[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 64351]]

_______________________________________________________________________

Part VIII





Department of Health and Human Services





_______________________________________________________________________



Semiannual Regulatory Agenda

[[Page 64352]]



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 semi-annual publication of an 
Agenda outlining all current, projected and recently completed 
rulemakings. Executive Order 12866 also requires the publication by the 
Department of a regulatory plan for fiscal year 2000. The Agenda thus 
informs the public about regulatory actions under development within 
the Department, and it provides an opportunity for all concerned with 
the impact of the regulations to participate in their development at an 
early stage. The last such Agenda was published on April 26, 1999.

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 regulatory actions described below 
continue to reflect the Department's efforts to embody in its 
rulemaking actions the President's initiative to modernize the Federal 
regulatory system so that it helps deliver important services and 
benefits to the American people while creating fewer burdens. These 
regulatory actions also are an indication of emerging policy mandates 
for HHS involving such national priorities as: strengthening and 
streamlining the Medicare program; assuring the safety of the American 
food supply; establishing improved access to health services for 
children; shoring up recent advances in welfare reform and health-
insurance reform; and eliminating waste, fraud and abuse from the 
Nation's health care system. For this edition of the Department's 
regulatory agenda, the most significant regulatory actions are included 
in the Regulatory Plan, which appears in part II of this issue of the 
Federal Register. In the background of the Department's discharge of 
its regulatory responsibilities in all of the above-mentioned 
programmatic areas, there continues the focus and discipline with which 
the principles of Executive Order 12866 and the many subsequent 
regulatory reform initiatives of the Administration have vitalized the 
Department's regulatory functions. Public commentary is invited to 
assist the Department in continuing these efforts. Comments should be 
sent to the addresses listed below, depending on the specific agenda 
entry that is of interest. Comments may be sent to the Office of the 
Secretary, if the responsible component of the Department is not 
apparent or if a comment covers subjects crossing agency lines.

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

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

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

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

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

    Centers for Disease Control: Thena Durham, Executive 
Secretariat, 1600 Clifton Road, Building 16, Atlanta, Georgia 
30333; Phone 404-639-7120.

    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, 9000 Rockville 
Pike, Building 31, Room 1B25, Bethesda, Maryland 20205; Phone 301-
496-4606.

    Substance Abuse and Mental Health Services Administration: Rose 
Shannon, Executive Secretariat, 5600 Fishers Lane, Room 12-95, 
Rockville, Maryland, 20857; Phone 301-443-3779.

    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                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1093         Civil Money Penalties for Medicare+Choice Organizations and Medicaid Managed Care       0991-AB03
            Organizations.......................................................................
1094         Civil Money Penalty Safe Harbor to Protect Payment of Medicare and Medigap Premiums     0991-AB04
            for ESRD Beneficiaries..............................................................
1095         Safe Harbor for Ambulance Re-Stocking..............................................     0991-AB05
1096         Safe Harbor for Arrangements Involving Federally Qualified Health Centers..........     0991-AB06
----------------------------------------------------------------------------------------------------------------


[[Page 64353]]


                                    Office of the Secretary--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1097         Clarification of the Initial OIG Safe Harbor Provisions and Establishment of            0991-AA66
            Additional Safe Harbor Provisions Under the Anti-Kickback Statute...................
1098         Reproduction and Sale of Official Forms and Publications...........................     0991-AA83
1099         Revised OIG Civil Money Penalties Resulting From Public Law 104-191................     0991-AA90
1100         Shared Risk Exception to the Safe Harbor Provisions................................     0991-AA91
1101         Block Grant Programs...............................................................     0991-AA97
1102         Health Care Fraud and Abuse Data Collection Program................................     0991-AA98
1103         Privacy Act Exempt Record System from the Healthcare Integrity and Protection Data      0991-AA99
            Bank................................................................................
1104         Standards for Privacy of Individually Indentifiable Health Information (Reg Plan        0991-AB08
            Seq. No. 27)........................................................................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.


                                   Office of the Secretary--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1105         Revised OIG Sanction Authorities Resulting From Public Law 105-33..................     0991-AA95
1106         Revision of HHS Freedom of Information Act Regulations.............................     0991-AB01
1107         Further Clarifications to the Safe Harbor Provisions Under the Anti-Kickback            0991-AB07
            Statute.............................................................................
----------------------------------------------------------------------------------------------------------------


                         Centers for Disease Control and Prevention--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1108         Interstate Shipment of Biological Materials That Contain or May Contain Infectious      0920-AA02
            Substances..........................................................................
----------------------------------------------------------------------------------------------------------------


                                  Departmental Management--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1109         Implementation of the Equal Access to Justice Act in Agency Proceedings............     0990-AA02
----------------------------------------------------------------------------------------------------------------


                                   Food and Drug Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1110         Investigational Use New Animal Drug Regulations (Section 610 Review)...............     0910-AB02
1111         Natural Rubber-Containing Drugs; User Labeling.....................................     0910-AB56
1112         Substances Prohibited From Use in Animal Food or Feed..............................     0910-AB90
----------------------------------------------------------------------------------------------------------------


