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



[[Page 61679]]

_______________________________________________________________________

Part VIII





Department of Health and Human Services





_______________________________________________________________________



Semiannual Regulatory Agenda

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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 informs the public about 
regulatory actions that are under development within the components of 
the Department, and it provides all concerned with the opportunity to 
participate in this work at an early stage. The last such agenda was 
published on April 27, 1998.

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 involving: Numerous innovations in the Medicare 
and Medicaid programs, new structures for assuring the safety of the 
Nation's food supply, access to health services for children, welfare 
reform, health insurance reform, new standards for electronic data 
interchange in health insurance transactions, more effective regulation 
of drugs and medical products, and the combating of waste, fraud, and 
abuse in the health care system.

    Underlying the Department's pursuit of its regulatory 
responsibilities in all of the above-mentioned programmatic areas, 
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 these 
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.

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

    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.

    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, MSC 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.

                                  Office of the Secretary--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1129         Health Care Fraud and Abuse Data Collection Program..................................    0991-AA98
----------------------------------------------------------------------------------------------------------------


[[Page 61681]]


                                    Office of the Secretary--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1130         Clarification of the Initial OIG Safe Harbor Provisions and Establishment of
            Additional Safe Harbor Provisions Under the Anti-Kickback Statute.....................    0991-AA66
1131         Reproduction and Sale of Official Forms and Publications.............................    0991-AA83
1132         Revised OIG Civil Money Penalties Resulting From Public Law 104-191..................    0991-AA90
1133         Shared Risk Exception to the Safe Harbor Provisions..................................    0991-AA91
----------------------------------------------------------------------------------------------------------------


                                   Office of the Secretary--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1134         Civil Money Penalties (CMPs) for Certain Hospital Physician Incentive Plans..........    0991-AA45
1135         Civil Money Penalties (CMPs) for Certain Practices Relating to Medicare Supplemental
            Policies..............................................................................    0991-AA53
1136         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
1137         Civil Money Penalties for False Information on Drug Manufacturer Price Surveys and
            Rebate Agreements.....................................................................    0991-AA80
1138         Senior Biomedical Research Service...................................................    0991-AA82
----------------------------------------------------------------------------------------------------------------


                                   Office of the Secretary--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1139         Revised OIG Exclusion Authorities Resulting From Public Law 104-191..................    0991-AA87
1140         Issuance of Advisory Opinions by the Inspector General...............................    0991-AA94
1141         Revised OIG Sanction Authorities Resulting From Public Law 105-33....................    0991-AA95
----------------------------------------------------------------------------------------------------------------


                  Substance Abuse and Mental Health Services Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1142         Block Grants for Prevention and Treatment of Substance Abuse.........................    0930-AA01
----------------------------------------------------------------------------------------------------------------


                                  Departmental Management--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1143         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
----------------------------------------------------------------------------------------------------------------
1144         Animal Drug Approvals for Minor Species and Minor Usage..............................    0910-AB07
1145         Electronic Submission of Adverse Drug Reaction Reports...............................    0910-AB42
1146         Pregnancy Labeling Revision..........................................................    0910-AB44
1147         Discontinuation of a Life-Saving Product.............................................    0910-AB60
----------------------------------------------------------------------------------------------------------------


[[Page 61682]]


                                Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1148         Over-the-Counter (OTC) Drug Review...................................................    0910-AA01
1149         Review of Warnings, Use Instructions, and Precautionary Information Under Section 314
            of the National Childhood Vaccine Injury Act of 1986..................................    0910-AA14
1150         Hearing Aids; Professional and Patient Labeling; Conditions for Sale (Reg Plan Seq.
            No. 22)...............................................................................    0910-AA39
1151         Bioavailability and Bioequivalence Requirements......................................    0910-AA51
1152         Drugs Used for Treatment of Narcotic Addicts.........................................    0910-AA52
1153         Investigational New Drugs: Export Requirements for Unapproved New Drug Products......    0910-AA61
1154         Adverse Drug Reaction Reporting, Recordkeeping, and Records Access Requirements for
            Marketed OTC Drugs....................................................................    0910-AA86
1155         Informed Consent for Human Drugs and Biologics; Determination That Informed Consent
            Is Not Feasible.......................................................................    0910-AA89
1156         Direct-to-Consumer Promotion Regulations.............................................    0910-AA90
1157         Labeling for Human Prescription Drugs; Revised Format (Reg Plan Seq. No. 23).........    0910-AA94
1158         Adverse Drug Reaction Reporting Requirements for Human Drug and Biological Products..    0910-AA97
1159         Use of Ozone-Depleting Substances....................................................    0910-AA99
1160         Radioactive Drugs for Basic Research.................................................    0910-AB00
1161         Veterinary Feed Directives...........................................................    0910-AB09
1162         Exports; Reporting and Recordkeeping Requirements....................................    0910-AB16
1163         Registration of Foreign Establishments and Product Listing...........................    0910-AB21
1164         Public Information; Communications With State and Foreign Government Officials.......    0910-AB22
1165         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
1166         Blood Initiative.....................................................................    0910-AB26
1167         Suitability Determination for Donors of Human Cellular and Tissue-Based Products.....    0910-AB27
1168         Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based
            Products..............................................................................    0910-AB28
1169         Shell Eggs: Warning, Notice and Safe Handling Labeling Statements and Refrigeration
            Requirements..........................................................................    0910-AB30
1170         Antibiotic Drug Approval and Exclusivity.............................................    0910-AB33
1171         Applications for FDA Approval to Market a New Drug or Antibiotic Drug; Complete
            Response Letter; Amendments to Unapproved Applications................................    0910-AB34
1172         Expanded Access to Investigational Therapies.........................................    0910-AB37
1173         Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs....    0910-AB39
1174         List of Drugs That Have Been Withdrawn or Removed From the Market for Reasons of
            Safety and Effectiveness..............................................................    0910-AB40
1175         Distinguishing Marks for Drug Products Containing Insulin............................    0910-AB43
1176         Progestational Drug Products for Human Use; Requirements for Labeling Directed to the
            Patient...............................................................................    0910-AB45
1177         Supplemental Manufacturing Changes for New Animal Drugs..............................    0910-AB49
1178         Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed................    0910-AB50
1179         Natural Rubber-Containing Drugs; User Labeling.......................................    0910-AB56
1180         Bulk Drug Substances for Use in Pharmacy Compounding.................................    0910-AB57
1181         Pharmacy Compounding; General Regulations............................................    0910-AB58
1182         Drug Products That Present Demonstrable Difficulties for Compounding Because of
            Reasons of Safety or Effectiveness....................................................    0910-AB59
1183         Manufacturing Changes for Drugs......................................................    0910-AB61
1184         Pediatric Studies of Drugs...........................................................    0910-AB62
1185         Positron Emission Tomography Drugs; Current Good Manufacturing Practices.............    0910-AB63
1186         Food Labeling: Trans Fatty Acids in Nutrition Labeling and Nutrient Content Claims...    0910-AB66
1187         Designated Journals..................................................................    0910-AB67
1188         Presubmission Conferences............................................................    0910-AB68
1189         Classification of Sheep as a Minor Species for All Data Collection Purposes..........    0910-AB69
1190         Implementation of the Import Tolerance Provisions of the Animal Drug Availability Act
            of 1996 and the Safe Level Provisions of the Animal Medicinal Drug Clarification Act
            of 1994...............................................................................    0910-AB71
1191         Mandatory HACCP Regulations for Manufacturers of Rendered Products...................    0910-AB72
1192         Surgeon's and Patient Examination Gloves; Reclassification; Restricted Devices.......    0910-AB74
1193         Current Good Manufacturing Practices for Blood and Blood Components: Notification of
            Consignees Receiving Blood and Blood Components at Increased Risk for Transmitting HCV
            Infection (Reg Plan Seq. No. 24)......................................................   0910-AB76
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.


[[Page 61683]]


                                 Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1194         New Animal Drug Approval Process; Implementation of Title I of the Generic Animal
            Drug and Patent Term Restoration Act (GADPTRA)........................................    0910-AA02
1195         Prescription Drug Marketing Act of 1987; Policy Information, Guidance, and
            Clarifications........................................................................    0910-AA08
1196         Biological Products: Reporting of Errors and Accidents in Manufacturing..............    0910-AA12
1197         Tamper-Evident Packaging Requirements for Over-the-Counter Human Drug Products.......    0910-AA26
1198         Prescription Drug Product Labeling; Medication Guide.................................    0910-AA37
1199         Fruit and Vegetable Juices: Development of HACCP and Label Warning Statements for
            Juices (Reg Plan Seq. No. 25).........................................................    0910-AA43
1200         Current Good Manufacturing Practice; Amendment of Certain Requirements for Finished
            Pharmaceuticals.......................................................................    0910-AA45
1201         Parenteral Drug Products Containing Aluminum as an Ingredient or Contaminant;
            Labeling Requirements; Warning Statement..............................................    0910-AA74
1202         New Drug Applications; Drug Master File..............................................    0910-AA78
1203         Over-the-Counter Human Drugs; Labeling Requirements (Reg Plan Seq. No. 26)...........    0910-AA79
1204         Investigational New Drug Applications; Clinical Holds for Drugs for Life-Threatening
            Illnesses.............................................................................    0910-AA84
1205         Sterility Requirements for Inhalation Solution Products..............................    0910-AA88
1206         Current Good Manufacturing Practice; Revision of Certain Labeling Controls...........    0910-AA98
1207         Establishment Registration and Listing of Human Cellular and Tissue-Based Products
            (Reg Plan Seq. No. 27)................................................................    0910-AB05
1208         Definition of Substantial Evidence...................................................    0910-AB08
1209         New Drugs for Human Use; Clarification of Requirements for Patent Holder Notification    0910-AB12
1210         Medicated Feed Mill Licenses.........................................................    0910-AB18
1211         Regulations Requiring Manufacturers To Assess the Safety and Effectiveness of New
            Drugs and Biological Products in Pediatric Patients...................................    0910-AB20
1212         Dissemination of Treatment Information on Unapproved Uses for Marketed Drugs and
            Devices (Reg Plan Seq. No. 28)........................................................    0910-AB23
1213         Biological Products Regulated Under Section 351 of the Public Health Service Act;
            Implementation of Biologics License; Elimination of Establishment License and Product
            License...............................................................................    0910-AB29
1214         Revocation of Antibiotic Certification Requirements; Conforming Revisions to
            Regulations...........................................................................    0910-AB32
1215         Clinical Hold; Streamlining Clinical Research........................................    0910-AB41
1216         Revisions to the General Safety Requirements for Biological Products; Direct Final
            Rule..................................................................................    0910-AB51
1217         Radiopharmaceuticals Used for In Vivo Diagnosis and Monitoring.......................    0910-AB52
1218         Medical Devices; IDE Modifications...................................................    0910-AB53
1219         Dispute Resolution...................................................................    0910-AB54
1220         Effective Date of Approval of an Abbreviated New Drug Application....................    0910-AB64
1221         Mutual Recog. of Pharmaceutical Good Manufacturing Inspection Rpts., Med. Device
            Quality Sys. Audit Rpts., and Certain Medical Device Product Eval. Rpts.; the U.S. and
            the European Community................................................................   0910-AB75
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.


                                 Food and Drug Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1222         Infant Formula: Good Manufacturing Practice, Quality Control Procedures, Quality
            Factors, Notification Requirements, and Records and Reports...........................    0910-AA04
1223         Food Labeling Review.................................................................    0910-AA19
1224         Medical Foods........................................................................    0910-AA20
1225         Amalgam Ingredient Labeling..........................................................    0910-AA33
1226         Classification of Computer Software Programs That Are Medical Devices................    0910-AA41
1227         Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution...    0910-AA49
1228         Reinventing FDA Food Regulations.....................................................    0910-AA58
1229         Dietary Supplement Regulations in Response to DSHEA..................................    0910-AA59
1230         Long-Term Contraceptive Drug Products and Medical Devices; Informed Consent
            Requirements..........................................................................    0910-AA75
1231         Debarment Certification Regulations for Drug Applications............................    0910-AA76
1232         Investigational New Drug Applications; Request for Information and Comments..........    0910-AA83
1233         Investigational Use New Animal Drug Regulations......................................    0910-AB02
1234         Administrative Practices and Procedures; Advisory Opinions and Guidelines............    0910-AB14
1235         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

[[Page 61684]]

 
1236         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
1237         Current Good Manufacturing Practice for Medicated Feeds..............................    0910-AB70
1238         Citizen Petitions; Actions That Can Be Requested by Petition; Summary Denial; and
            Referral for Other Administrative Action..............................................    0910-AB73
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1239         Fees for Certification Services; Insulin and Color Additive Certification Programs...    0910-AA07
1240         Reinvention of Administrative Procedures Regulations.................................    0910-AA69
1241         Use of Ozone-Depleting Substances in Aerosol Products or Other Pressurized Dispensers    0910-AB10
1242         Revocation of Lather Brushes Regulation..............................................    0910-AB25
1243         Removal of Regulations Regarding Certification of Antibiotic Drugs...................    0910-AB31
1244         Removal of Regulations Regarding Certification of Drugs Composed Wholly or Partly of
            Insulin...............................................................................    0910-AB38
1245         Natural Rubber Containing Medical Devices; User Labeling.............................    0910-AB65
----------------------------------------------------------------------------------------------------------------


                        Health Resources and Services Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1246         National Practitioner Data Bank for Adverse Information on Physicians and Other
            Health Care Practitioners: Corporate Shield...........................................    0906-AA41
1247         National Practitioner Data Bank for Adverse Information on Physicians and Other
            Health Care Practitioners: Reporting Adverse and Negative Actions.....................    0906-AA43
1248         Designation of Medically Underserved Populations and Health Professional Shortage
            Areas.................................................................................    0906-AA44
1249         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--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1250         Organ Procurement and Transplantation Network Rules..................................    0906-AA32
1251         Drug Pricing Program: Prime Vendor User Charge.......................................    0906-AA45
1252         Health Care Fraud and Abuse Data Collection Program..................................    0906-AA46
1253         National Vaccine Injury Compensation Program: Effective Date Provisions of Coverage
            of Certain Vaccines to the Vaccine Injury Table.......................................    0906-AA49
----------------------------------------------------------------------------------------------------------------


                                   Indian Health Service--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1254         Indian Child Protection and Family Violence Prevention Act Minimum Standards of
            Character.............................................................................    0917-AA02
----------------------------------------------------------------------------------------------------------------


[[Page 61685]]


                                     Indian Health Service--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1255         Currently Effective Indian Health Service Eligibility Regulations....................    0917-AA03
----------------------------------------------------------------------------------------------------------------


                                    Indian Health Service--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1256         Acquisition Under the Buy Indian Act.................................................    0917-AA00
----------------------------------------------------------------------------------------------------------------


                               National Institutes of Health--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1257         National Institutes of Health AIDS Research Loan Repayment Program...................    0925-AA02
1258         Undergraduate Scholarship Program Regarding Professions Needed by the NIH............    0925-AA10
1259         Traineeships.........................................................................    0925-AA11
1260         Additional DHHS Protections for Pregnant Women and Human Fetuses Involved as Subjects
            in Research, and Pertaining to Human In Vitro Fertilization...........................    0925-AA14
1261         National Research Service Awards.....................................................    0925-AA16
1262         Removal of National Cancer Institute Clinical Cancer Education Program...............    0925-AA17
1263         National Institutes of Health Loan Repayment Program for Research....................    0925-AA18
1264         National Institute of Child Health and Human Development Contraception and
            Infertility Research Loan Repayment Program...........................................    0925-AA19
----------------------------------------------------------------------------------------------------------------


                                 National Institutes of Health--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1265         National Institutes of Health Construction Grants....................................    0925-AA04
1266         National Institutes of Health Clinical Research Loan Repayment Program for
            Individuals From Disadvantaged Backgrounds............................................    0925-AA09
1267         Scientific Peer Review of Research Grant Applications and Research and Development
            Contract Projects.....................................................................    0925-AA20
1268         Federal Policy (Common Rule) for the Protection of Human Subjects....................    0925-AA21
1269         Service Fellowships..................................................................    0925-AA22
----------------------------------------------------------------------------------------------------------------


                           Office of Assistant Secretary for Health--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1270         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
----------------------------------------------------------------------------------------------------------------
1271         Public Health Service Standards for the Protection of Research Misconduct
            Whistleblowers........................................................................    0905-AE71
----------------------------------------------------------------------------------------------------------------


[[Page 61686]]


                               Health Care Financing Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1272         Prospective Fee Schedule for Ambulance Services (HCFA-1002-NR).......................    0938-AI72
----------------------------------------------------------------------------------------------------------------


                            Health Care Financing Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1273         Medicaid: Optional Coverage of TB-Related Services for Individuals Infected With
            Tuberculosis (HCFA-2082-P)............................................................    0938-AG72
1274         Liability for Third Parties To Pay for Care and Services (MB-080-P)..................    0938-AH01
1275         Medicare Coverage of Heart, Liver, and Lung Transplantation (HCFA-3835-PN)...........    0938-AH17
1276         Medicare Coverage of Services of Speech-Language Pathologists and Audiologists (HCFA-
            1843-P)...............................................................................    0938-AH37
1277         Supplier Participation Agreements and Limits on Actual Charges of Nonparticipating
            Physicians (HCFA-1862-P)..............................................................    0938-AH50
1278         Medicare Technical Conforming Amendments (HCFA-1858-FC)..............................    0938-AH67
1279         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
1280         Disclosure of Peer Review Organization Information in Response to Beneficiary
            Complaints (HCFA-3241-P)..............................................................    0938-AH85
1281         Medicaid Program; Amendment to the Preadmission Screening and Annual Resident Review
            Program (HCFA-2107-P).................................................................    0938-AH89
1282         Medicare and Medicaid Programs; Quarterly Listing of Program Issuances and Coverage
            Decissions--Second Quarter, 1998......................................................    0938-AI13
1283         Medicare Program; Prospective Payment System for Hospital Outpatient (HCFA-1005-P)
            (Reg Plan Seq. No. 29)................................................................    0938-AI56
1284         Medicaid Managed Care; Regulatory Program to Implement Certain Medicaid Provisions of
            the Balanced Budget Act of 1997 (HCFA-2001-P) (Reg Plan Seq. No. 30)..................    0938-AI70
1285         Coverage of Religious Non-Medical Health Care Institutions (HCFA-1909-IFC)...........    0938-AI93
1286         Expanded Coverage for Diabetes Outpatient Self-Management Training Services HCFA-3002-
            P (Reg Plan Seq. No. 31)..............................................................   0938-AI96
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.


                             Health Care Financing Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1287         Deduction of Incurred Medical Expenses (Spenddown) (HCFA-2020-F).....................    0938-AB07
1288         Participation in CHAMPUS and CHAMPVA, Hospital Admissions for Veterans, Discharge
            Rights Notice, and Hospital Responsibility for Emergency Care (HCFA-1393-IFC).........    0938-AC58
1289         Medicare Secondary Payer for Disabled Individuals (HCFA-1482-F)......................    0938-AD73
1290         Omnibus Nursing Home Reform Requirements (HCFA-3488-F)...............................    0938-AD81
1291         Revisions to Regulations Implementing CLIA (HCFA-2226-F).............................    0938-AE47
1292         Coverage of Screening Pap Smears (BPD-705-F).........................................    0938-AE98
1293         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
1294         Medicaid Payment for Covered Outpatient Drugs Under Rebate Agreements (HCFA-2046-FC).    0938-AF42
1295         Retroactive Enrollment and Disenrollment in Risk Health Maintenance Organizations and
            Competitive Medical Plans (HCFA-1015-F)...............................................    0938-AF98
1296         Payment for Preadmission Services (HCFA-1731-F)......................................    0938-AG00
1297         Revised Medicaid Management Information Systems (HCFA-2038-FN).......................    0938-AG10
1298         Description of HCFA's Evaluation Methodology for the Peer Review Organizations Fifth
            Scope of Work Contracts (HCFA-3207-N).................................................    0938-AG32
1299         Medicare Program: Limitations on Medicare Coverage of Intermittent Positive Pressure
            Breathing Machine Therapy (HCFA-3781-FN)..............................................    0938-AG44
1300         Request for Assessment on the Salitron System for the Treatment of Xerostomia
            Secondary to Sjogren's Syndrome (HCFA-3782-NC)........................................    0938-AG45
1301         Telephone Requests for Review of Part B Initial Claim Determinations (HCFA-4121-F)...    0938-AG48
1302         Clinical Laboratory Improvement Amendment (CLIA) Fee Schedule Revision (HCFA-3219-
            GNC)..................................................................................    0938-AG87
1303         CLIA Program: Categorization of Waived Tests (HCFA-2225-FC)..........................    0938-AG99
1304         Ambulance Services (HCFA-1813-F).....................................................    0938-AH13

[[Page 61687]]

