality Coverage and Analysis Group, Department of Health and Human 
Services, Health Care Financing Administration, C4-04-05, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4614

RIN: 0938-AG45
_______________________________________________________________________




1114. TELEPHONE REQUESTS FOR REVIEW OF PART B INITIAL CLAIM 
DETERMINATIONS (HCFA-4121-F)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1302; 42 USC 1395ff(b); 42 USC 1395hh; 42 USC 
1395ii; 42 USC 1395u(b)(3)(C)

CFR Citation:  42 CFR 405.802; 42 CFR 405.807

Legal Deadline: None

Abstract: This rule will make it easier for beneficiaries, providers, 
suppliers, physicians, and other practitioners who are entitled to 
appeal Medicare part B initial claim determinations to request a review 
of the carrier's initial determination. Currently, these initial claim 
requests must be in writing. This final rule will allow those requests 
to be made by telephone, which will expedite the appeals process, and 
save time and costs for all parties. Allowing the use of telephone 
requests will supplement, not replace, the current procedures for 
initiating appeals. By providing quick and easy access to the appeals 
process, this rule will also improve carrier relationships with the 
beneficiary, physician and other suppliers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/10/95                    60 FR 35544
NPRM Comment Period End         09/08/95
Final Action                    04/00/98

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPO-121

Agency Contact: Rosalind Little, Center for Beneficiary Services, 
Department of Health and Human Services, Health Care Financing 
Administration, S1-05-18, 7500

[[Page 22004]]

Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6972

RIN: 0938-AG48
_______________________________________________________________________




1115. HOME HEALTH AGENCY (HHA) CONDITIONS OF PARTICIPATION (HCFA-3819-F)

Priority:  Other Significant

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

Legal Authority:  42 USC 1302; 42 USC 1395x; 42 USC 1395cc(a); 42 USC 
1395hh; 42 USC 1395bb

CFR Citation:  42 CFR 484

Legal Deadline: None

Abstract: This final rule will revise home health agency conditions of 
participation to center on the patient, using outcome-oriented 
measures. Most of the current HHA conditions of participation have 
remained unchanged since home health services became a Medicare benefit 
in 1966. Some limited modifications have been made over the years to 
comply with legislative changes. As a result, most of the conditions of 
participation continue to be structure and process oriented. In 
addition, this final rule will require that HHAs use a standard core 
assessment data set the ``Outcome and Assessment Information Set'' 
(OASIS) when evaluating adult, nonmaternity patients receiving home 
health care.

Alternatives: We considered an alternative to requiring use of the 
OASIS. Specifically, rather than requiring HHAs to incorporate the 
OASIS items into their own assessment systems, we considered permitting 
HHAs to choose, with our approval. Among sets of measures including 
those they devise themselves. We rejected this option because the OASIS 
is the only rigorously validated and reliable core assessment data set 
available today in home care. In time we will entertain the possibility 
of other standard data sets if they meet our needs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/10/97                    62 FR 11005
NPRM Comment Period End         06/09/97
Final Action                    06/00/98

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: HCFA-3819-F

Agency Contact: Mary Vienna, Office of Clinical Standards and Quality, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-05-27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6940

RIN: 0938-AG81
_______________________________________________________________________




1116. CLIA PROGRAM: CATEGORIZATION OF WAIVED TESTS (HCFA-2225-FC)

Priority:  Other Significant. Major under 5 USC 801.

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

Legal Authority:  42 USC 263a

CFR Citation:  42 CFR 493.2; 42 CFR 493.7; 42 CFR 493.8; 42 CFR 493.9; 
42 CFR 493.15; 42 CFR 493.20; 42 CFR 493.25; 42 CFR 493.35; 42 CFR 
493.37; 42 CFR 493.39; 42 CFR 493.45; 42 CFR 493.47; 42 CFR 493.49; 42 
CFR 493.53; 42 CFR 493.1775

Legal Deadline: None

Abstract: As part of the CLIA program (see RIN: 0938-AE47), this rule 
will revise our current process of evaluating tests against generic 
criteria. A waiver will be granted to any test that meets the statutory 
criteria, provided that scientifically valid data are submitted 
verifying that the criteria were met.

Statement of Need: This final rule will clarify the waiver criteria and 
streamline the waiver process so that more tests may be categorized as 
waived; that is, exempt from CLIA performance and personnel 
requirements.

Summary of the Legal Basis: The CLIA statute specifically authorizes 
the Secretary to determine which simple laboratory procedures have an 
insignificant risk of an erroneous result, and to waive otherwise 
applicable quality standards for these procedures. Additionally, the 
Clinical Laboratory Improvement Advisory Committee (CLIAC) was 
established to advise and make recommendations on technical and 
scientific aspects of the regulations. The CLIAC recommended that the 
criteria for categorizing tests as waived be better defined. As a 
result of the comments concerning waived tests and the CLIAC 
recommendations, the Centers for Disease Control and Prevention 
developed criteria for placing tests in the waived category as outlined 
in this proposal.

Alternatives: Performance standards based on current analysis of 
specific criteria would continue to limit technology and inhibit 
expansion of waived tests.

Anticipated Costs and Benefits: This regulation decreases burden, 
especially for physician office laboratories performing waived tests 
due to virtually no regulatory oversight. It increases access to a 
greater variety of waived tests. Physician office laboratories may 
expand the range of tests they perform without an increase in costs/
burden. The regulation creates incentives for manufacturers to develop 
more test systems that meet the clarified waiver criteria and criteria 
for approval for home use. It eliminates inspection fees for many of 
the 60,000 physician offices and other small laboratories performing 
tests that will fall into the waived category as a result of the 
clarifications to the waived criteria.

Risks: The clarification of the waived criteria and development of a 
process protocol will provide for consistent application of detailed 
standards in order to ensure that tests categorized as waived preclude 
any reasonable risk of harm to a patient as a result of a testing 
error.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/13/95                    60 FR 47534
NPRM Comment Period End         11/13/95
Final Action                    04/00/98

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: HSQ-225

Agency Contact: Judy Yost, Division of Outcomes and Improvements, 
Department of Health and Human

[[Page 22005]]

Services, Health Care Financing Administration, S2-09-28, 7500 Security 
Blvd., Baltimore, MD 21244
Phone: 410 786-3531

RIN: 0938-AG99
_______________________________________________________________________




1117. AMBULANCE SERVICES (HCFA-1813-F)

Priority:  Other Significant

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 410.40; 42 CFR 410.41; 42 CFR 424.124

Legal Deadline: None

Abstract: This rule updates and revises policy on coverage of ambulance 
services. It bases coverage and payment for ambulance services on the 
medical services needed to treat the beneficiary's condition. It also 
clarifies Medicare policy on coverage of non-emergency ambulance 
services for Medicare beneficiaries. It defines an ambulance by 
describing the requirements for furnishing both basic and advanced life 
support levels of ambulance services. The rule would require use of 
additional HCFA common procedure coding systems (HCPCS) codes to show 
the origin and destination of the ambulance transportation on the 
billing form. It requires use of international classification of 
diseases, 9th revision, clinical modification (ICD-9-CM) codes to bill 
the Medicare program for basic and advanced levels of ambulance 
services.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/17/97                    62 FR 32715
NPRM Comment Period End         08/17/97
Final Action                    04/00/98

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: None

Additional Information: HCFA-1813-F

Agency Contact: Margot Blige, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-02-26, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4642

RIN: 0938-AH13
_______________________________________________________________________




1118. ADJUSTMENT IN PAYMENT AMOUNTS FOR NEW TECHNOLOGY INTRAOCULAR 
LENSES (HCFA-3831-F)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1395k(a)(2); 42 USC 1395l

CFR Citation:  42 CFR 416

Legal Deadline:  NPRM, Statutory, October 31, 1995.

Abstract: This rule establishes a process under which interested 
parties could request, with respect to a class of new technology 
intraocular lenses (IOLs), a review of the appropriateness of the 
current payment amount for IOLs furnished by Medicare-participating 
ambulatory surgical centers. This rule is part of HCFA's regulatory 
reform initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/04/97                    62 FR 46698
Final Action                    04/00/98

Small Entities Affected: None

Government Levels Affected: None

Additional Information: HCFA-3831-F

Agency Contact: Claude Mone, Office of Clinical Standards and Quality, 
Department of Health and Human Services, Health Care Financing 
Administration, C5-04-24, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5666

RIN: 0938-AH15
_______________________________________________________________________




1119. CLIA PROGRAM: CYTOLOGY PROFICIENCY TESTING (HCFA-2233-N)

Priority:  Other Significant

Legal Authority:  42 USC 263a(f)(4)(B)(iv)

CFR Citation:  42 CFR 493.855

Legal Deadline: None

Abstract: This notice announces the withdrawal of a proposed rule on 
cytology proficiency testing that was published in the Federal Register 
November 30, 1995, and instead, announces a supplement to the 
rulemaking record of a final rule published February 28, 1992. In 
publishing the proposed rule, HHS complied with a Federal court order 
requiring publication of a proposal that would require that cytology 
proficiency testing be conducted to the extent practicable, under 
normal working conditions. As required, we proposed to revise 
regulations to require that proficiency testing be conducted at a pace 
corresponding to the maximum workload rate for individuals examining 
slides. We also solicited comments on the use of computer facsimile 
representations of cytology specimens, as an alternative to glass-slide 
proficiency testing. After the proposed rule was published, the appeals 
court revised the lower court's order, allowing us to withdraw the 
proposed rule and supplement the record to the final rule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/30/95                    60 FR 61509
NPRM Comment Period End         01/29/96
Final Action                    04/00/98

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: HSQ-233-N. We are publishing a notice to advise 
the public that no final rule is necessary because the court decided 
the case in our favor.

Agency Contact: Rhonda Whalen, Senior Health Scientist, Department of 
Health and Human Services, Centers for Disease Control and Prevention, 
4770 Buford Highway, NE., MS F 11, Atlanta, GA 30341-3724
Phone: 770 488-7670

RIN: 0938-AH35
_______________________________________________________________________




1120. REQUIREMENTS FOR ENROLLMENT OF MEDICAID RECIPIENTS UNDER COST 
EFFECTIVE EMPLOYER-BASED GROUP HEALTH PLANS (HCFA-2047-FC)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396a(a)(10); 42 USC 1396a(u)(1); 42 USC 
1396d(a); 42 USC 1396a(a)(25); 42 USC 1396a(e); 42 USC 1396e

CFR Citation:  42 CFR 435; 42 CFR 436

Legal Deadline: None

[[Page 22006]]

Abstract: This rule will provide for continuation of payment of health 
insurance premiums for individuals who are entitled to elect COBRA 
continuation coverage under a group health plan provided by an employer 
with 75 or more employees. Medicaid recipients may be required to apply 
for enrollment in employer-based cost eligibility; require State 
agencies to pay for premiums, eligibility. This rule also requires 
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.'' In addition, this rule incorporates the changes of 
section 1906 due to the Balanced Budget Act of 1997.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/20/94                    59 FR 31569
NPRM Comment Period End         08/19/94
Final Action                    10/00/98

Small Entities Affected: None

Government Levels Affected: None

Additional Information: MB-047
Previously published under RIN 0938-AF64.

Agency Contact: Gwendolyn Talvert, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, C4-20-20, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-5928

RIN: 0938-AH48
_______________________________________________________________________




1121. LIMITATIONS ON LIABILITY (HCFA-4859-FC)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1302; 42 USC 1395hh; 42 USC 1395pp

CFR Citation:  42 CFR 411.404

Legal Deadline: None

Abstract: This final rule with comment period will implement section 
1879 (h) of the Social Security Act, which limits beneficiary liability 
for certain medical equipment and supplies. This rulemaking is part of 
the Reinventing Government effort. We are working with industry 
representatives to develop guidelines that will streamline 
requirements, reduce burden and duplication, and give beneficiaries the 
opportunity to make informed consumer decisions regarding certain 
medical equipment and supplies.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    04/00/98

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-859

Agency Contact: Denis Garrison, Division of Beneficiary Protections, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-06-21, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5643

RIN: 0938-AH51
_______________________________________________________________________




1122. TERMS, DEFINITIONS, AND ADDRESSES: TECHNICAL AMENDMENTS (HCFA-
9877-FC)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1302; 42 USC 1395x(v)(1)(A); 42 USC 1395hh

CFR Citation:  42 CFR 400 to 420; 42 CFR 421 to 430; 42 CFR 431 to 440; 
42 CFR 442 to 447; 42 CFR 455 to 456; 42 CFR 462 to 466; 42 CFR 473 to 
476; 42 CFR 482 to 489; 42 CFR 491 to 498

Legal Deadline: None

Abstract: This is a technical final rule with comment period that will 
initiate the rationalization of our system of definitions, correct 
outdated addresses and formulas, clarify which steps of the appeals 
process are binding and which are final, remove content that is 
duplicative or unnecessary, and make other clarifying editorial 
changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule With Comment Period  08/00/98

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-877

Agency Contact: Luisa Iglesias, Division of Regulation and Issuances, 
Department of Health and Human Services, Health Care Financing 
Administration, Room 409-B Humphry Bldg, 200 Independence Ave SW., 
Washington, DC
Phone: 202 690-6383

RIN: 0938-AH53
_______________________________________________________________________




1123. CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEM AND 
FISCAL YEAR 1998 RATES (HCFA-1878-F)

Priority:  Other Significant. Major under 5 USC 801.

Legal Authority:  42 USC 1395ww

CFR Citation:  42 CFR 412; 42 CFR 413; 42 CFR 489

Legal Deadline:  NPRM, Statutory, May 1, 1997. Final, Statutory, 
September 1, 1997.

Abstract: This final rule responds to public comments received on those 
portions of a final rule with comment period published in the Federal 
Register on August 29, 1997, that revised the Medicare hospital 
inpatient prospective payment systems for operating costs and capital-
related costs to implement necessary changes resulting from the 
Balanced Budget Act (BBA) of 1997, Public Law 105-33. This rule also 
addresses public comments on other BBA changes relating to cost limits 
for hospitals and hospital unites excluded from the prospective payment 
systems, as well as direct graduate medical education payments, that 
were included in the August 29, 1997 document. Generally, these BBA 
changes were applicable to hospital discharges occurring on or after 
October 1, 1997.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/02/97                    62 FR 29902
NPRM Comment Period End         08/01/97
Final Rule With Comment Period  08/29/97                    62 FR 45966
Final Rule Comment Period End   10/28/97
Final Action                    04/00/98

Small Entities Affected: Businesses, Organizations

Government Levels Affected: State, Federal

[[Page 22007]]

Additional Information: HCFA-1878-F
HCFA published a final rule with comment period on 8/29/97. HCFA is 
responding to the comments in a final rule under development.

Agency Contact: Tzvi Hefter, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, C5-08-27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4487

RIN: 0938-AH55
_______________________________________________________________________




1124. UTILIZATION CONTROL AND DISCONTINUED REVIEW ACTIVITIES; MEDICAID 
(MB-101-FC)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1302; 42 USC 1396a(a)(26); 42 USC 
1396a(a)(30); 42 USC 1396a(a)(31); 42 USC 1396a(a)(44); 42 USC 1396b(g)

CFR Citation:  42 CFR 400; 42 CFR 431; 42 CFR 456

Legal Deadline: None

Abstract: This proposed rule would codify in regulations the statutory 
requirements that make physician certification and development of plan 
of care and utilization review State plan requirements under the 
Medicaid program. States would no longer be required to make quarterly 
showings that they have complied with those requirements and other 
provisions would be removed. Regulatory provisions on regional staff 
subsampling of State Medicaid quality control.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    04/00/98

Small Entities Affected: Businesses

Government Levels Affected: State

Additional Information: MB-101

Agency Contact: Wanda White, Office of Medicaid and State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-25-02, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-2638

RIN: 0938-AH64
_______________________________________________________________________




1125. INDIVIDUAL MARKET HEALTH INS. REFORM PORTABILITY FROM GROUP TO 
INDIV. COVERAGE; FEDERAL RULES FOR ACCESS IN THE INDIV. MARKET; STATE 
ALTERNATIVE MECHANISMS TO FEDERAL RULES (HCFA-2882-F)

Priority:  Other Significant. Major under 5 USC 801.

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

Legal Authority:  42 USC 300gg-41, et seq

CFR Citation:  45 CFR 148

Legal Deadline: None

Abstract: This final rule will address comments received on the interim 
final rule published on April 8, 1997 and further clarifies the 
Departmental position on HIPAA requirements in the individual market.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/08/97                    62 FR 16985
Interim Final Rule Effective 
Date                            04/08/97
Interim Final Rule Comment 
Period End                      07/07/97
Final Action                    04/00/98

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Federal

Additional Information: BPD-882-F

Agency Contact: Gertrude Saunders, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-5888

RIN: 0938-AH75
_______________________________________________________________________




1126. MEDICAID PROGRAM; REDETERMINATIONS OF MEDICAID ELIGIBILITY DUE TO 
WELFARE REFORM (HCFA-2105-IFC)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302

CFR Citation:  42 CFR 435.1003; 42 CFR 457

Legal Deadline: None

Abstract: The Personal Responsibility and Work Opportunity 
Reconciliation Act of 1996 and the Contract With America Advancement 
Act of 1996 made statutory changes affecting the eligibility of large 
numbers of Medicaid recipients. Changes were made to the definition of 
disability for children and eligibility requirements of non-U.S. 
citizens and individuals receiving disability cash assistance based on 
a finding of alcoholism and drug addiction. In order to protect Federal 
financial participation in State Medicaid expenditures for States with 
unusual volumes of eligibility redeterminations caused by these 
statutory changes, we published a final rule with comment period on 
January 13, 1997. That rule changed our regulations to provide 
additional time for States to process redeterminations and provide 
services pending the redeterminations. We are analyzing the public 
comments to the January 13 rule in preparation of a final rule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule Effective            01/13/97
Final Rule With Comment Period  01/13/97                     62 FR 1682
Final Action                    06/00/98

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Bob Tomlinson, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, Medicaid Bureau, C4-20-21, 7500 Security 
Blvd., Baltimore, MD 21244
Phone: 410 786-4463

RIN: 0938-AH76
_______________________________________________________________________




1127. CLIA PROGRAM; SIMPLIFYING CLIA REGULATIONS TO ACCREDITATION 
EXEMPTION OF LABORATORIES UNDER A STATE LICENSURE PROGRAM, AND 
PROFICIENCY TESTING AND INSPECTION (HCFA-2239-FC)

Priority:  Substantive, Nonsignificant

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

[[Page 22008]]

duplication, or streamline requirements.