                                Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1113         Over-the-Counter (OTC) Drug Review.................................................     0910-AA01
1114         Hearing Aids; Professional and Patient Labeling; Conditions for Sale (Reg Plan Seq.     0910-AA39
            No. 28).............................................................................
1115         Investigational New Drugs: Export Requirements for Unapproved New Drug Products....     0910-AA61
1116         Adverse Drug Reaction Reporting and Recordkeeping Requirements for Marketed OTC         0910-AA86
            Drugs...............................................................................
1117         Direct-to-Consumer Promotion Regulations...........................................     0910-AA90
1118         Labeling for Human Prescription Drugs; Revised Format (Reg Plan Seq. No. 29).......     0910-AA94

[[Page 64354]]

 
1119         Suspected Adverse Drug Reaction Reporting Requirements for Human Drug and               0910-AA97
            Biological Products.................................................................
1120         Use of Ozone-Depleting Substances..................................................     0910-AA99
1121         Radioactive Drugs for Basic Research...............................................     0910-AB00
1122         Administrative Practices and Procedures; Advisory Opinions and Guidelines..........     0910-AB14
1123         Registration of Foreign Establishments and Product Listing.........................     0910-AB21
1124         Blood Initiative...................................................................     0910-AB26
1125         Suitability Determination for Donors of Human Cellular and Tissue-Based Products...     0910-AB27
1126         Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based       0910-AB28
            Products............................................................................
1127         Antibiotic Drug Approval and Exclusivity...........................................     0910-AB33
1128         Applications for FDA Approval to Market a New Drug, Complete Response Letter;           0910-AB34
            Amendments to Unapproved Applications...............................................
1129         Expanded Access to Investigational Therapies.......................................     0910-AB37
1130         Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs..     0910-AB39
1131         Electronic Submission of Adverse Drug Reaction Reports.............................     0910-AB42
1132         Distinguishing Marks for Drug Products Containing Insulin..........................     0910-AB43
1133         Pregnancy Labeling.................................................................     0910-AB44
1134         Supplemental Manufacturing Changes for New Animal Drugs............................     0910-AB49
1135         Pharmacy and Physician Compounding of Drug Products (Reg Plan Seq. No. 30).........     0910-AB58
1136         Drug Products That Present Demonstrable Difficulties for Compounding Because of         0910-AB59
            Reasons of Safety or Effectiveness..................................................
1137         Discontinuation of a Life-Saving Product...........................................     0910-AB60
1138         Pediatric Exclusivity..............................................................     0910-AB62
1139         Positron Emission Tomography Drugs; Current Good Manufacturing Practices...........     0910-AB63
1140         Food Labeling: Trans Fatty Acids in Nutrition Labeling and Nutrient Content Claims.     0910-AB66
1141         Designated Journals................................................................     0910-AB67
1142         Presubmission Conferences..........................................................     0910-AB68
1143         Current Good Manufacturing Practice for Medicated Feeds............................     0910-AB70
1144         Citizen Petitions; Actions That Can Be Requested by Petition; Summary Denial; and       0910-AB73
            Referral for Other Administrative Action............................................
1145         CGMPs for Blood and Blood Components: Notification of Consignees and Transfusion        0910-AB76
            Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting
            HCV Infection (Reg Plan Seq. No. 31)................................................
1146         Antibiotic Resistance Labeling.....................................................     0910-AB78
1147         Fixed-Combination Prescription and Over-the-Counter Drugs for Human Use............     0910-AB79
1148         Repackaging Approval Requirements..................................................     0910-AB81
1149         Stability Testing of Drugs.........................................................     0910-AB82
1150         Postmarketing Studies for Human Drugs and Licensed Biological Products: Status          0910-AB83
            Reports.............................................................................
1151         Amendment of Various Food Additive and Device Regulations to Reflect Current            0910-AB84
            American Society for Testing and Materials Citations................................
1152         Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary       0910-AB88
            Supplements (Reg Plan Seq. No. 32)..................................................
1153         Current Good Manufacturing for Blood and Blood Components; Blood Labeling               0910-AB89
            Standards; Direct Final Rule........................................................
1154         Submission in Electronic Format of Certain Labeling Information....................     0910-AB91
1155         Fees Relating to Drugs; Waiver and Reduction of Fees...............................     0910-AB92
1156         Skip Lot Testing...................................................................     0910-AB93
1157         Food Additives: Food Contact Substances Notification System........................     0910-AB94
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.


                                 Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1158         New Animal Drug Approval Process; Implementation of Title I of the Generic Animal       0910-AA02
            Drug and Patent Term Restoration Act (GADPTRA)......................................
1159         Prescription Drug Marketing Act of 1987; Policy Information, Guidance, and              0910-AA08
            Clarifications......................................................................
1160         Biological Product: Post-Marketing Surveillance Reports of Information Affecting        0910-AA12
            Biological Product Safety and Quality...............................................