 
1305         Criteria and Procedures for Extending Coverage to Certain Devices and Related
            Services (HCFA-3841-F)................................................................    0938-AH21
1306         CLIA Program: Cytology Proficiency Testing (HCFA-2233-N).............................    0938-AH35
1307         Requirements for Enrollment of Medicaid Recipients Under Cost Effective Employer-
            Based Group Health Plans (HCFA-2047-FC)...............................................    0938-AH48
1308         Terms, Definitions, and Addresses: Technical Amendments (HCFA-9877-FC)...............    0938-AH53
1309         Changes to the Hospital Inpatient Prospective Payment System and Fiscal Year 1998
            Rates (HCFA-1878-F)...................................................................    0938-AH55
1310         Utilization Control and Discontinued Review Activities; Medicaid (MB-101-FC).........    0938-AH64
1311         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
1312         Medicaid Program; Redeterminations of Medicaid Eligibility Due to Welfare Reform
            (HCFA-2105-IFC).......................................................................    0938-AH76
1313         Medicare Program; Beneficiary Incentives Programs (HCFA-6144-FC11)...................    0938-AH86
1314         Allocation of Enhanced Federal Matching Funds for Increased Administrative Costs (MB-
            103-N)................................................................................    0938-AH90
1315         Medically Needy Determinations Under Welfare Reform (HCFA-2109-IFC)..................    0938-AH92
1316         Final Limitations on Aggregate Payments to Disproportionate Share Hospitals: Federal
            Fiscal Year 1998 (HCFA-2110-N)........................................................    0938-AH93
1317         Revision to the Definition of an Unemployed Parent (HCFA-2106-FC)....................    0938-AH98
1318         National Standard Health Care Provider Identifier (HCFA-0045-F)......................    0938-AH99
1319         Health Insurance Reform: Parity in the Application of Certain Limits to Mental Health
            Benefits (HCFA-2891-IFC)..............................................................    0938-AI05
1320         Portability and Nondiscrimination in the Group Health Insurance Market (HCFA-2890-F).    0938-AI08
1321         Part A Premium for 1998 for the Uninsured Aged and for Certain Disabled Individuals
            Who Have Exhausted Other Entitlement (HCFA-5056-N)....................................    0938-AI10
1322         Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance
            Amounts for 1998 (HCFA-5057-N)........................................................    0938-AI12
1323         Medicaid Program: Charges for Vaccine Administration Under the Vaccines for Children
            (VCF) Program (HCFA-2084-FNC).........................................................    0938-AI20
1324         GME: Incentive Payments Under Plans for Voluntary Reduction in Number of Residents
            (HCFA-1001-IFC).......................................................................    0938-AI27
1325         Medicare+Choice Program; Regulatory Program to Implement Certain Medicare Provisions
            of the Balanced Budget Act of 1997 (HCFA-1030-F)......................................    0938-AI29
1326         Collection of User Fees From Medicare+Choice Plans and Risk-Sharing Contractors (HCFA-
            1911-IFC).............................................................................    0938-AI35
1327         Medicare Program: Payments for Teleconsultations in Rural Health Professional
            Shortage Areas (HCFA-1906-F)..........................................................    0938-AI44
1328         Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule for
            Calendar Year 1999 (HCFA-1006-FC) (HCFA-1006-P) (Reg Plan Seq. No. 32)................    0938-AI52
1329         Standards for Electronic Transactions (HCFA-0149-F)..................................    0938-AI58
1330         National Standard Employer Identifier (HCFA-0047-F)..................................    0938-AI59
1331         Medicare Program; Definition of Provider-Sponsored Organization and Related
            Requirements (HCFA-1027-IFC)..........................................................    0938-AI60
1332         Medicare and Medicaid Programs; Surety Bond Requirements for Home Health Agencies
            (HCFA-1038-NC)........................................................................    0938-AI82
1333         Solvency Standards for Provider-Sponsored Organizations (HCFA-1011-IFC)..............    0938-AI83
1334         Schedule of Per-Beneficiary Limitations on Home Health Agency Costs for Cost
            Reporting Periods Beginning On or After October 1, 1997 (HCFA-1905-FC)................    0938-AI84
1335         HHS' Recognition of NAIC Model Standards for Regulation of Medigap Policy (HCFA-2025-
            N)....................................................................................    0938-AJ07
1336         Reporting Outcome and Assessment Information Set (OASIS) Data as Part of the
            Conditions of Participation for Home Health Agencies (HCFA-3006-IFC)..................    0938-AJ10
1337         Request for Public Comments on Implementation of Risk Adjusted Payment for the
            Medicare+Choice Program and Notice of Public Meeting..................................    0938-AJ16
1338         Home Health Prospective Payment System (HCFA-1102-FC) (Reg Plan Seq. No. 33).........   0938-AJ24
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.


                             Health Care Financing Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1339         Payment for Clinical Diagnostic Laboratory Tests (HCFA-1309-F).......................    0938-AB50
1340         Criteria and Procedures for Developing Medical Services Coverage Policy (HCFA-3546-F)    0938-AD07
1341         Changes to Peer Review Organization Regulations (HCFA-3135-F)........................    0938-AD38
1342         ``Without Fault'' and Beneficiary Waiver of Recovery As It Applies to Medicare
            Overpayment Liability (HCFA-1719-P)...................................................    0938-AD95
1343         Protection of Income and Resources for Community Spouses of Institutionalized
            Individuals (HCFA-2023-P).............................................................    0938-AE12

[[Page 61688]]

 
1344         Survey Requirements and Alternative Sanctions for Home Health Agencies (HCFA-2169-F).    0938-AE39
1345         Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Services (MB-28-F)...    0938-AE72
1346         Payment for Nursing and Allied Health Science Education (HCFA-1685-F)................    0938-AE79
1347         Changes to the Long-Term Care Facility Survey Process (HCFA-3175-FC).................    0938-AF02
1348         Case Management (HCFA-2027-F)........................................................    0938-AF07
1349         Requirements for Certain Health Insuring Organizations and OBRA '90 Technical
            Amendments (HCFA-1018-F)..............................................................    0938-AF15
1350         Provider Reimbursement Determinations and Appeals (HCFA-1727-P)......................    0938-AF28
1351         Alternative Sanctions for Psychiatric Hospitals (HCFA-2191-P)........................    0938-AF32
1352         Referral to Child Support Enforcement Agencies of Medicaid Families (HCFA-2051-F)....    0938-AF68
1353         Medicaid: Outstationed Intake Locations for Certain Low-Income Pregnant Women,
            Infants, and Children Under Age 19 (HCFA-2052-F)......................................    0938-AF69
1354         Assessing Interest Against Medicare Secondary Payer (MSP) Debts (HCFA-6108-P)........    0938-AF87
1355         Revisions to Rules on Health Care Prepayment Plans (HCFA-1016-P).....................    0938-AF97
1356         Rural Health Clinics: Amendments to Participation Requirements and Payment Provisions
            and Establishment of a Quality Assessment and Performance Improvement Program (HCFA-
            1910-P)...............................................................................    0938-AG05
1357         Alternative Sanctions for Renal Dialysis Facilities (HCFA-3204-P)....................    0938-AG31
1358         Disclosure of Confidential PRO and ESRD Network Organization Information for Research
            Purposes (HCFA-3208-P)................................................................    0938-AG33
1359         Effect of Change of Ownership on Provider and Supplier Penalties, Sanctions,
            Underpayments and Overpayments (HCFA-2215-P)..........................................    0938-AG59
1360         Revision of Medicare/Medicaid Hospital Conditions of Participation (HCFA-3745-F).....    0938-AG79
1361         Physicians' Referrals to Health Care Entities With Which They Have Financial
            Relationships--Expanded to Designated Health Services (HCFA-1809-F)...................    0938-AG80
1362         Home Health Agency (HHA) Conditions of Participation (HCFA-3819-F)...................    0938-AG81
1363         End Stage Renal Disease (ESRD) Conditions for Coverage (HCFA-3818-P).................    0938-AG82
1364         Distinct Part Requirements for Nursing Homes and Prohibition of Financial Screening
            of Applicants for Nursing Home Admission (HCFA-3815-P)................................    0938-AG84
1365         Categorization and Certification Requirements for a New Subcategory of Moderate
            Complexity Testing (HCFA-2222-F)......................................................    0938-AG98
1366         Adjustment in Payment Amounts for New Technology Intraocular Lenses (HCFA-3831-F)....    0938-AH15
1367         Definition of Skilled Nursing Facility (SNF) for Coverage of Durable Medical
            Equipment (DME) and Home Health (HCFA-1834-P).........................................    0938-AH16
1368         Additional Supplier Standards (HCFA-1864-F)..........................................    0938-AH19
1369         Delegation of Civil Money Penalties (HCFA-6135-FC)...................................    0938-AH22
1370         State Plan Amendment (SPA) Reconsideration Process (HCFA-2096-P).....................    0938-AH24
1371         Hospice Care--Conditions of Participation (HCFA-3844-P)..............................    0938-AH27
1372         Payment Amount if Customary Charges Are Less Than Reasonable Costs (HCFA-1860-FC)....    0938-AH49
1373         Limitations on Liability (HCFA-4859-FC)..............................................    0938-AH51
1374         Medicare Secondary Payer Clarifications and Amendments (HCFA-1865-P).................    0938-AH52
1375         Conditions for Certification of Community Mental Health Centers and Coverage
            Requirements for Partial Hospitalization Services (HCFA-1871-P).......................    0938-AH58
1376         Revision to Accrual Basis of Accounting Policy (HCFA-1876-P).........................    0938-AH61
1377         Medicaid; Estate Recoveries (HCFA-2083-P)............................................    0938-AH63
1378         Medicaid Hospice Care (HCFA-2016-P)..................................................    0938-AH65
1379         Provider and Supplier Billing When Medicare Is Secondary Payor to Liability Insurance
            (HCFA-1848-P).........................................................................    0938-AH66
1380         Determination of Substandard Care in SNFs and NFs (HCFA-2240-P)......................    0938-AH69
1381         Waiver of Staffing Requirements for End Stage Renal Disease (ESRD) Facilities
            Participating in an Experiment (HCFA-2236-GNC)........................................    0938-AH72
1382         Provider and Supplier Enrollment Periodic Renewal of Eligibility Requirements (HCFA-
            1023-P)...............................................................................    0938-AH73
1383         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
1384         Revisions to Conditions for Coverage for Ambulatory Surgical Centers (HCFA-3887-P)...    0938-AH83
1385         National Standard for Identifiers of Health Plans (HCFA-4145-P)......................    0938-AH87
1386         Medicaid Program; Coverage and Payment for Federally Qualified Health Center Services
            (HCFA-2043-P).........................................................................    0938-AH95
1387         Medicare Coverage of Certified Nurse-Midwife Services (HCFA-1496-P)..................    0938-AH96
1388         Medicare Program; Medicare Integrity Program (HCFA-7020-F)...........................    0938-AI09
1389         Medicare Program; Improvements to the Appeals Process for Medicare Beneficiaries
            Enrolled in HMOs, CMPs, and HCPPs (HCFA-4024-P).......................................    0938-AI11

[[Page 61689]]

 
1390         Medicare Program; Physician Fee Schedule Conversion Factor for Calendar Year 1998 and
            Sustainable Growth Rate for Fiscal Year 1998 (HCFA-1893-FN)...........................    0938-AI16
1391         Health Insurance Portability: Newborns' and Mothers' Health Protection (HCFA-2892-
            IFC)..................................................................................    0938-AI17
1392         Medicaid: Medical Child Support (HCFA-2081-P)........................................    0938-AI21
1393         Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 1999
            Rates (HCFA-1003-P)...................................................................    0938-AI22
1394         Medicare Program; Notice for the Solicitation for Proposals for a Case Management
            Demonstration Project Focused on Congestive Heart Failure or Diabetes Mellitus (HCFA-
            1104-N)...............................................................................    0938-AI26
1395         Children's Health Insurance: Program Implementations; State Plan Approval; State
            Payment; Coordination With State Medicaid Program (HCFA-2006-P).......................    0938-AI28
1396         Medicare Program: Physicians' Referrals; Issuance of Advisory Opinions (HCFA-1902-F).    0938-AI38
1397         Medicaid Program; State Allotments for Payment of Medicare Part B Premiums for
            Qualified Individuals: Federal Fiscal Year 1998 (HCFA-2005-NC)........................    0938-AI39
1398         Medicare Program: User Fees (HCFA-6021-P)............................................    0938-AI46
1399         Medicare Program; Prospective Payment System and Consolidated Billing for Skilled
            Nursing Facilities. (HCFA-1913-IFC)...................................................    0938-AI47
1400         Surety Bond Requirements for Comprehensive Outpatient Rehab. Facilities, Rehab.
            Agencies, Community Mental Health Centers, and Independent Diagnostic Testing
            Facilities (HCFA-1026-P)..............................................................    0938-AI48
1401         Appeals of Carrier Determination That a Supplier Fails To Meet the Requirements for
            Medicare Billing Privileges (HCFA-1907-FC)............................................    0938-AI49
1402         Review and Payment for Claims Filed on Behalf of Medicare/Medicaid Dually Eligible
            Beneficiaries (HCFA-2097-3)...........................................................    0938-AI50
1403         Security and Electronic Signature Standards (HCFA-0049-P)............................    0938-AI57
1404         State Plan Requirements for Durable Medical Equipment Providers (HCFA-2007-P)........    0938-AI63
1405         Child Health Insurance Allotments FY 1999 (HCFA-2014-N)..............................    0938-AI64
1406         State Children's Health Insurance Program Allotments and Payments to States (HCFA-
            2114-FC)..............................................................................    0938-AI65
1407         DSH Payments - Institution for Mental Disease (HCFA-2012-N)..........................    0938-AI66
1408         Medicaid Program; Home and Community-Based Services (HCFA-2010-FC)...................    0938-AI67
1409         Recognition of the Community Health Accreditation Program, Inc. (CHAP) and Joint
            Commission for Accreditation of Healthcare Organizations (JCAHO) for Hospices (HCFA-
            2029-PN)..............................................................................    0938-AI69
1410         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
1411         Elimination of Application of Federal Financial Participation Limits (HCFA-2111-IFC).    0938-AI73
1412         Medicaid Program; Changes to Eligibility of Non-U.S. Citizens (HCFA-2108-P)..........    0938-AI74
1413         Medicare Program; Advance Refunding of Debt and Methodology for Repayment of Loan
            (HCFA-1777-P).........................................................................    0938-AI75
1414         Medicare Program; Advertising Costs (HCFA-1880-P)....................................    0938-AI76
1415         Medicare Hospice Care (HCFA-1022-P)..................................................    0938-AI77
1416         State Allotments for Additional Federal Funding of Emergency Health Services
            Furnished to Undocumented Aliens: Federal Fiscal Years 1998 Through (HCFA-2001-N).....    0938-AI78
1417         Medicaid Program; Extension of Waiver To Extend Medicaid Eligibility Timeframes (HCFA-
            2009-N)...............................................................................    0938-AI79
1418         Revision of Procedures for Requesting Exceptions to Cost Limits for SNFs and
            Elimination of Reclassifications (HCFA-1883-P)........................................    0938-AI80
1419         Expanded Coverage of Blood Glucose Monitors and Test Strips (HCFA-3003-IFC)..........    0938-AI85
1420         Hospice Wage Index Notice (HCFA-1039-N)..............................................    0938-AI87
1421         Medicare Program; Standardization of Medicare Coverage for Bone Mass Measurements
            (HCFA-3004-IFC).......................................................................    0938-AI89
1422         Recognition of the American Association for Accreditation of Ambulatory Surgery
            Facilities Inc., for Ambulatory Surgical Centers Program (HCFA-2008-PN)...............    0938-AI90
1423         Health Insurance Reform Universal Health Care Identifier (HCFA-0048-NOI).............    0938-AI91
1424         Coverage and Administrative Policies for Clinical Diagnostic Laboratory Tests; Intent
            To Form Negotiated Rulemaking Committee (HCFA-3250-NOI)...............................    0938-AI92
1425         Medicaid, Medicare CLIA Program; Extension of Certain Effective Dates for Clinical
            Laboratory Requirements Under CLIA (HCFA 2024-IFC)....................................    0938-AI94
1426         Hospital Conditions of Participation, Identification of Potential Organ, Tissue, and
            Eye Donor and Transplant Hospitals Provisions of Transplant Related Data (HCFA-3005-F)    0938-AI95
1427         Medicare Program; Monthly Actuarial Rates and Monthly Supplementary Medical Insurance
            Premium Rate Beginning January 1, 1999 (HCFA-8003-N)..................................    0938-AI98
1428         Peer Review Organization Contracts: Solicitation of Statements of Interest From In-
            State Organizations (HCFA-3009-N).....................................................    0938-AI99
1429         Replacement of Reasonable Charge Methodology by Fee Schedules (HCFA-1010-P)..........    0938-AJ00
1430         Notice Announcing Revised Positron Emission Tomography (PET) Policy (HCFA-3008-NC)...    0938-AJ01

[[Page 61690]]

 
1431         Medicare Program; Inpatient Hospital Deductible and Hospital and Extended Care
            Services Coinsurance Amounts for 1999 (HCFA-8001-N)...................................    0938-AJ02
1432         Medicare Program; Part A Premium for 1999 for the Uninsured Aged and for Certain
            Disabled Individuals Who Have Exhausted Other Entitlement (HCFA-8000-N)...............    0938-AJ03
1433         Inpatient Psychiatric Services Benefit for Individuals Under Age 21 (HCFA-2060-F)....    0938-AJ05
1434         External Quality Review of Medicaid Managed Care Organizations (HCFA-2015-P).........    0938-AJ06
1435         Physician Sustainable Growth Rate of Increase for FY 1999 (HCFA-1021-FN).............    0938-AJ09
1436         Comprehensive Assessment and Use of OASIS as Part of Conditions of Participation for
            Home Health Agencies (HCFA-3007-F)....................................................    0938-AJ11
1437         Medicare and Medicaid Programs; Quarterly Listing of Program Issuances--First Quarter
            1998 (HCFA-9879-NC)...................................................................    0938-AJ12
1438         Medicare Program; Criteria and Standards for Evaluating Intermediary and Carrier
            Performance: Millennium Compliance (HCFA-4002-GNC)....................................    0938-AJ15
1439         Rural Health Clinics: Amendments to Participation Requirements and Payment
            Provisions, and Establishment of a Quality Assessment and Improvement Program (HCFA-
            1910-P)...............................................................................    0938-AJ17
1440         Adjustments to Payment Amount for Erythropoietin/Epoietin for End-Stage Renal Disease
            Patients (HCFA-1098-PN)...............................................................    0938-AJ18
1441         Recognition of the Commission for Accreditation of Rehabilitation Facilities (HCFA-
            2036-NC)..............................................................................    0938-AJ25
1442         Revised Reserved Allotments to States for Fiscal Year 1998 (HCFA-2037-N).............    0938-AJ26
----------------------------------------------------------------------------------------------------------------


                             Health Care Financing Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1443         Medicare Coverage of Outpatient Occupational Therapy Services (HCFA-1425-P)..........    0938-AD32
1444         Change in Provider Agreement Regulations Related to Federal Employee Health Benefits
            (HCFA-1748-F).........................................................................    0938-AG03
1445         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
1446         Medicare Program: Update of Ambulatory Surgical Center Payment Rates Effective for
            Services On or Before October 1, 1997 (HCFA-1897-N)...................................    0938-AI18
1447         Solvency Standards for Provider-Sponsored Organizations (HCFA-1011-IFC)..............    0938-AI25
1448         Medicare/Medicaid Program: Surety Bond Requirements for Home Health Agencies (HCFA-
            1152.2-F).............................................................................    0938-AI86
1449         Medicare and Medicaid Programs; Surety Bond Requirements for Home Health Agencies
            (HCFA-1152.2F)........................................................................    0938-AJ08
----------------------------------------------------------------------------------------------------------------


                          Administration for Children and Families--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1450         Title IV-E Foster Care Eligibility Reviews and Child and Family Services State Plan
            Reviews, MEPA Implementation, ASFA Implementation, and Basic State Grant Program......    0970-AA97
1451         Construction of Head Start Facilities................................................    0970-AB54
1452         Methodology for Determining Whether an Increase in a State's Child Poverty Rate Is
            the Result of the TANF Program........................................................    0970-AB65
1453         Bonus To Reward High Performance States Under the Temporary Assistance for Needy
            Families Block Grant..................................................................    0970-AB66
1454         Child Support Enforcement for Indian Tribes..........................................    0970-AB73
1455         Requirements for the Tribal Programs.................................................    0970-AB78
1456         Refugee Resettlement Program: Responding to TANF Replacing AFDC......................    0970-AB83
1457         Child Support Penalties and Incentives...............................................    0970-AB85
1458         Family Child Care Program Option for Head Start Programs.............................    0970-AB90
1459         Implementation of Remaining Provisions of the Adoption and Safe Families Act of 1997
            and Other Title IV-B/IV-E Regulatory Amendments, AFCARS Penalties, and CAPTA
            Amendments............................................................................    0970-AB94
1460         State Self Assessments of State Plan Requirements To Determine Compliance With
            Federal Regulations...................................................................    0970-AB96
----------------------------------------------------------------------------------------------------------------


[[Page 61691]]


                           Administration for Children and Families--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1461         Standards for Safe Transportation....................................................    0970-AB24
1462         Standards for Purchase of Facilities.................................................    0970-AB31
1463         State Law Concerning Paternity Establishment.........................................    0970-AB69
1464         Grants to States for Access and Visitation Programs..................................    0970-AB72
1465         Temporary Assistance for Needy Families (TANF) (Reg Plan Seq. No. 34)................    0970-AB77
1466         Bonus to Reward Decrease in Illegitimacy Ratio.......................................    0970-AB79
1467         Child Support Enforcement Program Omnibus Conforming Regulation......................    0970-AB81
1468         Case Closure.........................................................................    0970-AB82
1469         Head Start Appeal Timelines..........................................................    0970-AB87
1470         Welfare-to-Work Data Collection......................................................    0970-AB92
1471         National Medical Support Notice......................................................   0970-AB97
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.


                           Administration for Children and Families--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1472         Designation of Alternative Agency To Serve Indian Tribal Children....................    0970-AB52
1473         Quarterly Wage and Unemployment Compensation Claims Reporting to the National
            Directory of New Hires................................................................    0970-AB67
1474         Automated Data Processing Requirements/State Case Registry...........................    0970-AB70
1475         Automated Data Processing Funding Limitation.........................................    0970-AB71
1476         Child Care and Development Fund......................................................    0970-AB74
1477         Child Abuse and Neglect Prevention and Treatment.....................................    0970-AB86
1478         Title IV-E Training..................................................................    0970-AB89
----------------------------------------------------------------------------------------------------------------


                                  Administration on Aging--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                     Regulation
 Sequence                                           Title                                            Identifier
  Number                                                                                               Number
----------------------------------------------------------------------------------------------------------------
1479         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)
_______________________________________________________________________

1129. HEALTH CARE FRAUD AND ABUSE DATA COLLECTION PROGRAM

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1320a-7e

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                            11/00/98
NPRM Comment Period End         01/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Additional Information: Was previously 0906-AA46.