Legal Authority:  42 USC 263a; 42 USC 1302; 42 USC 1395x(e); 42 USC 
1395x(s)(11) to 1395x(s)(16)

CFR Citation:  42 CFR 493

Legal Deadline: None

Abstract: This final rule with comment period will respond to various 
comments received on an earlier final rule with a comment period 
implementing the Clinical Laboratory Improvement Amendments of 1988, 
which was published in the Federal Register on February 28, 1992, in 
the areas of proficiency testing and inspections for clinical 
laboratories. This rule will follow the Administration's regulatory 
reform initiative by reducing duplicative material, emphasizing 
outcome-oriented results, and simplifying regulations. We also are 
streamlining our regulation in the areas of State exemption, and 
granting deemed status to laboratories accredited by an approved 
accreditation organization.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/00/98

Small Entities Affected: None

Government Levels Affected: None

Additional Information: HSQ-239

Agency Contact: Judy Yost, Center for Medicaid and State Operations, 
Division of Outcomes and Improvement, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security Blvd., 
Baltimore, MD 21244
Phone: 410 786-3531

RIN: 0938-AH82
_______________________________________________________________________




1128. ALLOCATION OF ENHANCED FEDERAL MATCHING FUNDS FOR INCREASED 
ADMINISTRATIVE COSTS (MB-103-N)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396a(a)

CFR Citation:  None

Legal Deadline: None

Abstract: This notice will provide a formula for the allocation of a 
special $500 million fund for enhanced Federal matching for State 
Agency's expenditures attributable to additional Medicaid 
administrative costs of Medicaid eligibility determinations as a result 
of the provisions of 1931 of the Social Security Act as amended by the 
Personal Responsibility and Work Opportunity Reconciliation Act of 
1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          05/14/97                    62 FR 26545
Notice Comment Period End       07/13/97
Final Action                    04/00/98

Small Entities Affected: None

Government Levels Affected: State

Additional Information: MB-103

Agency Contact: Richard Strauss, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd, C4-18-26, Baltimore, MD 
21244
Phone: 410 786-2019

RIN: 0938-AH90
_______________________________________________________________________




1129. MEDICALLY NEEDY DETERMINATIONS UNDER WELFARE REFORM (HCFA-2109-
IFC)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1302; 42 USC 1396a(a)(10)(C)

CFR Citation:  42 CFR 435; 42 CFR 436

Legal Deadline: None

Abstract: This interim final rule with comment period will revise our 
rules to allow States to include individuals who are described as 
categorically needy to be covered as medically needy. The State must 
specify the income and resources criteria for the medically needy group 
in the State plan. If an individual is also described as categorically 
needy, the individual would receive Medicaid as categorically needy if 
the State elected to cover the categorically needy group into which the 
individual fits. If the State has not elected to cover that group, the 
individual would be medically needy. This change will allow more 
individuals to become eligible for Medicaid as medically needy and 
eliminate an inequity in current regulations. This revision also allows 
some individuals who would otherwise lose their Medicaid benefits to 
retain their eligibility.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/00/98

Small Entities Affected: None

Government Levels Affected: State

Additional Information: MB-109

Agency Contact: Jackie Wilder, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd, C4-20-06, Baltimore, MD 
21244
Phone: 410 786-4579

RIN: 0938-AH92
_______________________________________________________________________




1130. FINAL LIMITATIONS ON AGGREGATE PAYMENTS TO DISPROPORTIONATE SHARE 
HOSPITALS: FEDERAL FISCAL YEAR 1998 (HCFA-2110-N)

Priority:  Substantive, Nonsignificant

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

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

Legal Deadline:  Other, Statutory, April 1998.
Regulatory Deadline

Abstract: This notice announces the final Federal fiscal year 1998 
national target and individual State allotments for Medicaid payment 
adjustments made to hospitals that serve a disproportionate number of 
Medicaid recipients and low-income patients with special needs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          11/00/98

Small Entities Affected: None

Government Levels Affected: State

Additional Information: MB-110

Agency Contact: Richard Strauss, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd., C4-17-27, Baltimore, MD 
21244
Phone: 410 786-2019

RIN: 0938-AH93

[[Page 22009]]

_______________________________________________________________________




1131. REVISION TO THE DEFINITION OF AN UNEMPLOYED PARENT (HCFA-2106-FC)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 607; 42 USC 1396u-1

CFR Citation:  45 CFR 233

Legal Deadline: None

Abstract: This final rule with comment period will make a change 
necessary for a State to further facilitate coordination of its 
Medicaid and foster care program in cases where coverage has been 
expanded under its Temporary Assistance for Needy Families beyond the 
definition of unemployed parent contained in existing Aid to Families 
with Dependent Children regulations. This rule revises the definition 
of unemployment of a principal wage earner for purposes of coverage of 
dependent children of unemployed parents. It will also allow States to 
eliminate inequitable policies that are a disincentive to family unity.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/00/98

Small Entities Affected: None

Government Levels Affected: State

Additional Information: HCFA-2106-FC

Agency Contact: Judith Rhoades, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd., CA-20-05, Baltimore, MD 
21244
Phone: 410 786-4462
Fax: 410 786-3252

RIN: 0938-AH98
_______________________________________________________________________




1132. HEALTH INSURANCE REFORM: PARITY IN THE APPLICATION OF CERTAIN 
LIMITS TO MENTAL HEALTH BENEFITS (HCFA-2891-IFC)

Priority:  Other Significant

Legal Authority:  42 USC 300gg-5

CFR Citation:  45 CFR 146

Legal Deadline: None

Abstract: This interim final rule will impose requirements on the large 
group health plan market. It will require parity of mental health 
benefits with medical and surgical benefits under a group health plan 
in the application of aggregate lifetime limits and annual limits. It 
will implement sections 702 and 703 of the Mental Health Parity Act of 
1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              12/22/97                    62 FR 66932
Final Action                    04/00/98

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Federal

Agency Contact: Marc Thomas, Center for Medicaid & State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-7154

RIN: 0938-AI05
_______________________________________________________________________




1133. PORTABILITY AND NONDISCRIMINATION IN THE GROUP HEALTH INSURANCE 
MARKET (HCFA-2890-F)

Priority:  Other Significant. Major under 5 USC 801.

Legal Authority:  42 USC 201

CFR Citation:  45 CFR 146

Legal Deadline: None

Abstract: This final rule will address comments received on the interim 
final rule published April 8, 1997. It will also further clarify the 
Department's position on the minimum requirements applicable with 
respect to group health plans and health insurance issuers offering 
group health insurance coverage. A group health plan or health 
insurance issuer offering group health coverage may provide greater 
rights to participants and beneficiaries than those currently provided. 
This rule will include the following: (1) limitations on preexisting 
condition exclusion periods; (2) certification and disclosure of 
previous coverage; (3) special enrollment periods for individuals (and 
dependents) losing other coverage; (4) use of affiliation period by 
HMOs as alternative to preexisting condition exclusion; (5) prohibited 
discrimination against individual participants and beneficiaries based 
on health status; (6) guaranteed availability in the small group 
market; and (7) guaranteed renewability in the large and small group 
markets.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/08/97                    62 FR 16894
Interim Final Rule Effective    06/07/97
Interim Final Rule Comment 
Period End                      07/07/97
Final Rule                      04/00/98

Small Entities Affected: Businesses

Government Levels Affected: Federal

Additional Information: BPD-890-IFC

Agency Contact: Dave Holstein, Insurance Standards Team, Department of 
Health and Human Services, Health Care Financing Administration, 7500 
Security Blvd., Baltimore, MD 21244
Phone: 410 786-1564

RIN: 0938-AI08
_______________________________________________________________________




1134. PART A PREMIUM FOR 1998 FOR THE UNINSURED AGED AND FOR CERTAIN 
DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER ENTITLEMENT (HCFA-5056-N)

Priority:  Other Significant. Major under 5 USC 801.

Legal Authority:  42 USC 1395i-2; 42 USC 1395i-20

CFR Citation:  45 CFR 300

Legal Deadline:  Other, Statutory, September 30, 1998.
Notice publication

Abstract: This notice announces the hospital insurance premium for 
calendar year 1998 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                          04/00/98

Small Entities Affected: None

[[Page 22010]]

Government Levels Affected: None

Agency Contact: John Wandishin, Office of Strategic Planning, 
Department of Health and Human Services, Health Care Financing 
Administration, N3-26-00, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-6389

RIN: 0938-AI10
_______________________________________________________________________




1135. INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED CARE 
SERVICES COINSURANCE AMOUNTS FOR 1998 (HCFA-5057-N)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395e

CFR Citation:  None

Legal Deadline: None

Abstract: This notice announces the inpatient hospital deductible and 
the hospital and extended care services coinsurance amounts for 
services furnished in calendar year 1998 under Medicare's hospital 
insurance program (Medicare part A). The Medicare statute specifies the 
formula to be used to determine these amounts.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          10/00/98

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: John Wandishin, Deputy Director, Division of Medicare 
and Medicaid Cost Estimates, Department of Health and Human Services, 
Health Care Financing Administration, N3-36-24, 7500 Security Blvd., 
Baltimore, MD 21244
Phone: 410 786-6389

RIN: 0938-AI12
_______________________________________________________________________




1136. HEALTH INSURANCE PORTABILITY: NEWBORNS' AND MOTHERS' HEALTH 
PROTECTION (HCFA-2892-IFC)

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

Legal Authority:  42 USC 300gg-4; 42 USC 300gg-51

CFR Citation:  45 CFR 146.136; 45 CFR 148.151

Legal Deadline: None

Abstract: This interim final rule implements the Newborns' and Mothers' 
Health Protection Act of 1996. It provides that a health insurance 
issuer that covers hospital length of stay in connection with 
childbirth may not restrict the stay for the mother or newborn to less 
than 48 hours following a normal vaginal delivery or 96 hours following 
a cesarean section. However, discharge may occur earlier if the 
attending provider in consultation with the mother decides to discharge 
earlier.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/00/98

Small Entities Affected: Undetermined

Government Levels Affected: None

Agency Contact: Marc Thomas, Health Insurance Standards Team, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, C4-02-16, Baltimore, MD 21244
Phone: 410 786-7154

RIN: 0938-AI17
_______________________________________________________________________




1137. MEDICARE PROGRAM: UPDATE OF AMBULATORY SURGICAL CENTER PAYMENT 
RATES EFFECTIVE FOR SERVICES ON OR BEFORE OCTOBER 1, 1997 (HCFA-1897-N)

Priority:  Other Significant

Legal Authority:  42 USC 1395l(a)(4); 42 USC 1395l(i)(l)(a); 42 USC 
1833(i)(2)(c)

CFR Citation:  42 CFR 416.25

Legal Deadline: None

Abstract: This notice implements section 1833(i)(2)(c) of the Social 
Security Act, which mandates an inflation adjustment to Medicare 
payment amounts for ambulatory surgical center (ASC) facility services 
during the years when the payment amounts are not updated based on a 
survey of the actual audited costs incurred by ASCs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    04/00/98

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Joan Sanow, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., C4-11-16, Baltimore, MD 21244
Phone: 410 786-5763

RIN: 0938-AI18
_______________________________________________________________________




1138. MEDICAID PROGRAM: CHARGES FOR VACCINE ADMINISTRATION UNDER THE 
VACCINES FOR CHILDREN (VCF) PROGRAM (HCFA-2084-FNC)

Priority:  Substantive, Nonsignificant

Unfunded Mandates: This action may affect State, local or tribal 
governments and the private sector.

Legal Authority:  42 USC 1302; 42 USC 1396(a)(62)

CFR Citation:  None

Legal Deadline: None

Abstract: This notice lists, by State, the finalized regional maximum 
charges that providers may impose for the administration of pediatric 
vaccines to federally vaccine-eligible children under the Vaccines for 
Children (VFC) program. This notice also specifies the methodology that 
HCFA used to establish the revised maximum charges. In addition, this 
notice provides States that purchase vaccines for all children the 
option to use these regional maximum charges or devise their own 
administration fees, and clarifies that State Medicaid agencies may 
establish lower fees than these maximum charges if the agencies assure 
access to immunizations for Medicaid-eligible children to the same 
extent as the general population. This notice also responds to comments 
on the October 3, 1994 notice with comment period.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice With Comment Period      10/03/94                    59 FR 50235
Notice                          04/10/95                    60 FR 18136
Final Notice                    04/00/98

Small Entities Affected: None

Government Levels Affected: None

Additional Information: HCFA-2084-FNC

Agency Contact: Marge Sciulli, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, C4-22-06, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-0691

RIN: 0938-AI20

[[Page 22011]]

_______________________________________________________________________




1139. SOLVENCY STANDARDS FOR PROVIDER-SPONSORED ORGANIZATIONS (HCFA-
1011-IFC)

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

Unfunded Mandates: Undetermined

Legal Authority:  42 USC 1395w-26(a)

CFR Citation:  42 CFR part 422

Legal Deadline: None

Abstract: This rule sets forth the solvency standards for provider 
sponsored organizations under Medicare part C

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/00/98

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Maureen Miller, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security Blvd, 
Baltimore, MD 21244
Phone: 410 786-1097

RIN: 0938-AI25
_______________________________________________________________________




1140. MEDICARE PROGRAM; NOTICE FOR THE SOLICITATION FOR PROPOSALS FOR A 
DEMONSTRATION PROJECT FOR CONGESTIVE HEART FAILURE CASE MANAGEMENT HCFA-
1104-N)

Priority:  Info./Admin./Other

Legal Authority:  42 USC 1395 (b)(1)

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: This notice announces HCFA's solicitation for proposals for a 
demonstration project to test the applicability of cost-effective, 
existing clinical case management delivery models for beneficiaries 
with congestive heart failure in the Medicare fee-for-service program. 
Section 402(a) of the Social Security Amendments of 1967 (P.L. 90-248) 
authorizes projects for one of eleven specified purposes. HCFA solicits 
proposals for demonstrations that will use innovative case management 
interventions to improve clinical outcomes and quality of life for 
Medicare beneficiaries with congestive heart failure while saving 
Medicare funds.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          04/00/98

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Catherine Jansto, Social Science Research Analyst, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Boulevard, C3-15-06, Baltimore, MD 21244
Phone: 410 786-7762
Email: [email protected]

RIN: 0938-AI26
_______________________________________________________________________




1141. GME: INCENTIVE PAYMENTS UNDER PLANS FOR VOLUNTARY REDUCTION IN 
NUMBER OF RESIDENTS (HCFA-1001-IFC)

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

Legal Authority:  42 USC 1395ww(h); PL 105-33, Sec 4626

CFR Citation:  42 CFR 413

Legal Deadline:  Other, Statutory, February 5, 1998.
Interim final regulations with comment period must be published within 
6 months of the date of enactment of the Balanced Budget Act 1997 
(August 5, 1997).

Abstract: Under current law and regulations, hospitals are paid for 
direct medical education based on the number of residents participating 
in accredited graduated medical education programs. This interim final 
rule would implement section 4626 of the Balanced Budget Act of 1997 
which allows hospitals to apply to received incentive payments for 
reducing the number of residents in training. The hospital must submit 
a plan to the Secretary outlining how they will make voluntary 
residency reductions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              06/00/98
Final Action                    08/00/98

Small Entities Affected: Businesses

Government Levels Affected: State, Local, Federal

Additional Information: HCFA-1003-IFC

Agency Contact: Marc Hartstein, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, C5-08-16, 7500 Security Blvd, Baltimore, MD 21244-1850
Phone: 410 786-4539

RIN: 0938-AI27
_______________________________________________________________________




1142. MEDICARE + CHOICE PROGRAM; REGULATORY PROGRAM TO IMPLEMENT CERTAIN 
MEDICARE PROVISIONS OF THE BALANCED BUDGET ACT OF 1997 (OMC-030-IFC)

Priority:  Economically Significant. Major under 5 USC 801.

Legal Authority:  42 USC 1302; 42 USC 1395w 21 to 27; 42 USC 1395hh

CFR Citation:  42 CFR 400; 42 CFR 403; 42 CFR 471; 42 CFR 422; 42 CFR 
489; 42 CFR 498

Legal Deadline:  Other, Statutory, June 1, 1998.
Interim Final Rule.

Abstract: This interim final rule implements the new Medicare+Choice 
program established by the Balanced Budget Act (BBA) of 1997. Under the 
Medicare+Choice program (part C of title XVIII of the Social Security 
Act) eligible individuals may choose to receive their Medicare benefits 
under any of several types of health care plans: coordinated care 
plans; medical savings account plans; fee-for service plans.

Statement of Need: The Balanced Budget Act of 1997, (Pub. L. 105-33) 
significantly expanded the types of organizations that may be eligible 
for contracts with us to provide all Medicare part A and Medicare part 
B items and services directly to beneficiaries on a prospective 
reimbursement basis. In addition, the current Medicare requirements for 
managed care organizations, with respect to reimbursement, beneficiary 
participation, beneficiary and program protections, organizational 
requirements, marketing activities, and provider participation, have 
been significantly revised by the Congress. The Act requires that the 
Secretary promulgate implementing regulations, which may be through an 
interim final rule, by June 1, 1998.

Summary of the Legal Basis: Section 1876 of the Social Security Act (42 
U.S.C. 1935mm) established the authority for Medicare reimbursement of 
managed care organizations that

[[Page 22012]]

meet specific requirements. Regulations implementing the statutory 
requirements are found at 42 CFR 417.400 et. seq. The Balanced Budget 
Act (BBA) establishes a new part C statutory authority under title 
XVIII of the Social Security Act. Provisions in the new part C 
establish the conditions under which entities may qualify to contract 
directly with HCFA as ``Medicare + Choice'' plans to provide all 
Medicare part A and part B services to beneficiaries. Part C also 
establishes significant new program requirements in the following 
areas: contractor reimbursement, beneficiary eligibility and 
enrollment, information dissemination, solvency standards, marketing, 
quality of care, data reporting, access and coverage.

Alternatives: The Balanced Budget Act of 1997 requires that the 
provisions in part C be implemented through regulations.

Anticipated Costs and Benefits: These rules will accomplish the 
objectives of increasing availability of services and access for 
beneficiaries that reside in rural and underserved urban areas of the 
country. The implementation of statutory provisions at part C will also 
result in significant Medicare program cost savings, by expanding the 
types of entities that can elect to receive payment on a capita basis, 
and by revising the reimbursement methodology for such payments.

Risks: Regulated industries and providers have a significant stake in 
the provisions of the final rules and we anticipate significant volume 
and complexity of comments once the rules are published. Publication 
will demonstrate the Administration's position on various sensitive and 
political issues related to the legislative provisions.
One possible risk is that beneficiaries will be confused by the wide 
array of choices and make selections that are not in their best 
interest. The comparative information provided by HCFA will facilitate 
plan selection.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule With Comment 
Period                          06/00/98

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Local, Federal

Agency Contact: Anthony Hausner, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security 
Boulevard, Room S3-23-24, Baltimore, MD 21244
Phone: 410 786-1093

RIN: 0938-AI29
_______________________________________________________________________




1143.  MEDICARE PROGRAM; PROSPECTIVE PAYMENT SYSTEM AND 
CONSOLIDATED BILLING FOR SKILLED NURSING FACILITIES. (HCFA-1913-IFC)

Priority:  Other Significant

Legal Authority:  PL 105-33, sec 4432(a)

CFR Citation:  42 CFR 409; 42 CFR 410; 42 CFR 411; 42 CFR 413; 42 CFR 
483; 42 CFR 489

Legal Deadline: None

Abstract: This interim final rule implements provisions in section 4432 
of the Balanced Budget Act of 1997 related to Medicare payment for 
skilled nursing facility services. These include the implementation of 
a Medicare prospective payment system for skilled nursing facilities, 
consolidated billing, and a number of related changes. The prospective 
payment system described in this rule replaces the retrospective 
reasonable cost based system currently utilized by Medicare for payment 
of skilled nursing facility services under part A of the program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/00/98

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: Federal

Agency Contact: Laurence Wilson, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, C4-7-04, Baltimore, MD 21244
Phone: 410 786-4603

RIN: 0938-AI47
_______________________________________________________________________




1144.  RESOURCE BASED PRACTICE EXPENSE PAYMENTS AND REVISIONS TO 
PAYMENT POLICIES FOR CY 1999 (HCFA-1006-P)

Priority:  Other Significant

Legal Authority:  42 USC 1395-W-4

CFR Citation:  42 CFR 405; 42 CFR 410; 42 CFR 414 to 415

Legal Deadline:  NPRM, Statutory, May 1, 1998.