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1161         Fruit and Vegetable Juices: Development of HACCP and Label Warning Statements for       0910-AA43
            Juices (Reg Plan Seq. No. 33).......................................................
1162         Current Good Manufacturing Practice; Amendment of Certain Requirements for Finished     0910-AA45
            Pharmaceuticals.....................................................................
1163         Bioavailability and Bioequivalence Requirements....................................     0910-AA51
1164         Drugs Used for Treatment of Narcotic Addicts.......................................     0910-AA52
1165         Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition..     0910-AA74
1166         New Drug Applications; Drug Master File............................................     0910-AA78
1167         Investigational New Drug Applications; Clinical Holds for Drugs for Life-               0910-AA84
            Threatening Illnesses...............................................................
1168         Sterility Requirements for Aqueous-Based Drug Products for Oral Inhalation.........     0910-AA88
1169         Informed Consent for Human Drugs and Biologics; Determination That Informed Consent     0910-AA89
            Is Not Feasible.....................................................................
1170         Current Good Manufacturing Practice; Revision of Certain Labeling Controls.........     0910-AA98
1171         Veterinary Feed Directives.........................................................     0910-AB09
1172         New Drugs for Human Use; Clarification of Requirements for Patent Holder                0910-AB12
            Notification........................................................................
1173         Exports; Reporting and Recordkeeping Requirements..................................     0910-AB16
1174         Medicated Feed Mill Licenses.......................................................     0910-AB18
1175         Public Information; Communications With State and Foreign Government Officials.....     0910-AB22
1176         FDA Export Reform and Enhancement Act of 1996; Reporting and Recordkeeping              0910-AB24
            Requirements for Unapproved or Violative Products Imported for Further Processing or
            Incorporation and Later Export......................................................
1177         Shell Eggs: Warning, Notice and Safe Handling Labeling Statements and Refrigeration     0910-AB30
            Requirements (Reg Plan Seq. No. 34).................................................
1178         Progestational Drug Products for Human Use; Requirements for Labeling Directed to       0910-AB45
            the Patient.........................................................................
1179         Revisions to the General Safety Requirements for Biological Products; Direct Final      0910-AB51
            Rule................................................................................
1180         Bulk Drug Substances for Use in Pharmacy Compounding...............................     0910-AB57
1181         Manufacturing Changes for Drugs....................................................     0910-AB61
1182         Classification of Sheep as a Minor Species for All Data Collection Purposes........     0910-AB69
1183         180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications.............     0910-AB80
1184         Structure/Function.................................................................     0910-AB97
----------------------------------------------------------------------------------------------------------------
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                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1185         Infant Formula: Good Manufacturing Practice, Quality Control Procedures, Quality        0910-AA04
            Factors, Notification Requirements, and Records and Reports.........................
1186         Food Labeling Review...............................................................     0910-AA19
1187         Medical Foods......................................................................     0910-AA20
1188         Classification of Computer Software Programs That Are Medical Devices..............     0910-AA41
1189         Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution.     0910-AA49
1190         Reinventing FDA Food Regulations...................................................     0910-AA58
1191         Debarment Certification Regulations for Drug Applications..........................     0910-AA76
1192         Investigational New Drug Applications; Request for Information and Comments........     0910-AA83
1193         Establishment Registration and Listing of Human Cellular and Tissue-Based Products.     0910-AB05
1194         Requirements Pertaining to the Sale and Distribution of Cigarettes and Smokeless        0910-AB17
            Tobacco to Protect Children and Adolescents; Use of Nontobacco Trade or Brand Names.
1195         Exemption From Preemption of State and Local Cigarette and Smokeless Tobacco            0910-AB19
            Requirements; Applications for Exemption Submitted by Various State Governments;
            Group 1; Group 2....................................................................
1196         Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed..............     0910-AB50
1197         Implementation of the Import Tolerance Provisions of the Animal Drug Availability       0910-AB71
            Act of 1996 and the Safe Level Provisions of the Animal Medicinal Drug Use
            Clarification Act of 1994...........................................................
1198         Mandatory HACCP Regulations for Manufacturers of Rendered Products.................     0910-AB72
1199         Surgeon's and Patient Examination Gloves; Reclassification.........................     0910-AB74
1200         Marking Requirements for Imported Food Products That Have Been Refused Admission        0910-AB95
            into the United States..............................................................
1201         Requirements for Persons Using Private Laboratories Regarding Actions Taken by the      0910-AB96
            Food and Drug Administration........................................................
----------------------------------------------------------------------------------------------------------------


[[Page 64356]]


                                 Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1202         Dietary Supplement Regulations in Response to DSHEA................................     0910-AA59
1203         Over-the-Counter Human Drugs; Labeling Requirements................................     0910-AA79
1204         Definition of Substantial Evidence.................................................     0910-AB08
1205         Biological Products Regulated Under Section 351 of the Public Health Service Act;       0910-AB29
            Implementation of Biologics License; Elimination of Establishment License and
            Product License.....................................................................
1206         Radiopharmaceuticals Used for In Vivo Diagnosis and Monitoring.....................     0910-AB52
1207         Requirements for Testing Human Blood Donors for Evidence of Infection Due to            0910-AB85
            Communicable Disease Agents.........................................................
1208         General Requirements for Blood, Blood Components, and Blood Derivatives;                0910-AB86
            Notification of Deferred Donors.....................................................
1209         Revisions to the Requirements Applicable to Blood, Blood Components, and Source         0910-AB87
            Plasma..............................................................................
----------------------------------------------------------------------------------------------------------------