Agency Contact: Joel Jay Schaer, Regulations Officer, Department of 
Health and Human Services, Office of the Secretary, 330 Independence 
Avenue SW., Washington, DC 20201

[[Page 61692]]

Phone: 202 619-0089

RIN: 0991-AA98
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)    Final Rule Stage
Office of the Secretary (OS)
_______________________________________________________________________

1130. 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                    01/00/99

Regulatory Flexibility Analysis Required: No

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 (59 FR 37202, 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
_______________________________________________________________________

1131. 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              12/00/98

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1132. 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/25/98                    63 FR 14393
NPRM Comment Period End         05/26/98
Final Action                    02/00/99

Regulatory Flexibility Analysis Required: No

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

[[Page 61693]]

_______________________________________________________________________

1133. 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              12/00/98

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)   Long-Term Actions
Office of the Secretary (OS)
_______________________________________________________________________

1134. 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

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1135. CIVIL MONEY PENALTIES (CMPS) FOR CERTAIN PRACTICES RELATING TO 
MEDICARE SUPPLEMENTAL POLICIES

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR 1003

Legal Deadline: None

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

Regulatory Flexibility Analysis Required: 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
_______________________________________________________________________

1136. 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 1302; 42 USC 1395bbb; 42 USC 1395hh; 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,

[[Page 61694]]

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

Regulatory Flexibility Analysis Required: 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
_______________________________________________________________________

1137. 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 that fails to 
respond to a request for information about charges or prices, or 
knowingly provides 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

Regulatory Flexibility Analysis Required: 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
_______________________________________________________________________

1138. SENIOR BIOMEDICAL RESEARCH SERVICE

Priority:  Info./Admin./Other

Legal Authority:  42 USC 228

CFR Citation:  42 CFR 24

Legal Deadline: None

Abstract: This regulation would finalize, with any necessary amendments 
based upon comments received, the Interim Final Rule published 2/21/96, 
61 FR 6557, implements the Senior Biomedical Research 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 of 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 procedures 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

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal

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

RIN: 0991-AA82
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)   Completed Actions
Office of the Secretary (OS)
_______________________________________________________________________

1139. REVISED OIG EXCLUSION AUTHORITIES RESULTING FROM PUBLIC LAW 104-
191

Priority:  Substantive, Nonsignificant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/02/98                    63 FR 46676

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0991-AA87
_______________________________________________________________________

1140. 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.

CFR Citation:  42 CFR 1008

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/16/98                    63 FR 38311

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Joel Schaer
Phone: 202 619-0089

RIN: 0991-AA94

[[Page 61695]]

_______________________________________________________________________

1141. REVISED OIG SANCTION AUTHORITIES RESULTING FROM PUBLIC LAW 105-33

Priority:  Substantive, Nonsignificant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/02/98                    63 FR 46736
Final Action Effective          11/02/98

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0991-AA95
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)   Long-Term Actions
Substance Abuse and Mental Health Services Administration (SAMHSA)
_______________________________________________________________________

1142. 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

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Tribal

Additional Information: Previously reported under RIN 0905-AD98.

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
Jim Sayers, DSP, C SAT SAMHSA, Department of Health and Human Services, 
Substance Abuse and Mental Health Services Administration, 5515 
Security Lane, Suite 800, Rockville, MD 20852
Phone: 301 443-3820

RIN: 0930-AA01
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Departmental Management (HHSDM)
_______________________________________________________________________

1143. 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                     11/00/98
Final Action                    01/00/99

Regulatory Flexibility Analysis Required: No

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

[[Page 61696]]

_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Prerule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________

1144. 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          12/00/98

Regulatory Flexibility Analysis Required: 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-114), 7500 Standish Place, Rockville, MD 20855
Phone: 301 827-0135

RIN: 0910-AB07
_______________________________________________________________________

1145. 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                           10/00/98
ANPRM Comment Period End        01/00/99

Regulatory Flexibility Analysis Required: 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
_______________________________________________________________________

1146. 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                           02/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Joseph Griffin, 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-AB44
_______________________________________________________________________

1147.  DISCONTINUATION OF A LIFE-SAVING PRODUCT

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

Unfunded Mandates: Undetermined

Legal Authority:  PL 105-115, sec 131

CFR Citation:  21 CFR 314

Legal Deadline: None

Abstract: Section 131 of the Food and Drug Administration Modernization 
Act of 1997 (Pub. L. 105-115) added section 506C to the Food, Drug, and 
Cosmetic Act (21 USC 356C). This ANPR will request comments on issues 
related to the implementation of section 131, which requires that the 
sole manufacturer of certain life-saving drug products notify the 
Secretary of the discontinuance of the manufacture of the product at 
least six months prior to the discontinuance of the drug.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           02/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

[[Page 61697]]

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-AB60
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________

1148. 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.

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.) 05/00/99

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)

[[Page 61698]]

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

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 Warning)  NPRM 10/20/93 (58 FR 54224)

Aspirin (Heart Labeling)  Final Action 12/00/98

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)(Diphenhydramine) 08/29/97 (62 FR 
45767)  Final Action 06/00/99

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)(Diphenhydramine) 08/29/97 (62 FR 45767)  NPRM 
(Amendment)(Flammability) 07/20/98 (63 FR 38762)  Final Action 06/00/99

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)  NPRM 
(Amendment)(Ephedrine) 10/00/98

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 (Ephedrine Combo) 10/00/98  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 03/00/99

Emetic Products  ANPRM 03/21/75 (40 FR 12939)  NPRM 09/05/78 (43 FR 
39544)  Final Action 00/00/00

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)

First Aid Antiseptic  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

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)

[[Page 61699]]

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

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 
(Alcohol Warning) 10/00/98  Final Action (Aspirin Prof Label) 10/00/
98  Final Action (Sodium Bicarbonate) 05/00/99  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 (Sodium Labeling) 04/
25/91 (56 FR 19222)  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)  Final Action (Sodium Labeling) 
04/22/96 (61 FR 17798)  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) 12/00/98  Final Action (Ca/Mg/K/
Na) 06/00/99

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) 05/21/98 (63 FR 27836)  NPRM (Amendment)(Phosphates Label) 
05/21/98 (63 FR 27886)  NPRM (Amendment)(Stim. Laxative) 06/19/98 (63 
FR 33592)  Final Action (Phenophthalein) 11/00/98  Final Action 06/00/
99  Final Action (Stim. Laxative) 06/00/00

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)  Final Action 12/00/01

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

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

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

Nighttime Sleep Aid Products  ANPRM 12/08/75 (40 FR 57292)  NPRM 06/13/
78 (43 FR 25544)  Final Action 02/14/89 (54 FR 6814)  NPRM (Amendment) 
08/26/93 (58 FR 45217)  Final Action (Amendment) 04/11/94 (59 FR 
16982)  NPRM (Amendment) (Warning) 08/29/97 (62 FR 45767)  Final Action 
06/00/99

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)  NPRM (Plaque/Gingivitis) 06/00/99  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)

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)  NPRM (Labeling 
Amendment) 12/00/99

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) 
03/00/99  Final Action 06/00/99

Quinine for Malaria  NPRM 04/19/95 (60 FR 19650)  Final Action 03/20/98 
(63 FR 13526)

Reporting of Adverse Reactions  NPRM 06/00/99

Salicylate (Reye Syndrome)  NPRM (Amendment)(Warning) 05/05/93 (58 FR 
26886)  ANPRM 10/20/93 (58 FR 54228)  FINAL ACTION (Warning) 12/00/98

Skin Bleaching Products  ANPRM 11/03/78 (43 FR 51546)  NPRM 09/03/82 
(47 FR 39108)  NPRM (Reproposed) 06/00/99

[[Page 61700]]

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) 12/00/98  Final Action 12/00/98

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)

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 04/22/98 (63 FR 
19799)

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 05/00/99

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)  NPRM (Amendment) 12/00/99

Vaginal Drug Products  ANPRM 10/13/83 (48 FR 46694)  Withdrawal 02/03/
95 (60 FR 5226)  NPRM (Douches) 06/00/00

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

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1149. 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                            12/00/98

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1150. HEARING AIDS; PROFESSIONAL AND PATIENT LABELING; CONDITIONS FOR 
SALE

Regulatory Plan:  This entry is Seq. No. 22 in Part II of this issue of 
the Federal Register.

RIN: 0910-AA39
_______________________________________________________________________

1151. 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

[[Page 61701]]

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/98
NPRM Comment Period End         02/00/99

Regulatory Flexibility Analysis Required: 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
_______________________________________________________________________

1152. 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 257a; 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                            01/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

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

RIN: 0910-AA52
_______________________________________________________________________

1153. 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. In general, the proposed rule would 
provide 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) and is being exported for use in the investigation. 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 specified developed countries. The fourth 
route would permit exportation without an IND, to any country provided 
that the exporter sends a written certification to FDA at the time the 
drug is first exported. 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 the second or third routes would be subject to additional 
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                            12/00/98

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1154. 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

[[Page 61702]]

reactions, and permit access by FDA to adverse drug reaction records.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/99
NPRM Comment Period End         07/00/99

Regulatory Flexibility Analysis Required: 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
_______________________________________________________________________

1155. 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 permitted 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                            11/00/98

Regulatory Flexibility Analysis Required: No

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: 301 827-4450
Fax: 301 443-1863

RIN: 0910-AA89
_______________________________________________________________________

1156. 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                            05/00/99
NPRM Comment Period End         08/00/99

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1157. LABELING FOR HUMAN PRESCRIPTION DRUGS; REVISED FORMAT

Regulatory Plan:  This entry is Seq. No. 23 in Part II of this issue of 
the Federal Register.

RIN: 0910-AA94
_______________________________________________________________________

1158. 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                            02/00/99
NPRM Comment Period End         05/00/99

[[Page 61703]]

Regulatory Flexibility Analysis Required: 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
_______________________________________________________________________

1159. USE OF OZONE-DEPLETING SUBSTANCES

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 the regulation that permits the use 
of ozone-depleting substances in particular circumstances to set the 
standard FDA will use to determine when the use of ozone-depleting 
substances (ODS) is no longer essential under the Clean Air Act (CAA) 
and set a new standard to determine when a new essential-use 
designation should be granted after the effective date of the rule. 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 proposing to 
eliminate out-of-date transitional provisions and make other 
nonsubstantive housekeeping changes to its regulations on ozone-
depleting substances. The intended effect of the proposed rule is to 
protect the health and safety of medical device users while complying 
with the CAA and the Montreal Protocol.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           03/06/97                    62 FR 10242
ANPRM Comment Period End        05/05/97
NPRM                            04/00/99
NPRM Comment Period End         07/00/99

Regulatory Flexibility Analysis Required: 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
_______________________________________________________________________

1160. 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 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                            01/00/99
NPRM Comment Period End         04/00/99

Regulatory Flexibility Analysis Required: 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
_______________________________________________________________________

1161. VETERINARY FEED DIRECTIVES

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) 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

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: George Graber, Department of Health and Human Services, 
Food and Drug Administration, Center for Veterinary Medicine (HFV-220), 
7500 Standish Place, Rockville, MD 20855
Phone: 301 827-6651
Fax: 301 594-1812

RIN: 0910-AB09

[[Page 61704]]

_______________________________________________________________________

1162. 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                            12/00/98

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1163. 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 establishments engaged in the 
manufacture, preparation, propagation, compounding, or processing of 
such products that are imported or offered for import into the United 
States to register and to register the name of a United States agent 
for the foreign establishment.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/98

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

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
_______________________________________________________________________

1164. 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 final 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                            07/27/98                    63 FR 40069
NPRM Comment Period End         10/13/98
Final Rule                      04/00/99

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1165. 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,

[[Page 61705]]

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                            10/00/98

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1166. BLOOD INITIATIVE

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 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 by FDA. 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. Some of the subjects 
intended 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:

Definition for ``Analogous Products''  NPRM 03/00/99

Minor Changes to Reqs. for CGMP for Blood and Blood Components  Direct 
Final Rule 12/00/98

Notification of End Users of Plasma Derivative Products  ANPRM 01/00/99

Notification of Permanently Deferred Donors  NPRM 12/00/98

Reqs. Applicable to Albumin (Human), Plasma Protein Fraction  Direct 
Final Rule 12/00/98

Requirements for Donor Testing  NPRM 12/00/98

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

Viral Inactivation  NPRM 03/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Additional Information: See RIN 0910-AB76.

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
_______________________________________________________________________

1167. 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 211.1(b); 21 CFR 820.1(a)(1); 21 CFR 820.1(c); 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 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                            12/00/98

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Paula S. McKeever, Regulatory Policy Analyst, 
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

[[Page 61706]]

_______________________________________________________________________

1168. 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

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Paula S. McKeever, Regulatory Policy Analyst, 
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
_______________________________________________________________________

1169. 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 (SE), 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 Celsius (45 degrees Fahrenheit). 
USDA intends to finalize that requirement shortly. However, the USDA 
rulemaking does not include refrigeration at retail. As part of a 
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

________________________________________________________________________

NPRM                            03/00/99

Regulatory Flexibility Analysis Required: 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 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
_______________________________________________________________________

1170. 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:  21 CFR 314

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)(5)(D) of the Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/99
NPRM Comment Period End         05/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Wayne Mitchell, 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-AB33

[[Page 61707]]

_______________________________________________________________________

1171. APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG OR ANTIBIOTIC 
DRUG; COMPLETE RESPONSE 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 response letters.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/99
NPRM Comment Period End         04/00/99

Regulatory Flexibility Analysis Required: 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
_______________________________________________________________________

1172. 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:  21 CFR 312

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                            02/00/99
NPRM Comment Period End         05/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Joseph Griffin, 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-AB37
_______________________________________________________________________

1173. 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 proposed rule would 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 would 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

________________________________________________________________________

NPRM                            02/00/99
NPRM Comment Period End         05/00/99

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1174. 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, sec 127

CFR Citation:  21 CFR 216

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 practitioners.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/08/98                    63 FR 54082
NPRM Comment Period End         11/23/98

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Regulatory 
Policy

[[Page 61708]]

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
_______________________________________________________________________

1175. 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                            03/00/99
NPRM Comment Period End         06/00/99

Regulatory Flexibility Analysis Required: 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
_______________________________________________________________________

1176. 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                            12/00/98
NPRM Comment Period End         03/00/99

Regulatory Flexibility Analysis Required: Undetermined

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
_______________________________________________________________________

1177. SUPPLEMENTAL MANUFACTURING CHANGES FOR NEW ANIMAL DRUGS

Priority:  Other Significant

Legal Authority:  PL 105-115, sec 116

CFR Citation:  21 CFR 514.8

Legal Deadline:  Final, Statutory, November 21, 1999.

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 sets forth categories for the reporting of manufacturing 
changes to a drug product. These categories are based on the potential 
of the change to adversely affect the identity, strength, quality, 
purity, and potency of the drug as they may relate to the safety and 
effectiveness of the drug. The rulemaking will propose the procedures 
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

________________________________________________________________________

NPRM                            12/00/98

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: William Marnane, Department of Health and Human 
Services, Food and Drug Administration, Center for Veterinary Medicine 
(HFV-140), 7500 Standish Place, Rockville, MD 20855
Phone: 301 594-0678

RIN: 0910-AB49
_______________________________________________________________________

1178. 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.

[[Page 61709]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/99

Regulatory Flexibility Analysis Required: 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: 301 827-6652

RIN: 0910-AB50
_______________________________________________________________________

1179.  NATURAL RUBBER-CONTAINING DRUGS; USER LABELING

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 to 358; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 
379; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264

CFR Citation:  21 CFR 201

Legal Deadline: None

Abstract: This proposed rule specifies requirements for labeling 
statements on products regulated as drugs (including combination 
products regulated under drug labeling provisions) that contain natural 
rubber that contacts humans.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/99
NPRM Comment Period End         05/00/99

Regulatory Flexibility Analysis Required: 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-AB56
_______________________________________________________________________

1180.  BULK DRUG SUBSTANCES FOR USE IN PHARMACY COMPOUNDING

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

Unfunded Mandates: Undetermined

Legal Authority:  PL 105-115, sec 127

CFR Citation:  21 CFR 216

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 USC 353a). Section 503A governs the application of 
Federal law to the practice of pharmacy compounding. Section 
503A(b)(1)(A) directs FDA to issue by regulation a list of bulk drug 
substances that may be used in compounding that are not covered by a 
United States Pharmacopeia (USP) or National Formulary (NF) monograph 
and are not components of FDA-approved drugs. Bulk drug substances that 
do not appear on the list may not be used in compounding under section 
127 unless such substances are covered by a USP or NF monograph or are 
components of approved drugs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/98

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Richard Schwartzbard, 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-AB57
_______________________________________________________________________

1181.  PHARMACY COMPOUNDING; GENERAL REGULATIONS

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

Unfunded Mandates: Undetermined

Legal Authority:  PL 105-115, sec 127

CFR Citation:  21 CFR 216

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 USC 353A). Section 503A governs the application of 
Federal law to the practice of pharmacy compounding. This rule will 
propose regulations for the interpretation and enforcement of section 
503A. The proposed regulations will delineate the conditions under 
which compounding is exempt from the manufacturing, misbranding, and 
new drug provisions of the Food, Drug, and Cosmetic Act. The proposed 
regulations will also set forth other definitions and conditions for 
distinguishing legitimate pharmacy compounding from pharmaceutical drug 
manufacturing performed under the guise of compounding.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/99

Regulatory Flexibility Analysis Required: 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-AB58
_______________________________________________________________________

1182.  DRUG PRODUCTS THAT PRESENT DEMONSTRABLE DIFFICULTIES FOR 
COMPOUNDING BECAUSE OF REASONS OF SAFETY OR EFFECTIVENESS

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

Unfunded Mandates: Undetermined

Legal Authority:  PL 105-115, sec 127

CFR Citation:  21 CFR 216

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 USC 353a). Section 503A governs the application of 
Federal law to the practice of pharmacy compounding, and exempts

[[Page 61710]]

compounded drug products, under certain circumstances, from several key 
provisions of the Food, Drug, and Cosmetic Act. Section 503A(b)(3)(A) 
directs FDA to issue by regulation a list of drug products that, if 
compounded, will not qualify for these exemptions because their 
compounding would be demonstrably difficult in terms of assuring the 
safety or effectiveness of the compounded product.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Richard Schwartzbard, 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-AB59
_______________________________________________________________________

1183.  MANUFACTURING CHANGES FOR DRUGS

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

Unfunded Mandates: Undetermined

Legal Authority:  PL 105-115, sec 116

CFR Citation:  21 CFR 314

Legal Deadline:  Final, Statutory, November 21, 1999.

Abstract: Section 116 of the Food and Drug Administration Modernization 
Act of 1997 (Pub. L. 105-115) added section 506A to the Food, Drug, and 
Cosmetic Act (21 USC 356A). Pursuant to section 116, the rulemaking 
will propose to revise current procedures for approving manufacturing 
changes and generally classify such changes into three categories. 
Major manufacturing changes, which are of a type determined by the 
Secretary to have a substantial potential to adversely affect the 
identity, strength, quality, purity, and potency of the drug as they 
may relate to the safety and effectiveness of a drug, require prior 
approval of a supplemental application. Other changes may be made 
pending review of a supplemental application if FDA has not notified 
the company within 30 days after the submission of a supplement that 
prior approval is required. The proposed rule will also identify 
another category of changes that may be made without the submission of 
a supplement but which must be reported in an annual report.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/99

Regulatory Flexibility Analysis Required: 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-AB61
_______________________________________________________________________

1184.  PEDIATRIC STUDIES OF DRUGS

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

Unfunded Mandates: Undetermined

Legal Authority:  PL 105-115, sec 111

CFR Citation:  21 CFR 314

Legal Deadline: None

Abstract: Section 111 of the Food and Drug Administration Modernization 
Act of 1997 (Pub. L. 105-115) added section 505A to the Food, Drug, and 
Cosmetic Act (21 USC 355A). Section 505A permits certain applications 
to obtain an additional six months of marketing exclusivity if, in 
accordance with the requirements of the statute, the sponsor submits 
information relating to the use of the drug in the pediatric 
population. The proposed regulations would implement the pediatric 
exclusivity provisions of section 111. FDA is proposing to amend 21 CFR 
part 314 to add pediatric exclusivity to FDA's new drug product 
exclusivity regulations. FDA is also proposing to add new regulations 
describing the requirements an applicant must fulfill in order to 
qualify for pediatric exclusivity.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/99
NPRM Comment Period End         04/00/99

Regulatory Flexibility Analysis Required: 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-AB62
_______________________________________________________________________

1185.  POSITRON EMISSION TOMOGRAPHY DRUGS; CURRENT GOOD 
MANUFACTURING PRACTICES

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

Unfunded Mandates: Undetermined

Legal Authority:  PL 105-115, sec 121

CFR Citation:  21 CFR 220

Legal Deadline:  Final, Statutory, November 21, 1999.