Abstract: This proposed rule would make several policy changes 
affecting Medicare part B payment. The changes relate to physician 
services, including resource-based practice expense relative value 
units, medical direction and medical supervision rules for 
anesthesiologists, payment for Pap smears and for outpatient 
rehabilitation services, and payment based on actual charges. Under the 
law, we are required to develop a resource-based system for determining 
practice expense relative value units. The Balance Budged Act of 1997 
(BBA 1997) delayed, for 1 year, implementation of the resource-based 
practice expense relative value units until January 1, 1999. Under BBA 
1997, we are required to revise our payment policy for nonphysician 
practitioners for drugs and biologicals not paid on a cost or 
prospective payment basis. In addition, BBA 1997 permits certain 
physicians and practitioners to opt out of Medicare and furnish covered 
serviced to medicare beneficiaries through private contracts. Also, we 
would rebase the Medicare Economic Index from a 1989 base year to a 
1996 base year.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/00/98
Final Action Effective          01/00/99

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: Legal Authority: PL-105-33, sec 4505 PL-105-33, 
sec 4505 PL-105-33, sec 4507 PL-105-33, sec 4511 PL-105-33, sec 4512 
PL-105-33, sec 4541 PL-105-33, sec 4556

Agency Contact: Stanley Weintraub, Center for Health Plans and 
Providers, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-4498

RIN: 0938-AI52

[[Page 22013]]

_______________________________________________________________________




1145.  MEDICARE PROGRAM; DEFINITION OF PROVIDER-SPONSORED 
ORGANIZATION AND RELATED REQUIREMENTS (HCFA-1027-IFC)

Priority:  Other Significant

Legal Authority:  Social Security Act Amendment, sec 1851 and 1855

CFR Citation:  42 CFR 422.350; 42 CFR 422.352; 42 CFR 422.354; 42 CFR 
422.356

Legal Deadline: None

Abstract: The Balanced Budget Act of 1997 establishes a new 
Medicare+Choice program that significantly expands the health care 
options available to Medicare beneficiaries. Under this program, 
eligible individuals may elect to receive Medicare benefits through 
enrollment in a provider-sponsored organization. This interim final 
rule with comment period defines the term ``provider-sponsored 
organization'' for purposes of the Medicare program and establishes 
requirements related to meeting this definition.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/00/98

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Maureen Miller, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, S3-23-07, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-1097
Email: [email protected]

RIN: 0938-AI60
_______________________________________________________________________


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


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1146. CRITERIA AND PROCEDURES FOR DEVELOPING MEDICAL SERVICES COVERAGE 
POLICY (HCFA-3546-F)

Priority:  Other Significant

Legal Authority:  42 USC 1395y

CFR Citation:  42 CFR 400.404; 42 CFR 405.201; 42 CFR 405.203; 42 CFR 
405.205; 42 CFR 405.207; 42 CFR 405.211

Legal Deadline: None

Abstract: This rule will announce generally applicable criteria and 
procedures for determining whether a service is ``reasonable and 
necessary'' under the Medicare program. It will also announce generally 
applicable criteria and procedures for determining whether a service is 
``reasonable and necessary'' under the Medicare program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/30/89                     54 FR 4302
NPRM Comment Period End         03/31/89
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-432

Agency Contact: Ron Milhorn, Office of Clinical Standards and Quality, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-10-07, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-5663

RIN: 0938-AD07
_______________________________________________________________________




1147. MEDICARE COVERAGE OF OUTPATIENT OCCUPATIONAL THERAPY SERVICES 
(HCFA-1425-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  2 USC 1302; 42 USC 1395hh; 42 USC 1395k; 42 USC 
13951; 42 USC 1395w-4; 42 USC 1395x(s); 42 USC 1395x(p); 42 USC 
1395cc(e); 44 USC 3501 to 3511

CFR Citation:  42 CFR 400; 42 CFR 410; 42 CFR 424; 42 CFR 484; 42 CFR 
485; 42 CFR 486; 42 CFR 488; 42 CFR 489; 42 CFR 498

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-425

Agency Contact: Sheridan Gladhill, Center for Health Plans and 
Providers, Division of Chronic Care Management, Department of Health 
and Human Services, Health Care Financing Administration, C4-03-18, 
7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-1782

RIN: 0938-AD32
_______________________________________________________________________




1148. CHANGES TO PEER REVIEW ORGANIZATION REGULATIONS (HCFA-3135-F)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1320c; 42 USC 1396a(a)(30); 42 USC 1395cc(a)

CFR Citation:  42 CFR 400.200; 42 CFR 411.15; 42 CFR 431.630; 42 CFR 
433.15; 42 CFR 462.1; 42 CFR 462.101; 42 CFR 462.102; 42 CFR 462.106; 
42 CFR 462.107; 42 CFR 466.1; 42 CFR 466.71; 42 CFR 466.76; 42 CFR 
466.78; 42 CFR 466.83

Legal Deadline: None

Abstract: This rule will set forth several changes to regulations that 
govern Peer Review Organizations (PROs) and is based on statutory 
changes contained in COBRA '85 and OBRA '86. In addition, several 
technical changes will be included as a result of experience gained 
with the PRO program by HCFA. This rule also implements the new quality 
review requirements for certain Medicaid health maintenance 
organization contracts.

[[Page 22014]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: None

Additional Information: HSQ-135

Agency Contact: Bill Roskey, Office of Clinical Standards and Quality, 
Health Standards and Quality Bureau, Department of Health and Human 
Services, Health Care Financing Administration, S1-09-18, 7500 Security 
Blvd., Baltimore, MD 21244
Phone: 410 786-0433

RIN: 0938-AD38
_______________________________________________________________________




1149. PROTECTION OF INCOME AND RESOURCES FOR COMMUNITY SPOUSES OF 
INSTITUTIONALIZED INDIVIDUALS (HCFA-2023-P)

Priority:  Other Significant

Legal Authority:  42 USC 1396r-5; 42 USC 1302

CFR Citation:  42 CFR 435.650 to 674; 42 CFR 435.750 to 754

Legal Deadline: None

Abstract: This rule would interpret statutory changes made in 1988, 
1989, 1990 and 1993 that allocate income and resources between an 
institutionalized spouse and the spouse remaining in the community. It 
would also provide special post-eligibility rules for institutionalized 
individuals who have spouses in the community to retain more income to 
meet living expenses.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: State, Local

Additional Information: HCFA-2023

Agency Contact: Roy Trudel, Center for Medicaid & State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-20-15, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3417

RIN: 0938-AE12
_______________________________________________________________________




1150. SURVEY REQUIREMENTS AND ALTERNATIVE SANCTIONS FOR HOME HEALTH 
AGENCIES (HCFA-2169-F)

Priority:  Other Significant

Legal Authority:  42 USC 1395bbb; 42 USC 1395hh; 42 USC 1302

CFR Citation:  42 CFR 488; 42 CFR 489; 42 CFR 498

Legal Deadline: None

Abstract: These rules will establish periodic, unannounced surveys of 
home health agencies (HHAs) and other survey requirements and also will 
specify sanctions that could be used when an HHA is out of compliance 
with Federal requirements (as an alternative or in addition to 
terminating an HHA's participation in the Medicare program).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/02/91                    56 FR 37054
NPRM Comment Period End         10/01/91
Final Action                    00/00/00

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Local, Federal

Additional Information: HSQ-169
TIMETABLE CONT: Pending completion of RIN 0938-AG81 (HCFA-3819-P)

Agency Contact: Wayne Smith, Ph.D., Director, Division of Integrated 
Health Systems, Department of Health and Human Services, Health Care 
Financing Administration, S2-11-07, 7500 Security Blvd., Baltimore, MD 
21244
Phone: 410 786-6762

RIN: 0938-AE39
_______________________________________________________________________




1151. REVISIONS TO REGULATIONS IMPLEMENTING CLIA (HCFA-2226-F)

Priority:  Other Significant

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

Legal Authority:  42 USC 263a

CFR Citation:  42 CFR 493

Legal Deadline: None

Abstract: This rule will respond to public comments received on a final 
rule with comment period published on February 28, 1992. The rule 
revised regulations applicable to laboratories and implemented 
provisions of the Clinical Laboratory Improvement Amendments of 1988 
(CLIA). The regulations apply to laboratories that examine human 
specimens for the diagnosis, prevention, or treatment of any disease or 
impairment of, or the assessment of the health of, human beings. They 
specify the performance requirements, based on test complexity and risk 
factors related to erroneous test results as required by CLIA. They 
also list requirements that permit waiver of the certification and 
inspection requirements for laboratories performing only limited 
testing.

Statement of Need: On October 31, 1988, the Congress enacted 
comprehensive changes to existing laboratory regulations in CLIA. This 
statute requires the regulation of any facility (including physician 
offices) that performs tests on human beings for the purpose of 
providing information for the diagnosis, prevention, or treatment of 
any disease or impairment of, or the assessment of the health of, human 
beings. CLIA requires that the Department regulate by test, using what 
is commonly referred to as the ``complexity model'' to categorize 
individual laboratory tests based on the experience, skills, and 
judgement required to perform each test accurately. Requirements vary 
as a function of the complexity of the tests the laboratory conducts.
The law requires the Secretary to implement the numerous provisions 
through regulation to ensure the quality of laboratory testing, 
regardless of where it is provided or who is providing the testing. The 
law also requires that the CLIA program be operated through the 
assessment of user fees paid by entities subject to these requirements.
On May 21, 1990, the Department published proposed rules to implement 
CLIA and received public comments from over 60,000 commenters. Based on 
analysis of these comments, the Centers for Disease Control and 
Prevention together with Health Care Financing Administration developed 
a final rule with comment period that set forth standards for all 
entities performing laboratory testing based on test complexity. This 
rule was published on February 28, 1992, and was effective

[[Page 22015]]

September 1, 1992. This regulation was revised by regulations with 
comment periods published on January 19, 1993, December 6, 1994, April 
24, 1995, and May 12, 1997.
Issues addressed in this rule include quality control; quality 
assurance; personnel standards; cytology requirements; proficiency 
testing (PT) requirements; employee workplace drug testing; and other 
issues raised by commenters based on experience with CLIA 
implementation.
The Clinical Laboratory Improvement Advisory Committee (CLIAC), which 
is composed of members of professional organizations and private 
citizens, is actively involved in making recommendations regarding 
technical and scientific aspects of the regulations. In addition, we 
actively solicit comments from outside organizations such as the 
American Medical Association, the Association of State and Territorial 
Public Health Laboratory Directors, and other professional and medical 
organizations regarding the interpretive guidelines for surveyors.

Summary of the Legal Basis: This rule summarizes and responds to CLIA 
recommendations and public comments to several previously published 
CLIA regulations.

Alternatives: We continually assess ongoing program experience and 
input from laboratories and our partners in carrying out CLIA-related 
activities. Issues not requiring regulation changes are addressed using 
administrative mechanisms.

Anticipated Costs and Benefits: It is not possible to project costs and 
benefits of the rule at this time. These regulations serve to ensure 
consistent, reliable laboratory testing that is an integral part of 
ensuring that individuals receive appropriate treatment.

Risks: Inferior and inappropriate laboratory testing can result in 
misdiagnosis causing patient harm. CLIA reduces the potential for 
inaccurate diagnosis resulting from poorly performed laboratory testing 
since entities must meet requirements (e.g., quality assurance, 
proficiency testing, quality control, personnel requirements) that have 
a direct impact on laboratory testing results. Overly stringent 
standards could, however, discourage needed testing and reduce early 
detection of health problems. The Department does not at this time have 
an estimate of the magnitude and severity of these types of risks, but 
believes that both the original regulations and the revisions will, on 
balance, contribute to better diagnosis.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/21/90                    55 FR 20896
Comment Period End              09/21/90
Final Rule With Comment Period  02/28/92                     57 FR 7002


Next Action Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: HSQ-226

Agency Contact: David Cade, Family & Children's Health Programs Group, 
Center for Medicaid and State Operations, Department of Health and 
Human Services, Health Care Financing Administration, 7500 Security 
Blvd., Baltimore, MD 21244
Phone: 410 786-3870

RIN: 0938-AE47
_______________________________________________________________________




1152. EARLY AND PERIODIC SCREENING, DIAGNOSTIC, AND TREATMENT (EPSDT) 
SERVICES (MB-28-F)

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 441.50; 42 CFR 440.40

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: Undetermined

Government Levels Affected: State, Local

Additional Information: MB-028

Agency Contact: Cindy Ruff, Center for Medicaid and State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-16-08, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5916

RIN: 0938-AE72
_______________________________________________________________________




1153. PAYMENT FOR NURSING AND ALLIED HEALTH SCIENCE EDUCATION (HCFA-
1685-F)

Priority:  Other Significant

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

CFR Citation:  42 CFR 413

Legal Deadline:  Final, Statutory, June 30, 1990.

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

[[Page 22016]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: None

Additional Information: HCFA-1685

Agency Contact: Marc Hartstein, Center for Health Plans & Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, C5-08-27, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4539

RIN: 0938-AE79
_______________________________________________________________________




1154. MEDICARE COVERAGE OF, AND APPLICATION OF THE OUTPATIENT MENTAL 
HEALTH TREATMENT LIMITATION TO, CLINICAL PSYCHOLOGIST AND CLINICAL 
SOCIAL WORKER SERVICES (HCFA-3706-F)

Priority:  Substantive, Nonsignificant

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

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

Legal Deadline: None

Abstract: This rule will address provisions of OBRA '89 and OBRA '90. 
OBRA '89 provides the services of clinical psychologists (CPs) and 
clinical social workers. It requires CPs to agree to consult with the 
patient's primary care or attending physician. (Also, it will eliminate 
the dollar limitation that previously applied to mental health 
services, although the 62.5 percent limitation still applies). OBRA '89 
also provides coverage for clinical social worker services, but places 
two limitations on separate payment, which apply to services provided 
to inpatients of hospitals and skilled nursing facilities that are 
Medicare participating. OBRA '90 unbundled CP services from the 
definition of ``inpatient hospital services.'' It also implements two 
sections (psychology services in hospitals and consultation by social 
workers) of the Social Security Act Amendments of 1994.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Small Entities Affected: None

Government Levels Affected: None

Additional Information: HCFA-3706-F

Agency Contact: Regina Walker-Wren, Center for Health Plans and 
Providers, Division of Practitioner & Ambulatory Care, Department of 
Health and Human Services, Health Care Financing Administration, C4-08-
16, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-6735

RIN: 0938-AE99
_______________________________________________________________________




1155. CHANGES TO THE LONG-TERM CARE FACILITY SURVEY PROCESS (HCFA-3175-
FC)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  PL 101-239, Sec 6901(a); 42 USC 1395i-3; 42 USC 
1395aa(d); 42 USC 1396r

CFR Citation:  42 CFR 442; 42 CFR 488

Legal Deadline: None

Abstract: This final rule with comment period will amend the Medicare 
and Medicaid regulations by removing obsolete long-term care survey 
forms, guidelines, and procedures used by State agencies when they 
evaluate a Medicare skilled nursing facility or a Medicaid nursing 
facility for compliance with Federal certification requirements. 
Effective October 1, 1990, the application of new Federal participation 
requirements for these facilities with an increased focus on actual or 
potential resident outcomes has made the survey forms and process in 
existing regulations outdated. Retention of the outdated items can 
cause confusion in connection with directions State survey agencies 
must follow in determining facility compliance. This rule is part of 
the Administration's reinventing government and regulatory reform 
initiatives. Publication of this regulation is dependent upon court 
approval which has been sought.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Additional Information: HSQ-175
TIMETABLE: This regulation may be published only with the concurrence 
of the U.S. District Court in Smith v. Shalala.

Agency Contact: Helene Fredeking, Director, Division of Outcomes and 
Improvements, Department of Health and Human Services, Health Care 
Financing Administration, S2-21-27, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-7304

RIN: 0938-AF02
_______________________________________________________________________




1156. REQUIREMENTS FOR CERTAIN HEALTH INSURING ORGANIZATIONS AND OBRA'90 
TECHNICAL AMENDMENTS (HCFA-1018-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396b(m); 42 USC 1396a(e)(2)(A)

CFR Citation:  42 CFR 434.20 to 72; 42 CFR 435.212; 42 CFR 435.326

Legal Deadline: None

Abstract: This final rule amends the Medicaid regulations to apply 
Medicaid regulations governing prepaid health plans to those health 
insuring organizations that provide or arrange for health care services 
to Medicaid recipients but are not subject to the requirements for 
health maintenance organizations (HMOs) set forth in section 
1903(m)(2)(A) of the Social Security Act. It also incorporates 
technical amendments relating to HMO and/or competitive medical plan 
enrollment, disenrollments, guaranteed eligibility, and provisional 
status included in OBRA '90 and the Balanced Budget Act of 1997.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/09/94                    59 FR 23820
NPRM Comment Period End         07/08/94
Final Action                    00/00/00

Small Entities Affected: Organizations

Government Levels Affected: None

Additional Information: OMC-018

Agency Contact: Jane McClard, Center for Medicaid and State Operations, 
Department of Health and Human Services, Health Care Financing

[[Page 22017]]

Administration, S3-02-14, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4460

RIN: 0938-AF15
_______________________________________________________________________




1157. ALTERNATIVE SANCTIONS FOR PSYCHIATRIC HOSPITALS (HCFA-2191-P)

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 488

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Businesses, Organizations

Government Levels Affected: State, Federal

Additional Information: HSQ-191

Agency Contact: Robert Streimer, Center for Medicaid and State 
Operations, Disabled and Elderly Health Program Group, Department of 
Health and Human Services, Health Care Financing Administration, S2-14-
27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6810

RIN: 0938-AF32
_______________________________________________________________________




1158. REFERRAL TO CHILD SUPPORT ENFORCEMENT AGENCIES OF MEDICAID 
FAMILIES (HCFA-2051-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1396k; 42 USC 1302

CFR Citation:  42 CFR 433.135; 42 CFR 433.137; 42 CFR 433.151; 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
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: State

Additional Information: HCFA-2051-F

Agency Contact: Robert Nakielny, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, C4-21-01, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4466

RIN: 0938-AF68
_______________________________________________________________________




1159. ASSESSING INTEREST AGAINST MEDICARE SECONDARY PAYER (MSP) DEBTS 
(HCFA-6108-P)

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 405.378; 42 CFR 411.24(m); 42 CFR 411.39

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BP0-108

Agency Contact: John Albert, Office of Financial Management, Department 
of Health and Human Services, Health Care Financing Administration, S3-
02-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7457

RIN: 0938-AF87
_______________________________________________________________________




1160. DESCRIPTION OF HCFA'S EVALUATION METHODOLOGY FOR THE PEER REVIEW 
ORGANIZATIONS FIFTH SCOPE OF WORK CONTRACTS (HCFA-3207-N)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302; 42 USC 1320c; 42 USC 1320c-2(h)(z)

CFR Citation:  42 CFR part 462

Legal Deadline: None

Abstract: This notice with comment period will provide general criteria 
and standards that will be used to evaluate the effective and efficient 
performance of Utilization and Quality Control Peer Review 
Organizations (known as PROs) for contracts entered into on or after 
April 1, 1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/02/97                    62 FR 35824
NPRM Comment Period End         09/02/97


Next Action Undetermined

Small Entities Affected: None

Government Levels Affected: None

Additional Information: HSQ-207

Agency Contact: Heidi Gelzer, Office of Clinical Standards and Quality, 
Department of Health and Human Services, Health Care Financing 
Administration, S1-08-24, 7500 Security Boulevard, Baltimore, MD 21244

[[Page 22018]]

Phone: 410 786-9352

RIN: 0938-AG32
_______________________________________________________________________




1161. DISCLOSURE OF CONFIDENTIAL PRO AND ESRD NETWORK ORGANIZATION 
INFORMATION FOR RESEARCH PURPOSES (HCFA-3208-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1320c-9; 42 USC 1302

CFR Citation:  42 CFR 405.2115; 42 CFR 476.144

Legal Deadline: None

Abstract: This rule would allow Peer Review Organizations (PROs) to 
disclose confidential information to researchers without the consent of 
the individuals who would be identified. The research must be directly 
related to the purposes of the PRO or ESRD program. Currently, PROs can 
only disclose to the public nonconfidential aggregate data where no one 
is specifically identified. The statute, however, provides for limited 
disclosure and allows the Secretary to provide for disclosure in the 
regulations while assuring adequate protection of the rights and 
interests of patients, health care practitioners, and 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 would make confidential PRO information accessible 
to researchers while still protecting the identities of beneficiaries 
and practitioners from unwarranted disclosure.