                        Health Resources and Services Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1210         Designation of Medically Underserved Populations and Health Professional Shortage       0906-AA44
            Areas...............................................................................
1211         Compliance Alternatives for Provision of Uncompensated Services....................     0906-AA52
----------------------------------------------------------------------------------------------------------------


                         Health Resources and Services Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1212         Final Rule for the Health Professions, Nursing, Public Health, and Allied Health        0906-AA53
            Training Grant Programs under 42 CFR Parts 57 and 58................................
----------------------------------------------------------------------------------------------------------------


                         Health Resources and Services Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1213         National Practitioner Data Bank for Adverse Information on Physicians and Other         0906-AA41
            Health Care Practitioners: Corporate Shield.........................................
----------------------------------------------------------------------------------------------------------------


                         Health Resources and Services Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1214         National Practitioner Data Bank for Adverse Information on Physicians and Other         0906-AA51
            Health Care Practitioners: Reporting Adverse and Negative Actions...................
----------------------------------------------------------------------------------------------------------------


                                   Indian Health Service--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1215         Contracts Under the Indian Self-Determination Act..................................     0917-AA04
----------------------------------------------------------------------------------------------------------------


[[Page 64357]]


                                     Indian Health Service--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1216         Indian Child Protection and Family Violence Prevention Act Minimum Standards of         0917-AA02
            Character...........................................................................
----------------------------------------------------------------------------------------------------------------


                                    Indian Health Service--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1217         Currently Effective Indian Health Service Eligibility Regulations..................     0917-AA03
----------------------------------------------------------------------------------------------------------------


                               National Institutes of Health--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1218         National Institutes of Health AIDS Research Loan Repayment Program.................     0925-AA02
1219         Undergraduate Scholarship Program Regarding Professions Needed by the NIH..........     0925-AA10
1220         National Cancer Institute Clinical Cancer Education Program........................     0925-AA17
1221         National Institutes of Health Loan Repayment Program for Research..................     0925-AA18
1222         National Institute of Child Health and Human Development Contraception and              0925-AA19
            Infertility Research Loan Repayment Program.........................................
1223         Scientific Peer Review of Research Grant Applications and Research and Development      0925-AA20
            Contract Projects...................................................................
----------------------------------------------------------------------------------------------------------------


                                 National Institutes of Health--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1224         Traineeships.......................................................................     0925-AA11
1225         Additional DHHS Protections for Pregnant Women and Human Fetuses Involved as            0925-AA14
            Subjects in Research, and Pertaining to Human In Vitro Fertilization................
1226         National Research Service Awards...................................................     0925-AA16
1227         Federal Policy (Common Rule) for the Protection of Human Subjects..................     0925-AA21
1228         Service Fellowships................................................................     0925-AA22
1229         NIH Privacy Act System of Records, 09-25-0213, ``Administration: Investigative          0925-AA23
            Records''...........................................................................
----------------------------------------------------------------------------------------------------------------


                                National Institutes of Health--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1230         National Institutes of Health Construction Grants..................................     0925-AA04
----------------------------------------------------------------------------------------------------------------


                            Office of Public Health and Science--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1231         Public Health Service Standards for the Protection of Research Misconduct               0940-AA01
            Whistleblowers......................................................................
----------------------------------------------------------------------------------------------------------------


[[Page 64358]]


                             Office of Public Health and Science--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1232         Standards of Compliance for Abortion-Related Services in Family Planning Service        0940-AA00
            Projects............................................................................
----------------------------------------------------------------------------------------------------------------


                               Health Care Financing Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1233         End Stage Renal Disease (ESRD) Conditions for Coverage (HCFA-3818-F) (Section 610       0938-AG82
            Review).............................................................................
1234         Criteria for Medicare Coverage of Heart, Liver, and Lung Transplants (HCFA-3835-        0938-AH17
            ANPRM)..............................................................................
----------------------------------------------------------------------------------------------------------------