Abstract: Section 121 of the Food and Drug Administration Modernization 
Act of 1997 (Pub. L. 105-115) directs FDA to establish requirements for 
current good manufacturing practices (CGMPs) for positron emission 
tomography (PET) drugs, a type of radiopharmaceutical. The proposed 
rule would adopt CGMPs that reflect the unique characteristics of PET 
drugs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/99

Regulatory Flexibility Analysis Required: 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

[[Page 61711]]

Fax: 301 827-5562

RIN: 0910-AB63
_______________________________________________________________________

1186.  FOOD LABELING: TRANS FATTY ACIDS IN NUTRITION LABELING 
AND NUTRIENT CONTENT CLAIMS

Priority:  Other Significant

Legal Authority:  21 USC 321; 21 USC 343; 21 USC 371

CFR Citation:  21 CFR 101

Legal Deadline: None

Abstract: Section 403(q) of the Federal Food, Drug, and Cosmetic Act, 
which was added by the Nutrition Labeling and Education Act of 1990, 
requires that the label or labeling of food products bear nutrition 
information. Among other things, section 403(q) authorizes the Food and 
Drug Administration (FDA) to add or delete nutrients that are to be 
declared on the labels or labeling of food products by regulation if it 
finds such action necessary to assist consumers in maintaining healthy 
dietary practices. In response to this section, FDA published a 
proposal on November 27, 1991 (56 FR 60366). Among other things, FDA 
discussed including trans fatty acids among the nutrients that could 
voluntarily be listed on the nutrition label but concluded that there 
was no basis for doing so. On January 6, 1993, FDA issued a final rule 
entitled ``Food Labeling: Mandatory Status of Nutrition Labeling and 
Nutrient Content Revision, Format for Nutrition Label'' (58 FR 2079) 
prescribing how nutrition labeling is to be provided on the food. Based 
on its review of the comments to the proposal, the agency stated that 
it was premature to consider the listing of trans fatty acids on the 
nutrition label because of a lack of consensus on the dietary 
implications of trans fatty acids intake. However, the agency 
acknowledged that it might be necessary to readdress the labeling of 
trans fatty acids in the future. FDA subsequently received a citizen 
petition requesting that FDA amend the definition of saturated fatty 
acid in section 101.9(c)(2)(i) to include trans fatty acid. In response 
to this petition and based on new evidence, FDA is proposing to amend 
its regulations to provide for the declaration of trans fatty acids in 
nutrition labeling, to add a requirement that prevents foods from 
bearing nutrient content claims for saturated fat (i.e., saturated 
fatty acids) and cholesterol if they contain trans fatty acids above a 
specified level, and to define a ``trans fatty acids free'' nutrient 
content claim.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/99

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: Susan Thompson, Chemist, Department of Health and Human 
Services, Food and Drug Administration, Center for Food Safety and 
Applied Nutrition, (HFS-165), 200 C Street SW., Washington, DC 20204
Phone: 202 205-5587
Fax: 202 205-5532
Email: [email protected]

RIN: 0910-AB66
_______________________________________________________________________

1187.  DESIGNATED JOURNALS

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 360b

CFR Citation:  21 CFR 510.95

Legal Deadline: None

Abstract: FDA intends to remove this rule. The current rule lists the 
veterinary and scientific journals available in FDA's library and 
allows sponsors to reference an article from a listed journal in 
applications rather than submitting a copy of the article. FDA is 
taking this action because the list of journals is outdated and is no 
longer being used by sponsors except on an extremely limited basis. 
Also, the application of this rule is not an efficient use of agency 
resources.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/98

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

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-AB67
_______________________________________________________________________

1188.  PRESUBMISSION CONFERENCES

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 360b

CFR Citation:  21 CFR 514

Legal Deadline: None

Abstract: This rule will implement section 512(b)(3) of the Federal 
Food, Drug, and Cosmetic Act (the act). This section of the act states 
that any person intending to file a new animal drug application or 
supplemental new animal drug application, or to investigate a new 
animal drug is entitled to one or more conferences with the agency 
prior to submission to reach an agreement establishing a submission or 
investigational requirement. This rule would describe how to request a 
presubmission conference and describe the procedures for the conduct of 
presubmission conferences.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

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-AB68
_______________________________________________________________________

1189.  CLASSIFICATION OF SHEEP AS A MINOR SPECIES FOR ALL DATA 
COLLECTION PURPOSES

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 360b

CFR Citation:  21 CFR 514.1

Legal Deadline: None

Abstract: This rule would amend 21 CFR 514.1(d) to state that sheep are 
minor species for all data collection purposes, thereby allowing 
extrapolation from major species data and limited studies to fulfill 
the human food safety data requirements for New Animal Drug 
Applications. Sheep were originally classified as major species for 
human food safety requirements based

[[Page 61712]]

upon certain expectations of consumption levels. However, over the 
years, domestic production of sheep for food has declined drastically.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Margaret Oeller, Veterinary Medical Officer, Department 
of Health and Human Services, Food and Drug Administration, Center for 
Veterinary Medicine (HFV-130), 7500 Standish Place, Rockville, MD 20855
Phone: 301 594-1650

RIN: 0910-AB69
_______________________________________________________________________

1190.  IMPLEMENTATION OF THE IMPORT TOLERANCE PROVISIONS OF THE 
ANIMAL DRUG AVAILABILITY ACT OF 1996 AND THE SAFE LEVEL PROVISIONS OF 
THE ANIMAL MEDICINAL DRUG CLARIFICATION ACT OF 1994

Priority:  Substantive, Nonsignificant

Unfunded Mandates: Undetermined

Legal Authority:  21 USC 360b

CFR Citation:  21 CFR 556

Legal Deadline: None

Abstract: Section 4 of the Animal Drug Availability Act of 1996 (Pub. 
L. 104-250) requires the establishment of tolerances for animal drugs 
used or intended for use in animals grown in an exporting nation from 
which an edible portion is imported into the United States. The 
standards used to establish tolerances are to be similar to the 
criteria used by the Secretary of HHS to establish tolerances for drugs 
administered to animals grown in the United States. The data used for 
establishing the tolerances may be from the manufacturer and include 
data upon which a foreign approval is based or data available to an 
international organization such as the Codex Alimentarius Commission. 
The Animal Medicinal Drug Clarification Act of 1994 (Pub. L. 103-396) 
allows the Secretary to establish a safe level for a residue of an 
animal drug when the drug is used in an extralabel manner, if there is 
a reasonable probability that an extralabel use may present a risk to 
the public health.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

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-AB71
_______________________________________________________________________

1191.  MANDATORY HACCP REGULATIONS FOR MANUFACTURERS OF RENDERED 
PRODUCTS

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

Unfunded Mandates: Undetermined

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

CFR Citation:  21 CFR 589

Legal Deadline: None

Abstract: During the notice and comment rulemaking for 21 CFR 589, 
``Listing of Specific Substances Prohibited from Use in Animal Food or 
Feed; Animal Proteins Prohibited in Ruminant Feed;'' FDA received 
several comments supporting the application of mandatory Hazard 
Analysis Critical Control Point (HACCP) regulations for renderers. Some 
of these comments were from renderers. Because of the need to expedite 
the rulemaking for 21 CFR 589, FDA stated that it would take up the 
HACCP regulations for renderers as a separate initiative. This 
rulemaking is to address the need expressed in the comments to 21 CFR 
589 by promulgating mandatory HACCP regulations for renderers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Daniel G. McChesney, Team Leader, Feed Safety Team, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Veterinary Medicine (HFV-222), 7500 Standish Place, 
Rockville, MD 20855
Phone: 301 827-6653

RIN: 0910-AB72
_______________________________________________________________________

1192.  SURGEON'S AND PATIENT EXAMINATION GLOVES; 
RECLASSIFICATION; RESTRICTED DEVICES

Priority:  Other Significant. 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 to 
352; 21 USC 355 to 357; 21 USC 360; 21 USC 360c; 21 USC 360e; 21 USC 
360i; 21 USC 360j to 360l; 21 USC 361 to 362; 21 USC 371; 21 USC 374

CFR Citation:  21 CFR 800.75; 21 CFR 801.440; 21 CFR 878.4460; 21 CFR 
878.4461; 21 CFR 880.6250; 21 CFR 880.6251

Legal Deadline: None

Abstract: FDA is considering revising its present regulations governing 
the classification of surgeon's and patient examination gloves. The 
present rule classifies surgeon's and patient examination gloves as 
class I devices. FDA is considering reclassifying surgeon's and patient 
examination gloves as class II devices subject to special controls and 
restricting the use of powdered surgeon's gloves and patient 
examination gloves. FDA is also considering requiring additional 
labeling concerning powder and protein levels for these devices.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/99

Regulatory Flexibility Analysis Required: 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: 301 594-4765

RIN: 0910-AB74

[[Page 61713]]

_______________________________________________________________________

1193.  CURRENT GOOD MANUFACTURING PRACTICES FOR BLOOD AND BLOOD 
COMPONENTS: NOTIFICATION OF CONSIGNEES RECEIVING BLOOD AND BLOOD 
COMPONENTS AT INCREASED RISK FOR TRANSMITTING HCV INFECTION

Regulatory Plan:  This entry is Seq. No. 24 in Part II of this issue of 
the Federal Register.

RIN: 0910-AB76
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)    Final Rule Stage
Food and Drug Administration (FDA)
_______________________________________________________________________

1194. 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 guidances 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

Regulatory Flexibility Analysis Required: Yes
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 Epidemiology 
and Surveillance, Center for Veterinary Medicine, Food and Drug 
Administration, 7500 Standish Place, Rockville, MD 20855, (301) 594-
6642. For further information concerning generic animal drugs, contact 
Lonnie W. Luther, Chief, Quality Assurance Support Team, Center for 
Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, 
Rockville, MD 20855, (301) 827-0209.

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
_______________________________________________________________________

1195. 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

[[Page 61714]]

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/14/94                    59 FR 11842
NPRM Comment Period End         08/01/94
Final Action                    12/00/98

Regulatory Flexibility Analysis Required: Yes
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
_______________________________________________________________________

1196. BIOLOGICAL PRODUCTS: REPORTING OF ERRORS AND ACCIDENTS IN 
MANUFACTURING

Priority:  Other Significant

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; provide 
FDA with a more accurate surveillance of the Nation's blood supply 
enabling FDA to monitor actions taken in response to the errors and 
accidents detected for all establishments involved in 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

Regulatory Flexibility Analysis Required: Yes
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
_______________________________________________________________________

1197. 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                    10/00/98

Regulatory Flexibility Analysis Required: Yes
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

[[Page 61715]]

_______________________________________________________________________

1198. 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 
five products annually) 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                    10/00/98

Regulatory Flexibility Analysis Required: Yes
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
_______________________________________________________________________

1199. FRUIT AND VEGETABLE JUICES: DEVELOPMENT OF HACCP AND LABEL WARNING 
STATEMENTS FOR JUICES

Regulatory Plan:  This entry is Seq. No. 25 in Part II of this issue of 
the Federal Register.

RIN: 0910-AA43
_______________________________________________________________________

1200. 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; 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                    05/00/99

Regulatory Flexibility Analysis Required: Yes
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
_______________________________________________________________________

1201. 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                    01/00/99

Regulatory Flexibility Analysis Required: 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

[[Page 61716]]

Rockville Pike, Suite 3047, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA74
_______________________________________________________________________

1202. 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                    11/00/98

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Thomas Kuchenburg, 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-AA78
_______________________________________________________________________

1203. OVER-THE-COUNTER HUMAN DRUGS; LABELING REQUIREMENTS

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

RIN: 0910-AA79
_______________________________________________________________________

1204. 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                    01/00/99

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

RIN: 0910-AA84
_______________________________________________________________________

1205. 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                    01/00/99

Regulatory Flexibility Analysis Required: 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
_______________________________________________________________________

1206. 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

[[Page 61717]]

NPRM Comment Period End         10/27/97
Final Action                    03/00/99

Regulatory Flexibility Analysis Required: 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
_______________________________________________________________________

1207. ESTABLISHMENT REGISTRATION AND LISTING OF HUMAN CELLULAR AND 
TISSUE-BASED PRODUCTS

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

RIN: 0910-AB05
_______________________________________________________________________

1208. 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 Animal Drug Availability Act (ADAA) requires FDA to issue 
within 24 months after the date of its enactment final 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

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1209. 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 final rule will 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                    03/00/99

Regulatory Flexibility Analysis Required: 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
_______________________________________________________________________

1210. 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 
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

Regulatory Flexibility Analysis Required: No

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

[[Page 61718]]

Phone: 301 827-6652

RIN: 0910-AB18
_______________________________________________________________________

1211. 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/15/97                    62 FR 43899
NPRM Comment Period End         11/13/97
Final Action                    12/00/98

Regulatory Flexibility Analysis Required: Yes
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: [email protected]

RIN: 0910-AB20
_______________________________________________________________________

1212. DISSEMINATION OF TREATMENT INFORMATION ON UNAPPROVED USES FOR 
MARKETED DRUGS AND DEVICES

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

RIN: 0910-AB23
_______________________________________________________________________

1213. BIOLOGICAL PRODUCTS REGULATED UNDER SECTION 351 OF THE PUBLIC 
HEALTH SERVICE 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 eliminating 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                            07/31/98                    63 FR 40858
Public Workshop                 08/11/98                    63 FR 42773
Final Action                    03/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Robert A. Yetter, Department of Health and Human 
Services, Food and Drug Administration, Center for Biologics Evaluation 
and Research (HFM-10), 1401 Rockville Pike, Suite 200N, Rockville, MD 
20852
Phone: 301 827-0373

RIN: 0910-AB29
_______________________________________________________________________

1214. 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:  21 CFR 2; 21 CFR 3; 21 CFR 5; 21 CFR 10; 21 CFR 12; 21 
CFR 16; 21 CFR 20; 21 CFR 25; 21 CFR 50; 21 CFR 54; 21 CFR 56; 21 CFR 
58; 21 CFR 60; 21 CFR 70; 21 CFR 71; ...

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               11/00/98

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1215. CLINICAL HOLD; 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               11/00/98

[[Page 61719]]

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1216. 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) issued a direct final 
rule and companion proposed rule to amend 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 an exemption from the GST requirements for 
other biological products. Because the agency received significant 
adverse comment on the administrative procedure portion of the direct 
final rule, FDA withdrew that portion of the rule and confirmed the 
remaining portion. FDA intends to finalize the companion proposed rule 
to respond to the significant adverse comment on the administrative 
procedure portion of the rule. 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 action 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Direct Final Rule               04/20/98                    63 FR 19399
Proposed Rule - Companion 
Document to Direct Final Rule   04/20/98                    63 FR 19431
Direct Final Rule Confirmation 
in Part                         08/05/98                    63 FR 41718
Direct Final Rule Withdrawal in 
Part                            08/05/98                    63 FR 41718
Final Action                    05/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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-AB51
_______________________________________________________________________

1217. RADIOPHARMACEUTICALS USED FOR IN VIVO DIAGNOSIS AND MONITORING

Priority:  Other Significant

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 consideration 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                            05/22/98                    63 FR 28301
Final Action                    05/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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-AB52
_______________________________________________________________________

1218. 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. 105-115), 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

________________________________________________________________________

NPRM                            06/15/98                    63 FR 38131
Final Action                    11/00/98

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

[[Page 61720]]

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
_______________________________________________________________________

1219. 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

________________________________________________________________________

NPRM                            06/16/98                    63 FR 32772
Direct Final Rule               06/16/98                    63 FR 32733
Withdrawal of Direct Final Rule 09/23/98                    63 FR 50757
Final Action                    03/00/99

Regulatory Flexibility Analysis Required: 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
_______________________________________________________________________

1220.  EFFECTIVE DATE OF APPROVAL OF AN ABBREVIATED NEW DRUG 
APPLICATION

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 
USC 353; 21 USC 355; 21 USC 356; 21 USC 357; 21 USC 371; 21 USC 374; 21 
USC 379e

CFR Citation:  21 CFR 314

Legal Deadline: None

Abstract: The interim rule will amend FDA regulations establishing the 
effective date of approval of Abbreviated New Drug Applications (ANDAs) 
by eliminating the requirement that an ANDA applicant successfully 
defend a patent infringement suit to be entitled to 180 days of 
marketing exclusivity.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              11/00/98

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Virgina G. Beakes, 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-AB64
_______________________________________________________________________

1221.  MUTUAL RECOG. OF PHARMACEUTICAL GOOD MANUFACTURING 
INSPECTION RPTS., MED. DEVICE QUALITY SYS. AUDIT RPTS., AND CERTAIN 
MEDICAL DEVICE PRODUCT EVAL. RPTS.; THE U.S. AND THE EUROPEAN COMMUNITY

Priority:  Other Significant

Legal Authority:  5 USC 552; 15 USC 1453; 15 USC 1454; 15 USC 1455; 18 
USC 1905; 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 353; 21 USC 360; 
21 USC 360b; 21 USC 360c; 21 USC 360d; 21 USC 360e; 21 USC 360f; ...

CFR Citation:  21 CFR 26

Legal Deadline: None

Abstract: The Food and Drug Administration is codifying certain 
commitments and obligations contained as part of an overall agreement 
on Mutual Recognition (MRA) between the United States of America and 
the European Community (EC) which will be binding on FDA. This 
regulation sets forth conditions under which FDA will normally endorse 
certain reports prepared by EC's regulatory authorities in the case of 
inspections to ascertain conformity with pharmaceutical good 
manufacturing practices (GMPs) and by designated third-party conformity 
assessment bodies in the case of quality systems audits and certain 
medical device premarket evaluations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/10/98                    63 FR 17744
NPRM Comment Period End         05/11/98
Final Action                    10/00/98

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: Federal

Agency Contact: Merton V. Smith, Associate Director for International 
Agreements, Department of Health and Human Services, Food and Drug 
Administration, Office of the Commissioner (HFG-1), 5600 Fishers Lane, 
Room 15A-33, Rockville, MD 20857
Phone: 301 443-4480
Email: [email protected]

RIN: 0910-AB75

[[Page 61721]]

_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)   Long-Term Actions
Food and Drug Administration (FDA)
_______________________________________________________________________

1222. 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 
records 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)

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

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
_______________________________________________________________________

1223. 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 on 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)

Regulatory Flexibility Analysis Required: Yes
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
_______________________________________________________________________

1224. 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

[[Page 61722]]

Legal Deadline: None

Abstract: The Food and Drug Administration is considering development 
of regulations for medical foods, as defined by the Orphan Drug Act 
Amendments of 1988 (21 USC 360ee(b)(3)) to assure, among other things, 
the safety and effectiveness of these products, proper labeling of the 
nutrient content and purported uses, including adequate and appropriate 
directions for use, and quality control and good manufacturing 
practices.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes
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
_______________________________________________________________________

1225. 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

Regulatory Flexibility Analysis Required: 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
_______________________________________________________________________

1226. 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

Regulatory Flexibility Analysis Required: 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
_______________________________________________________________________

1227. 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

Regulatory Flexibility Analysis Required: 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

[[Page 61723]]

_______________________________________________________________________

1228. REINVENTING FDA FOOD REGULATIONS

Priority:  Substantive, Nonsignificant

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

Legal Authority:  15 USC 1453; 15 USC 1454; 15 USC 1455; 21 USC 321 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 (ANPRM) on December 29, 1995, requesting 
information on the need to retain, revise, or revoke its food standards 
of identity regulations and its common or usual name regulations. In 
the same issue of the Federal Register FDA proposed to 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 ANPRM 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 ANPRM seeking public 
comment on possible ways to streamline various food additive 
regulations. FDA also proposed on June 12, 1996, to revoke certain food 
labeling regulations pertaining to labeling of food with number of 
servings and labeling Kosher and Kosher-style foods and to revoke the 
agency's voluntary filing of cosmetic product experiences. 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) was 
published on June 3, 1996. A confirmation of effective date (CED) on 
those regulations promulgated under the formal rulemaking procedures of 
section 701(e) of the Federal Food, Drug, and Cosmetic Act (21 USC 
371(e)) pertaining to diabetic labeling (21 CFR 105.67) and sodium 
intake labeling (21 CFR 105.69) 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 to inform 
FDA of a company's determination that use of a substance in food is 
generally recognized as safe (GRAS).

Timetable:

Exempt Infant Formula; Plan for Revisions  ANPRM 06/12/96 (61 FR 
29701)  Comment Period Ended 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 Ended 06/28/96  NPRM 00/00/00

Food, Color Additive, GRAS Regulations  ANPRM 06/12/96 (61 FR 
29701)  Comment Period Ended 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 Ended 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 Ended 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 Ended 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 Ended 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 Ended 01/11/96  Final Action 06/03/96 (61 FR 
27771)  Confirmation of Eff. Date 08/27/96 (61 FR 43963)

Regulatory Flexibility Analysis Required: Yes
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 to 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
_______________________________________________________________________

1229. 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 statutory 
provisions governing labeling of dietary supplements. FDA has initiated 
rulemaking to modify its regulations for dietary supplements 
accordingly. One proposal would modify the nutrition labeling and

[[Page 61724]]

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 
``Antioxidant'' 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. In 
response to these petitions, FDA pubished a final rule revising the 
nutrition labeling requirements for dietary supplements that contain 
liquid or dried extracts.
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 
supplements, including the use of 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. On 
April 29, 1998, FDA issued 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 the 
structure or function of the body.

Timetable:

Comments on Report of the Commission on Dietary Supp. Labels  Notice 
04/29/98 (63 FR 23633)

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)  Final Action 06/05/98 (63 FR 30615)

Regs on Statements Made for Diet. Supps re Effect of Product  NPRM 04/
29/98 (63 FR 23624)

Regulatory Flexibility Analysis Required: Yes
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
_______________________________________________________________________

1230. 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

Regulatory Flexibility Analysis Required: 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
_______________________________________________________________________

1231. 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

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Leanne Cusumano, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug

[[Page 61725]]

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
_______________________________________________________________________

1232. 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

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Joseph Griffin, 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: 301 594-5562

RIN: 0910-AA83
_______________________________________________________________________

1233. INVESTIGATIONAL USE 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 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                            00/00/00

Regulatory Flexibility Analysis Required: 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
_______________________________________________________________________

1234. 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

Regulatory Flexibility Analysis Required: 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
_______________________________________________________________________

1235. 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.

[[Page 61726]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            00/00/00

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1236. 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

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 00/00/00

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

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1237.  CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS

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 eliminate existing text in the CFR.