Timetable: Next Action Undetermined

Small Entities Affected: None

Government Levels Affected: None

Additional Information: HSQ-208

Agency Contact: Bill Roskey, Office of Clinical Standards and Quality, 
Department of Health and Human Services, Health Care Financing 
Administration, S1-09-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0433

RIN: 0938-AG33
_______________________________________________________________________




1162. MEDICARE PROGRAM: LIMITATIONS ON MEDICARE COVERAGE OF INTERMITTENT 
POSITIVE PRESSURE BREATHING MACHINE THERAPY (HCFA-3781-FN)

Priority:  Substantive, Nonsignificant

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

CFR Citation:  45 CFR 500

Legal Deadline: None

Abstract: Intermittent positive pressure breathing (IPPB) machine 
therapy is currently covered under Medicare as durable medical 
equipment for patients whose ability to breathe is severely impaired. 
Based on an Office of Health Technology Assessment recommendation, we 
will place limitations on Medicare coverage of IPPB machine therapy.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Notice                 06/29/94                    59 FR 33520
Comment Period End              08/29/94


Next Action Undetermined

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-781

Agency Contact: Francine Spencer, Office of Clinical Standards and 
Quality Coverage and Analysis Group, Department of Health and Human 
Services, Health Care Financing Administration, C4-04-05, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4614

RIN: 0938-AG44
_______________________________________________________________________




1163. REVISION OF MEDICARE HOSPITAL CONDITIONS OF PARTICIPATION (HCFA-
3745-F)

Priority:  Other Significant

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

Legal Authority:  42 USC 1395x; 42 USC 1302; 42 USC 1395(cc); 42 USC 
1395(hh); 42 USC 1320(b)(8)

CFR Citation:  42 CFR 416; 42 CFR 482; 42 CFR 485; 42 CFR 489

Legal Deadline: None

Abstract: This final rule will revise the requirements that hospitals 
must meet to participate in the Medicare and Medicaid programs. The 
revised requirements focus on patient care and the outcomes of that 
care, reflect a cross-functional view of patient treatment, encourage 
flexibility in meeting quality standards, and eliminate unnecessary 
procedural requirements. These changes are necessary to reflect 
advances in health care practices since the requirements were last 
revised in 1986.

Statement of Need: The purpose of the hospital conditions of 
participation is to protect patient health and safety and help assure 
that quality care is furnished to all hospital patients. Hospitals must 
meet the conditions of participation in order to participate in 
Medicare or Medicaid. Revised conditions are necessary to ensure that 
our regulations focus primarily on the actual quality of care furnished 
to patients, and the outcomes of that care, rather than on procedural 
compliance. These changes are intended to give hospitals the 
flexibility needed to achieve high-quality outcomes in the most cost-
effective manner.
In addition, the regulations are intended to promote a cross-
functional, interdisciplinary approach to hospital performance, instead 
of an approach geared towards evaluating each department of a hospital 
as a stand-alone entity. This approach is in line with current best 
practices in hospitals, in which patients routinely encounter many 
care-givers and services that often cut across department lines.

Summary of the Legal Basis: Section 1861(e) of the Social Security Act 
(the Act) provides that a hospital participating in the Medicare 
program must meet certain specified requirements. In addition, section 
1861(e)(9) of the Act specifies that a hospital also must meet such 
requirements that the Secretary finds are necessary in the interest of 
the health and safety of the hospital's patients. Under this authority, 
the Secretary has established in regulations the requirements that a 
hospital must meet to participate in Medicare. These requirements are 
set forth in regulations at 42 CFR part 482, Conditions of 
Participation for Hospitals. Section 1905(a) of the Act provides that 
Medicaid payments may be applied to hospital services. Under 
regulations at 42 CFR 440.10(a)(3)(iii), hospitals generally are 
required to meet the

[[Page 22019]]

Medicare conditions of participation in order to participate in 
Medicaid.

Alternatives: HCFA considered the possibility of revising individual 
sections of the current hospital regulations. However, we determined 
that the best means of achieving the systematic changes needed in the 
regulations was to revise the hospital conditions in their entirety. 
The specific areas that are likely to form the core of the revised 
requirements include patient rights, patient assessment, patient care, 
quality assessment and improvement, and information management.

Anticipated Costs and Benefits: There would not be significant costs 
associated with this final rule. The benefits that would be derived 
from the rule are discussed in the Need section, above.

Risks: By revising these regulations to focus on the quality of the 
actual care given to an individual and the effectiveness of that care 
for the individual patient, we hope to reduce risks to beneficiaries' 
health and safety. Revised procedures can better focus on ensuring that 
the care being given to a patient is the care that is actually 
necessary and effective for that patient. No quantitative estimates of 
risk reductions are available yet.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/19/97                    62 FR 66726
NPRM Comment Period End         03/20/98
Final Action                    00/00/00

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: HCFA-3745-F

Agency Contact: Frank Emerson, Office of Clinical Standards and 
Quality, Department of Health and Human Services, Health Care Financing 
Administration, C7-08-24, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4656

RIN: 0938-AG79
_______________________________________________________________________




1164. DISTINCT PART REQUIREMENTS FOR NURSING HOMES AND PROHIBITION OF 
FINANCIAL SCREENING OF APPLICANTS FOR NURSING HOME ADMISSION (BPD-815-P)

Priority:  Other Significant

Legal Authority:  42 USC 1395i-3; 42 USC 1396r(a); 42 USC 1302; 42 USC 
1395hh

CFR Citation:  42 CFR 409; 42 CFR 483

Legal Deadline: None

Abstract: This proposed rule would define ``distinct part'' by 
specifying that a distinct part is a physically identifiable unit of an 
institution (that is, an entire ward, wing, floor, or building) 
including all beds in the unit. This proposed rule would also prohibit 
nursing homes from financially screening private pay applicants for 
admission. Instead, nursing homes would be permitted to charge private 
pay applicants up to a 2-month deposit before admission to ensure that 
sufficient funds are available to pay for care which the individual may 
receive before discharge.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-815

Agency Contact: Deborah Schoeneman, Office of Clinical Standards & 
Quality, Department of Health and Human Services, Health Care Financing 
Administration, S2-19-04, 7500 Security Blvd., Baltimore, MD 21244
Phone: 401 786-6771

RIN: 0938-AG84
_______________________________________________________________________




1165. CLINICAL LABORATORY IMPROVEMENT AMENDMENT (CLIA) FEE SCHEDULE 
REVISION (HCFA-3219-GNC)

Priority:  Other Significant

Legal Authority:  42 USC 1302; 42 USC 1395x(e); 42 USC 1395x(s)(11); 42 
USC 1395x(s)(12); 42 USC 1395x(s)(13); 42 USC 1395x(s)(14); 42 USC 
1395x(s)(15)

CFR Citation:  42 CFR 493.638; 42 CFR 493.639

Legal Deadline: None

Abstract: This general notice with comment period will announce updated 
certificate fees that laboratories must pay as required by CLIA '88. 
Fee increases are necessary to meet the costs of program 
administration, which are to be borne by the laboratories.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

General Notice With Comment 
Period                          08/29/97                    62 FR 45815
Comment Period End              10/28/97


Next Action Undetermined

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: HSQ-219

Agency Contact: Judy Yost, Division of Outcomes and Improvements, 
Department of Health and Human Services, Health Care Financing 
Administration, S2-09-28, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-3531

RIN: 0938-AG87
_______________________________________________________________________




1166. CATEGORIZATION AND CERTIFICATION REQUIREMENTS FOR A NEW 
SUBCATEGORY OF MODERATE COMPLEXITY TESTING (HCFA-2222-F)

Priority:  Other Significant

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

Legal Authority:  42 USC 263a

CFR Citation:  42 CFR 493.2; 42 CFR 493.3; 42 CFR 493.5; 42 CFR 493.18; 
42 CFR 493.20; 42 CFR 493.21; 42 CFR 493.25; 42 CFR 493.43; 42 CFR 
493.45; 42 CFR 493.48; 42 CFR 493.49; 42 CFR 493.51; 42 CFR 493.53; 42 
CFR 493.638

Legal Deadline: None

Abstract: As part of the CLIA program (see RIN 0938-AE47), this rule 
will develop criteria for simple and easy-to-use test systems that have 
demonstrated accuracy and precision through scientific studies. We have 
proposed to waive the routine 2-year survey of users of accurate and 
precise technology (APT) tests, conducting surveys only if there are 
indications of problems or complaints. We also proposed that a small 
number of surveys be conducted to validate the criteria for determining 
APT and to assure quality.

[[Page 22020]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/15/95                    60 FR 47982
NPRM Comment Period End         11/14/95
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Additional Information: HSQ-222

Agency Contact: Judy Yost, Center for Medicaid and State Operations, 
Division of Outcomes and Improvement, Department of Health and Human 
Services, Health Care Financing Administration, S2-09-28, 7500 Security 
Blvd., Baltimore, MD 21244
Phone: 410 786-3531

RIN: 0938-AG98
_______________________________________________________________________




1167. ADDITIONAL SUPPLIER STANDARDS (HCFA-1864-P)

Priority:  Other Significant

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 424.57

Legal Deadline: None

Abstract: This rule would establish additional standards for entities 
seeking to qualify as Medicare suppliers for purposes of submitting 
claims for durable medical equipment and supplies. This rule is part of 
HCFA's regulatory reform initiative and includes changes related to 
surety bonds as required by the Balanced Budget Act of 1997.

Statement of Need: Section 131 of The Social Security Act Amendments of 
1994, established additional requirements that a supplier of durable 
medical equipment, prosthetics, orthotics, and supplies (DMEPOS) must 
meet, effective January 1, 1996, in order to obtain a number to bill 
the Medicare program. In addition, the Amendments gave the Secretary of 
HHS responsibility to develop other supplier standards. The 
requirements are designed to protect beneficiaries from abusive 
practices by suppliers. These legislative changes indicate that the 
Congress has serious concerns about the business practices employed by 
certain suppliers, and that beneficiaries require additional protection 
from these practices. We believe it is the Congress' intent to 
strengthen existing supplier standards in order to protect the public 
interest. Three of the standards spontaneously required by section 
1834(j)(i)(B) were addressed in a final rule with comment period 
published in the Federal Register on December 11, 1995, (60 FR 3440). 
At the same time we incorporated the statutorily required standards 
items in regulations, we intensified our oversight of fraudulent and 
abusive supplier practices and identified a number of additional 
requirements that, if implemented, would provide additional safeguards. 
Failure to comply with any one of the standards may result in 
revocation of the supplier billing number.

Summary of the Legal Basis: Section 131 of the Social Security Act 
Amendments of 1994 (Public Law 103-432, enacted on October 31, 1994) 
added a new subsection (j) to section 1834 of the Act dealing with 
supplier standards and required the Secretary to promulgate regulations 
setting forth additional standards after consulting with 
representatives of suppliers, carriers and consumers. Section 4312 of 
the Balanced Budget Act of 1997 (Pub. L. 105-33) requires Durable 
Medical Equipment suppliers to provide the Secretary with a surety bond 
in an amount that is not less than $50,000. The Secretary also issues 
regulations under the general authority of section 1102 of the Social 
Security Act.

Alternatives: We believe it was the Congress' intent to strengthen 
DMEPOS supplier standards to protect beneficiaries and the Medicare 
program from potential fraud and abuse in billing practices. The 
statutorily listed supplier standards are minimal safeguards and we 
attempted to balance any additional requirements against possible 
barriers to competition and adding burdens on the many small businesses 
involved in this area of activity. For example, imposing requirements 
with respect to liability insurance but not proposing a specified 
minimum amount. Similarly, we are proposing a requirement that 
suppliers obtain a surety bond but suggest use of a sliding scale so 
that the final bond amount will not discourage new participants to the 
Medicare program.

Anticipated Costs and Benefits: In that the regulation will diminish 
the possibility of abusive suppliers getting or retaining a Medicare 
billing number, the Trust Funds will not suffer from fraudulent and 
abusive practices found in the past. It should be noted that HCFA also 
is energetically pursuing other opportunities to find and stop abusive 
practices of all those who furnish services to our beneficiaries. 
Therefore, the savings specifically associated with this rule are 
indeterminable at this time.

Risks: Durable Medical Equipment associations and leaders of the 
industry join us in a quest to strengthen supplier standards in order 
to keep out fraudulent suppliers. As noted, many of the proposed 
requirements are good business practices currently being met 
voluntarily. The supplies that Medicare patients need are abundantly 
available in all sections of the country, so that no scarcity will 
result. Rather we believe that what these standards would do in terms 
of protecting the health and safety of beneficiaries and preserving the 
Medicare Trust Fund far outweighs any slight cutback in the overall 
number of suppliers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/20/98                     63 FR 2926
NPRM Comment Period End         03/23/98


Next Action Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: HCFA-1864-P

Agency Contact: Larry Bonander, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-11-24, 7500 Security Boulevard, Baltimore, MD 21214
Phone: 410 786-4479

RIN: 0938-AH19
_______________________________________________________________________




1168. CRITERIA AND PROCEDURES FOR EXTENDING COVERAGE TO CERTAIN DEVICES 
AND RELATED SERVICES (HCFA-3841-F)

Priority:  Other Significant

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

CFR Citation:  42 CFR 405.201 TO 215; 42 CFR 411.15; 42 CFR 411.406

Legal Deadline: None

Abstract: We published a final rule with comment period. It provided 
that certain medical devices with an investigational device exemption 
approved by the FDA may be covered under Medicare. It set forth the 
process

[[Page 22021]]

by which the FDA is to assist HCFA in identifying nonexperimental 
investigational devices that may be potentially covered under Medicare. 
This final rule responds to comments on that rule and restates the 
policy after considering the comments.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule                      09/19/95                    60 FR 48417
Comment Period End              10/20/95
Effective Date                  11/01/95


Next Action Undetermined

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-841

Agency Contact: Sharon Hippler, Office of Clinical Standards & Quality, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-11-04, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4633

RIN: 0938-AH21
_______________________________________________________________________




1169. DELEGATION OF CIVIL MONEY PENALTIES (HCFA-6135-FC)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 405(a); 42 USC 1302; 42 USC 1320a to 7a; 42 
USC 1395cc; 42 USC 1395u(j)(2); 42 USC 1395hh; 42 USC 1395ii

CFR Citation:  42 CFR 402

Legal Deadline: None

Abstract: This final rule with comment period will contain the 
processes and procedures to be undertaken in the imposition of civil 
money penalties and assessments and in the appeals process.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Additional Information: HCFA-6135-FC

Agency Contact: Joel Cohen, Office of Financial Management, Department 
of Health and Human Services, Health Care Financing Administration, S3-
11-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3349

RIN: 0938-AH22
_______________________________________________________________________




1170. MEDICARE SECONDARY PAYER CLARIFICATIONS AND AMENDMENTS (HCFA-1865-
P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR part 411

Legal Deadline: None

Abstract: This proposed rule would codify in regulations policies 
regarding liability insurance, such as structured liability 
settlements, future medical expenses, provider malpractice, wrongful 
death, and Federal Tort Claims Act policy. It would also clarify the 
rules dealing with group health plan bankruptcies, religious orders, 
and foreign group health plans, and make numerous other changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: None

Government Levels Affected: None

Additional Information: BPD-865

Agency Contact: Herb Pollock, Center for Health Plans & Providers, 
Division of Integrated Services, Department of Health and Human 
Services, Health Care Financing Administration, C4-08-27, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4474

RIN: 0938-AH52
_______________________________________________________________________




1171. CONDITIONS FOR CERTIFICATION OF COMMUNITY MENTAL HEALTH CENTERS 
AND COVERAGE REQUIREMENTS FOR PARTIAL HOSPITALIZATION SERVICES (HCFA-
1871-P)

Priority:  Other Significant

Legal Authority:  42 USC 1395k; 42 USC 1395x; 42 USC 1395cc

CFR Citation:  42 CFR 410.43; 42 CFR 410.110; 42 CFR 410.150; 42 CFR 
410.172

Legal Deadline: None

Abstract: This proposed rule would establish health and safety 
standards that Community Mental Health Centers (CMHCs) must meet to 
participate in the Medicare program. It would also establish 
requirements for coverage of partial hospitalization services furnished 
by CMHCs or furnished in hospital outpatient settings. These changes 
would provide oversight for CMHCs, help curtail inappropriate 
utilization of partial hospitalization services, and ensure Medicare 
payment of reasonable and necessary services to eligible individuals.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Additional Information: BPD-871

Agency Contact: Janet Samen, Center for Health Plans and Policy, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-08-15, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-9161

RIN: 0938-AH58
_______________________________________________________________________




1172. MEDICAID HOSPICE CARE (HCFA-2016-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395hh; 42 USC 1302

CFR Citation:  42 CFR 418.24; 42 CFR 418.28; 42 CFR 418.98; 42 CFR 
440.167; 42 CFR 440.250(q); 42 CFR 441; 42 CFR 447

Legal Deadline: None

Abstract: This proposed rule would provide for optional Medicaid 
coverage of hospice care for terminally ill recipients who elect to 
receive care from a participating hospice, establish eligibility 
requirements, covered services, reimbursement procedures, and 
conditions that a hospice must meet to provide services to Medicaid 
recipients. It would make conforming technical revisions to the 
Medicare regulations governing hospice care.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Local

Additional Information: HCFA-2016-P

Agency Contact: Tom Shenk, Center for Medicaid and State Operations, 
Medicaid Bureau, Department of Health

[[Page 22022]]

and Human Services, Health Care Financing Administration, C4-13-01, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3295

RIN: 0938-AH65
_______________________________________________________________________




1173. WAIVER OF STAFFING REQUIREMENTS FOR END STAGE RENAL DISEASE (ESRD) 
FACILITIES PARTICIPATING IN AN EXPERIMENT (HCFA-2236-GNC)

Priority:  Other Significant

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

Legal Authority:  42 USC 1302; 42 USC 1320; 42 USC 1395x; 42 USC 1395y; 
42 USC 1395hh; 42 USC 1395rr

CFR Citation:  42 CFR 405.2136; 42 CFR 405.2161; 42 CFR 405.2162; 42 
CFR 405.2163

Legal Deadline: None

Abstract: This general notice with comment period announces our 
intention to conduct a demonstration that would grant selected ESRD 
facilities a 2-year waiver of staffing requirements. The ESRD staffing 
requirements pertain to: the governing body and management, director of 
a facility, on-duty licensed health care professionals, and providing 
adequate laboratory, social, and dietetic services. Facilities would be 
given flexibility to deviate from specified regulation requirements, 
provided assurances are in place ensuring that quality of care 
standards are not being compromised.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    00/00/00

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: HSQ-236

Agency Contact: William Roskey, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, S1-09-07, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-0433

RIN: 0938-AH72
_______________________________________________________________________




1174. PROVIDER AND SUPPLIER ENROLLMENT AND RE-ENROLLMENT REQUIREMENTS 
(HCFA-1023-P)

Priority:  Other Significant

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 489

Legal Deadline: None

Abstract: This proposed rule would establish conditions for enrolling 
providers and suppliers that furnish items or services to Medicare 
beneficiaries. These conditions would improve current enrollment 
procedures so as to more accurately identify such providers and 
suppliers and to secure information and documentation necessary to the 
effective and efficient administration of the Medicare program. The 
more accurate identification of providers and suppliers, coupled with 
the collection of certain information, will facilitate the 
administration of many aspects of the Medicare program including, but 
not necessarily limited to, monitoring for compliance with program 
rules and combating fraud and abuse. Improvements in enrolling 
providers and suppliers will afford both the Medicare trust funds and 
program beneficiaries with greater protection.