                            Health Care Financing Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1235         Medicare Program; Qualifications for Establishing and Maintaining Medicare Billing      0938-AH73
            Privileges (HCFA-6002-P) (Reg Plan Seq. No. 35).....................................
1236         National Standard for Identifiers of Health Plans (HCFA-4145-P)....................     0938-AH87
1237         State Child Health; Implementing Regulations for the State Children's Health            0938-AI28
            Insurance Program (HCFA-2006-P).....................................................
1238         Appeals of Carrier Determination That a Supplier Fails To Meet the Requirements for     0938-AI49
            Medicare Billing Privileges (HCFA-6003-P)...........................................
1239         Prospective Fee Schedule for Ambulance Services (HCFA-1002-NR) (Reg Plan Seq. No.       0938-AI72
            36).................................................................................
1240         Medicare Program; Coverage and Administrative Policies for Clinical Diagnostic          0938-AI92
            Laboratory Tests; Intent To Form Negotiated Rulemaking Committee (HCFA-3250-P)......
1241         Decision on the Funding for the AIDS Healthcare Foundation START Program, (HCFA-        0938-AJ43
            2041-N).............................................................................
1242         Protection for Women Who Elect Reconstruction After a Mastectomy (HCFA-2040-IFC)...     0938-AJ44
1243         Accelerated Payments to Providers Furnishing Services Under Medicare Part A and         0938-AJ45
            Part B and Advance Payments to Suppliers Furnishing Items or Services Under Medicare
            Part B (HCFA-1066-FC)...............................................................
1244         Medicare/Medicaid and CLIA Programs: Clinical Laboratory Improvement Amendments of      0938-AJ47
            1988 Exemption of Laboratories in the State of California (HCFA-2245-N).............
1245         Federal Enforcement in Group and Individual Health Insurance Markets (HCFA-2019-FC)     0938-AJ48
1246         Medicare Program: Prospective Payment System for Inpatient Rehabilitation Hospital      0938-AJ55
            Services (HCFA-1069-P) (Reg Plan Seq. No. 37).......................................
1247         DME Surety Bonds (HCFA-6006-P) (Reg Plan Seq. No. 38)..............................     0938-AJ64
1248         Reapplication of the Joint Commission for Accreditation of Health Care                  0938-AJ68
            Organizations JCAHO (HCFA-2058-PN)..................................................
1249         Reapplication of the Community Health Accreditation Program, Incorporated (CHAP for     0938-AJ69
            continued approval of Deeming Authority for whom Health Care Agencies HCFA-2059-PN).
1250         HHA Surety Bond (HCFA-6001-P) (Reg Plan Seq. No. 39)...............................     0938-AJ81
----------------------------------------------------------------------------------------------------------------
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                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1251         Additional Supplier Standards (HCFA-6004-F)........................................     0938-AH19
1252         Requirements for Enrollment of Medicaid Recipients Under Cost Effective Employer-       0938-AH48
            Based Group Health Plans (HCFA-2047-FC).............................................
1253         Terms, Definitions, and Addresses: Technical Amendments (HCFA-9877-FC).............     0938-AH53
1254         Utilization Control and Discontinued Review Activities; Medicaid (HCFA-2101-FC)....     0938-AH64
1255         Update of Ratesetting Methodology, Payment Rates and the List of Covered Surgical       0938-AH81
            Procedures for Ambulatory Surgical Centers Effective for Calendar Year 2000 (HCFA-
            1885-F).............................................................................
1256         National Standard Health Care Provider Identifier (HCFA-0045-F) (Reg Plan Seq. No.      0938-AH99
            40).................................................................................
1257         Medicare Program; Medicare+Choice Program (HCFA-1030-2-F) (Reg Plan Seq. No. 41)...     0938-AI29
1258         Medicare Program; Prospective Payment System for Hospital Outpatient Services (HCFA-    0938-AI56
            1005-F) (Reg Plan Seq. No. 42)......................................................

[[Page 64359]]