Legal Authority:  21 USC 351; 21 USC 352; 21 USC 360(b); 21 USC 371; 21 
USC 374

CFR Citation:  21 CFR 225

Legal Deadline: None

Abstract: Proposal is in response to a citizen petition request to 
merge the separate requirements of the current good manufacturing 
practice (CGMP) regulations, 21 CFR part 225 applicable to licensed and 
unlicensed feed manufacturing facilities, respectively. The merger 
would produce a single set of updated, streamlined CGMPs that apply to 
all medicated feed manufacturers. This consolidation of existing CGMPs 
would preserve and strengthen food safety, be more appropriate given 
the changing structure of the medicated feed industry, and enhance 
uniformity and enforcement.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

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: George Graber, Director, Division of Animal Feeds, 
Department of Health and Human Services, Food and Drug Administration, 
Center for Veterinary Medicine (HFV-220), 7500 Standish Place, 
Rockville, MD 20855
Phone: 301 827-6651
Fax: 301 594-1812
Email: [email protected]

RIN: 0910-AB70
_______________________________________________________________________

1238.  CITIZEN PETITIONS; ACTIONS THAT CAN BE REQUESTED BY 
PETITION; SUMMARY DENIAL; AND REFERRAL FOR OTHER ADMINISTRATIVE ACTION

Priority:  Info./Admin./Other

Legal Authority:  5 USC 551 to 558; 5 USC 701 to 706; 15 USC 1451 to 
1461; 21 USC 41 to 50; 21 USC 141 to 149; 21 USC 321 to 393; 21 USC 
467f; 21 USC 679; 21 USC 821; 21 USC 1034; 28 USC 2112; 42 USC 201; 42 
USC 262; 42 USC 263b to 263n; 42 USC 264

CFR Citation:  21 CFR 10

Legal Deadline: None

Abstract: The proposed rule would amend the agency's regulations 
pertaining to citizen petitions by specifying the types of actions that 
could be requested through a petition. The proposal would also revise 
the content requirements for citizen petitions and would establish a 
mechanism for receiving and filing citizen petitions. These changes are 
intended to improve the citizen petition mechanism by focusing FDA's 
resources on important public health issues.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal

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, Rockville, MD 20857
Phone: 301 827-3380

[[Page 61727]]

Fax: 301 443-6906
Email: [email protected]

RIN: 0910-AB73
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)   Completed Actions
Food and Drug Administration (FDA)
_______________________________________________________________________

1239. 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.

CFR Citation:  21 CFR 80; 21 CFR 429

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/13/98                    63 FR 26694

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: David R. Petak
Phone: 301 827-5004
Fax: 301 443-6242

RIN: 0910-AA07
_______________________________________________________________________

1240. 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.

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - No Action Planned at 
This Time                       09/22/98

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Tribal, Federal

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

RIN: 0910-AA69
_______________________________________________________________________

1241. 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
Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will eliminate existing text in the CFR.

CFR Citation:  21 CFR 2

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Combined With RIN 0910-AA99     07/31/98

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Leanne Cusumano
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB10
_______________________________________________________________________

1242. REVOCATION OF LATHER BRUSHES REGULATION

Priority:  Info./Admin./Other

CFR Citation:  21 CFR 1240.70

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/12/98                    63 FR 26077

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Philip L. Chao
Phone: 301 827-3380
Fax: 301 443-6906
Email: [email protected]

RIN: 0910-AB25
_______________________________________________________________________

1243. 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.

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; ...

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/12/98                    63 FR 26066

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Christine Rogers
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB31
_______________________________________________________________________

1244. 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.

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/13/98                    63 FR 26694

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

[[Page 61728]]

Fax: 301 827-5562

RIN: 0910-AB38
_______________________________________________________________________

1245.  NATURAL RUBBER CONTAINING MEDICAL DEVICES; USER LABELING

Priority:  Substantive, Nonsignificant

Legal Authority:  21 USC 352

CFR Citation:  None

Legal Deadline: None

Abstract: This ``final rule; clarification'' provides notice that FDA 
does not intend to apply to combination products currently regulated 
under human drug or biologic labeling provisions the September 30, 
1997, final rule requiring certain labeling statements for all medical 
devices that contain or have packaging that contains natural rubber 
that contacts humans.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/06/98                    63 FR 24934
Final Action Effective          09/30/98

Regulatory Flexibility Analysis Required: No

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
Fax: 301 827-5562

RIN: 0910-AB65
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Health Resources and Services Administration (HRSA)
_______________________________________________________________________

1246. 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 60.7

Legal Deadline: None

Abstract: This NPRM proposes to require that in addition to reporting 
to the National Practitioner Data Bank medical malpractice payments 
made where physicians or other health care practitioners are named in 
final judgments or settlements, payments be reported where they are 
made for the benefit of physicians or other health care practitioners 
not named in the judgments 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 
health care entity to ``shield'' the parties to the health care 
practitioner from being reported.
It would also require malpractice payers, 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, and the name (if known) of any hospital or 
health care organization with which the practitioner is affiliated or 
associated with.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/98

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1247. 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 
discipline licensure actions taken against 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 licensing agency 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).
The NPRM provides for the Department to collect and maintain this 
information and make the information available to authorized parties to 
determine the fitness of individuals to provide health care services, 
to protect the health and safety of individuals receiving health care 
services, and to protect the physical integrity of the Medicaid/
Medicare programs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/98

Regulatory Flexibility Analysis Required: No

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

[[Page 61729]]

_______________________________________________________________________

1248. 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                            09/01/98                    63 FR 46538
NPRM Comment Period End         11/02/98

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1249. 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 in 
light of the rapid evolution of the health care system. This NPRM would 
more fully implement Congressional intent, which was to give access to 
Data Bank information to 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                            03/00/99

Regulatory Flexibility Analysis Required: No

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)   Completed Actions
Health Resources and Services Administration (HRSA)
_______________________________________________________________________

1250. ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK RULES

Priority:  Other Significant. Major under 5 USC 801.

CFR Citation:  42 CFR 121

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule With Comment Period - 
(Comment Period End 08/31/98)   04/02/98                    63 FR 16296

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: D.W. Chen, M.D.
Phone: 301 443-7577

RIN: 0906-AA32
_______________________________________________________________________

1251. 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.

CFR Citation:  45 CFR 8

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       10/06/98

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Jimmy Mitchell
Phone: 301 594-4353
Fax: 301 594-4992

RIN: 0906-AA45
_______________________________________________________________________

1252. HEALTH CARE FRAUD AND ABUSE DATA COLLECTION PROGRAM

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Transfer Development to - RIN 
0991-AA98                       08/11/98

RIN: 0906-AA46
_______________________________________________________________________

1253. NATIONAL VACCINE INJURY COMPENSATION PROGRAM: EFFECTIVE DATE 
PROVISIONS OF COVERAGE OF CERTAIN VACCINES TO THE VACCINE INJURY TABLE

Priority:  Info./Admin./Other

CFR Citation:  42 CFR 100

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/11/98                    63 FR 25777

[[Page 61730]]

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Thomas E. Balbier
Phone: 301 443-6593

RIN: 0906-AA49
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Indian Health Service (IHS)
_______________________________________________________________________

1254. INDIAN CHILD PROTECTION AND FAMILY VIOLENCE PREVENTION ACT MINIMUM 
STANDARDS OF CHARACTER

Priority:  Info./Admin./Other

Legal Authority:  25 USC 3201 et seq

CFR Citation:  42 CFR 36

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/99
NPRM Comment Period End         04/00/99

Regulatory Flexibility Analysis Required: No

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)    Final Rule Stage
Indian Health Service (IHS)
_______________________________________________________________________

1255.  CURRENTLY EFFECTIVE INDIAN HEALTH SERVICE ELIGIBILITY 
REGULATIONS

Priority:  Info./Admin./Other

Legal Authority:  42 USC 2001; 42 USC 2003

CFR Citation:  42 CFR 36

Legal Deadline: None

Abstract: The Department of Health and Human Services is publishing in 
the Federal Register, final regulations governing eligibility for 
Indian Health Service. The regulations currently codified at 42 CFR36 
are under moratorium of undetermined length. For the convenience of the 
public and in conformance with the Administrative Procedures Act, 5USC 
552(a)(a) that the CFR contain currently effective regulations, these 
regulations are to be codified side by side with the regulation under 
moratorium.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/00/99

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: Tribal

Agency Contact: Betty J. Penn, Regulations Officer, Department of 
Health and Human Services, Indian Health Service, 12300 Twinbrook 
Parkway, Suite 450, Rockville, MD 20857
Phone: 301 443-1116
Fax: 301 443-2316
Email: [email protected]

RIN: 0917-AA03
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)   Completed Actions
Indian Health Service (IHS)
_______________________________________________________________________

1256. ACQUISITION UNDER THE BUY INDIAN ACT

Priority:  Substantive, Nonsignificant

CFR Citation:  48 CFR ch 3, app A

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - ASMB Has Final 
Responsibility for Publication  07/31/98

Regulatory Flexibility Analysis Required: No

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.

Agency Contact: Robyn York
Phone: 301 443-3134

RIN: 0917-AA00

[[Page 61731]]

_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
National Institutes of Health (NIH)
_______________________________________________________________________

1257. 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                            01/00/99

Regulatory Flexibility Analysis Required: 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
_______________________________________________________________________

1258. 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 NIH. For each year of scholarship support, the recipient 
agrees to service (employment) after graduation, at the NIH, for one 
year. Additionally, the individual agrees to at least ten consecutive 
weeks of service (employment) at the NIH during which the individual is 
attending the institution and receiving the NIH scholarship. The 
proposed new regulations will cover this program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/99

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1259. 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                            11/00/98

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1260. 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                            11/00/98

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

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., Ste. 3B01, MSC 7507, Rockville, MD 20892-7507
Phone: 301 435-5649
Fax: 301 402-2071

RIN: 0925-AA14
_______________________________________________________________________

1261. 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 National Institutes of Health 
Revitalization Act of 1993. New language concerning the service payback 
obligation will set forth, specifically, that a service payback 
obligation is incurred only during the first twelve months of 
postdoctoral support and individuals may pay back this service 
obligation by engaging in an equal period of health-related

[[Page 61732]]

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                            11/00/98

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1262. 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 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                            01/00/99

Regulatory Flexibility Analysis Required: No

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-AA17
_______________________________________________________________________

1263. 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                            03/00/99

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1264. 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/98

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)    Final Rule Stage
National Institutes of Health (NIH)
_______________________________________________________________________

1265. 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

[[Page 61733]]

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 construction grants.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/06/95                    60 FR 35266
NPRM Comment Period End         09/05/95
Final Action                    02/00/99

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1266. 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                    12/00/98

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1267. 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. These 
regulations, which govern the first level of review, are being amended 
to reflect current policies and procedures.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              12/00/98

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1268. 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 from conducting or 
supporting classified human subject research without having proposed 
and promulgated the common rule and the changes.

Abstract: In compliance with the President's Memorandum of March 27, 
1997, this interim final 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 
interim final 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 IRB approvals of classified 
research.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/00/99

Regulatory Flexibility Analysis Required: No

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
Fax: 301 402-2071

RIN: 0925-AA21

[[Page 61734]]

_______________________________________________________________________

1269. SERVICE FELLOWSHIPS

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 would amend 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              02/27/98                     63 FR 9949
Final Action                    11/00/98

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)   Long-Term Actions
Office of Assistant Secretary for Health (OASH)
_______________________________________________________________________

1270. 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

Regulatory Flexibility Analysis Required: No

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: 301 594-4001

RIN: 0937-AA00
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Public Health Service (PHS)
_______________________________________________________________________

1271. 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 
adequately respond to an allegation of, research misconduct, and (2) 
persons who cooperate in good faith with an investigation of research 
misconduct.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/99
NPRM Comment Period End         04/00/99

Regulatory Flexibility Analysis Required: Yes
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

[[Page 61735]]

_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)       Prerule Stage
Health Care Financing Administration (HCFA)
_______________________________________________________________________

1272. 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   12/00/98
Final Action                    01/00/99

Regulatory Flexibility Analysis Required: 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
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Health Care Financing Administration (HCFA)
_______________________________________________________________________

1273. 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                            11/00/98

Regulatory Flexibility Analysis Required: No

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, S2-16-25, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4461

RIN: 0938-AG72
_______________________________________________________________________

1274. 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                            12/00/98

Regulatory Flexibility Analysis Required: Yes
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
_______________________________________________________________________

1275. MEDICARE COVERAGE OF HEART, LIVER, AND LUNG TRANSPLANTATION (HCFA-
3835-PN)

Priority:  Other Significant

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

CFR Citation:  None

Legal Deadline: None

Abstract: This notice proposes to revise the criteria for approval of a 
facility to perform Medicare covered transplants. The revised criteria 
would focus on a facility's ability to perform successful transplants, 
rather than on a facility's policies and procedures.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Notice                 12/00/98
Final Action                    01/00/99

[[Page 61736]]

Regulatory Flexibility Analysis Required: Undetermined
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, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4653

RIN: 0938-AH17
_______________________________________________________________________

1276. 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                            11/00/98

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1277. 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

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                            11/00/98

Regulatory Flexibility Analysis Required: Yes
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
_______________________________________________________________________

1278. 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 
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                            12/00/98

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1279. 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 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.

[[Page 61737]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/98

Regulatory Flexibility Analysis Required: No
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
_______________________________________________________________________

1280. 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                            12/00/98

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: HSQ-241-P

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 
21244-1850
Phone: 410 786-0433

RIN: 0938-AH85
_______________________________________________________________________

1281. 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 
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

Regulatory Flexibility Analysis Required: Yes
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, S2-15-10, Baltimore, MD 21244
Phone: 410 786-9004
Fax: 410 786-3262

RIN: 0938-AH89
_______________________________________________________________________

1282. MEDICARE AND MEDICAID PROGRAMS; QUARTERLY LISTING OF PROGRAM 
ISSUANCES AND COVERAGE DECISSIONS--SECOND QUARTER, 1998

Priority:  Routine and Frequent

Legal Authority:  42 USC 1302

CFR Citation:  42 CFR ch IV

Legal Deadline: None

Abstract: This notice lists HCFA manual instructions, substantive and 
interpretive regulations, and other Federal Register notices that were 
published during April, May, and June of 1998 that relate to Medicare 
and Medicaid programs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          12/00/98

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Kristy Nishimoto, Office of Communications and 
Operations, Support, Department of Health and Human Services, Health 
Care Financing Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-8517

RIN: 0938-AI13
_______________________________________________________________________

1283. MEDICARE PROGRAM; PROSPECTIVE PAYMENT SYSTEM FOR HOSPITAL 
OUTPATIENT (HCFA-1005-P)

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

RIN: 0938-AI56

[[Page 61738]]

_______________________________________________________________________

1284. MEDICAID MANAGED CARE; REGULATORY PROGRAM TO IMPLEMENT CERTAIN 
MEDICAID PROVISIONS OF THE BALANCED BUDGET ACT OF 1997 (HCFA-2001-P)

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

RIN: 0938-AI70
_______________________________________________________________________

1285.  COVERAGE OF RELIGIOUS NON-MEDICAL HEALTH CARE 
INSTITUTIONS (HCFA-1909-IFC)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395i-5; 42 USC 1395x(d)(e)(y) and (ss); 42 
USC 1395ff; 42 USC 1395oo; 42 USC 1302

CFR Citation:  42 CFR 403g; 42 CFR 412.90; 42 CFR 412.98; 42 CFR 
431.610; 42 CFR 440.155; 42 CFR 442.12; 42 CFR 456.351; 42 CFR 456.601; 
42 CFR 466.1; 42 CFR 440.170; 42 CFR 488.2; 42 CFR 488.6; 42 CFR 
489.102

Legal Deadline:  Final, Statutory, July 1, 1998.

Abstract: This final rule with comment period implements section 4454 
of the Balanced Budget Act of 1997, BBA '99 amended section 1861 of the 
Social Security Act (the Act). Section 4454 of BBA '97 removed all 
references to Christian Science and Christian sanatoria from the Act 
and substituted religious nonmedical health care institutions in their 
place. This change permits any religious organization to apply to be 
paid for furnishing nonmedical services under Medicare. The rule sets 
forth minimum requirements and conditions of participation to qualify 
as a religious nonmedical health care institution for purposes of 
receiving payment for services furnished under Medicare.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/98

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Jean Marie Moore, Center for Health Plans and 
Providers, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-3508

RIN: 0938-AI93
_______________________________________________________________________

1286.  EXPANDED COVERAGE FOR DIABETES OUTPATIENT SELF-MANAGEMENT 
TRAINING SERVICES HCFA-3002-P

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

RIN: 0938-AI96
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)    Final Rule Stage
Health Care Financing Administration (HCFA)
_______________________________________________________________________

1287. 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

________________________________________________________________________

Final Rule With Comment Period  01/12/94                     59 FR 1659
Comment Period End              03/14/94
Effective Date                  03/14/94
Final Action                    01/00/99

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: State

Additional Information: HCFA-2020

Agency Contact: Jackie Wilder, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, S2-17-18, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4579

RIN: 0938-AB07
_______________________________________________________________________

1288. 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 it has 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.

[[Page 61739]]

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                    01/00/99

Regulatory Flexibility Analysis Required: Undetermined
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
_______________________________________________________________________

1289. 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 that 
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                    01/00/99

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: None

Additional Information: BPD-482

Agency Contact: Herbert Pollock, Center for Health Plans and Providers, 
Division of Integrated Services, Department of Health and Human 
Services, Health Care Financing Administration, C4-03-23, 7500 Security 
Blvd., Baltimore, MD 21244
Phone: 410 786-4474

RIN: 0938-AD73
_______________________________________________________________________

1290. 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                    06/00/99

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-488

Agency Contact: Nancy Archer, Office of Clinical Standards and Quality, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-0596

RIN: 0938-AD81
_______________________________________________________________________

1291. REVISIONS TO REGULATIONS IMPLEMENTING CLIA (HCFA-2226-F)

Priority:  Other Significant

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.

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
Final Action                    01/00/99

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: HSQ-226

[[Page 61740]]

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
_______________________________________________________________________

1292. 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                    12/00/98

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1293. 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 With Comment Period        02/28/94
Final Rule                      04/23/98                    63 FR 20110
Final Action                    01/00/99

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

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
_______________________________________________________________________

1294. 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
NPRM Comment Period End         11/20/95
Final Action                    12/00/98

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses

Government Levels Affected: State

Additional Information: HCFA-2046-FC

Agency Contact: Tami Bruce, Center for Medicaid and State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-1519

RIN: 0938-AF42
_______________________________________________________________________

1295. 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

[[Page 61741]]

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                    01/00/99

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

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
_______________________________________________________________________

1296. 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                    01/00/99

Regulatory Flexibility Analysis Required: Undetermined
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
_______________________________________________________________________

1297. REVISED MEDICAID MANAGEMENT INFORMATION SYSTEMS (HCFA-2038-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 Systems (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                    01/00/99

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

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, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4451

RIN: 0938-AG10
_______________________________________________________________________

1298. 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 462

Legal Deadline: None

Abstract: This notice with a comment period would 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
Final Action                    01/00/99

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

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
Phone: 410 786-9352

RIN: 0938-AG32
_______________________________________________________________________

1299. 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

[[Page 61742]]

whose ability to breathe is severely impaired. Based on an Office of 
Health Technology Assessment recommendation, we will place limitations 
on Medicare coverage of IPPB machine therapy.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Notice                 06/29/94                    59 FR 33520
Comment Period End              08/29/94
Final Action                    01/00/99

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1300. REQUEST FOR ASSESSMENT ON THE SALITRON SYSTEM FOR THE TREATMENT OF 
XEROSTOMIA SECONDARY TO SJOGREN'S SYNDROME (HCFA-3782-NC)

Priority:  Substantive, Nonsignificant

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

CFR Citation:  42 CFR ch IV

Legal Deadline: None

Abstract: This notice announces our withdrawal of a prior proposed 
notice. It also announces a request for the Agency for Health Care 
Policy and Research to conduct a new technology assessment on the 
salivary electrostimulation in Sjogren's syndrome which includes the 
use of the salitron system for the treatment of xerostomia (dry mouth) 
secondary to Sjogren's syndrome.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule                      06/01/98                    63 FR 29743
Final Action                    01/00/99

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: Undetermined

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
_______________________________________________________________________

1301. 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, 
and suppliers, 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                    12/00/98

Regulatory Flexibility Analysis Required: No

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 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6972

RIN: 0938-AG48
_______________________________________________________________________

1302. 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 a 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
Final Action                    01/00/99

Regulatory Flexibility Analysis Required: No
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
_______________________________________________________________________

1303. 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

[[Page 61743]]

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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/13/95                    60 FR 47534
NPRM Comment Period End         11/13/95
Final Action                    06/00/99

Regulatory Flexibility Analysis Required: Yes
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 Services, Health Care Financing 
Administration, S2-09-28, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-3531

RIN: 0938-AG99
_______________________________________________________________________

1304. AMBULANCE SERVICES (HCFA-1813-F)

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

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

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, ninth 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                    10/00/98

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses

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
_______________________________________________________________________

1305. 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 by which the FDA is to assist HCFA in identifying non-
experimental 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
Final Action                    01/00/99

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

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
_______________________________________________________________________

1306. 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

[[Page 61744]]

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                    12/00/98

Regulatory Flexibility Analysis Required: Yes
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
_______________________________________________________________________

1307. 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

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

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1308. 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  12/00/98
Final Action                    01/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: BPD-877

Agency Contact: Luisa V. Iglesias, Division of Regulation and 
Issuances, Department of Health and Human Services, Health Care 
Financing Administration, Room 409-B, Hubert H. Humphrey Bldg., 200 
Independence Ave. SW., Washington, DC
Phone: 202 690-6383

RIN: 0938-AH53
_______________________________________________________________________

1309. 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 45968
Comment Period End              10/28/97
Final Rule                      05/12/98                    63 FR 26318
Final Action                    01/00/99

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses, Organizations

[[Page 61745]]

Government Levels Affected: State, Federal

Additional Information: HCFA-1878-F
HCFA published a final rule with comment period on 8/29/97.