Timetable: Next Action Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: HCFA-1023-P

Agency Contact: Ralph Goldberg, Center for Health Plans and Providers, 
Provider Purchasing and Administration Group, Department of Health and 
Human Services, Health Care Financing Administration, S3-16-07, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4870

RIN: 0938-AH73
_______________________________________________________________________




1175. MEDICARE PROGRAM; MEDICARE INTEGRITY PROGRAM (HCFA-7020-P)

Priority:  Other Significant. Major under 5 USC 801.

Legal Authority:  PL 104-191

CFR Citation:  42 CFR 400; 42 CFR 421

Legal Deadline: None

Abstract: This rule implements section 1893 of the Social Security Act 
(added by section 202 of the Health Insurance Portability and 
Accountability Act of 1996) by establishing the Medicare Integrity 
Program to carry out Medicare payment integrity activities. Under this 
program HCFA may enter into new contracts with entities to perform 
these activities. This proposed rule would identify the services to be 
procured, set forth competitive requirements, establish procedures for 
identification, evaluation, and resolution of conflicts of interest, 
and rules regarding contractor liability. In addition, this proposed 
rule would revise the list of intermediary and carrier functions set 
forth in existing regulations to make them consistent with sections 
1816, 1842, and 1893 of the Social Security Act.

Statement of Need: The Health Insurance Portability and Accountability 
Act of 1996 (HIPAA), Public Law 104-191 creates the Medicare Integrity 
Program (MIP). Among other things, it requires the Department to set 
forth procedures for entering into contracts for the performance of 
specific Medicare program integrity activities.
The MIP will help us shift emphasis from post-payment recoveries on 
fraudulent claims to prepayment strategies to ensure claims are paid 
correctly the first time. It will allow us to broaden our use of 
contractors to include a variety of contractors with new and different 
skill sets, bringing innovation into the fraud and abuse prevention 
arena. Through conflict of interest provisions, it will permit us to 
deal with the current phenomenon of diversification of ownership 
arrangements, especially where Medicare intermediaries and carriers 
become closely allied with managed care and other providers and 
suppliers.

Summary of the Legal Basis: Sections 1816(a) and 1842(a), (b) and (f) 
of the Social Security Act, which pertain to contracting with 
intermediaries and carriers remain in effect. HIPPA added a new section 
1893 to the Act, under which HCFA is required to establish by 
regulation, procedures for awarding MIP contracts.

Alternatives: We considered identifying specific situations in which we 
would never award a contract because potential conflicts of interest 
existed. We favor an approach that permits an offeror to mitigate 
conflicts, thereby opening competition to both current Medicare 
contractors and other entities.

[[Page 22023]]

We also considered whether the regulation should specify all the 
information that would be needed in all situations to determine whether 
a conflict of interest exists. We decided on an approach that gives us 
flexibility to tailor our requirements for information to the specific 
procurement.

Anticipated Costs and Benefits: The Congress provided a direct 
appropriation from the Health Insurance Trust Funds for carrying out 
the Medicare Integrity Program. We expect that, on average, every 
dollar expended in fiscal year 1998 to perform integrity functions will 
save $12 in Medicare program costs.

Risks: The statute provides that we may enter into MIP contracts 
without final rules having been published. However, the statute 
requires that we establish, by regulation, competitive procedures to be 
used in awarding those contracts, as well as procedures for 
identifying, evaluating, and resolving conflicts of interest, and 
procedures under which a contract may be renewed noncompetitively. It 
also requires that we provide, in regulations, for limitation of a 
contractor's liability under the contract. We believe that this 
proposed rule should be published as soon as possible so that the 
procedures related to conflicts of interest can be established in 
regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/20/98                    63 FR 13590
Final Action                    00/00/00

Small Entities Affected: None

Government Levels Affected: None

Additional Information: OFH-020-P, PL 104-191, sec. 202

Agency Contact: Rodney Benson, Office of Internal Customer Support, 
Department of Health and Human Services, Health Care Financing 
Administration, C2-02-17, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-9280

RIN: 0938-AI09
_______________________________________________________________________




1176. MEDICARE PROGRAM; PHYSICIAN FEE SCHEDULE CONVERSION FACTOR FOR 
CALENDAR YEAR 1998 AND SUSTAINABLE GROWTH RATE FOR FISCAL YEAR 1998 
(HCFA-1893-FN)

Priority:  Other Significant. Major under 5 USC 801.

Legal Authority:  42 USC 1395w-4

Legal Deadline: None

Abstract: This notice announces the calendar year 1998 Medicare 
physician fee schedule conversion factor and the fiscal year 1998 
sustainable growth rate for expenditures for physicians' services under 
the Medicare Supplementary Medical Insurance (part B) program as 
required by sections 1848(d) and (f) of the Social Security Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           10/31/97                    62 FR 59261


Next Action Undetermined

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Terrence Kay, Center for Health Plans and Providers, 
Division of Practitioner and Ambulatory Care, Department of Health and 
Human Services, Health Care Financing Administration, 7500 Security 
Blvd., C4-10-26, Baltimore, MD 21244
Phone: 410 786-4497

RIN: 0938-AI16
_______________________________________________________________________




1177. MEDICAID: MEDICAL CHILD SUPPORT (HCFA-2081-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302; 42 USC 1396a(a)(60)

CFR Citation:  42 CFR 433

Legal Deadline: None

Abstract: This proposed rule would require States to provide assurances 
satisfactory to the Secretary that the State has in effect laws 
relating to medical child support. This requirement would implement 
section 13623 of the Omnibus Budget Reconciliation Act of 1993 (Public 
Law 103-66), commonly cited as OBRA 1993. The medical child support 
laws that the States must have in effect are set forth in section 1908 
of the Social Security Act (the Act). These laws would impose 
requirements on insurers, employers, and State Medicaid agencies.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State

Additional Information: HCFA-2081-P

Agency Contact: Sue Knefley, Center for Medicaid and State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0488

RIN: 0938-AI21
_______________________________________________________________________




1178.  COLLECTION OF USER FEES FROM MEDICARE+CHOICE PLANS AND 
RISK-SHARING CONTRACTORS (HCFA-1911-IFC)

Priority:  Other Significant

Legal Authority:  42 USC 1302; 42 USC 1395hh; 42 USC 1395mm(k)(4)(d)

CFR Citation:  42 CFR 417.470; 42 CFR 417.472

Legal Deadline: None

Abstract: This interim final rule with a request for comments 
establishes the methodology that will be employed to assess fees 
applicable to Medicare risk-sharing contractors for fiscal year (FY) 
1998. Under section 4002 of the Balanced Budget Act of 1997, these 
contractors must contribute their pro rata share of costs relating to 
beneficiary enrollment, dissemination of information, and certain 
counseling and assistance programs. The Medicare+Choice regulation to 
be published in June of 1998 will implement this requirement for 
Medicare+Choice plans.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              12/02/97                    62 FR 63669
Effective Date                  01/01/98
Comment Period End              02/02/98


Next Action Undetermined

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Marty Abeln, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing

[[Page 22024]]

Administration, 7500 Security Blvd, S3-21-17, Baltimore, MD 21244-1850
Phone: 410 786-1032

RIN: 0938-AI35
_______________________________________________________________________




1179.  MEDICARE PROGRAM: PHYSICIANS' REFERRALS; ISSUANCE OF 
ADVISORY OPINIONS (HCFA-1902-F)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395nn(g)(6)

CFR Citation:  42 CFR 411.370 to 411.389

Legal Deadline: None

Abstract: This final rule will set forth the procedures HCFA will use 
to issue written advisory opinions to outside parties concerning 
whether a physician's referral of a Medicare beneficiary for certain 
designated health services is prohibited under section 1877 of the 
Social Security Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/09/98                     63 FR 1646


Next Action Undetermined

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Joanne Sinsheimer, Technical Assistant, CHPPS, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-4620

RIN: 0938-AI38
_______________________________________________________________________




1180.  MEDICAID PROGRAM; STATE ALLOTMENTS FOR PAYMENT OF 
MEDICARE PART B PREMIUMS FOR QUALIFIED INDIVIDUALS: FEDERAL FISCAL YEAR 
1998 (HCFA-2005-NC)

Priority:  Economically Significant. Major under 5 USC 801.

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

Legal Authority:  42 USC 1396a(a)(10)(E)(iv); 42 USC 1396u-3

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: This notice announces the availability of individual State 
allotments for Federal fiscal year 1998 for the Medicaid payment of 
Medicare part B premiums for qualifying individuals identified under 
section 1902(a)(10)(E)(iv)(I) and (II) of the Act. In this notice, we 
are not applying precisely the statutory formula to determine the 
individual State allotments. A precise application of the allocation 
formula in the statue would require us to determine State-specific 
estimates of the number of individuals who are entitled to Medicare 
part A; have incomes in the poverty level ranges specified; have assets 
not exceeding twice the amount allowed under the SSI program; and would 
not be eligible for Medicaid but for the provisions of section 
1902(a)(19)(E) of the Act regarding QI's.

Timetable: Next Action Undetermined

Small Entities Affected: None

Government Levels Affected: State, Federal

Agency Contact: Miles McDermott, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-3722
Email: mmcdermott

RIN: 0938-AI39
_______________________________________________________________________




1181.  MEDICARE PROGRAM: PAYMENTS FOR TELECONSULTATIONS IN RURAL 
HEALTH PROFESSIONAL SHORTAGE AREAS (HCFA-1906-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 105-33

CFR Citation:  42 CFR 410.75; 42 CFR 414.1; 42 CFR 414.62

Legal Deadline: None

Abstract: This proposed rule would provide for payment for 
teleconsultation with regard to a Medicare beneficiary who resides in a 
rural health professional shortage area. This proposed rule would also 
establish a methodology for determining the amount of payment.

Timetable: Next Action Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Craig Dobyski, Program Analyst, CHPPS, Department of 
Health and Human Services, Health Care Financing Administration, 7500 
Security Blvd., Baltimore, MD
Phone: 410 786-4584

RIN: 0938-AI44
_______________________________________________________________________




1182.  MEDICARE PROGRAM: USER FEES (HCFA-6021-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  31 USC 9701

CFR Citation:  42 CFR 401

Legal Deadline: None

Abstract: This proposed rule would establish regulations relating to 
user fees for services HCFA provides that confer benefits on specific 
individuals that are over and above those benefits received by the 
general public.

Timetable: Next Action Undetermined

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: David Escobedo, Office of Financial Management, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, Baltimore, MD
Phone: 410 786-5401

RIN: 0938-AI46
_______________________________________________________________________




1183.  SURETY BOND REQUIREMENTS FOR COMPREHENSIVE OUTPATIENT 
REHAB. FACILITIES, REHAB. AGENCIES, COMMUNITY MENTAL HEALTH CENTERS, AND 
INDEPENDENT DIAGNOSTIC TESTING FACILITIES (HCFA-1026-P)

Priority:  Other Significant

Legal Authority:  42 USC 1302; 42 USC 1395x(v); 42 USC 1395hh

CFR Citation:  42 CFR 413; 42 CFR 489

Legal Deadline: None

Abstract: The Balanced Budget Act of 1997 (BBA 1997) requires suppliers 
of durable medical equipment, home health agencies, comprehensive 
outpatient rehabilitation facilities, and rehabilitation agencies to 
furnish us with a surety bond in order to participate in the Medicare 
Program. The BBA 1997 also affords us the discretion to require other 
health care providers (other than physicians or other practitioners) to 
furnish us with a surety bond to participate in the Medicare program. 
This proposed rule discusses the implementation of these provisions to 
require comprehensive outpatient rehabilitation facilities, 
rehabilitation agencies, and certain other providers and suppliers we 
have selected to furnish us with a surety bond on a continuing basis in 
order to participate in the Medicare program.

[[Page 22025]]

Timetable: Next Action Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Ralph Goldberg, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-4870
Email: [email protected]

RIN: 0938-AI48
_______________________________________________________________________




1184.  ADMINISTRATIVE APPEALS PROCESS FOR SUPPLIERS SEEKING TO 
ENROLL IN MEDICARE PROGRAM (HCFA-1907-FC)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302; 42 USC 1395u(b)(3)(C); 42 USC 1395ff(b)

CFR Citation:  42 CFR 405.874

Legal Deadline: None

Abstract: This rule would establish an administrative appeal process 
whereby suppliers can request an appeal for a determination that 
affects their Medicare part B billing numbers. The purpose of this rule 
is to update and clarify our policy and the administrative appeal 
rights for current and prospective providers and suppliers who are 
denied enrollment in the Medicare program or whose Medicare billing 
privileges are revoked.

Timetable: Next Action Undetermined

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Charles Waldhauser, Division of Provider/Supplier 
Enrollment, Department of Health and Human Services, Health Care 
Financing Administration, S1-03-07, 75 Security Blvd., Baltimore, MD 
21207-0476
Phone: 410 786-6140

RIN: 0938-AI49
_______________________________________________________________________




1185.  MEDICARE PROGRAM; PROSPECTIVE PAYMENT SYSTEM FOR HOSPITAL 
OUTPATIENT (HCFA-1005-P)

Priority:  Economically Significant. Major under 5 USC 801.

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

Legal Authority:  PL 105-33, Sec 4521; PL 105-33, Sec 4522; PL 105-33, 
Sec 4523; PL 99-509, Sec 9343(c)

CFR Citation:  42 CFR 409.10; 42 CFR 410.2; 42 CFR 410.27; 42 CFR 
410.28; 42 CFR 410.30; 42 CFR 411.15; 42 CFR 412.50; 42 CFR 413.118; 42 
CFR 413.122; 42 CFR 413.124; 42 CFR 413.130; 42 CFR 413-New subpart L; 
42 CFR 489.20; 42 CFR 1003.101 to 102; 42 CFR 1003.105

Legal Deadline:  Final, Statutory, November 1, 1998.

Abstract: As required by sections 4521, 4522, and 4523 of the Balanced 
Budget Act of 1997, this proposed rule would eliminate formula driven 
overpayment for certain outpatient hospital services extend reductions 
in payment for costs of hospital outpatient services, and establish in 
regulations a prospective payment system for hospital outpatient 
services (and for Medicare part B services furnished to inpatients who 
have no part A coverage), effective January 1, 1999. The prospective 
payment system would simplify our current payment system and apply to 
all hospitals, including those that are exempt from the inpatient 
prospective payment system. However, the Balanced Budget Act delays 
application of the system to cancer hospitals until January 1, 2000.
This proposed rule would also implement section 9343(c) of the Omnibus 
Budget Reconciliation Act of 1986, which prohibits Medicare payment for 
nonphysician services furnished to a hospital outpatient by a provider 
or supplier other than a hospital unless the services are furnished 
under an arrangement with the hospital. This section also authorizes 
the Department of Health and Human Services' Office of Inspector 
General to impose a civil monetary penalty, not to exceed $2,000 
against any individual who knowingly and willfully presents a bill in 
violation of an arrangement.
This proposed rule would also establish in regulations the requirements 
for designating certain entities as provider-based or as a department 
of a hospital.

Timetable: Next Action Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Janet Wellham, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-4510

RIN: 0938-AI56
_______________________________________________________________________




1186.  SECURITY AND ELECTRONIC SIGNATURE STANDARDS (HCFA-0049-P)

Priority:  Other Significant. Major under 5 USC 801.

Legal Authority:  42 USC 1320d

CFR Citation:  45 CFR 142 subpart C

Legal Deadline:  Final, Statutory, February 21, 1998.

Abstract: This rule would implement some of the requirements of the 
administrative simplification subtitle of the Health Insurance 
Portability and Accountability Act of 1996. It proposes standards for 
the security of individual health information and electronic signature 
use by health plans, health care clearing houses, and health care 
providers.

Timetable: Next Action Undetermined

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: John Parmigiani, Office of Internal Customer Support, 
Department of Health and Human Services, Health Care Financing 
Administration, N3-14-14, 7500 Security Blvd., Baltimore, MD
Phone: 410 786-2976

RIN: 0938-AI57
_______________________________________________________________________




1187.  SURETY BOND FOR SUPPLIERS OF MEDICAL EQUIPMENT (HCFA-
2007-P)

Priority:  Other Significant

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

Legal Authority:  42 USC 1396(a)a

CFR Citation:  42 CFR 441

Legal Deadline: None

Abstract: This proposed rule would establish in regulations a 
requirement that durable medical equipment suppliers be required to 
furnish Medicaid State agencies with a surety bond in order to 
participate in the Medicaid program. This proposed rule would implement 
section 4724(g) of the Balanced Budget Act of 1997.

Timetable: Next Action Undetermined

Small Entities Affected: Governmental Jurisdictions

[[Page 22026]]

Government Levels Affected: State

Agency Contact: Mary Linda Morgan, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd, C4-20-07, Baltimore, MD 
21244
Phone: 410 786-2011
Email: [email protected]

RIN: 0938-AI63
_______________________________________________________________________




1188.  CHILD HEALTH INSURANCE ALLOTMENTS FY 1999 (HCFA-2014-N)

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

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

Legal Authority:  42 USC 1302, PL 105-33, sec 4901

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: This notice provides advance notification of the reserved 
fiscal year (FY) 1999 State allotments available to provide Federal 
funding to individual States, Commonwealths, and Territories for 
expenditures in the new State Children's Health Insurance Program 
established under title XXI of the Social Security Act. The reserved 
allotments is determined in accordance with section 2104 of the Act. 
These reserved State allotments are estimates of States FY 1999 title 
XXI allotments, assuming that each State were to submit, and receive 
approval for, a State child health plan. Under title XXI the amount of 
a State's allotment for a fiscal year is available for 3 years for 
States with approved child health plans.

Timetable: Next Action Undetermined

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State

Agency Contact: Richard Strauss, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, C4-18-26, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-2014
Email: [email protected]

RIN: 0938-AI64
_______________________________________________________________________




1189.  STATE CHILDREN HEALTH PLAN ALLOTMENTS AND PAYMENTS TO 
STATES (HCFA-2114-FC)

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

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

Legal Authority:  42 USC 1302

CFR Citation:  45 CFR 92.4; 45 CFR 95.1; 45 CFR 95.13; 45 CFR 95.503; 
45 CFR 95.601; 45 CFR 95.611; 45 CFR 95.703; 42 CFR 459

Legal Deadline: None

Abstract: This interim final rule with comment period will establish in 
regulations the methodology and procedures that HCFA will use to 
determine the fiscal year State allotments available to provide Federal 
funding to individual States, Commonwealths and Territories for 
expenditures for the new State Children's Health Insurance Program 
(CHIP) established under title XXI of the Social Security Act.
This rule also establishes in regulations the payment and grant award 
process that will be used for the States, the Commonwealths and 
Territories to claim and receive Federal financial payment (FFP) for 
expenditures under the State Children's Health Insurance Program and 
related Medicaid expansions.

Timetable: Next Action Undetermined

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State, Federal

Agency Contact: Richard Strauss, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, C4-18-26, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-2019
Email: [email protected]

RIN: 0938-AI65
_______________________________________________________________________




1190.  DSH PAYMENTS - INSTITUTION FOR MENTAL DISEASE (HCFA-2007-
P)

Priority:  Other Significant

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

Legal Authority:  PL 105-33, sec 4721(b); 42 USC 1396r-4(a); 42 USC 
1396r-4(f); 42 USC 1396r-4(h); 42 USC 1396r-4(i)

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: This notice announces the Federal share disproportionate 
share hospital (DSH) allotments for Federal fiscal year (FFYs) 1998 
through 2002. This notice also describes the methodology for 
calculating the Federal share DSH allotments for FFYs 2003 and 
thereafter as well as announces the FFY 1998 and FFY 1999 limitations 
on aggregate DSH payments States may make to institutions for mental 
disease (IMD) and other mental health facilities. It also provides 
clarification of the new requirement for direct DSH payment by the 
State on behalf of managed care enrollees and the DSH reporting 
requirements required by section 4721(b) of the Balanced Budget Act of 
1997.