 
1259         Security and Electronic Signature Standards (HCFA-0049-F) (Reg Plan Seq. No. 43)...     0938-AI57
1260         Health Insurance Reform: Standards for Electronic Transactions (HCFA-0149-F) (Reg       0938-AI58
            Plan Seq. No. 44)...................................................................
1261         National Standard Employer Identifier (HCFA-0047-F) (Reg Plan Seq. No. 45).........     0938-AI59
1262         Medicaid Program; Home and Community-Based Services (HCFA-2010-FC).................     0938-AI67
1263         Medicaid Managed Care; Regulatory Program To Implement Certain Medicaid Provisions      0938-AI70
            of the Balanced Budget Act of 1997 (HCFA-2001-P) (Reg Plan Seq. No. 46).............
1264         Coverage of Religious Non-Medical Health Care Institutions (HCFA-1909-IFC).........     0938-AI93
1265         Home Health Prospective Payment System (HCFA-1059-P) (Reg Plan Seq. No. 47)........     0938-AJ24
1266         Establishment of a Program To Collect Suggestions for Improving Medicare Program        0938-AJ30
            Efficiency and To Reward Suggestors (HCFA-4000-FC)..................................
1267         The Children's Health Insurance Program: Implementing the Balanced Budget Act of        0938-AJ75
            1997 (HCFA-2006-P) (Reg Plan Seq. No. 48)...........................................
----------------------------------------------------------------------------------------------------------------
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                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1268         Payment for Clinical Diagnostic Laboratory Tests (HCFA-1309-F).....................     0938-AB50
1269         Changes to Peer Review Organization Regulations (HCFA-3135-F)......................     0938-AD38
1270         Omnibus Nursing Home Reform Requirements (HCFA-3488-F).............................     0938-AD81
1271         ''Without Fault'' and Beneficiary Waiver of Recovery As It Applies to Medicare          0938-AD95
            Overpayment Liability (HCFA-1719-P).................................................
1272         Protection of Income and Resources for Community Spouses of Institutionalized           0938-AE12
            Individuals (HCFA-2023-P)...........................................................
1273         Survey Requirements and Alternative Sanctions for Home Health Agencies (HCFA-2169-      0938-AE39
            F)..................................................................................
1274         Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Services (HCFA-2028-    0938-AE72
            F)..................................................................................
1275         Payment for Nursing and Allied Health Science Education (HCFA-1685-F)..............     0938-AE79
1276         Coverage of Screening Pap Smears (HCFA-3705-F).....................................     0938-AE98
1277         Changes to the Long-Term Care Facility Survey Process (HCFA-3175-FC)...............     0938-AF02
1278         Requirements for Certain Health Insuring Organizations and OBRA `90 Technical           0938-AF15
            Amendments (HCFA-1018-F)............................................................
1279         Provider Reimbursement Determinations and Appeals (HCFA-1727-P)....................     0938-AF28
1280         Alternative Sanctions for Psychiatric Hospitals (HCFA-2191-P)......................     0938-AF32
1281         Medicaid Payment for Covered Outpatient Drugs Under Rebate Agreements (HCFA-2046-       0938-AF42
            FC).................................................................................
1282         Referral to Child Support Enforcement Agencies of Medicaid Families (HCFA-2051-F)..     0938-AF68
1283         Medicaid: Outstationed Intake Locations for Certain Low-Income Pregnant Women,          0938-AF69
            Infants, and Children Under Age 19 (HCFA-2052-F)....................................
1284         Assessing Interest Against Medicare Secondary Payer (MSP) Debts (HCFA-6108-P)......     0938-AF87
1285         Revised Medicaid Management Information Systems (HCFA-2038-FN).....................     0938-AG10
1286         Alternative Sanctions for Renal Dialysis Facilities (HCFA-3204-P)..................     0938-AG31
1287         Description of HCFA's Evaluation Methodology for the Peer Review Organizations          0938-AG32
            Fifth Scope of Work Contracts (HCFA-3207-N).........................................
1288         Disclosure of Confidential PRO and ESRD Network Organization Information for            0938-AG33
            Research Purposes (HCFA-3208-P).....................................................
1289         Medicare Program: Limitations on Medicare Coverage of Intermittent Positive             0938-AG44
            Pressure Breathing Machine Therapy (HCFA-3781-FN)...................................
1290         Telephone Requests for Review of Part B Initial Claim Determinations (HCFA-4121-F).     0938-AG48
1291         Effect of Change of Ownership on Provider and Supplier Penalties, Sanctions,            0938-AG59
            Underpayments and Overpayments (HCFA-2215-P)........................................
1292         Medicaid: Optional Coverage of TB-Related Services for Individuals Infected With        0938-AG72
            Tuberculosis (HCFA-2082-P)..........................................................
1293         Revision of Medicare/Medicaid Hospital Conditions of Participation (HCFA-3745-F)...     0938-AG79
1294         Physicians' Referrals to Health Care Entities With Which They Have Financial            0938-AG80
            Relationships--Expanded to Designated Health Services (HCFA-1809-F).................
1295         Home Health Agency (HHA) Conditions of Participation (HCFA-3819-F).................     0938-AG81
1296         Distinct Part Requirements for Nursing Homes and Prohibition of Financial Screening     0938-AG84
            of Applicants for Nursing Home Admission (HCFA-3815-P)..............................
1297         CLIA Program: Categorization of Waived Tests (HCFA-2225-FC)........................     0938-AG99
1298         Liability for Third Parties To Pay for Services (HCFA-2080-P)......................     0938-AH01

[[Page 64360]]