Agency Contact: Tzvi Hefter, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-07-17, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4487

RIN: 0938-AH55
_______________________________________________________________________

1310. 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 final rule with comment period amends current 
regulations to reflect statutory changes under which physician 
certification, plan of care, and utilization review requirements become 
State plan requirements and are no longer included in the quarterly 
``showings'' of compliance that States must submit. Those showings are 
now limited to inspection of care reviews in institutions for mental 
diseases and intermediate care facilities for the mentally retarded. 
The rule also reflects the discontinuance of the State-operated claims 
processing assessment system and of regional office review of a 
subsample of each State's Medicaid quality control sample.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    04/00/99

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: State

Additional Information: MB-101

Agency Contact: Mike Fiore, Center for Medicaid and State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0623

RIN: 0938-AH64
_______________________________________________________________________

1311. 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 to 341

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                    12/00/98

Regulatory Flexibility Analysis Required: Undetermined
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
_______________________________________________________________________

1312. 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                    01/00/99

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Bob Tomlinson, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, S2-08-24, 7500 Security Blvd., Baltimore, MD 
21244
Phone: 410 786-4463

RIN: 0938-AH76
_______________________________________________________________________

1313. MEDICARE PROGRAM; BENEFICIARY INCENTIVES PROGRAMS (HCFA-6144-FC11)

Priority:  Other Significant

Legal Authority:  PL 104-191, sec 203

[[Page 61746]]

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

________________________________________________________________________

Final Rule With Comment Period  06/08/98                    63 FR 31123
Final Action                    01/00/99

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

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
_______________________________________________________________________

1314. 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                    01/00/99

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1315. 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              12/00/98

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

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, S2-16-17, Baltimore, MD 
21244
Phone: 410 786-4579

RIN: 0938-AH92
_______________________________________________________________________

1316. 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 1, 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                          12/00/98
Final Action                    01/00/99

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

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 61747]]

_______________________________________________________________________

1317. 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              11/00/98

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

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., S2-08-05, Baltimore, MD 
21244
Phone: 410 786-4462
Fax: 410 786-3252

RIN: 0938-AH98
_______________________________________________________________________

1318. NATIONAL STANDARD HEALTH CARE PROVIDER IDENTIFIER (HCFA-0045-F)

Priority:  Other Significant. Major under 5 USC 801.

Legal Authority:  42 USC 1320(d)2

CFR Citation:  45 CFR 142

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

Abstract: This rule addresses the health care industry's need for a 
standardized provider identifier. It implements one of the requirements 
for administrative simplification in section 262 of the Health 
Insurance Portability and Accountability Act of 1996. A standard 
provider identifier will save the health insurance industry significant 
costs incurred in maintaining multiple identifier systems.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/07/98                    63 FR 25340
NPRM Comment Period End         07/06/98
Final Action                    12/00/98

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: Undetermined

Additional Information: HCFA-0045-P

Agency Contact: Pat Peyton, Office of Information Services, Department 
of Health and Human Services, Health Care Financing Administration, 
7500 Security Blvd., N3-20-05, Baltimore, MD 212244
Phone: 410 786-1812

RIN: 0938-AH99
_______________________________________________________________________

1319. 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                    12/00/98

Regulatory Flexibility Analysis Required: Yes
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
_______________________________________________________________________

1320. 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 Action                    01/00/99

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses

[[Page 61748]]

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
_______________________________________________________________________

1321. 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                          12/00/98
Final Action                    01/00/99

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

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
_______________________________________________________________________

1322. 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                          12/00/98
Final Action                    01/00/99

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

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
_______________________________________________________________________

1323. 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 Action                    01/00/99

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

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
_______________________________________________________________________

1324. 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

[[Page 61749]]

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 receive incentive payments for 
reducing the number of residents in training. The hospital must submit 
a plan to the Secretary outlining how it will make voluntary residency 
reductions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              10/00/98
Final Action                    12/00/98

Regulatory Flexibility Analysis Required: Yes
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, 7500 Security Blvd, Baltimore, MD 21244-1850
Phone: 410 786-4539

RIN: 0938-AI27
_______________________________________________________________________

1325. MEDICARE+CHOICE PROGRAM; REGULATORY PROGRAM TO IMPLEMENT CERTAIN 
MEDICARE PROVISIONS OF THE BALANCED BUDGET ACT OF 1997 (HCFA-1030-F)

Priority:  Economically Significant. Major under 5 USC 801.

Legal Authority:  42 USC 1302; 42 USC 1395w21 to 27; 42 USC 1395hh; 42 
USC 1395mm; PL 105-33, sec 1876

CFR Citation:  42 CFR 400; 42 CFR 403; 42 CFR 417; 42 CFR 422; 42 CFR 
471; 42 CFR 489; 42 CFR 498

Legal Deadline:  Other, Statutory, June 1, 1998.
Interim Final Rule.

Abstract: This 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule With Comment 
Period                          06/26/98                    63 FR 34968
Final Action                    01/00/99

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State

Agency Contact: Anthony Hausner, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1093

RIN: 0938-AI29
_______________________________________________________________________

1326. 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); 
PL 105-33, sec 4002

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 rate 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
Final Action                    01/00/99

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Marty Abeln, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, Baltimore, MD 21244-1850
Phone: 410 786-1032

RIN: 0938-AI35
_______________________________________________________________________

1327. MEDICARE PROGRAM: PAYMENTS FOR TELECONSULTATIONS IN RURAL HEALTH 
PROFESSIONAL SHORTAGE AREAS (HCFA-1906-F)

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 rule provides 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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/22/98                    63 FR 33882
Interim Final Rule              12/00/98

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Craig Dobyski, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD
Phone: 410 786-4584

RIN: 0938-AI44
_______________________________________________________________________

1328. MEDICARE PROGRAM; REVISIONS TO PAYMENT POLICIES UNDER THE 
PHYSICIAN FEE SCHEDULE FOR CALENDAR YEAR 1999 (HCFA-1006-FC) (HCFA-1006-
P)

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

RIN: 0938-AI52

[[Page 61750]]

_______________________________________________________________________

1329. STANDARDS FOR ELECTRONIC TRANSACTIONS (HCFA-0149-F)

Priority:  Other Significant. Major under 5 USC 801.

Legal Authority:  42 USC 1320d

CFR Citation:  45 CFR 142

Legal Deadline:  Final, Statutory, February 1, 1998.

Abstract: The rule puts in place 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 will significantly reduce costs for processing health care 
transactions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/07/98                    63 FR 25277
NPRM Comment Period End         07/06/98
Final Action                    01/00/99

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: None

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
_______________________________________________________________________

1330. NATIONAL STANDARD EMPLOYER IDENTIFIER (HCFA-0047-F)

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 institutes 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 will reduce the cost of identifying employers in electronic 
health care transactions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/16/98                    63 FR 32784
NPRM Comment Period End         08/17/98
Final Action                    01/00/99

Regulatory Flexibility Analysis Required: 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, N2-12-22, Baltimore, MD 21244
Phone: 410 786-7065
Email: [email protected]

RIN: 0938-AI59
_______________________________________________________________________

1331. MEDICARE PROGRAM; DEFINITION OF PROVIDER-SPONSORED ORGANIZATION 
AND RELATED REQUIREMENTS (HCFA-1027-IFC)

Priority:  Other Significant

Legal Authority:  42 USC 1302

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              04/14/98                    63 FR 18124
Final Action                    01/00/99

Regulatory Flexibility Analysis Required: Undetermined
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
_______________________________________________________________________

1332. MEDICARE AND MEDICAID PROGRAMS; SURETY BOND 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.

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR ch IV

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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice With Comment Period      03/04/98                    63 FR 10732
Final Action                    01/00/99

Regulatory Flexibility Analysis Required: No

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

[[Page 61751]]

Phone: 410 786-4870

RIN: 0938-AI82
_______________________________________________________________________

1333. 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

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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              05/07/98                    63 FR 25360
Interim Final Rule Effective    06/08/98
Interim Final Rule Comment 
Period End                      07/06/98
Final Action                    01/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Aaron Brown, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-1033

RIN: 0938-AI83
_______________________________________________________________________

1334. SCHEDULE OF PER-BENEFICIARY LIMITATIONS ON HOME HEALTH AGENCY 
COSTS FOR COST REPORTING PERIODS BEGINNING 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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule Effective            10/01/97
Final Rule with Comment Period  03/31/98                    63 FR 15718
Comment Period End              06/01/98
Final Action                    01/00/99

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

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
_______________________________________________________________________

1335.  HHS' RECOGNITION OF NAIC MODEL STANDARDS FOR REGULATION 
OF MEDIGAP POLICY (HCFA-2025-N)

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

Unfunded Mandates: Undetermined

Legal Authority:  42 USC 1395(ss)

CFR Citation:  42 CFR ch IV

Legal Deadline: None

Abstract: This notice describes changes made by the Balanced Budget Act 
of 1997 and the Health Insurance Portability and Accountability Act of 
1996 to section 1882 of the Social Security Act, which governs Medicare 
supplemental insurance. It also provides notice that the model 
regulation adopted by the National Association of Insurance 
Commissioners (NAIC) on April 29, 1998, and reprinted in its entirety 
as an addendum to this notice, constitutes the applicable NAIC model 
regulation that is incorporated by reference in section 1882.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          09/30/98
Final Action                    01/00/99

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Larry Cutler, Center for Medicaid and State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-5903

RIN: 0938-AJ07
_______________________________________________________________________

1336.  REPORTING OUTCOME AND ASSESSMENT INFORMATION SET (OASIS) 
DATA AS PART OF THE CONDITIONS OF PARTICIPATION FOR HOME HEALTH AGENCIES 
(HCFA-3006-IFC)

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 1395(hh)

CFR Citation:  42 CFR 484.11; 42 CFR 484.20; 42 CFR 488.68

Legal Deadline: None

Abstract: This interim final rule with comment period requires 
electronic reporting of data from the Outcome and Assessment 
Information Set (OASIS) as a condition of participation for HHAs. 
Specifically, this rule provides guidelines for HAAs for the electronic 
transmission of the OASIS data set as well as responsibilities of the 
State agency or contractor in collecting and transmitting this 
information to HCFA. This interim final rule also sets forth provisions 
concerning the privacy of patient identifiable information generates by 
the OASIS.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           08/15/98
Final Action                    12/00/98

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses

Government Levels Affected: State

Agency Contact: Tracey Mummert, Center for Medicaid and State

[[Page 61752]]

Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd, Baltimore, MD
Phone: 410 786-3398

RIN: 0938-AJ10
_______________________________________________________________________

1337.  REQUEST FOR PUBLIC COMMENTS ON IMPLEMENTATION OF RISK 
ADJUSTED PAYMENT FOR THE MEDICARE+CHOICE PROGRAM AND NOTICE OF PUBLIC 
MEETING

Priority:  Info./Admin./Other

Legal Authority:  PL 105-33, Sec 4011

CFR Citation:  42 CFR ch IV

Legal Deadline: None

Abstract: This notice solicits public comments on issues related to the 
implementation of risk adjusted payment for Medicare+Choice 
organizations. This notice also informs the public of a meeting to 
discuss risk adjustment and the collection of encounter data.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          09/08/98
Final Action                    01/00/99

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Cynthia Tudor, Department of Health and Human Services, 
Health Care Financing Administration, 7500 Security Blvd, Baltimore, MD 
21244
Phone: 410 786-6499

RIN: 0938-AJ16
_______________________________________________________________________

1338.  HOME HEALTH PROSPECTIVE PAYMENT SYSTEM (HCFA-1102-FC)

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

RIN: 0938-AJ24
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)   Long-Term Actions
Health Care Financing Administration (HCFA)
_______________________________________________________________________

1339. 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


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

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
_______________________________________________________________________

1340. 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 Medicaid program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/30/89                     54 FR 4302
NPRM Comment Period End         03/31/89


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1341. 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

[[Page 61753]]

Legal Deadline: None

Abstract: This rule will set forth several changes to regulations that 
govern Peer Review Organizations (PROs) and is based on statutory 
changes contained in COBRA '85 and OBRA '86. In addition, several 
technical changes will be included as a result of experience gained 
with the PRO program by HCFA. This rule also implements the new quality 
review requirements for certain Medicaid health maintenance 
organization contracts.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1342. ``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: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1343. 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: Next Action Undetermined

Regulatory Flexibility Analysis Required: 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
_______________________________________________________________________

1344. 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


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
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: Patricia Miller, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, S2-11-07, 7500 Security Blvd., Baltimore, MD 
21244
Phone: 410 786-6780

RIN: 0938-AE39

[[Page 61754]]

_______________________________________________________________________

1345. 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


Next Action Undetermined

Regulatory Flexibility Analysis Required: 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
_______________________________________________________________________

1346. 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/22/92                    57 FR 43659
NPRM Comment Period End         11/23/92


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1347. 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: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

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, S2-18-07, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-7304

RIN: 0938-AF02
_______________________________________________________________________

1348. 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

[[Page 61755]]

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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/15/93                    58 FR 53481
NPRM Comment Period End         12/14/93


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

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, S2-14-26, 
7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-5900

RIN: 0938-AF07
_______________________________________________________________________

1349. 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


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
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 
Administration, S3-02-14, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-4460

RIN: 0938-AF15
_______________________________________________________________________

1350. 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: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

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, C4-26-22, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4477

RIN: 0938-AF28
_______________________________________________________________________

1351. 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

Regulatory Flexibility Analysis Required: Yes
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

[[Page 61756]]

Phone: 410 786-6810

RIN: 0938-AF32
_______________________________________________________________________

1352. 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

Regulatory Flexibility Analysis Required: No

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, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4466

RIN: 0938-AF68
_______________________________________________________________________

1353. 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              09/23/94                    59 FR 48805
Interim Final Rule Effective 
Date                            10/24/94
Interim Final Rule Comment 
Period End                      11/22/94


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

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, S2-08-24, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4463

RIN: 0938-AF69
_______________________________________________________________________

1354. 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: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

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
_______________________________________________________________________

1355. 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: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

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

[[Page 61757]]

_______________________________________________________________________

1356. RURAL HEALTH CLINICS: AMENDMENTS TO PARTICIPATION REQUIREMENTS AND 
PAYMENT PROVISIONS AND ESTABLISHMENT OF A QUALITY ASSESSMENT AND 
PERFORMANCE IMPROVEMENT PROGRAM (HCFA-1910-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 491

Legal Deadline: None

Abstract: This proposed rule would amend our regulations to revise 
certification and payment requirements for Rural Health Clinics (RHCs). 
It would include new refinements of what constitutes a qualifying rural 
shortage area in which a Medicare RHC must be located, including the 
requirement that shortage areas be redesignated every three years; 
establish criteria for identifying RHCs essential to delivery of 
primary care services that can continue to be approved as Medicare RHCs 
in areas no longer designated as medically underserved; and include 
recent statutory provisions that provide a temporary waiver of certain 
nonphysician practitioners staffing requirement. It also would impose 
payment limits on provider-based RHCs and prohibit ``commingling'', the 
use of the space, equipment and other resources of a provider-based 
RHCs to establish a quality assessment and performance improvement 
program that goes beyond current regulatory requirements.
This proposed rule would implement section 4205 of the Balanced Budget 
Act of 1997 and makes other revisions for clarity and uniformity and to 
improve program administration.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: BPD-764

Agency Contact: David Worgo, Center for Health Plans and Providers, 
Division of Integrated Services, Department of Health and Human 
Services, Health Care Financing Administration, C4-15-18, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-5919

RIN: 0938-AG05
_______________________________________________________________________

1357. 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 end-stage renal dialysis (ERSD) 
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: Next Action Undetermined

Regulatory Flexibility Analysis Required: 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
_______________________________________________________________________

1358. 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

Regulatory Flexibility Analysis Required: No

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

[[Page 61758]]

_______________________________________________________________________

1359. 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: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

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
_______________________________________________________________________

1360. REVISION OF MEDICARE/MEDICAID 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/19/97                    62 FR 66726
NPRM Comment Period End         03/20/98


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: HCFA-3745-F

Agency Contact: Doris Jackson, Office of Clinical Standards and 
Quality, Department of Health and Human Services, Health Care Financing 
Administration, S3-05-18, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4656

RIN: 0938-AG79
_______________________________________________________________________

1361. PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY HAVE 
FINANCIAL RELATIONSHIPS--EXPANDED TO DESIGNATED HEALTH SERVICES (HCFA-
1809-F)

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

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 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

Regulatory Flexibility Analysis Required: Yes
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, C4-02-04, 7500 Security Blvd., Baltimore, MD 
21244
Phone: 410 786-4620

RIN: 0938-AG80
_______________________________________________________________________

1362. 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

[[Page 61759]]

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, non-maternity 
patients receiving home health care.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/10/97                    62 FR 11005
NPRM Comment Period End         06/09/97


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
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
_______________________________________________________________________

1363. 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.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
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, S3-04-25, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4652

RIN: 0938-AG82
_______________________________________________________________________

1364. DISTINCT PART REQUIREMENTS FOR NURSING HOMES AND PROHIBITION OF 
FINANCIAL SCREENING OF APPLICANTS FOR NURSING HOME ADMISSION (HCFA-3815-
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: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
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
_______________________________________________________________________

1365. 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/15/95                    60 FR 47982
NPRM Comment Period End         11/14/95
Final Action                    00/00/00

Regulatory Flexibility Analysis Required: No

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

[[Page 61760]]

_______________________________________________________________________

1366. 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


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1367. DEFINITION OF SKILLED NURSING FACILITY (SNF) FOR COVERAGE OF 
DURABLE MEDICAL EQUIPMENT (DME) AND HOME HEALTH (HCFA-1834-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 coverage. This would define non-
Medicare nursing homes as skilled facilities based upon the receipt of 
skilled care at least once a week by a proportion of its residents 
population.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
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
_______________________________________________________________________

1368. ADDITIONAL SUPPLIER STANDARDS (HCFA-1864-F)

Priority:  Other Significant

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 424.57

Legal Deadline: None

Abstract: This rule will 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/20/98                     63 FR 2926


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: HCFA-1864-P

Agency Contact: Charles Waldhauser, Center for Health Plans and 
Providers, Department of Health and Human Services, Health Care 
Financing Administration, C4-13-03, 7500 Security Boulevard, Baltimore, 
MD 21214
Phone: 410 786-6140

RIN: 0938-AH19
_______________________________________________________________________

1369. 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

Regulatory Flexibility Analysis Required: No

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, C3-
04-06, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3349

RIN: 0938-AH22
_______________________________________________________________________

1370. 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

[[Page 61761]]

Legal Deadline: None

Abstract: This proposed rule would revise and streamline the State Plan 
Amendment (SPA) reconsideration process. Currently, when a State 
requests reconsideration of a denied SPA, a hearing is held in all 
cases, even when the only dispute is over the interpretation of the 
statute. Under the proposed regulation, the State and HCFA could avoid 
the cost and delay of the hearing process when the only issue is 
interpretation of the statute by permitting the State expedited 
judicial review, without a full administrative hearing, after HCFA has 
a brief opportunity to reconsider its decision.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

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
_______________________________________________________________________

1371. 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: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
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
_______________________________________________________________________

1372. 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 percent 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 percent of the DME fee schedule amount, the lesser of costs or 
charges provision no longer applies and should be deleted from the CFR.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: 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
_______________________________________________________________________

1373. 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: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

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

[[Page 61762]]

_______________________________________________________________________

1374. MEDICARE SECONDARY PAYER CLARIFICATIONS AND AMENDMENTS (HCFA-1865-
P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 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

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1375. 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

Regulatory Flexibility Analysis Required: 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
_______________________________________________________________________

1376. 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: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
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
_______________________________________________________________________

1377. 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: Next Action Undetermined

Regulatory Flexibility Analysis Required: 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, S2-16-25, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4461

RIN: 0938-AH63
_______________________________________________________________________

1378. 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

[[Page 61763]]

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

Regulatory Flexibility Analysis Required: Yes
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, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3295

RIN: 0938-AH65
_______________________________________________________________________

1379. 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 411; 42 CFR 489

Legal Deadline: None

Abstract: This proposed rule would revise current regulations to 
require that providers and suppliers attempt to collect payment from 
the proceeds of liability insurance during the ``promptly period.'' 
This rule would also permit providers and suppliers to choose either to 
pursue collection of payment from the proceeds of liability insurance 
after the ``promptly period'' has ended or to bill Medicare.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
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
_______________________________________________________________________

1380. 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: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses, Governmental Jurisdictions, 
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
_______________________________________________________________________

1381. 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: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
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

[[Page 61764]]

_______________________________________________________________________

1382. PROVIDER AND SUPPLIER ENROLLMENT PERIODIC RENEWAL OF ELIGIBILITY 
REQUIREMENTS (HCFA-1023-P)

Priority:  Other Significant

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 405

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 to more accurately identify providers and suppliers, and 
secure information and documentation necessary for the effective and 
efficient administration of the Medicare program. The improved 
identification of providers and suppliers, coupled with the collection 
of certain information, would 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 would 
afford both the Medicare Trust Funds and program beneficiaries with 
greater protection.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: HCFA-1023-P

Agency Contact: Kim Sullivan, Center for Health Plans and Providers, 
Provider Purchasing and Administration Group, Department of Health and 
Human Services, Health Care Financing Administration, C-4-12-26, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5374

RIN: 0938-AH73
_______________________________________________________________________

1383. 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:  Other 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); 42 CFR 488.1

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                            06/12/98                    63 FR 32290


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
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
_______________________________________________________________________