Timetable: Next Action Undetermined

Small Entities Affected: Undetermined

Government Levels Affected: State

Agency Contact: Christine Hinds, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-4578

RIN: 0938-AI66
_______________________________________________________________________




1191.  MEDICAID PROGRAM; HOME AND COMMUNITY-BASED SERVICES 
(HCFA-2010-FC)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1302; PL 105-33, sec 4743

CFR Citation:  42 CFR 440; 42 CFR 441

Legal Deadline: None

Abstract: This final rule with comment period expands State flexibility 
in providing prevocational, educational and supported employment 
services under the Medicaid home and community-based services waiver 
provisions of section 1915(c) of the Social Security Act.

Timetable: Next Action Undetermined

Small Entities Affected: Undetermined

Government Levels Affected: State

Agency Contact: Bill Coons, Center for Medicaid and State Operations,

[[Page 22027]]

Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-5921

RIN: 0938-AI67
_______________________________________________________________________




1192.  REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE 
SCHEDULE AND OTHER PART B PAYMENT POLICIES FOR CALENDAR YEAR 1999 AND 
THE REBASING OF THE MEDICARE ECONOMIC INDEX (HCFA-1006-P)

Priority:  Other Significant. Major under 5 USC 801.

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

Legal Authority:  42 USC 1395w-4; 42 USC 1385x

CFR Citation:  42 CFR 405; 42 CFR 414

Legal Deadline: None

Abstract: This rule proposes updates to physician payments by Medicare 
as required by sections 1848 and 1861 of the Social Security Act. In 
this proposal we set forth policy involving resource-based practice 
expense relative value units, payment for drugs, the use of private 
contracts by Medicare beneficiaries and rebasing the Medicare Economic 
Index.

Timetable: Next Action Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Stanley Weintraub, Center for Health Plans and 
Providers, Department of Health and Human Services, Health Care 
Financing Administration, C4-10-26, 7500 Security Blvd, Baltimore, MD 
21244-1850
Phone: 410 786-4498

RIN: 0938-AI69
_______________________________________________________________________




1193.  MANAGED CARE: GLOBAL MEDICAID MANAGED CARE PROVISIONS IN 
THE BALANCED BUDGET ACT OF 1997 (HCFA-2001-P)

Priority:  Other Significant

Legal Authority:  PL 105-33, sec 4701(a)

CFR Citation:  42 CFR 430; 42 CFR 434; 42 CFR 435; 42 CFR 440

Legal Deadline: None

Abstract: This regulation will include new BBA provisions that were 
effective October 1, 1997, including the use of Mandatory Managed Care 
under a State plan, requirements for beneficiary Choice, enrollment and 
termination provisions, and primary care management services. It will 
also delete current regulations no longer required as a result of the 
BBA. Until this regulation is published, States will be unable to use 
the BBA exception from Choice requirements for rural areas and 
provisions of current regulations will remain in effect.

Timetable: Next Action Undetermined

Small Entities Affected: Undetermined

Government Levels Affected: State, Federal

Agency Contact: Bruce Johnson, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-6015

RIN: 0938-AI70
_______________________________________________________________________




1194.  NEW AND PENDING DEMONSTRATION PROJECT PROPOSALS SUBMITTED 
PURSUANT TO SECTION 1115(A) OF THE SOCIAL SECURITY ACT JULY, AUGUST, 
SEPTEMBER, OCTOBER, AND NOVEMBER 1997

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1315

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: This notice lists any new, pending, approved, disapproved, 
and withdrawn proposals for the demonstration projects.

Timetable: Next Action Undetermined

Small Entities Affected: None

Government Levels Affected: Undetermined

Agency Contact: Gloria Smiddy, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd, C3-18-26, Baltimore, MD 
21244
Phone: 410 786-7723

RIN: 0938-AI71
_______________________________________________________________________




1195.  ELIMINATION OF APPLICATION OF FEDERAL FINANCIAL 
PARTICIPATION LIMITS (HCFA-2111-IFC)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302

CFR Citation:  42 CFR 435

Legal Deadline: None

Abstract: This interim final rule with comment period eliminates the 
requirement that Federal financial participation income limits be 
applied when States use less restrictive income and resource 
methodologies to determine eligibility for aged, blind and disabled 
individuals, as well as for the optional categorically needy and the 
medically needy. This rule conforms the application of the FFP limits 
to the policy that the use of less restrictive income methodologies are 
not subject to FFP limits. This change will give States additional 
flexibility in setting Medicaid eligibility requirements.

Timetable: Next Action Undetermined

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Jackie Wilder, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd, C4-22-06, Baltimore, MD 
21244
Phone: 410 786-4579
Email: jwilder@hcfa.

RIN: 0938-AI73
_______________________________________________________________________




1196.  MEDICAID PROGRAM; CHANGES TO ELIGIBILITY OF NON-U.S. 
CITIZENS (HCFA-2108-P)

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

Unfunded Mandates: Undetermined

Legal Authority:  42 USC 1302; PL 104-193, sec 401 to 403

CFR Citation:  42 CFR 435; 42 CFR 436; 42 CFR 440

Legal Deadline: None

Abstract: The Personal Responsibility and Work Opportunity 
Reconciliation Act of 1996 created changes in Federal law making most 
non-U.S. citizens ineligible for Supplemental Security Income (SSI). In 
most States, receipt of SSI confers automatic Medicaid eligibility. 
Although many States have elected optional eligibility, groups that

[[Page 22028]]

provide a basis for covering persons who do not receive SSI, some 
States have not done so. In these States, these individuals would be 
left without access to Medicaid (including emergency services). To 
conform with the new law, we are proposing regulations that would 
result in the loss of Medicaid for qualified aliens in those States 
that cover only SSI recipients. We are also seeking comments on whether 
there remains any statutory basis to continue Medicaid coverage for 
these individuals.

Timetable: Next Action Undetermined

Small Entities Affected: None

Government Levels Affected: Undetermined

Agency Contact: Bob Tomlinson, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-4463

RIN: 0938-AI74
_______________________________________________________________________




1197.  MEDICARE PROGRAM; ADVANCE REFUNDING OF DEBT AND 
METHODOLOGY FOR REPAYMENT OF LOAN (HCFA-1777-P)

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

Unfunded Mandates: Undetermined

Legal Authority:  42 USC 1302; 42 USC 1395hh; 42 USC 1395x(v)

CFR Citation:  42 CFR 413

Legal Deadline: None

Abstract: This proposed rule would amend current regulations to clarify 
our policies regarding the treatment of interest expense. The rule 
would require that, when only part of the interest on a loan is 
allowable, repayment would be made first to that portion of the loan on 
which expense is allowable. This rule also would clarify how this 
policy is to be applied in situations in which there are multiple loans 
and one or more of the loans are not related to patient care. In 
addition, we would define the allowable costs associated with advance 
refunding of debt, and clarify the treatment of revenue and expenses.

Timetable: Next Action Undetermined

Small Entities Affected: Undetermined

Government Levels Affected: None

Agency Contact: Ann Pash, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-4516
Email: [email protected]

RIN: 0938-AI75
_______________________________________________________________________




1198.  MEDICARE PROGRAM; ADVERTISING COSTS (HCFA-1880-P)

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

Unfunded Mandates: Undetermined

Legal Authority:  42 USC 1302; 42 USC 1395 x(v); 42 USC 1395 hh

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: This proposed rule would clarify our long-standing policy on 
advertising costs that is found in section 2136 of the Medicare 
Provider Reimbursement Manual. Our policy is that advertising to 
solicit new patients is an unallowable cost under Medicare. We would 
add a new section that addresses issues including, but not limited to, 
advertising for outreach programs and recruitment of new employees, and 
yellow pages advertising.

Timetable: Next Action Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: William Gill, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-7156
Fax: 410 786-0594

RIN: 0938-AI76
_______________________________________________________________________




1199.  MEDICARE HOSPICE CARE (HCFA-1022-P)

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

Unfunded Mandates: Undetermined

Legal Authority:  PL 105-33, sec 4441(a); PL 105-33, sec 4442 to 4446; 
PL 105-33, sec 4448

CFR Citation:  42 CFR 418

Legal Deadline: None

Abstract: This proposed rule would implement section 4441(a), 4442-
4446, and 4448 of the Balanced Budget Act of 1997. Specific changes 
include: updating hospice payment rates, specifying payment according 
to the site of service, modifying the hospice benefit periods, 
clarifying the services covered under the benefit, allowing hospices to 
contract for physician services, allowing waivers of certain staffing 
requirements for hospice care programs in non-urbanized areas, and 
extending the period for physician certification of an individual's 
terminal illness. Additionally, the proposed rule would also clarify 
other current policies.

Timetable: Next Action Undetermined

Small Entities Affected: None

Government Levels Affected: Undetermined

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

Agency Contact: Carol Blackford, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-5909
Email: [email protected]

RIN: 0938-AI77
_______________________________________________________________________




1200.  STATE ALLOTMENTS FOR ADDITIONAL FEDERAL FUNDING OF 
EMERGENCY HEALTH SERVICES FURNISHED TO UNDOCUMENTED ALIENS: FEDERAL 
FISCAL YEARS 1998 THROUGH 2001

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

Legal Authority:  PL 105-33, sec 4723

CFR Citation:  Not yet determined

Legal Deadline: None
notice

Abstract: This notice announces the Federal fiscal year allotments that 
are available to certain States to furnish emergency health services to 
undocumented aliens. The 12 States having the highest number of 
undocumented aliens residing in the State will receive limited Federal 
funds for fiscal years 1998 through 2001 as additional compensation for 
providing emergency health services to the

[[Page 22029]]

undocumented alien population. This notice also describes the 
methodology used to determine each State's allotment.
This notice implements section 4723 of the Balanced Budget Act of 1997, 
Public Law 105-33.

Timetable: Next Action Undetermined

Small Entities Affected: None

Government Levels Affected: State, Federal

Additional Information: HCFA-2000-N

Agency Contact: Miles McDermott, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-3722
Email: [email protected]

RIN: 0938-AI78
_______________________________________________________________________




1201.  MEDICAID PROGRAM; EXTENSION OF WAIVER TO EXTEND MEDICAID 
ELIGIBILITY TIMEFRAMES (HCFA-2009-N)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: Included in the passage of the Balanced Budget Act of 1997 
Public Law 105-33 are the development of the Child Health Insurance 
Program, the extension of the Supplemental Security Income Insurance 
(SSI) cut off date for aliens, and the continuance of Medicaid 
eligibility for children who lose SSI. These are changes in Federal law 
that affect a large number of individuals while placing a significant 
additional workload on States.
This notice protects Federal financial participation (FFP) State 
Medicaid expenditures for States with unusual volumes of eligibility 
redeterminations caused by these recent changes in the law. Under this 
provision, the usual FFP timeframe requirements are waived, and States 
are allowed up to 120 days to process the unusual volume of 
redeterminations.

Timetable: Next Action Undetermined

Small Entities Affected: None

Government Levels Affected: State

Additional Information: HCFA-2009-N

Agency Contact: Mark Ross, Center for Medicaid and State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-5855
Email: [email protected]

RIN: 0938-AI79
_______________________________________________________________________




1202.  REVISION OF PROCEDURES FOR REQUESTING EXCEPTIONS TO COST 
LIMITS FOR SNFS AND ELIMINATION OF RECLASSIFICATIONS (HCFA-1883-P)

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

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

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 413.30

Legal Deadline: None

Abstract: This proposed rule would revise the procedures for granting 
exceptions to the cost limits for skilled nursing facilities and retain 
the current procedures for exceptions to the cost limits for home 
health agencies. It would remove the provision allowing 
reclassification for all providers.

Timetable: Next Action Undetermined

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

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: Steve Raitzyk, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-4599

RIN: 0938-AI80
_______________________________________________________________________




1203.  MEDICARE AND MEDICAID PROGRAMS; SURETY BOND AND 
CAPITALIZATION REQUIREMENTS FOR HOME HEALTH AGENCIES (HCFA-1038-NC)

Priority:  Routine and Frequent

Unfunded Mandates: This action may affect State, local or tribal 
governments and the private sector.
Major: Undetermined

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: The Balanced Budget Act of 1997 requires each home health 
agency to secure a surety bond in order to participate in the medicare 
and medicaid programs. Our January 5, 1998 publication in the Federal 
Register required each home health agency to secure a bond that is the 
greater of $50,000 or 15 percent of the annual amount paid to the home 
health agency and submit the bond to HCFA or the states medicaid 
agency, or both, by February 27, 1998. This notice announces our intent 
to make technical changes to the January 5, 1998 document to help home 
health agencies secure surety bonds. These changes were brought to our 
attention after the publication of our January 5, 1998 final rule.

Timetable: Next Action Undetermined

Small Entities Affected: None

Government Levels Affected: State, Tribal

Agency Contact: Ralph Goldberg, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-4870

RIN: 0938-AI82
_______________________________________________________________________




1204.  SOLVENCY STANDARDS FOR PROVIDER-SPONSORED ORGANIZATIONS 
(HCFA-1011-IFC)

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

Unfunded Mandates: Undetermined

Legal Authority:  42 USC 1302; 42 USC 1395w-21 to 1395w-27; 42 USC 
1395hh

CFR Citation:  42 CFR 422

Legal Deadline: None

[[Page 22030]]

Abstract: This interim final rule with a request for comments 
establishes solvency standards for provider-sponsored organizations 
(PSO's) under the new Medicare+Choice Program. The Balanced Budget Act 
of 1997 requires the Secretary to establish these standards by April 1, 
1998.

Timetable: Next Action Undetermined

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Maureen Miller, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-1097

RIN: 0938-AI83
_______________________________________________________________________




1205.  SCHEDULE OF PER-BENEFICIARY LIMITATIONS ON HOME HEALTH 
AGENCY COSTS FOR COST REPORTING PERIODS BEGINING ON OR AFTER OCTOBER 1, 
1997 (HCFA-1905-FC)

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

Unfunded Mandates: Undetermined

Legal Authority:  42 USC 1395x; PL 105-33, Balanced Budget Act of 1997

CFR Citation:  42 CFR 413.30

Legal Deadline:  Final, Statutory, April 1998.

Abstract: This final rule with comment period sets forth, in accordance 
with section 4602 of the Balanced Budget Act of 1997, a new schedule of 
limitations on home health agency costs that may be paid under the 
medicare program for cost reporting periods beginning on or after 
October 1, 1997.

Timetable: Next Action Undetermined

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Mike Bussacca, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244-1850
Phone: 410 786-4602

RIN: 0938-AI84
_______________________________________________________________________




1206.  EXPANDED COVERAGE OF BLOOD GLUCOSE MONITORS AND TEST 
STRIPS (HCFA-3003-IFC)

Priority:  Other Significant

Legal Authority:  PL 105-33, Balanced Budget Act of 1997

CFR Citation:  42 CFR 410.38

Legal Deadline: None

Abstract: This interim final rule with comment period expands Medicare 
coverage for blood glucose monitors and test strips, under certain 
conditions, to a diabetic beneficiary without regard to the beneficiary 
use of insulin. It implements part of section 4105 of the BBA '97.

Timetable: Next Action Undetermined

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Betty S. Burrier, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security Blvd, 
Baltimore, MD 21244-1850
Phone: 410 786-4649

RIN: 0938-AI85
_______________________________________________________________________




1207.  SURETY BOND REQUIREMENTS FOR HOME HEALTH AGENCIES (HCFA-
1152.1-F)

Priority:  Substantive, Nonsignificant

Unfunded Mandates: This action may affect State, local or tribal 
governments and the private sector.

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 441.16; 42 CFR 489.60 to 489.62; 42 CFR 489.65 to 
489.67; 42 CFR 489.71; 42 CFR 489.73

Legal Deadline: None

Abstract: This final rule revises several provisions of the final rule 
with comment period published in the Federal Register on January 5, 
1998 and establishes the surety bond compliance date, as described in a 
notice and final rule published in the Federal Register on March 4, 
1998. The March 4, 1998 documents advised the public that we intended 
to make technical revisions to the January 5, 1998 final rule and 
extend the February 27, 1998 compliance date for all home health 
agencies to furnish a surety bond to HCFA and/or state medicaid agency, 
or both, until 60 days after the date of publication of this final 
rule. In this rule we are also responding to comments we received in 
response to the January 5, 1998 final rule that pertains to the issues 
discussed in the March 4, 1998 notice, (HCFA-1038-N).

Timetable: Next Action Undetermined

Small Entities Affected: None

Government Levels Affected: State, Tribal

Agency Contact: Ralph Goldberg, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-4870

RIN: 0938-AI86
_______________________________________________________________________




1208.  HOSPICE WAGE INDEX NOTICE (HCFA-1039-N)

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

Unfunded Mandates: Undetermined

Legal Authority:  42 USC 1395F(i)

CFR Citation:  42 CFR 418.306(c)

Legal Deadline: None

Abstract: A revised Hospice Wage Index was published in the Federal 
Register on August 8, 1997. This wage index was applicable for services 
provided beginning on October 1, 1997 through September 1998. The 
revised hospic wage index will be phased in under a three year 
transition period. The second transition year is scheduled to begin 
October 1, 1998. Annual updates are required to begin with the start of 
the second transition year (October 1, 1998). This note will provide 
the wage index values for the second transition year as required.

Timetable: Next Action Undetermined

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Carol Blackford, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-5909
Fax: 410 786-0169
Email: [email protected]

RIN: 0938-AI87

[[Page 22031]]

_______________________________________________________________________




1209.  MEDICARE PROGRAM; STANDARDIZATION OF MEDICARE COVERAGE 
FOR BONE MASS MEASUREMENTS (HCFA-3004-IFC)

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

Unfunded Mandates: Undetermined

Legal Authority:  42 USC 1302; 42 USC 1395hh; 42 USC 1395rr(b)(1); 42 
USC BBA 4106

CFR Citation:  42 CFR 410; 42 CFR 414

Legal Deadline:  Other, Statutory, July 1, 1998.
BBA Section 4106

Abstract: This interim final rule with comment period provides for the 
standardization of coverage of bone mass measurements for qualified 
Medicare beneficiaries for services furnished on or after July 1, 1998. 
It implements provisions in section 4106 of the Balanced Budget Act of 
1997.

Timetable: Next Action Undetermined

Small Entities Affected: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Bill Larson, Office of Communications & Operations 
Support, Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-4639

RIN: 0938-AI89
_______________________________________________________________________




1210.  RECOGNITION OF THE AMERICAN ASSOCIATION FOR ACCREDITATION 
OF AMBULATORY SURGERY FACILITIES INC., FOR AMBULATORY SURGICAL CENTERS 
PROGRAM (HCFA-2008-PN)

Priority:  Info./Admin./Other

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

Legal Authority:  42 USC 1395bb

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: This notice announces the receipt of an application from the 
American Association of Ambulatory Surgery Facilities, Inc. for 
recognition as a national accreditation program for ambulatory surgical 
centers that wish to participate in the Medicare and Medicaid programs.