 
1299         Definition of Skilled Nursing Facility (SNF) for Coverage of Durable Medical            0938-AH16
            Equipment (DME) and Home Health (HCFA-1834-P).......................................
1300         State Plan Amendment (SPA) Reconsideration Process (HCFA-2096-P)...................     0938-AH24
1301         Hospice Care--Conditions of Participation (HCFA-3844-P)............................     0938-AH27
1302         CLIA Program; Cytology Proficiency Testing (HCFA-2233-N)...........................     0938-AH35
1303         Medicare Coverage of Services of Speech-Language Pathologists and Audiologists          0938-AH37
            (HCFA-1843-P).......................................................................
1304         Payment Amount if Customary Charges Are Less Than Reasonable Costs (HCFA-1860-FC)..     0938-AH49
1305         Limitations on Liability (HCFA-4859-FC)............................................     0938-AH51
1306         Medicare Secondary Payer Clarifications and Amendments (HCFA-1865-P)...............     0938-AH52
1307         Revision to Accrual Basis of Accounting Policy (HCFA-1876-F).......................     0938-AH61
1308         Medicaid; Estate Recoveries (HCFA-2083-P)..........................................     0938-AH63
1309         Medicaid Hospice Care (HCFA-2016-P)................................................     0938-AH65
1310         Provider and Supplier Billing When Medicare Is Secondary Payor to Liability             0938-AH66
            Insurance (HCFA-1848-P).............................................................
1311         Medicare Technical Conforming Amendments (HCFA-1858-FC)............................     0938-AH67
1312         Elimination of Certain Requirements for Peer Review Organizations in the                0938-AH68
            Utilization and Quality Review Process and a Change in the Length of Peer Review
            Organization Contracts (HCFA-3235-FC)...............................................
1313         Determination of Substandard Care in SNFs and NFs (HCFA-2240-P)....................     0938-AH69
1314         Waiver of Staffing Requirements for End Stage Renal Disease (ESRD) Facilities           0938-AH72
            Participating in an Experiment (HCFA-2236-GNC)......................................
1315         Individual Market Health Ins. Reform Portability From Group to Indiv. Coverage;         0938-AH75
            Federal Rules for Access in the Indiv. Market; State Alternative Mechanisms to
            Federal Rules (HCFA-2882-F).........................................................
1316         Revisions to Conditions for Coverage for Ambulatory Surgical Centers (HCFA-3887-P).     0938-AH83
1317         Disclosure of Peer Review Organization Information in Response to Beneficiary           0938-AH85
            Complaints (HCFA-3241-P)............................................................
1318         Medicaid Program; Amendment to the Preadmission Screening and Annual Resident           0938-AH89
            Review Program (HCFA-2107-P)........................................................
1319         Medically Needy Determinations Under Welfare Reform (HCFA-2109-IFC)................     0938-AH92
1320         Medicaid Program; Coverage and Payment for Federally Qualified Health Center            0938-AH95
            Services (HCFA-2043-P)..............................................................
1321         Revision to the Definition of an Unemployed Parent (HCFA-2106-FC)..................     0938-AH98
1322         Portability and Nondiscrimination in the Group Health Insurance Market (HCFA-2890-      0938-AI08
            F)..................................................................................
1323         Medicare Program; Medicare Integrity Program (HCFA-7020-F).........................     0938-AI09
1324         Medicare Program; Improvements to the Appeals Process for Medicare Beneficiaries        0938-AI11
            Enrolled in HMOs, CMPs, and HCPPs (HCFA-4024-P).....................................
1325         Medicare Program; Physician Fee Schedule Conversion Factor for Calendar Year 1998       0938-AI16
            and Sustainable Growth Rate for Fiscal Year 1998 (HCFA-1893-FN).....................
1326         Medicaid: Medical Child Support (HCFA-2081-P)......................................     0938-AI21
1327         Medicare Program: Physicians' Referrals; Issuance of Advisory Opinions (HCFA-1902-      0938-AI38
            F)..................................................................................
1328         Medicare/Medicaid Program; User Fees for Information, Prodcuts, and Services (HCFA-     0938-AI46
            6021-P).............................................................................
1329         Surety Bond Requirements for Comprehensive Outpatient Rehab. Facilities, Rehab.         0938-AI48
            Agencies, Community Mental Health Centers, and Independent Diagnostic Testing
            Facilities (HCFA-6005-P)............................................................
1330         State Plan Requirements for Durable Medical Equipment Providers (HCFA-2007-P)......     0938-AI63
1331         Recognition of the Community Health Accreditation Program, Inc. (CHAP) and Joint        0938-AI69
            Commission for Accreditation of Healthcare Organizations (JCAHO) for Hospices (HCFA-
            2029-PN)............................................................................
1332         Elimination of Application of Federal Financial Participation Limits (HCFA-2111-        0938-AI73
            IFC)................................................................................
1333         Medicaid Program; Changes to Eligibility of Non-U.S. Citizens (HCFA-2108-P)........     0938-AI74
1334         Medicare Program; Advance Refunding of Debt and Methodology for Repayment of Loan       0938-AI75
            (HCFA-1777-P).......................................................................
1335         Medicare Hospice Care (HCFA-1022-P)................................................     0938-AI77
1336         Revision of Procedures for Requesting Exceptions to Cost Limits for SNFs and            0938-AI80
            Elimination of Reclassifications (HCFA-1883-P)......................................
1337         Solvency Standards for Provider-Sponsored Organizations (HCFA-1011-F)..............     0938-AI83
1338         Medicare Program; Medicare Coverage of and Payment for Bone Mass Measurements (HCFA-    0938-AI89
            3004-F).............................................................................
1339         Health Insurance Reform Universal Health Care Identifier (HCFA-0048-NOI)...........     0938-AI91
1340         Peer Review Organization Contracts: Solicitation of Statements of Interest From In-     0938-AI99
            State Organizations (HCFA-3009-N)...................................................
1341         Replacement of Reasonable Charge Methodology by Fee Schedules (HCFA-1010-P)........     0938-AJ00
1342         External Quality Review of Medicaid Managed Care Organizations (HCFA-2015-P).......     0938-AJ06
1343         HHS' Recognition of NAIC Model Standards for Regulation of Medigap Policy (HCFA-        0938-AJ07
            2025-N).............................................................................
1344         Reporting Outcome and Assessment Information Set (OASIS) Data as Part of the            0938-AJ10
            Conditions of Participation for Home Health Agencies (HCFA-3006-IFC)................