1384. REVISIONS TO CONDITIONS FOR COVERAGE FOR AMBULATORY SURGICAL 
CENTERS (HCFA-3887-P)

Priority:  Other Significant

Legal Authority:  42 USC 1302; 42 USC 1395hh

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: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
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 Boulevard, S2-199.06, Baltimore, MD 21244
Phone: 410 786-6747

RIN: 0938-AH83
_______________________________________________________________________

1385. 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: Next Action Undetermined

Regulatory Flexibility Analysis Required: 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, S1-07-06, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-3342

RIN: 0938-AH87
_______________________________________________________________________

1386. 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

[[Page 61765]]

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: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
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
_______________________________________________________________________

1387. 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: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1388. MEDICARE PROGRAM; MEDICARE INTEGRITY PROGRAM (HCFA-7020-F)

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 rule will 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 rule will 
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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/20/98                    63 FR 13590


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

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
_______________________________________________________________________

1389. 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: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Cheryl Slay, Director, Division of Beneficiary 
Protections, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd., Baltimore, MD 21244-1850
Phone: 410 786-6478

RIN: 0938-AI11
_______________________________________________________________________

1390. 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

CFR Citation:  42 CFR ch IV

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

[[Page 61766]]

1848(d) and (f) of the Social Security Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           10/31/97                    62 FR 59261


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

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
_______________________________________________________________________

1391. 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: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

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
_______________________________________________________________________

1392. MEDICAID: MEDICAL CHILD SUPPORT (HCFA-2081-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1302; 42 USC 1396a(a)(60); 42 USC 1396g

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

Regulatory Flexibility Analysis Required: Yes
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
_______________________________________________________________________

1393. 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/08/98                    63 FR 25576


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
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, C4-07-17, Baltimore, MD 21244
Phone: 410 786-4487

RIN: 0938-AI22
_______________________________________________________________________

1394. MEDICARE PROGRAM; NOTICE FOR THE SOLICITATION FOR PROPOSALS FOR A 
CASE MANAGEMENT DEMONSTRATION PROJECT FOCUSED ON CONGESTIVE HEART 
FAILURE OR DIABETES MELLITUS (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 or diabetes mellitus in the Medicare fee-
for-service program. Section 402(a) of the Social

[[Page 61767]]

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                          06/11/98                    63 FR 32015


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

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, Baltimore, MD 21244
Phone: 410 786-7762
Email: [email protected]

RIN: 0938-AI26
_______________________________________________________________________

1395. 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM Allotments and State 
Payment Policies                12/00/99

Regulatory Flexibility Analysis Required: Yes
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: 410 786-5647

RIN: 0938-AI28
_______________________________________________________________________

1396. 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

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1397. 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 qualified individuals.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

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: [email protected]

RIN: 0938-AI39

[[Page 61768]]

_______________________________________________________________________

1398. 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 we provide that confer benefits on specific 
individuals that are over and above those benefits received by the 
general public.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1399. MEDICARE PROGRAM; PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED 
BILLING FOR SKILLED NURSING FACILITIES. (HCFA-1913-IFC)

Priority:  Economically 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              05/12/98                    63 FR 26252


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
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
_______________________________________________________________________

1400. 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.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
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
_______________________________________________________________________

1401. APPEALS OF CARRIER DETERMINATION THAT A SUPPLIER FAILS TO MEET THE 
REQUIREMENTS FOR MEDICARE BILLING PRIVILEGES (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 number. The purpose of this rule 
is to update and clarify our policy and extend administrative appeal 
rights to all current and prospective suppliers who are denied 
enrollment in the Medicare program or whose Medicare billing privileges 
are revoked. This rule does not apply to those suppliers covered under 
the appeals provisions for our regulations at 42 CFR 498.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Charles Waldhauser, Division of Provider/Supplier 
Enrollment, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd., Baltimore, MD 21244-1850
Phone: 410 786-6140

RIN: 0938-AI49
_______________________________________________________________________

1402.  REVIEW AND PAYMENT FOR CLAIMS FILED ON BEHALF OF 
MEDICARE/MEDICAID DUALLY ELIGIBLE BENEFICIARIES (HCFA-2097-3)

Priority:  Other Significant

Legal Authority:  42 USC 1395cc

CFR Citation:  42 CFR 489.53

Legal Deadline: None

Abstract: This rule clarifies that it is the responsibility of a 
provider to bill Medicare appropriately, and not the responsibility of 
Medicaid agencies. It also clarifies that States and providers must 
work together to prescreen claims to determine if basic Medicare

[[Page 61769]]

eligibility and coverage requirements are met and that all the regular 
Medicare claims filing rules and procedures, including time limits for 
filing claims, are followed.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: State, Tribal

Agency Contact: Robert Nakielng, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd, S2-14-26, Baltimore, MD 
21244
Phone: 410 786-4466

RIN: 0938-AI50
_______________________________________________________________________

1403. SECURITY AND ELECTRONIC SIGNATURE STANDARDS (HCFA-0049-P)

Priority:  Economically Significant. Major under 5 USC 801.

Legal Authority:  42 USC 1320d

CFR Citation:  45 CFR 142

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

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

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 21244
Phone: 410 786-2976

RIN: 0938-AI57
_______________________________________________________________________

1404. STATE PLAN REQUIREMENTS FOR DURABLE MEDICAL EQUIPMENT PROVIDERS 
(HCFA-2007-P)

Priority:  Other Significant

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

Legal Authority:  42 USC 1396aa

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

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Governmental Jurisdictions

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, S2-26-12, Baltimore, MD 
21244
Phone: 410 786-2011
Email: [email protected]

RIN: 0938-AI63
_______________________________________________________________________

1405. 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:  42 CFR ch IV

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 are 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

Regulatory Flexibility Analysis Required: 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, S3-14-06, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-2014
Email: [email protected]

RIN: 0938-AI64
_______________________________________________________________________

1406. STATE CHILDREN'S HEALTH INSURANCE PROGRAM 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:  42 CFR 457.200; 42 CFR 457.202; 42 CFR 457.204; 42 CFR 
457.206; 42 CFR 457.208; 42 CFR 457.210; 42 CFR 457.212; 42 CFR 
457.216; 42 CFR 457.218; 42 CFR 457.600; 42 CFR 457.602; 42 CFR 
457.606; 42 CFR 457.608; 42 CFR 457.610; 42 CFR 457.614

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

[[Page 61770]]

payment (FFP) for expenditures under the State Children's Health 
Insurance Program and related Medicaid expansions.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State, Federal

Additional Information: CFR CITATION CONT: 42 CFR 457.220; 42 CFR 
457.222; 42 CFR 457.224; 42 CFR 457.226; 42 CFR 457.228; 42 CFR 
457.230; 42 CFR 457.232; 42 CFR 457.234; 42 CFR 457.236; 42 CFR 457.238

Agency Contact: Richard Strauss, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, S3-14-06, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-2019
Email: [email protected]

RIN: 0938-AI65
_______________________________________________________________________

1407. DSH PAYMENTS - INSTITUTION FOR MENTAL DISEASE (HCFA-2012-N)

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:  42 CFR ch IV

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 the 
DSH reporting requirements required by section 4721(b) of the Balanced 
Budget Act of 1997.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

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, S2-05-27, Baltimore, MD 
21244
Phone: 410 786-4578

RIN: 0938-AI66
_______________________________________________________________________

1408. 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

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Bill Coons, Center for Medicaid and State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-5921

RIN: 0938-AI67
_______________________________________________________________________

1409. RECOGNITION OF THE COMMUNITY HEALTH ACCREDITATION PROGRAM, INC. 
(CHAP) AND JOINT COMMISSION FOR ACCREDITATION OF HEALTHCARE 
ORGANIZATIONS (JCAHO) FOR HOSPICES (HCFA-2029-PN)

Priority:  Routine and Frequent

Legal Authority:  42 USC 1395bb(b)(1)

CFR Citation:  42 CFR ch IV

Legal Deadline:  Other, Statutory, September 8, 1998.
The statue requires us to publish a notice within 60 days of receipt of 
a completed application.

Abstract: This notice announces the receipt of an application from the 
Community Health Accreditation Program, Inc. (CHAP) and Joint 
Commission for Accreditation of Healthcare Organizations (JCAHO) for 
recognition as a national accreditation program for hospices that wish 
to participate in the Medicare or Medicaid programs.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Joan Barry, Center for Medicaid and State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, Baltimore, MD 21244-1850
Phone: 410 786-7233
Email: [email protected]

RIN: 0938-AI69
_______________________________________________________________________

1410. 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

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

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

[[Page 61771]]

_______________________________________________________________________

1411. 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

Regulatory Flexibility Analysis Required: No

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: [email protected]

RIN: 0938-AI73
_______________________________________________________________________

1412. 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 
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

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1413. 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

Regulatory Flexibility Analysis Required: 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
_______________________________________________________________________

1414. 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 1395x(v); 42 USC 1395hh

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

Regulatory Flexibility Analysis Required: Yes
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
_______________________________________________________________________

1415. MEDICARE HOSPICE CARE (HCFA-1022-P)

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

Unfunded Mandates: Undetermined

[[Page 61772]]

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

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1416. STATE ALLOTMENTS FOR ADDITIONAL FEDERAL FUNDING OF EMERGENCY 
HEALTH SERVICES FURNISHED TO UNDOCUMENTED ALIENS: FEDERAL FISCAL YEARS 
1998 THROUGH (HCFA-2001-N)

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

Legal Authority:  PL 105-33, sec 4723

CFR Citation:  42 CFR ch IV

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 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

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1417. 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) in 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

Regulatory Flexibility Analysis Required: No

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, S2-08-17, Baltimore, MD 21244
Phone: 410 786-5855
Email: [email protected]

RIN: 0938-AI79
_______________________________________________________________________

1418. 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

Regulatory Flexibility Analysis Required: 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

[[Page 61773]]

Services, Health Care Financing Administration, 7500 Security Blvd, 
Baltimore, MD 21244
Phone: 410 786-4599

RIN: 0938-AI80
_______________________________________________________________________

1419. 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

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1420. 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 hospice 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 notice will provide 
the wage index values for the second transition year as required.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: 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
_______________________________________________________________________

1421. MEDICARE PROGRAM; STANDARDIZATION OF MEDICARE COVERAGE FOR BONE 
MASS MEASUREMENTS (HCFA-3004-IFC)

Priority:  Economically 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 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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              07/24/98                    63 FR 34320


Next Action Undetermined

Regulatory Flexibility Analysis Required: 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
_______________________________________________________________________

1422. 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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/30/98                    63 FR 23790


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes
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
_______________________________________________________________________

1423.  HEALTH INSURANCE REFORM UNIVERSAL HEALTH CARE IDENTIFIER 
(HCFA-0048-NOI)

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

Unfunded Mandates: Undetermined

Legal Authority:  42 USC 1320d-2

CFR Citation:  42 CFR ch IV

Legal Deadline:  Final, Statutory, February 28, 1998.

Abstract: This notice announces our intent to publish a proposed rule 
on requirements for a unique health identifier for individuals. These 
requirements are mandated by law and are part of a national framework 
for health data standards and health information privacy that will 
support

[[Page 61774]]

the efficient electronic exchange of specified administrative and 
financial health care transactions. This notice discusses the options 
for the identifier that have been put forward for consideration and 
asks for public comments.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Mary Emerson, Office of Information Services; 
Information, Management, Department of Health and Human Services, 
Health Care Financing Administration, 7500 Security Blvd, Baltimore, MD 
21244
Phone: 410 786-7065

RIN: 0938-AI91
_______________________________________________________________________

1424.  COVERAGE AND ADMINISTRATIVE POLICIES FOR CLINICAL 
DIAGNOSTIC LABORATORY TESTS; INTENT TO FORM NEGOTIATED RULEMAKING 
COMMITTEE (HCFA-3250-NOI)

Priority:  Other Significant

Legal Authority:  PL 105-33, sec 4554(b)(i)

CFR Citation:  42 CFR ch IV

Legal Deadline:  Final, Statutory, January 1, 1999.

Abstract: The Balanced Budget Act of 1997 requires the Secretary to 
establish a negotiated rulemaking committee under the Negotiated 
Rulemaking Act and Federal Advisory Committee Act. The Negotiated 
Rulemaking Committee's (the Committee) purpose will be to negotiate 
national coverage and administrative policies for clinical diagnostic 
laboratory tests under part B of the Medicare program as required by 
the Balanced Budget Act of 1997 (BBA). The Committee will consist of 
representatives of interested parties that are likely to be 
significantly affected by the proposed rule. The Committee will be 
assisted by a neutral facilitator. This notice outlines the scope of 
issues to be negotiated by the Committee and requests public comments 
as to whether we have identified the interests that will be affected by 
the key issues.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Jackie Sheridan, Office Of Clinical Standards & 
Quality, Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-4635
Judy Ballard, Office of Clinical Standards & Quality, Department of 
Health and Human Services, Health Care Financing Administration, 7500 
Security Blvd, Baltimore, MD 21244
Phone: 202 690-7419

RIN: 0938-AI92
_______________________________________________________________________

1425.  MEDICAID, MEDICARE CLIA PROGRAM; EXTENSION OF CERTAIN 
EFFECTIVE DATES FOR CLINICAL LABORATORY REQUIREMENTS UNDER CLIA (HCFA 
2024-IFC)

Priority:  Other Significant

Legal Authority:  42 USC 263a

CFR Citation:  42 CFR 493

Legal Deadline: None

Abstract: This final rule extends certain effective dates for clinical 
laboratory requirements that implemented provisions of CLIA. It also 
extends the phase-in date of certain quality control requirements and 
extends the date by which an individual with a doctoral degree must 
possess board certification to qualify as a director of a laboratory 
that performs high complexity testing.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Federal

Additional Information: If we fail to publish this rule, certain 
laboratories and individuals will not meet the requirements and, 
consequently, some individuals may not qualify for positions they 
currently hold. In addition, some laboratories will be subject to more 
stringent CLIA quality control regulations.

Agency Contact: Diane Milstead, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-3355

RIN: 0938-AI94
_______________________________________________________________________

1426.  HOSPITAL CONDITIONS OF PARTICIPATION, IDENTIFICATION OF 
POTENTIAL ORGAN, TISSUE, AND EYE DONOR AND TRANSPLANT HOSPITALS 
PROVISIONS OF TRANSPLANT RELATED DATA (HCFA-3005-F)

Priority:  Other Significant

Legal Authority:  42 USC 1320(b)(8); 42 USC 1395x(e); 42 USC 1396d(a)

CFR Citation:  42 CFR 482

Legal Deadline: None

Abstract: This final rule addresses only provisions relating to organ 
donation and transplantation, by requiring a hospital to meet several 
requirements designed to increase organ donation. These requirements 
include that the hospital have an agreement with the Organ Procurement 
Organization (OPO) to contact the OPO about every death or imminent 
death that occurs in the hospital. This final rule also requires a 
hospital to work with the OPO and at least one tissue bank and one eye 
bank in educating staff on donation issues, reviewing death records, 
and maintaining potential donors while necessary testing and placement 
of organs and tissues take place. Additionally, this final rule 
requires transplant hospitals to provide organ-transplant-related data, 
as requested by the Organ Procurement and Transplantation Network 
(OPTN), the Scientific Registry, and the OPOs. The hospital must also 
provide, if requested, such data directly to the Department.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/19/97                    62 FR 66726
NPRM Comment Period End         03/03/98


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses

Government Levels Affected: State

Agency Contact: Marcia Newton, Office Of Clinical Standards and 
Quality, Department of Health and Human Services, Health Care Financing

[[Page 61775]]

Administration, S3-0201, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-5265

RIN: 0938-AI95
_______________________________________________________________________

1427.  MEDICARE PROGRAM; MONTHLY ACTUARIAL RATES AND MONTHLY 
SUPPLEMENTARY MEDICAL INSURANCE PREMIUM RATE BEGINNING JANUARY 1, 1999 
(HCFA-8003-N)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 1395r

CFR Citation:  42 CFR ch IV

Legal Deadline: None

Abstract: This notice announces the monthly actuarial rates for aged 
(age 65 and over) and disabled (under age 65) enrollees in the Medicare 
Supplementary Insurance (SMI) Program for the 12 months beginning 
January 1, 1999. It also announces the monthly SMI premium rate to be 
paid by all enrollees during the 12 months beginning January 1, 1999.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Carter S. Warfield, Office of Medicare and Medicaid 
Cost, Estimates, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-6396

RIN: 0938-AI98
_______________________________________________________________________

1428.  PEER REVIEW ORGANIZATION CONTRACTS: SOLICITATION OF 
STATEMENTS OF INTEREST FROM IN-STATE ORGANIZATIONS (HCFA-3009-N)

Priority:  Other Significant

Legal Authority:  44 USC 35

CFR Citation:  42 CFR ch IV

Legal Deadline: None

Abstract: This notice, in accordance with section 1153(i) of the Social 
Security Act, gives at least 6 months' advance notice of the expiration 
dates of contracts with out-ot-state utilization and quality control 
peer review organizations. It also specifies the period of time in 
which in-state organizations may submit a statement of interest so that 
they may be eligible to compete for these contracts.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

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: Udo Nwachukwu, Office of Clinical Standards and 
Quality, Department of Health and Human Services, Health Care Financing 
Administration, 75OO Security Blvd, Baltimore, MD 21244
Phone: 410 786-7234

RIN: 0938-AI99
_______________________________________________________________________

1429.  REPLACEMENT OF REASONABLE CHARGE METHODOLOGY BY FEE 
SCHEDULES (HCFA-1010-P)

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 13945u

CFR Citation:  42 CFR 414

Legal Deadline: None

Abstract: We are proposing to implement fee schedules to be used for 
payment of services, excluding ambulance services, still subject to the 
reasonable charge payment methodology.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Joel Kaiser, Center for Health Plan and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-4499

RIN: 0938-AJ00
_______________________________________________________________________

1430.  NOTICE ANNOUNCING REVISED POSITRON EMISSION TOMOGRAPHY 
(PET) POLICY (HCFA-3008-NC)

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

Unfunded Mandates: Undetermined

Legal Authority:  42 USC 1302

CFR Citation:  42 CFR ch IV

Legal Deadline: None

Abstract: Memorandum was published in January 1998 clarifying existing 
policy on PET. This notice describes the process HCFA will use to 
review additional uses of PET and also lists a priority list for 
reviewing additional uses.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Federal

Agency Contact: Ron Milhourn, Office of Clinical Standards & Quality, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-5666
Email: [email protected]

RIN: 0938-AJ01
_______________________________________________________________________

1431.  MEDICARE PROGRAM; INPATIENT HOSPITAL DEDUCTIBLE AND 
HOSPITAL AND EXTENDED CARE SERVICES COINSURANCE AMOUNTS FOR 1999 (HCFA-
8001-N)

Priority:  Other Significant

Legal Authority:  42 USC 1395i to 2(d)2; 42 USC 1395i to 2a(d)2

CFR Citation:  42 CFR ch IV

Legal Deadline:  Other, Statutory, September 15, 1998.
Must be published between Sept. 1, and Sept. 15, 1998

Abstract: This notice announces the inpatient hospital deductible and 
the hospital and extended care services Coinsurance amounts for 
services furnished in calendar year 1999 under Medicares' hospital 
insurance program (Medicare part A). This will be effective January 1, 
1999. This is an annual update.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: John Wandishin, OACT, Department of Health and

[[Page 61776]]

Human Services, Health Care Financing Administration, 7500 Security 
Blvd, Baltimore, MD 21244
Phone: 410 786-6389

RIN: 0938-AJ02
_______________________________________________________________________

1432.  MEDICARE PROGRAM; PART A PREMIUM FOR 1999 FOR THE 
UNINSURED AGED AND FOR CERTAIN DISABLED INDIVIDUALS WHO HAVE EXHAUSTED 
OTHER ENTITLEMENT (HCFA-8000-N)

Priority:  Other Significant

Legal Authority:  42 USC 1395i to 2(d)2; 42 USC 1395i to 2a(d)2

CFR Citation:  42 CFR ch IV

Legal Deadline: None
Must be published in September of each year.

Abstract: This notice will announce the hospital insurance premium for 
calendar year 1999 under Medicare's hospital insurance program (part A) 
for the uninsured aged and for certain disabled individuals who have 
exhausted other entitlement. This will be effective January 1, 1999 for 
the qualifying individuals. This is an annual update.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: John Wandishin, Actuary, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security Blvd, 
Baltimore, MD 21244
Phone: 410 786-6389
Fax: 410 786-1295
Email: [email protected]

RIN: 0938-AJ03
_______________________________________________________________________

1433.  INPATIENT PSYCHIATRIC SERVICES BENEFIT FOR INDIVIDUALS 
UNDER AGE 21 (HCFA-2060-F)

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

CFR Citation:  42 CFR ch IV

Legal Deadline: None

Abstract: This rule removes the requirement for accreditation of 
hospitals and health care facilities by the Joint Commission for 
approval of Medicare coverage of the inpatient psychiatric services 
benefit for individuals under 21.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Winona Hocutt, Center for Medicaid and States 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd, Baltimore, MD 21224
Phone: 410 786-4666

RIN: 0938-AJ05
_______________________________________________________________________

1434.  EXTERNAL QUALITY REVIEW OF MEDICAID MANAGED CARE 
ORGANIZATIONS (HCFA-2015-P)

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

Unfunded Mandates: Undetermined

Legal Authority:  42 USC 1302

CFR Citation:  42 CFR 438

Legal Deadline: None

Abstract: This proposed rule would amend the regulation to conform with 
the provisions of section 4705 of the Balanced Budget Act of 1997. It 
would require State Agencies that contract with managed care 
organizations to implement quality improvement strategies that address 
access and other aspects of care and services directly that related to 
the quality of care provided by these managed care organizations, 
performance through annual external independent reviews conducted by 
accrediting organizations that are approved by HCFA.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Kathleen Headen, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-6865

RIN: 0938-AJ06
_______________________________________________________________________

1435.  PHYSICIAN SUSTAINABLE GROWTH RATE OF INCREASE FOR FY 1999 
(HCFA-1021-FN)

Priority:  Other Significant

Legal Authority:  42 USC 1395w(4)(f)

CFR Citation:  42 CFR ch IV

Legal Deadline:  Final, Statutory, October 1, 1998.