Timetable: Next Action Undetermined

Small Entities Affected: Organizations

Government Levels Affected: None

Agency Contact: Joan C. Berry, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-7233

RIN: 0938-AI90
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1211. EFFECTIVE DATES FOR PROVIDER AGREEMENTS AND SUPPLIER APPROVALS 
(HCFA-3139-F)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 431; 42 CFR 442; 42 CFR 488; 42 CFR 489; 42 CFR 
498

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/18/97                    62 FR 43931
Final Action Effective          08/18/97

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Agency Contact: Diane Bavaria
Phone: 410 786-6773

RIN: 0938-AC88
_______________________________________________________________________




1212. PROHIBITION ON UNBUNDLING OF HOSPITAL OUTPATIENT SERVICES (HCFA-
1426-F)

Priority:  Other Significant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Incorporated into RIN 0938-AI56 02/16/98

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Janet Wellham
Phone: 410 786-4510

RIN: 0938-AD33
_______________________________________________________________________




1213. RESIDENT ASSESSMENT IN LONG-TERM CARE FACILITIES (HCFA-2180-F)

Priority:  Other Significant

CFR Citation:  42 CFR 483

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/23/97                    62 FR 67174
Final Action Effective          12/23/97

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Cindy Hake
Phone: 410 786-3404

RIN: 0938-AE61
_______________________________________________________________________




1214. POST-CONTRACT BENEFICIARY PROTECTIONS AND OTHER PROVISIONS (OMC-
003-F)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 417

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn due to the BBA of 199712/29/97

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Tracy Jensen
Phone: 410 786-1033

RIN: 0938-AE63
_______________________________________________________________________




1215. SALARY EQUIVALENCY GUIDELINES FOR PHYSICAL THERAPY, RESPIRATORY 
THERAPY, SPEECH PATHOLOGY, AND OCCUPATIONAL THERAPY (HCFA-1808-F)

Priority:  Other Significant. Major under 5 USC 801.

CFR Citation:  42 CFR 413.106

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/31/98
Final Action Effective          01/31/98

[[Page 22032]]

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Jacqueline Gordon
Phone: 410 786-4517

RIN: 0938-AG70
_______________________________________________________________________




1216. HOME HEALTH AGENCY PHYSICIAN CERTIFICATION REGULATIONS (BPD-875-
NC)

Priority:  Substantive, Nonsignificant

CFR Citation:  42 CFR 424.22

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/05/98                    62 FR 59818

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Jennifer Carter
Phone: 410 786-4615

RIN: 0938-AH59
_______________________________________________________________________




1217. MEDICARE PROGRAM; ESTABLISHMENT OF AN EXPEDITED REVIEW PROCESS FOR 
MEDICARE BENEFICIARIES ENROLLED IN HMOS, CMPS, AND HCPPS (HCFA-1025-FC)

Priority:  Other Significant

CFR Citation:  42 CFR 417.600; 42 CFR 417.604; 42 CFR 417.606; 42 CFR 
417.608; 42 CFR 417.609; 42 CFR 417.614; 42 CFR 417.616; 42 CFR 
417.617; 42 CFR 417.618; 42 CFR 417.620

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    04/30/97                    62 FR 23368
Final Action Effective          06/30/97

Small Entities Affected: None

Government Levels Affected: Federal

Agency Contact: Maureen Miller
Phone: 410 786-1097

RIN: 0938-AH62
_______________________________________________________________________




1218. USE OF THE OASIS AS PART OF THE CONDITIONS OF PARTICIPATION FOR 
HOME HEALTH AGENCIES (HCFA-3238-F)

Priority:  Other Significant

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

CFR Citation:  42 CFR 484

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/10/97                    62 FR 11035
Final Action Effective          04/01/98

Small Entities Affected: Businesses

Government Levels Affected: Local

Agency Contact: Mary Vienna
Phone: 410 786-6940

RIN: 0938-AH74
_______________________________________________________________________




1219. MEDICARE PROGRAM; REVISIONS TO PAYMENT POLICIES AND ADJUSTMENTS TO 
THE RELATIVE VALUE UNITS UNDER THE PHYSICIAN FEE SCHEDULE, OTHER PART B 
PAYMENT POLICIES FOR CALENDAR YR 1998 (HCFA-1884-FC)

Priority:  Other Significant

CFR Citation:  42 CFR 410; 42 CFR 414

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/31/97                    62 FR 59048

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Stanley Weintraub
Phone: 410 786-4498

RIN: 0938-AH94
_______________________________________________________________________




1220. MEDICARE PROGRAM: MONTHLY ACTUARIAL RATES AND MONTHLY 
SUPPLEMENTARY MEDICARE INSURANCE PREMIUM RATE BEGINNING JANUARY 1, 1998 
(OACT-055-N)

Priority:  Substantive, Nonsignificant

CFR Citation:  45 CFR 900

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/04/97                    62 FR 59715
Final Action Effective          11/01/97

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Carter Warfield
Phone: 410 786-6396

RIN: 0938-AI03
_______________________________________________________________________




1221. SCHEDULE OF LIMITS ON HOME HEALTH AGENCY COST PER VISIT FOR COST 
REPORTING PERIODS BEGINNING ON OR AFTER OCTOBER 1, 1997 (BPD-904-FC)

Priority:  Other Significant. Major under 5 USC 801.

CFR Citation:  42 CFR 50

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/02/98                       63 FR 89
Final Action Effective          01/01/98

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Michael Bussacca
Phone: 410 786-4602

RIN: 0938-AI24
_______________________________________________________________________




1222. SURETY BOND AND CAPITALIZATION REQUIREMENTS FOR HOME HEALTH 
AGENCIES (HCFA-1152-FC)

Priority:  Substantive, Nonsignificant

Unfunded Mandates: This action may affect State, local or tribal 
governments and the private sector.

CFR Citation:  42 CFR 441.16; 42 CFR 489.67

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/05/98                      63 FR 292

Small Entities Affected: None

Government Levels Affected: State, Tribal

Agency Contact: Ralph Goldberg
Phone: 410 786-4870

RIN: 0938-AI31
_______________________________________________________________________




1223. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPPA) OF 
1996: ADMINISTRATIVE SIMPLIFICATION

Priority:  Other Significant

CFR Citation:  45 CFR 142

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Superseded by 
Individual Regulations          02/12/98

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Karen Trudel

[[Page 22033]]

Phone: 410 786-9937

RIN: 0938-AI32
_______________________________________________________________________




1224.  MEDICARE PROGRAM: DELAY IN IMPLEMENTING ADJUSTMENTS TO 
PRACTICE EXPENSE RELATIVE VALUE UNITS UNDER THE PHYSICIAN FEE SCHEDULE 
FOR CALENDAR YEAR 1998 (HCFA-1901-NC)

Priority:  Info./Admin./Other

Legal Authority:  42 USC 1302; 42 USC 1395w-4; 42 USC 1395hh

Legal Deadline: None

Abstract: This notice identifies provisions in the Medicare Physician 
Fee Schedule regulations that are affected by the enactment of the 
Balanced Budget Act of 1997 (BBA 1997). Section 4505 of the BBA 1997 
postponed implementation of a resource-based practice expense relative 
value unit system until January 1, 1999 and provides for a 4-year 
transition. In addition, it provides for new practice expense relative 
value units by May 1, 1998, thus requiring significant revision of our 
proposal contained in the proposed rule published June 18, 1997 (62 FR 
33158).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/31/97                    62 FR 59267

Small Entities Affected: None

Government Levels Affected: None

Agency Contact: Stan Weinstraub, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, C4-05-23, Baltimore, MD 21244
Phone: 410 786-4498

RIN: 0938-AI33
_______________________________________________________________________




1225.  MEDICARE PROGRAM; LIMIT ON THE VALUATION OF DEPRECIABLE 
ASSET RECOGNIZED AS AN ALLOWANCE FOR DEPRECIATION AND INTEREST ON 
CAPITAL INDEBTEDNESS AFTER A CHANGE OF OWNERSHIP (HCFA-1004-FC)

Priority:  Economically Significant. Major under 5 USC 801.

Legal Authority:  PL 105-33, sec 4404

CFR Citation:  42 CFR 413.134(b); 42 CFR 413.134(f); 42 CFR 413.134(g)

Legal Deadline: None

Abstract: This final rule with comment period revises the Medicare 
provider reimbursement regulations relative to allowable costs and sets 
a limit on the valuation of a depreciable asset that may be recognized 
in establishing an appropriate allowance for depreciation and for 
interest on capital indebtedness after a change of ownership that 
occurs on or after December 1, 1997. These provisions apply to 
providers that are reimbursed on the basis of reasonable costs. This 
change implements the mandate in section 4404 of the Balanced Budget 
Act of 1997 (Pub. L. 105-33).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/09/98                     63 FR 1379
Final Action Effective          01/09/98

Small Entities Affected: Businesses

Government Levels Affected: None

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

Agency Contact: Ann Pash, Health Insurance Specialist, Department of 
Health and Human Services, Health Care Financing Administration, 7500 
Security Boulevard C5-03-03, Baltimore, MD 21207
Phone: 410 786-4516

RIN: 0938-AI34
_______________________________________________________________________




1226.  APPLICATION OF INHERENT REASONABLENESS TO ALL MEDICARE 
PART B SERVICES (OTHER THAN PHYSICIAN SERVICES) (HCFA-1908-IFC)

Priority:  Other Significant

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 405

Legal Deadline: None

Abstract: This interim final rule implements section 4316 of the 
Balanced Budget Act of 1997. It revises the process for establishing a 
realistic and equitable payment amount for all Medicare part B services 
(except physician services) when the existing payment amounts are 
inherently unreasonable because they are grossly excessive or 
deficient. This rule describes the factors HCFA (or its carrier) will 
consider and the procedures it will follow in establishing realistic 
and equitable payment amounts.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/07/98                      63 FR 687
Final Action                    01/07/98                      63 FR 687
Final Action Effective          03/09/98

Small Entities Affected: None

Government Levels Affected: State, Federal

Agency Contact: William J. Long, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-12-18, 7500 Security Blvd207, Baltimore, MD 21228
Phone: 410 786-5655
Email: [email protected]

RIN: 0938-AI37
_______________________________________________________________________




1227.  MEDICARE PROGRAM: REQUEST FOR PUBLIC COMMENTS ON 
IMPLEMENTATION OF THE MEDICARE+CHOICE PROGRAM AND NOTICE OF TIMEFRAMES 
FOR SUBMISSION OF APPLICATIONS FOR CONTRACTS (HCFA-1014-N)

Priority:  Info./Admin./Other

Legal Authority:  PL 105-33, sec 4001

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: This notice solicits public comments on issues related to 
implementation of the Medicare+Choice Program. It also includes 
preliminary information regarding applications procedures for 
organizations that intend to contract with us to participate in the 
Medicare+Choice Program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/20/98
Final Action Effective          01/20/98

Small Entities Affected: None

Government Levels Affected: None

Additional Information: Legal authority sections 4001 of Public Law 
105-33

Agency Contact: Tony Hausner, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244

[[Page 22034]]

Phone: 410 786-1093

RIN: 0938-AI45
_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




1228. TITLE IV-E FOSTER CARE ELIGIBILITY REVIEWS AND CHILD AND FAMILY 
SERVICES STATE PLAN REVIEWS, MEPA IMPLEMENTATION, AND ASFA 
IMPLEMENTATION

Priority:  Other Significant

Legal Authority:  42 USC 627; 42 USC 671; 42 USC 1302; 42 USC 1320a-1a

CFR Citation:  45 CFR 1355; 45 CFR 1356

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

Abstract: This NPRM will propose requirements that implement the 
statutory provisions of the Social Security Act Amendments of 1994 on 
review of State programs under parts B and E of the Social Security Act 
for conformity with State Plan requirements including the Adoption and 
Safe Families Act requirements related to State plan issue. It will 
propose requirements that govern on-site eligibility reviews that the 
Administration for Children and Families conducts to assure State 
agencies' compliance with the statutory requirements under title IV-E 
of the Social Security Act for the eligibility of foster care providers 
and the eligibility of children in foster care. The NPRM will provide 
for enforcement of the prohibition on race-based discrimination in the 
foster care and adoptive placements.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/98

Small Entities Affected: None

Government Levels Affected: State

Additional Information: This action was previously reported under RIN 
0970-AB60.

Agency Contact: Kathleen McHugh, CB/ACYF, Department of Health and 
Human Services, Administration for Children and Families, Washington, 
DC 20013
Phone: 202 401-5789

RIN: 0970-AA97
_______________________________________________________________________




1229. CONSTRUCTION OF HEAD START FACILITIES

Priority:  Other Significant

Legal Authority:  42 USC 9801 et seq

CFR Citation:  45 CFR 1309

Legal Deadline: None

Abstract: This NPRM will establish procedures to be used by Head Start 
agencies in requesting to use Head Start grant funds to construct or 
renovate a Head Start facility.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/98

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: Local, Tribal

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start Bureau, Department of Health and Human Services, Administration 
for Children and Families, P.O. Box 1182, Washington, DC 20013
Phone: 202 205-8569

RIN: 0970-AB54
_______________________________________________________________________




1230. METHODOLOGY FOR DETERMINING CHILD POVERTY RATES

Priority:  Other Significant

Legal Authority:  42 USC 613(i)(5)

CFR Citation:  45 CFR CFR 284(new)

Legal Deadline: None

Abstract: This NPRM will propose a methodology to be used by States to 
determine their child poverty rates: section 413(i) of the Social 
Security Act, as amended, requires that the Secretary establish this 
methodology by regulation and mentions three specific factors which 
shall be included in the methodology.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/98

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Howard Rolston, Director, Office of Planning, Research, 
and Evaluation, Department of Health and Human Services, Administration 
for Children and Families, 7th Floor, 370 L'Enfant Promenade SW., 
Washington, DC 20447
Phone: 202 401-9220
Fax: 202 205-3598

RIN: 0970-AB65
_______________________________________________________________________




1231. BONUS TO REWARD HIGH PERFORMANCE STATES UNDER THE TEMPORARY 
ASSISTANCE FOR NEEDY FAMILIES BLOCK GRANT

Priority:  Other Significant

Legal Authority:  42 USC 603 (a)(4)

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: The Administration for Children and Families in consultation 
with the National Governors' Association and the American Public 
Welfare Association, will propose a formula for measuring State 
performance under the Temporary Assistance for Needy Families Block 
Grant as the basis for payment of a bonus to high performing States.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/98

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Howard Rolston, Director, Office of Planning, Research 
and Evaluation, Department of Health and Human Services, Administration 
for Children and Families, 370 L'Enfant Promenade SW., 7th Floor West, 
Washington, DC 20447
Phone: 202 401-9220
Fax: 202 205-3598

RIN: 0970-AB66
_______________________________________________________________________




1232. CHILD SUPPORT ENFORCEMENT FOR INDIAN TRIBES

Priority:  Other Significant

Legal Authority:  42 USC 655(f)

[[Page 22035]]

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: This NPRM will specify how tribes can obtain direct payments 
from the Department of Health and Human Services for provision of child 
support enforcement services if they submit a plan meeting the 
objectives of title IV-D, including establishment of paternity 
establishment, modification and enforcement of support orders, and 
location of absent parents.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/99

Small Entities Affected: None

Government Levels Affected: State, Tribal

Agency Contact: Elizabeth C. Matheson, Director, Division of Policy and 
Planning, Department of Health and Human Services, Administration for 
Children and Families, OCSE, 370 L'Enfant Promenade SW., Mail Stop: 
OCSE/DPP, Washington, DC 20447
Phone: 202 401-9386
Fax: 202 401-5559
Email: [email protected]

RIN: 0970-AB73
_______________________________________________________________________




1233. REQUIREMENTS FOR THE TRIBAL PROGRAMS

Priority:  Other Significant

Legal Authority:  42 USC 612

CFR Citation:  45 CFR 286(New); 45 CFR 287(New)

Legal Deadline: None

Abstract: 
This NPRM proposes a process for: the completion and submission of 
Tribal TANF plans; the determination of funding levels for Tribal Tanf 
grants; establishing criteria to determine minimum work participation 
requirements and time limits for Tribal TANF programs; and the review 
and approval of Tribal TANF plans. This NPRM proposes program 
requirements for the application of penalties and for data collection 
and reporting.
The NPRM proposes procedures for planning and operating a program to 
make work activities available to Tribal members. Funds for this 
program are available to Indian tribes and Alaska Native organizations 
that operated a Job Opportunities and Basic Skills Training (JOBS) 
program in fiscal year 1995. This Tribal work activities program is 
called the Native Employment Works (NEW) Program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/98

Small Entities Affected: None

Government Levels Affected: State, Tribal, Federal

Agency Contact: John Bushman, Director, Division of Tribal Services, 
Department of Health and Human Services, Administration for Children 
and Families, Office of Community Services, 370 L'Enfant Promenade SW., 
Washington, DC 20447
Phone: 202 401-2418
Fax: 202 205-5887
Email: [email protected]

RIN: 0970-AB78
_______________________________________________________________________




1234. REFUGEE RESETTLEMENT PROGRAM: RESPONDING TO TANF REPLACING AFDC

Priority:  Other Significant

Legal Authority:  8 USC 1522(a)(9)

CFR Citation:  45 CFR 400

Legal Deadline: None

Abstract: This regulation will revise refugee resettlement program 
regulations to respond to the Temporary Assistance for Needy Families 
(TANF) program replacing the Aid to Families with Dependent Children 
(AFDC) program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/98

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Toyo Biddle, Director, Division of Refugee Self-
Sufficiency, Department of Health and Human Services, Administration 
for Children and Families, 370 L'Enfant Promenade SW., Washington, DC 
20447
Phone: 202 401-9250

RIN: 0970-AB83
_______________________________________________________________________




1235. CHILD SUPPORT NON-PERFORMANCE PENALTY

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 609(a)(8)

CFR Citation:  45 CFR 305

Legal Deadline: None

Abstract: This regulation will implement the requirements in 42 USC 
609(a)(8) which provides for a penalty of 1 percent to 5 percent of a 
State's Temporary Assistance for Needy Families (TANF) funds if the 
Secretary of HHS determines that the State failed to meet the paternity 
establishment percentages or other performance measures established by 
the Secretary.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/99

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Elizabeth C. Matheson, Director, Division of Policy and 
Planning, Department of Health and Human Services, Administration for 
Children and Families, 370 L'Enfant Promenade SW., Mail Stop OCSE/DPP, 
Washington, DC 20447
Phone: 202 401-9385
Fax: 202 401-5559
Email: [email protected]

RIN: 0970-AB85
_______________________________________________________________________




1236. CHILD ABUSE AND NEGLECT PREVENTION AND TREATMENT

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 5101 et seq

CFR Citation:  45 CFR 1340

Legal Deadline: None

Abstract: These proposed rules would amend current regulations to 
reflect statutory changes made by the CAPTA Amendments of 1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/98

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State

Agency Contact: Emily Cooke, Department of Health and Human Services, 
Administration for Children and Families, CB/OCAN, 330 C Street SW., 
Room 2106, Switzer Building, Washington, DC 20201
Phone: 202 205-8709
Fax: 202 260-9351
Email: [email protected]

RIN: 0970-AB86

[[Page 22036]]

_______________________________________________________________________




1237. HEAD START APPEAL TIMELINES

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 9801 et seq

CFR Citation:  45 CFR 1303

Legal Deadline: None

Abstract: This proposed amendment to part 1303 will provide timelines 
and selected procedural changes for conducting administrative hearings 
on adverse actions taken against Head Start agencies.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/98

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Local, Tribal

Agency Contact: Douglas Klafehn, Deputy Commissioner, Head Start 
Bureau, Department of Health and Human Services, Administration for 
Children and Families, ACYF, P.O. Box 1182, Washington, DC 20013
Phone: 202 205-8569

RIN: 0970-AB87
_______________________________________________________________________




1238. TITLE IV-E TRAINING

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 672; 42 USC 673

CFR Citation:  45 CFR 1356.60; 45 CFR 235.63 to 235.66(a)

Legal Deadline: None

Abstract: This NPRM will revise the title IV-E training regulations. 
The current title IV-E training regulations are a carryover from the 
old title IV-A regulations. They have never been revised to reflect the 
different requirements and emphases that Public Law 96-272 placed on 
states regarding the removal of children from their homes, the efforts 
required to prevent removal and work for reunification or other 
permanent placements for children in foster care. In addition, there 
are areas of ambiguity in the current rule which need clarification to 
assure consistent application of policy.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/98

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Judith Reich, Training Specialist, Children's Bureau, 
Department of Health and Human Services, Administration for Children 
and Families, DHHS/ACYF/ACF, Washington, DC 20013
Phone: 202 205-8713

RIN: 0970-AB89
_______________________________________________________________________




1239. FAMILY CHILD CARE PROGRAM OPTION FOR HEAD START PROGRAMS

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 9801 et seq

CFR Citation:  45 CFR 1306

Legal Deadline: None

Abstract: This rule would allow Head Start programs to choose Family 
Child Care as Head Start program option.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/98

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Local, Tribal

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start, Bureau, Department of Health and Human Services, Administration 
for Children and Families, ACYF, PO Box 1182, Washington, DC 20013
Phone: 202 205-8569

RIN: 0970-AB90
_______________________________________________________________________




1240.  IMPLEMENTATION OF ADOPTION & SAFE FAMILIES ACT OF 
REMAINING PROVISIONS OF THE 1997 AND OTHER TITLE IV-B/IV-E REGULATORY 
AMENDMENTS

Priority:  Other Significant

Legal Authority:  42 USC 620 to 628; 42 USC 629 to 629(c); 42 USC 670 
to 679

CFR Citation:  45 CFR 1355; 45 CFR 1356; 45 CFR 1357

Legal Deadline: None

Abstract: This NPRM implements the changes in titles IV-B and IV-E of 
the Social Security Act as mandated by the Adoption & Safe Families Act 
of 1997, Public Law 105-89. These changes include: reasonable efforts, 
dispositional (permanency) hearings, background checks, termination of 
parental rights and procedures for expediting a fostercare child's 
permanent placement and to assure the child's safety in all aspects. In 
addition, the NPRM will revise the title IV-B, subpart 1 planning 
requirements to make the plans more accurately reflect the amount of 
funding available to Indian Tribes/Tribal Organizations through the 
program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/99

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Kathleen McHugh, Director, Policy Division, Department 
of Health and Human Services, Administration for Children and Families, 
330 C St. SW., Wasington, DC 20201
Phone: 202 401-5789
Email: [email protected]

RIN: 0970-AB94
_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




1241. STANDARDS FOR SAFE TRANSPORTATION

Priority:  Other Significant

Legal Authority:  42 USC 9801 et seq

CFR Citation:  45 CFR 1310

Legal Deadline: None

Abstract: This rule establishes Head Start Performance Standards for 
the safe transportation of Head Start children, including vehicle 
requirements, driver qualifications and training and safety rules for 
children and staff while en route and loading and unloading of 
vehicles.

[[Page 22037]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/15/95                    60 FR 31612
NPRM Comment Period End         08/14/95
Final Action                    02/00/99

Small Entities Affected: Organizations

Government Levels Affected: Local, Tribal

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start Bureau, Department of Health and Human Services, Administration 
for Children and Families, P.O. Box 1182, Washington, DC 20013
Phone: 202 205-8569

RIN: 0970-AB24
_______________________________________________________________________




1242. STANDARDS FOR PURCHASE OF FACILITIES

Priority:  Other Significant

Legal Authority:  42 USC 9801 et seq

CFR Citation:  45 CFR 1309

Legal Deadline: None

Abstract: This regulation establishes standards for the purchase of 
facilities as required by the Head Start Improvement Act of 1992.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/01/94                    59 FR 61575
NPRM Comment Period End         01/30/95
Final Action                    08/00/98

Small Entities Affected: Organizations

Government Levels Affected: Local, Tribal

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start Bureau, Department of Health and Human Services, Administration 
for Children and Families, P.O. Box 1182, Washington, DC 20013
Phone: 202 205-8569

RIN: 0970-AB31
_______________________________________________________________________




1243. DESIGNATION OF ALTERNATIVE AGENCY TO SERVE INDIAN TRIBAL CHILDREN

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 9801 et seq

CFR Citation:  45 CFR 1302

Legal Deadline: None

Abstract: This NPRM will specify a process by which an Indian tribe may 
identify and establish an alternative agency to provide Head Start 
Services if the agency previously serving the tribe is terminated.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/16/97                    62 FR 65778
Final Action                    08/00/98

Small Entities Affected: Organizations

Government Levels Affected: Tribal

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start Bureau, Department of Health and Human Services, Administration 
for Children and Families, P.O. Box 1182, Washington, DC 20013
Phone: 202 205-8569

RIN: 0970-AB52
_______________________________________________________________________




1244. QUARTERLY WAGE AND UNEMPLOYMENT COMPENSATION CLAIMS REPORTING TO 
THE NATIONAL DIRECTORY OF NEW HIRES

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 653A(g)(2)(B)

CFR Citation:  45 CFR 303.108 (new)

Legal Deadline: None

Abstract: This regulation specifies the information on wages and 
unemployment compensation paid to individuals that certain State 
entities will be required to provide to the National Directory of New 
Hires on a quarterly basis.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/07/97                    62 FR 52306
NPRM Comment Period End         12/08/97
Final Action                    07/00/98

Small Entities Affected: None

Government Levels Affected: State, Federal

Agency Contact: Anne M. Benson, Program Specialist, Department of 
Health and Human Services, Administration for Children and Families, 
OCSE, 370 L'Enfant Promenade SW., Mail Stop: OCSE/DPP, Washington, DC 
20447
Phone: 202 401-1467
Fax: 202 401-5559
Email: [email protected]

RIN: 0970-AB67
_______________________________________________________________________




1245. STATE LAW CONCERNING PATERNITY ESTABLISHMENT

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 666(a)(5)

CFR Citation:  45 CFR 302.70; 45 CFR 303.5; 45 CFR 304.20

Legal Deadline: None

Abstract: This regulation covers voluntary paternity establishment 
services offered by hospitals and birth record agencies and specifies 
the types of other entities that may offer voluntary paternity 
establishment services. The provision of such services must include a 
requirement that such an entity use the same notice provision, 
materials, training, and evaluation as the ones used by the voluntary 
paternity establishment programs of hospitals and birth record 
agencies.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/05/98                      63 FR 187
NPRM Comment Period End         03/06/98
Final Action                    01/00/99

Small Entities Affected: None

Government Levels Affected: State, Local

Agency Contact: Jan Rothstein, Program Specialist, Division of Policy 
and Planning, Department of Health and Human Services, Administration 
for Children and Families, OCSE, DHHS, 370 L'Enfant Promenade SW., Mail 
Stop: OCSE/DPP, Washington, DC 20447
Phone: 202 401-5073
Fax: 202 401-5559
Email: [email protected]

RIN: 0970-AB69
_______________________________________________________________________




1246. AUTOMATED DATA PROCESSING REQUIREMENTS/STATE CASE REGISTRY

Priority:  Other Significant

Legal Authority:  42 USC 654(24); 42 USC 654A(e) and 654A(f)

CFR Citation:  45 CFR 302.85; 45 CFR 304.20; 45 CFR 307

Legal Deadline:  Final, Statutory, August 22, 1998.

Abstract: This regulation implements statutory provisions in the 
Personal Responsibility and Work Opportunity Reconciliation Act of 1996 
related to child support automation. It sets a

[[Page 22038]]

deadline of October 1, 2000, for implementation of new Automated Data 
Processing requirements for the Child Support Enforcement Program. The 
rule also sets the framework to support ACF's standards for certifying 
computerized child support enforcement systems and addresses security 
and confidentiality safeguards. The regulation also specifies what 
constitutes the minimum amount of information on child support cases 
recorded in the State Case Registry that is necessary to operate the 
Federal Case Registry.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/25/98                    63 FR 14402
NPRM Comment Period End         05/11/98
Final Action                    08/00/98

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Michael P. Fitzgerald, Senior Computer Specialist, 
Department of Health and Human Services, Administration for Children 
and Families, DHHS Room 326F, 200 Independence Avenue SW., Washington, 
DC 20201
Phone: 202 401-6403

RIN: 0970-AB70
_______________________________________________________________________




1247. AUTOMATED DATA PROCESSING FUNDING LIMITATION

Priority:  Other Significant

Legal Authority:  PL 104-193, sec 344

CFR Citation:  45 CFR 307.30

Legal Deadline: None

Abstract: This regulation will set the allocation formula for the total 
amount payable to a State for fiscal years 1996 through 2001 based on 
the $400 million in federal funds for automated child support 
enforcement systems enhancements under the Personal Responsibility and 
Work Opportunity Reconciliation Act of 1996 (P.L. 104-193).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/02/98                    63 FR 10173
Final Action                    08/00/98

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Helen Morgan Smith, Electronic Benefits Transfer 
Specialist, Department of Health and Human Services, Administration for 
Children and Families, OPS/OSS/OD, Room 326F, 200 Independence Avenue 
SW., Washington, DC 20201
Phone: 202 690-6639
Fax: 202 401-6400

RIN: 0970-AB71
_______________________________________________________________________




1248. GRANTS TO STATES FOR ACCESS AND VISITATION PROGRAMS

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 669B

CFR Citation:  45 CFR 303.109(New)

Legal Deadline: None

Abstract: This regulation specifies the monitoring, evaluating, and 
reporting of State grants designed to support and facilitate absent 
parents' access to and visitation of their children.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/31/98                    63 FR 15351
Final Action                    12/00/98

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: David Arnaudo, Technical Advisor, Department of Health 
and Human Services, Administration for Children and Families, OCSE, 370 
L'Enfant Promenade SW., Mail Stop: OCSE/DPP, Washington, DC 20447
Phone: 202 401-5364
Fax: 202 401-5559
Email: [email protected]

RIN: 0970-AB72
_______________________________________________________________________




1249. CHILD CARE AND DEVELOPMENT FUND

Priority:  Other Significant

Legal Authority:  42 USC 618; 42 USC 9858

CFR Citation:  45 CFR 98; 45 CFR 99

Legal Deadline: None

Abstract: The Administration for Children and Families will amend 
existing regulations which govern the administration of the Child Care 
and Development Block Grant program. The purpose of this regulatory 
package will be to implement the legislative changes contained in the 
Personal Responsibility and Work Opportunity Reconciliation Act of 
1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/23/97                    62 FR 39610
Final Action                    07/00/98

Small Entities Affected: None

Government Levels Affected: State, Tribal

Agency Contact: Carmen Nazario, Associate Commissioner, Child Care 
Bureau, Department of Health and Human Services, Administration for 
Children and Families, P.O. Box 1182, Washington, DC 20013
Phone: 202 690-6782

RIN: 0970-AB74
_______________________________________________________________________




1250. TEMPORARY ASSISTANCE FOR NEEDY FAMILIES (TANF)

Priority:  Other Significant

Legal Authority:  42 USC 601; 42 USC 601 note; 42 USC 603 to 604; 42 
USC 606 to 611; 42 USC 613; 42 USC 617; 42 USC 619; 42 USC 862a; 42 USC 
1302; 42 USC 1308

CFR Citation:  45 CFR 270 to 275(new)

Legal Deadline: None

Abstract: This regulation governs key provisions of the new welfare 
block grant program enacted in August 1996 as part of the Personal 
Responsibility and Work Opportunity Reconciliation Act of 1996 
(PRWORA). This new program, called the Temporary Assistance for Needy 
Families -- or TANF -- program, replaced the national welfare program 
known as Aid to Families with Dependent Children (AFDC) and the related 
programs known as the Job Opportunities and Basic Skills Training 
Program (JOBS) and the Emergency Assistance (EA) program. The 
regulation addresses the five-year time limit, work, accountability, 
and data collection and reporting provisions of the new TANF program.

Statement of Need: This regulation is necessary to provide States with 
a basic set of rules which will assist them in implementing the TANF 
program.

Alternatives: There are no viable alternatives.

Anticipated Costs and Benefits: No additional costs to the public.

Risks: None.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/20/97                    62 FR 62124

[[Page 22039]]

NPRM Comment Period End         02/18/98
Final Action                    08/00/98

Small Entities Affected: None

Government Levels Affected: State, Tribal, Federal

Additional Information: This action includes information previously 
reported under RIN 0970-AB64 and RIN 0970-AB76.

Agency Contact: Mack Storrs, Director, Division of Self-Sufficiency 
Programs, Department of Health and Human Services, Administration for 
Children and Families, Office of Family Assistance, 370 L'Enfant 
Promenade SW., Washington, DC 20447
Phone: 202 401-9289
Fax: 202 205-5887
Email: [email protected]

RIN: 0970-AB77
_______________________________________________________________________




1251. BONUS TO REWARD DECREASE IN ILLEGITIMACY

Priority:  Other Significant

Legal Authority:  42 USC 603

CFR Citation:  45 CFR 283(new)

Legal Deadline: None

Abstract: This regulation describes how bonuses will be awarded to 
those States that experience the largest decreases in out-of-wedlock 
childbearing and also reduce their abortion rates. The total amount of 
the bonus will be $100 million in each of fiscal years 1999 through 
2002.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/02/98                    63 FR 10264
NPRM Comment Period End         05/01/98
Final Action                    10/00/98

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Kelleen Kaye, Office of the Assistant Secretary for 
Planning and Evaluation, Department of Health and Human Services, 
Administration for Children and Families, 200 Independence Avenue SW., 
Washington, DC 20201
Phone: 202 401-6634
Email: [email protected]

RIN: 0970-AB79
_______________________________________________________________________




1252. CHILD SUPPORT ENFORCEMENT PROGRAM OMNIBUS CONFORMING REGULATION

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1302

CFR Citation:  45 CFR 304; 45 CFR 305

Legal Deadline: None

Abstract: This rule eliminates child support enforcement program 
regulations rendered obsolete or inconsistent with the Personal 
Responsibility and Work Opportunity Reconciliation Act of 1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              06/00/98

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Marilyn R. Cohen, Program Specialist, Department of 
Health and Human Services, Administration for Children and Families, 
370 L'Enfant Promenade SW., Mail Stop: OCSE/DPP, Washington, DC 20447
Phone: 202 401-5366
Fax: 202 401-5559
Email: [email protected]

RIN: 0970-AB81
_______________________________________________________________________




1253. CASE CLOSURE

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 651 to 658; 42 USC 660; 42 USC 663; 42 USC 
664; 42 USC 666; 42 USC 667; 42 USC 1302; 42 USC 1396a(a)(25); 42 USC 
1396(d)(2); 42 USC 1396b(o); 42 USC 1396b(p); 42 USC 1396(k)

CFR Citation:  45 CFR 303.11

Legal Deadline: None

Abstract: This rule amends regulations governing the case closure 
process in the child support enforcement program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/24/98                     63 FR 9172
NPRM Comment Period End         04/27/98
Final Action                    11/00/98

Small Entities Affected: None

Government Levels Affected: State, Local, Tribal

Agency Contact: Elizabeth C. Matheson, Director, Division of Policy and 
Planning, Department of Health and Human Services, Administration for 
Children and Families, 370 L'Enfant Promenade SW., Mail Stop: OCSE/DPP, 
Washington, DC 20447
Phone: 202 401-9385
Fax: 202 401-5559
Email: [email protected]

RIN: 0970-AB82
_______________________________________________________________________




1254. DATA COLLECTION AND ELEMENTS FOR THE WELFARE TO WORK PROGRAM

Priority:  Other Significant

Legal Authority:  42 USC 611

CFR Citation:  45 CFR 276(new)

Legal Deadline: None

Abstract: This interim final rule will specify the data elements that 
will have to be reported for the Welfare-to-Work program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              08/00/98

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Howard Rolston, Director, Office of Planning, Research 
and Evaluation, Department of Health and Human Services, Administration 
for Children and Families, 370 L'Enfant Promenade SW., 7th Floor West, 
Washington, DC 20447
Phone: 202 401-9220
Fax: 202 205-3598

RIN: 0970-AB92

[[Page 22040]]

_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Administration for Children and Families (ACF)



_______________________________________________________________________




1255. INCOME ELIGIBILITY CRITERIA FOR INDIAN TRIBES

Priority:  Substantive, Nonsignificant

CFR Citation:  45 CFR 1305

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/16/98                    63 FR 12652
Final Action Effective          04/15/98

Small Entities Affected: Organizations

Government Levels Affected: Tribal

Agency Contact: Douglas Klafehn
Phone: 202 205-8569

RIN: 0970-AB53
_______________________________________________________________________




1256. INCOME AND RESOURCE DISREGARDS RELATED TO INTERESTS OF INDIVIDUAL 
INDIANS IN TRUST OR RESTRICTED LANDS

Priority:  Substantive, Nonsignificant

CFR Citation:  45 CFR 233

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Regulation no longer 
necessary due to PRWORA of 1996.03/02/98

Small Entities Affected: None

Government Levels Affected: State

Agency Contact: Mack A. Storrs
Phone: 202 401-9289

RIN: 0970-AB59
_______________________________________________________________________




1257. STATE CASE REGISTRY AND EXPANSION OF THE FEDERAL PARENT LOCATOR 
SERVICE (FPLS)

Priority:  Substantive, Nonsignificant

CFR Citation:  45 CFR 307

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Incorporated Into 
RIN 0970-AB70                   03/02/98

Small Entities Affected: None

Government Levels Affected: State, Federal

Agency Contact: Anne M. Benson
Phone: 202 401-1467
Fax: 202 401-5559
Email: [email protected]

RIN: 0970-AB68
_______________________________________________________________________




1258. PERSONAL RESPONSIBILITY AND WORK OPPORTUNITY RECONCILIATION ACT OF 
1996 CONFORMING REGULATION

Priority:  Substantive, Nonsignificant

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

CFR Citation:  45 CFR 205; 45 CFR 232; 45 CFR 233; 45 CFR 250; 45 CFR 
255; 45 CFR 256; 45 CFR 257

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/05/97                    62 FR 64301

Small Entities Affected: None

Government Levels Affected: State, Tribal, Federal

Agency Contact: Ann Burek
Phone: 202 401-9223

RIN: 0970-AB84
_______________________________________________________________________




1259. TITLE IV-B PLANNING REQUIREMENTS FOR TRIBES

Priority:  Substantive, Nonsignificant

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

CFR Citation:  45 CFR 1356; 45 CFR 1357

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Merged With RIN 0970-AB94       03/25/98

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State, Tribal

Agency Contact: Angelina, Palmiero
Phone: 202 205-8666

RIN: 0970-AB88
_______________________________________________________________________


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


Administration on Aging (AOA)



_______________________________________________________________________




1260. GRANTS FOR STATE AND COMMUNITY PROGRAMS ON AGING, INTRASTATE 
FUNDING FORMULAS; TRAINING, RESEARCH AND DISCRETIONARY PROGRAMS; 
VULNERABLE ELDER RIGHTS; AND GRANTS TO INDIANS & NATIVE HAWAIIANS

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 3001 et seq

CFR Citation:  45 CFR 1321; 45 CFR 1324; 45 CFR 1326; 45 CFR 1327; 45 
CFR 1328

Legal Deadline: None
Unknown until law is reauthorized.

Abstract: The Administration on Aging (AoA) anticipates revising 
current rules to reflect the changes resulting from the pending 
reauthorization of the Older Americans Act which incorporates greater 
flexibility for the States. PURPOSE: The purpose of these revisions 
will be to implement new legislation on the development and provision 
of community-based services.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM - OAA Amendments in FY '98 11/00/98

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Tribal

Additional Information: The Administration on Aging, in consultation 
with the Office of Management and Budget, has determined that it is no 
longer necessary to pursue final action on rules earlier proposed to 
implement the 1992 amendments to the Older Americans Act. The 
provisions of the

[[Page 22041]]

Act remain in force and need no further regulations to implement them. 
AoA anticipates promulgating rules in the latter part of 1998 to 
implement the provisions to the next reauthorization of the Older 
Americans Act, if necessary.

Agency Contact: Edwin Walker, Director, Office of Program Operations 
and Development, Department of Health and Human Services, 
Administration on Aging, 330 Independence Avenue SW., Room 4733, Cohen 
Bldg., Washington, DC 20201
Phone: 202 619-0011

RIN: 0985-AA00
[FR Doc. 98-8612 Filed 04-24-98; 8:45 am]
BILLING CODE 4150-04-F]