Abstract: This final notice announces the fiscal year 1999 sustainable 
growth rate (SGR) for expenditures for physician's services under the 
Medicare Supplementary Medical Insurance (part B) program as required 
by section 1848(f) of the Social Security Act.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Elizabeth Holland, Center for Health Plans and 
Providers, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-1309

RIN: 0938-AJ09
_______________________________________________________________________

1436.  COMPREHENSIVE ASSESSMENT AND USE OF OASIS AS PART OF 
CONDITIONS OF PARTICIPATION FOR HOME HEALTH AGENCIES (HCFA-3007-F)

Priority:  Substantive, Nonsignificant

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

Legal Authority:  42 USC 1302; 42 USC 1395(hh)

CFR Citation:  42 CFR 484.18; 42 CFR 484.55

Legal Deadline: None

Abstract: This final rule requires that each patient receive from the 
HHA a patient-specific comprehensive assessment that identifies the 
patient's need for home care and meets the

[[Page 61777]]

patient's medical, nursing, rehabilitative, social and discharge 
planning needs. This final rule also requires that as part of the 
comprehensive assessment, HHAs use a standard core assessment data set, 
the ``Outcome and Assessment Information Set'' (OASIS) when evaluating 
adult, non-maternity patients.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/10/97                    62 FR 11004
NPRM Comment Period End         06/09/97
ANPRM Comment Period End        05/15/98


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Janice Stevenson, Office of Clinical Standards and 
Quality, Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-4882
Mary Weakland, Center for Medicaid and State Operations, Department of 
Health and Human Services, Health Care Financing Administration, 7500 
Security Blvd, Baltimore, MD 21244
Phone: 410 786-6835

RIN: 0938-AJ11
_______________________________________________________________________

1437.  MEDICARE AND MEDICAID PROGRAMS; QUARTERLY LISTING OF 
PROGRAM ISSUANCES--FIRST QUARTER 1998 (HCFA-9879-NC)

Priority:  Routine and Frequent

Unfunded Mandates: Undetermined
Major: Undetermined

Legal Authority:  42 USC 1302

CFR Citation:  42 CFR ch IV

Legal Deadline: None

Abstract: This notice lists regulations and notices that relate to the 
Medicare and Medicaid programs that were published during January, 
February, and March of 1998.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Bridget Wilhite, Office of Communications and 
Operations, Support, Department of Health and Human Services, Health 
Care Financing Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-5248

RIN: 0938-AJ12
_______________________________________________________________________

1438.  MEDICARE PROGRAM; CRITERIA AND STANDARDS FOR EVALUATING 
INTERMEDIARY AND CARRIER PERFORMANCE: MILLENNIUM COMPLIANCE (HCFA-4002-
GNC)

Priority:  Info./Admin./Other

Legal Authority:  42 USC 1395(h); 42 USC 1395 (u)

CFR Citation:  42 CFR ch IV

Legal Deadline: None

Abstract: This notice revises the criteria and standards to be used for 
evaluating the performance of our contractors in administering the 
Medicare program. The revisions establish a performance standard 
requiring contractors to meet requirements for millennium compliance. 
We require contractors to certify that they have made all necessary 
system(s) changes and have tested those systems in accordance with our 
guideline.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

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: Sue Lathroum, Center for Beneficiary Service, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-7409

RIN: 0938-AJ15
_______________________________________________________________________

1439.  RURAL HEALTH CLINICS: AMENDMENTS TO PARTICIPATION 
REQUIREMENTS AND PAYMENT PROVISIONS, AND ESTABLISHMENT OF A QUALITY 
ASSESSMENT AND IMPROVEMENT PROGRAM (HCFA-1910-P)

Priority:  Other Significant

Legal Authority:  42 USC 1302; 42 USC 1395hh

CFR Citation:  42 CFR 405

Legal Deadline: None

Abstract: This proposed rule would amend our requirements to revise 
certification and payment requirements for rural health clinics (RHCs) 
as required by section 4205 of the Balanced Budget Act of 1997 (BBA 
1997). It would include new refinements of what constitutes a 
qualifying rural shortage area in which a medicare RHC must be located; 
establish criteria for identifying RHCs essential to delivery of 
primary care services that can continue to be approved as medicare RHCs 
in areas no longer designated as medically underserved; and include 
recent statutory provisions that provide a temporary waiver of certain 
nonphysician practitioner staffing requirement. It would impose payment 
limits on provider based RHCs, prohibit commercial use, the use of 
space equipment and other resources of an RHC by another entity. The 
rule also requires establishment of a quality assessment and 
performance improvement program.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: David Vorgo, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-5919
Email: [email protected]

RIN: 0938-AJ17

[[Page 61778]]

_______________________________________________________________________

1440.  ADJUSTMENTS TO PAYMENT AMOUNT FOR ERYTHROPOIETIN/EPOIETIN 
FOR END-STAGE RENAL DISEASE PATIENTS (HCFA-1098-PN)

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

Unfunded Mandates: Undetermined

Legal Authority:  42 USC 1395rr(b)(11)(B)

CFR Citation:  42 CFR 413.174

Legal Deadline: None

Abstract: This proposed notice announces HCFA's proposed revision in 
the payment amount to Medicare-approved renal dialysis facilities and 
suppliers of home dialysis equipment and supplies for Erythopoietin/
Epoietin (EPO), and anti-anemia drugs administered to certain patients 
with end-stage renal disease (ESRD).

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Henry E. Richter, Center for Health Plans and 
Providers, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd, C5-05-24, Baltimore, MD 
21244
Phone: 410 786-4562

RIN: 0938-AJ18
_______________________________________________________________________

1441.  RECOGNITION OF THE COMMISSION FOR ACCREDITATION OF 
REHABILITATION FACILITIES (HCFA-2036-NC)

Priority:  Info./Admin./Other

Legal Authority:  42 USC 1395bb

CFR Citation:  42 CFR 785

Legal Deadline: None

Abstract: This notice with comment period announces and invites 
comments on the receipt of an application from the commission for 
accreditation of rehabilitation facilities (CARF) for recognition as a 
national accreditation organization with deemed status authority. The 
Social Security Act requires HCFA to publish this notice in which we 
identify the national accreditation body making the application, 
describe the nature of the request, and provide a 30-day comment period 
to solicit public comments on this request.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Susan Cuerdon, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-1146

RIN: 0938-AJ25
_______________________________________________________________________

1442.  REVISED RESERVED ALLOTMENTS TO STATES FOR FISCAL YEAR 
1998 (HCFA-2037-N)

Priority:  Info./Admin./Other

Legal Authority:  PL 105-174

CFR Citation:  Not yet determined

Legal Deadline: None

Abstract: This notice provides notification of the revised reserved 
fiscal year (FY) 1998 State allotments available to provide Federal 
funding to individual States, Commonwealths, and Territories for 
expenditures in the new State Children's Health Insurance Program 
(CHIP) established under title XXI of the Social Security Act (the 
Act). The reserved FY 1998 State CHIP allotments were originally 
published in the Federal Register on September 12, 1997. This notice 
describes the methodology and process that HCFA uses to determine the 
reserved State CHIP allotments in accordance with section 2104 of the 
Act, and explains the reason for this revision to the FY 1998 reserved 
allotments.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Richard Strauss, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-2019
Email: [email protected]

RIN: 0938-AJ26
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)   Completed Actions
Health Care Financing Administration (HCFA)
_______________________________________________________________________

1443. MEDICARE COVERAGE OF OUTPATIENT OCCUPATIONAL THERAPY SERVICES 
(HCFA-1425-P)

Priority:  Substantive, Nonsignificant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Issues have been 
covered in HCFA-1006-P          06/05/98

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Sheridan Gladhill
Phone: 410 786-1782

RIN: 0938-AD32
_______________________________________________________________________

1444. 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.

CFR Citation:  42 CFR 489

[[Page 61779]]

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/29/97                    62 FR 56106
Final Action Effective          11/28/97

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: David Walczak
Phone: 410 786-4475

RIN: 0938-AG03
_______________________________________________________________________

1445. 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 
duplication, or streamline requirements.

CFR Citation:  42 CFR 493

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/14/98                    63 FR 26722
Final Action Effective          06/15/98

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Judy Yost
Phone: 410 786-3531

RIN: 0938-AH82
_______________________________________________________________________

1446. MEDICARE PROGRAM: UPDATE OF AMBULATORY SURGICAL CENTER PAYMENT 
RATES EFFECTIVE FOR SERVICES ON OR BEFORE OCTOBER 1, 1997 (HCFA-1897-N)

Priority:  Other Significant

CFR Citation:  42 CFR 416.25

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    02/19/98                     63 FR 8462
Final Action Effective          10/01/97

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Joan Sanow
Phone: 410 786-5763

RIN: 0938-AI18
_______________________________________________________________________

1447. SOLVENCY STANDARDS FOR PROVIDER-SPONSORED ORGANIZATIONS (HCFA-
1011-IFC)

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Duplicate of RIN 
0938-AI83                       07/07/98

RIN: 0938-AI25
_______________________________________________________________________

1448. MEDICARE/MEDICAID PROGRAM: SURETY BOND REQUIREMENTS FOR HOME 
HEALTH AGENCIES (HCFA-1152.2-F)

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Duplicate of RIN 
0938-AJ08                       07/31/98

RIN: 0938-AI86
_______________________________________________________________________

1449.  MEDICARE AND MEDICAID PROGRAMS; SURETY BOND REQUIREMENTS 
FOR HOME HEALTH AGENCIES (HCFA-1152.2F)

Priority:  Other Significant

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 489.67

Legal Deadline: None

Abstract: This final rule revises Medicare and Medicaid regulations 
concerning surety bond requirements published in the Federal Register 
(63 FR 29648) on June 1, 1998. Those regulations specified submission 
compliance dates for all home health agencies (HHAs) to furnish a 
surety bond to HCFA and/or to the State Medicaid agency. This rule 
removes those submission compliance dates.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/31/98                    63 FR 41169

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

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
Mary Linda Morgan, Center for Medicaid and State Operations, Department 
of Health and Human Services, Health Care Financing Administration, 
7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-2011

RIN: 0938-AJ08

[[Page 61780]]

_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Administration for Children and Families (ACF)
_______________________________________________________________________

1450. TITLE IV-E FOSTER CARE ELIGIBILITY REVIEWS AND CHILD AND FAMILY 
SERVICES STATE PLAN REVIEWS, MEPA IMPLEMENTATION, ASFA IMPLEMENTATION, 
AND BASIC STATE GRANT PROGRAM

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; 45 CFR 1357

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

Abstract: This rule will contain 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 
contain 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 rule will provide 
for enforcement of the prohibition on race-based discrimination in the 
foster care and adoptive placements.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/18/98                    63 FR 50058
NPRM Comment Period End         12/17/98
Final Action                    11/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Additional Information: This action was previously reported under RIN 
0970-AB60.

Agency Contact: Kathleen McHugh, ACYF/Children's Bureau, Department of 
Health and Human Services, Administration for Children and Families, 
Washington, DC 20013
Phone: 202 401-5789
Email: [email protected]

RIN: 0970-AA97
_______________________________________________________________________

1451. 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                            12/00/98

Regulatory Flexibility Analysis Required: No
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
_______________________________________________________________________

1452. METHODOLOGY FOR DETERMINING WHETHER AN INCREASE IN A STATE'S CHILD 
POVERTY RATE IS THE RESULT OF THE TANF PROGRAM

Priority:  Other Significant

Legal Authority:  42 USC 613(i)

CFR Citation:  45 CFR 284 (New)

Legal Deadline: None

Abstract: This rule will set forth a methodology to determine whether 
an increase in a State's child poverty rate is the result of the TANF 
Program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/23/98                    63 FR 50837
NPRM Comment Period End         11/23/98
Final Action                    10/00/99

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1453. 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:  45 CFR 285 (New)

Legal Deadline: None

Abstract: The Administration for Children and Families, in consultation 
with the National Governor's Association and the American Public 
Welfare Association (now known as the American Public Human Services 
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                            02/00/99

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1454. CHILD SUPPORT ENFORCEMENT FOR INDIAN TRIBES

Priority:  Other Significant

Legal Authority:  42 USC 655(f)

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-

[[Page 61781]]

D, including establishment of paternity, modification and enforcement 
of support orders, and location of absent parents.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/99

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1455. 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 rule sets forth a process for: the completion and 
submission of tribal TANF plans; the determination of funding levels 
for tribal TANF grants; the establishement of criteria to determine 
minimum work participation requirements and time limits for tribal TANF 
programs; and the review and approval of tribal TANF plans. This rule 
sets forth program requirements for the application of penalties and 
for data collection and reporting.
The rule also sets forth 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                            07/22/98                    63 FR 39366
NPRM Comment Period End         11/20/98
Final Action                    10/00/99

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1456. 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 would 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; this rule proposes to establish the refugee cash 
assistance program as a public/private partnership between States and 
local resettlement agencies.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/98

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1457. CHILD SUPPORT PENALTIES AND INCENTIVES

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 609(a)(8); 42 USC 658A

CFR Citation:  45 CFR 305; 45 CFR 302.55; 45 CFR 304.12

Legal Deadline:  NPRM, Statutory, April 1999.

Abstract: This regulation will implement the requirements in 42 USC 
609(a)(8) which provide 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. It will also implement a new incentive system, enacted 
under Pub.L. 105-200. Based on 42 USC 658A States will receive 
incentives according to their performance on key statutory indicators 
and performance standards from a capped pool of funds beginning in FY 
2000. These funds must be reinvested in the IV-D program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Joyce Pitts, 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: 202 401-5374
Fax: 202 401-5559
Email: [email protected]

RIN: 0970-AB85
_______________________________________________________________________

1458. 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 a Head Start program option.

[[Page 61782]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/99

Regulatory Flexibility Analysis Required: No
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
_______________________________________________________________________

1459. IMPLEMENTATION OF REMAINING PROVISIONS OF THE ADOPTION AND SAFE 
FAMILIES ACT OF 1997 AND OTHER TITLE IV-B/IV-E REGULATORY AMENDMENTS, 
AFCARS PENALTIES, AND CAPTA 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 foster care 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. The NPRM will also address AFCARS penalties and the Child 
Abuse Prevention and Treatment Act Amendments (formerly included in RIN 
0970-AB86).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Additional Information: Merge RIN 0970-AB86 with RIN 0970-AB94

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
_______________________________________________________________________

1460.  STATE SELF ASSESSMENTS OF STATE PLAN REQUIREMENTS TO 
DETERMINE COMPLIANCE WITH FEDERAL REGULATIONS

Priority:  Substantive, Nonsignificant

Legal Authority:  42 USC 654(15)(A)

CFR Citation:  45 CFR 306

Legal Deadline: None

Abstract: Would require States to conduct annual reviews on certain 
aspects of the State title IV-D Program and provide a report to the 
Secretary.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/99

Regulatory Flexibility Analysis Required: No
Small Entities Affected: No

Government Levels Affected: State

Agency Contact: John Seneta, Program Specialist, Office of Child 
Support Enforcement/DHHS, Department of Health and Human Services, 
Administration for Children and Families, 370 L'Enfant Promenade SW., 
Mail Stop: OCSE/DPP, Washington, DC 20447
Phone: 202 401-5154
Fax: 202 401-5559
Email: [email protected]

RIN: 0970-AB96
_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)    Final Rule Stage
Administration for Children and Families (ACF)
_______________________________________________________________________

1461. STANDARDS FOR SAFE TRANSPORTATION

Priority:  Other Significant

Legal Authority:  42 USC 9801 et seq

CFR Citation:  45 CFR 1310

Legal Deadline: None

Abstract: This rule establishes Head Start Performance Standards for 
the safe transportation of Head Start children, including vehicle 
requirements, driver qualifications and training and safety rules for 
children and staff while en route and loading and unloading of 
vehicles.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/15/95                    60 FR 31612
NPRM Comment Period End         08/14/95
Final Action                    06/00/99

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1462. 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.

[[Page 61783]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/01/94                    59 FR 61575
NPRM Comment Period End         01/30/95
Final Action                    12/00/98

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1463. 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

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1464. 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

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1465. TEMPORARY ASSISTANCE FOR NEEDY FAMILIES (TANF)

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

RIN: 0970-AB77
_______________________________________________________________________

1466. BONUS TO REWARD DECREASE IN ILLEGITIMACY RATIO

Priority:  Other Significant

Legal Authority:  42 USC 603(a)(2)

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                    02/00/99

Regulatory Flexibility Analysis Required: No

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
Fax: 202 690-6562
Email: [email protected]

RIN: 0970-AB79
_______________________________________________________________________

1467. 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; 45 CFR 301; 45 CFR 302; 45 CFR 
303

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              12/00/98

Regulatory Flexibility Analysis Required: No

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

[[Page 61784]]

Fax: 202 401-5559
Email: [email protected]

RIN: 0970-AB81
_______________________________________________________________________

1468. 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                    02/00/99

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1469. 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                            06/30/98                    63 FR 35554
NPRM Comment Period End         08/31/98
Final Action                    06/00/99

Regulatory Flexibility Analysis Required: No
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
_______________________________________________________________________

1470. WELFARE-TO-WORK DATA COLLECTION

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 
grantees must report for the Welfare-to-Work program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              10/00/98

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________

1471.  NATIONAL MEDICAL SUPPORT NOTICE

Priority:  Substantive, Nonsignificant

Legal Authority:  Not yet determined

CFR Citation:  45 CFR 310

Legal Deadline:  Final, Statutory, May 16, 2000.

Abstract: Joint DHHS/DOL regulations mandating use of a national 
medical support notice and including procedures for issuance and 
transmittal to employers by States to enforce health care coverage in a 
child support order.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              05/00/99

Regulatory Flexibility Analysis Required: Undetermined
Small Entities Affected: No

Government Levels Affected: State, Local, Tribal

Agency Contact: John Seneta, 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: 202 401-5154
Fax: 202 401-5559
Email: [email protected]

RIN: 0970-AB97

[[Page 61785]]

_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)   Completed Actions
Administration for Children and Families (ACF)
_______________________________________________________________________

1472. DESIGNATION OF ALTERNATIVE AGENCY TO SERVE INDIAN TRIBAL CHILDREN

Priority:  Substantive, Nonsignificant

CFR Citation:  45 CFR 1302

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/24/98                    63 FR 34328

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Organizations

Government Levels Affected: Tribal

Agency Contact: Douglas Klafehn
Phone: 202 205-8569

RIN: 0970-AB52
_______________________________________________________________________

1473. QUARTERLY WAGE AND UNEMPLOYMENT COMPENSATION CLAIMS REPORTING TO 
THE NATIONAL DIRECTORY OF NEW HIRES

Priority:  Substantive, Nonsignificant

CFR Citation:  45 CFR 303.108 (New)

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/02/98                    63 FR 36185

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Federal

Agency Contact: Anne M. Benson
Phone: 202 401-1467
Fax: 202 401-5559
Email: [email protected]

RIN: 0970-AB67
_______________________________________________________________________

1474. AUTOMATED DATA PROCESSING REQUIREMENTS/STATE CASE REGISTRY

Priority:  Other Significant

CFR Citation:  45 CFR 302.85; 45 CFR 304.20; 45 CFR 307

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/21/98                    63 FR 44795

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Michael P. Fitzgerald
Phone: 202 401-6403

RIN: 0970-AB70
_______________________________________________________________________

1475. AUTOMATED DATA PROCESSING FUNDING LIMITATION

Priority:  Other Significant

CFR Citation:  45 CFR 307.30

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/19/98                    63 FR 44401

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Helen Morgan Smith
Phone: 202 690-6639
Fax: 202 401-6400

RIN: 0970-AB71
_______________________________________________________________________

1476. CHILD CARE AND DEVELOPMENT FUND

Priority:  Other Significant

CFR Citation:  45 CFR 98; 45 CFR 99

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/24/98                    63 FR 39936

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Tribal

Agency Contact: Carmen Nazario
Phone: 202 690-6782

RIN: 0970-AB74
_______________________________________________________________________

1477. CHILD ABUSE AND NEGLECT PREVENTION AND TREATMENT

Priority:  Substantive, Nonsignificant

CFR Citation:  45 CFR 1340

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Merged With RIN 0970-AB94       08/12/98

Regulatory Flexibility Analysis Required: No
Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State

Agency Contact: Emily Cooke
Phone: 202 205-8709
Fax: 202 260-9351
Email: [email protected]

RIN: 0970-AB86
_______________________________________________________________________

1478. TITLE IV-E TRAINING

Priority:  Substantive, Nonsignificant

CFR Citation:  45 CFR 1356.60; 45 CFR 235.63 to 235.66(a)

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn - Postponed 
Indefinitely                    09/01/98

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Judith Reich
Phone: 202 205-8713

RIN: 0970-AB89

[[Page 61786]]

_______________________________________________________________________
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) Proposed Rule Stage
Administration on Aging (AOA)
_______________________________________________________________________

1479. 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 12/00/98

Regulatory Flexibility Analysis Required: Yes
Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Tribal

Additional Information: The Administration on Aging, in consultation 
with the Office of Management and Budget, has determined that it is no 
longer necessary to pursue final action on rules earlier proposed to 
implement the 1992 amendments to the Older Americans Act. The 
provisions of the Act remain in force and need no further regulations 
to implement them. AoA anticipates promulgating rules in the latter 
part of 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. 98-28281 Filed 11-06-98; 8:45 am]
BILLING CODE 4150-04-F