[[Page 64361]]

 
1345         Medicare Program; Criteria and Standards for Evaluating Intermediary and Carrier        0938-AJ15
            Performance: Millennium Compliance (HCFA-4002-GNC)..................................
1346         Rural Health Clinics: Amendments to Participation Requirements and Payment              0938-AJ17
            Provisions, and Establishment of a Quality Assessment and Improvement Program (HCFA-
            1910-P).............................................................................
1347         Hospital Conditions of Participation: Laboratory Services (HCFA-3 014-P)...........     0938-AJ29
1348         Medicare Program; Procedures for Making Medical Services National Coverage              0938-AJ31
            Decisions (HCFA-3432-GN)............................................................
1349         Medicare Program; Special Payment Limits for Certain Durable Medical Equipment and      0938-AJ34
            Prosthetic Devices (HCFA-1050-PN)...................................................
1350         Medicare Hospice Care Amendments (HCFA-1022-P).....................................     0938-AJ36
1351         Emergency Medical Treatment and Labor Act (EMTALA) (HCFA-1063-FC)..................     0938-AJ39
1352         Changes to the Hospital Inpatient Prospective Payment System and Fiscal Year 2000       0938-AJ50
            Rates (HCFA-1053-P) (Section 610 Review)............................................
----------------------------------------------------------------------------------------------------------------


                             Health Care Financing Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1353         Case Management (HCFA-2027-F)......................................................     0938-AF07
1354         Adjustment in Payment Amounts for New Technology Intraocular Lenses (HCFA-3831-F)..     0938-AH15
1355         Medicare and Medicaid Programs; Quarterly Listing of Program Issuances and Coverage     0938-AI13
            Decisions--Second Quarter, 1998 (HCFA-9002-N).......................................
1356         GME: Incentive Payments Under Plans for Voluntary Reduction in Number of Residents      0938-AI27
            (HCFA-1001-F).......................................................................
1357         Medicare Program; Prospective Payment System and Consolidated Billing for Skilled       0938-AI47
            Nursing Facilities. (HCFA-1913-IFC).................................................
1358         Medicare and Medicaid Programs; Quarterly Listing of Program Issuances -- First         0938-AJ12
            Quarter 1998 (HCFA-9879-N)..........................................................
1359         Medicare Program State Allotments for Payments of Medicare Part B Premium for           0938-AJ28
            Qualifying Individuals: Federal Fiscal Year for 1999 (HCFA-2032-N)..................
1360         Medicaid Program; Civil Money Penalties for Nursing Homes (SNF/NF), Change in           0938-AJ35
            Notice Requirements, and Expansion of Discretionary Remedy (HCFA-2035-FC)...........
1361         Medicare and Medicaid Programs; Quarterly Listing of Program Issuances -- Third         0938-AJ37
            Quarter, 1998 (HCFA-9000-N).........................................................
1362         Recognition of the Joint Commission for Accreditation of Healthcare Organizations       0938-AJ41
            (JCAHO) for Hospices (HCFA-2039-FN).................................................
1363         Recognition of the Community Health Accreditation Program, Inc. (CHAP) for Hospices     0938-AJ42
            (HCFA-2029-FN)......................................................................
1364         Prospective Payment System and Consolidated Billing for Home Health Agencies (HCFA-     0938-AJ51
            1059-P).............................................................................
1365         Medicare and Medicaid Programs: Hospital Conditions of Participation; Patients'         0938-AJ56
            Rights (HCFA-3018-IFC)..............................................................
1366         Medicare Program: Prospective Payment System and Consolidated Billing for Skilled       0938-AJ58
            Nursing Facilities Update...........................................................
1367         Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year        0938-AJ61
            2000 (HCFA-1065-P)..................................................................
1368         Medicaid Managed Care; Regulatory Program to Implement Certain Medicaid Provisions      0938-AJ73
            of the Balanced Budget Act of 1997..................................................
----------------------------------------------------------------------------------------------------------------


                          Administration for Children and Families--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1369         Bonus To Reward High Performance States Under the Temporary Assistance for Needy        0970-AB66
            Families Block Grant................................................................
1370         Child Support Enforcement for Indian Tribes........................................     0970-AB73
1371         Family Child Care Program Option for Head Start Programs...........................     0970-AB90
1372         National Medical Support Notice....................................................     0970-AB97
1373         Program Performance Standards for the Operation of Head Start Programs.............     0970-AB99
1374         Safeguarding Child Support and Expanded FPLS Information...........................     0970-AC01
----------------------------------------------------------------------------------------------------------------


[[Page 64362]]


                           Administration for Children and Families--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1375         Title IV-E Foster Care Eligibility Reviews and Child and Family Services State Plan     0970-AA97
            Reviews, MEPA Implementation, and ASFA Implementation...............................
1376         Standards for Safe Transportation..................................................     0970-AB24
1377         Construction of Head Start Facilities..............................................     0970-AB54
1378         Methodology for Determining Whether an Increase in a State's Child Poverty Rate is      0970-AB65
            the Result of the TANF Program......................................................
1379         Requirements for the Tribal Programs...............................................     0970-AB78
1380         Child Support Enforcement Program Omnibus Conforming Regulation....................     0970-AB81
1381         Refugee Resettlement Program: Refugee Cash and Medical Assistance Programs.........     0970-AB83
1382         Incentive Payments and Audit Penalties to States and Political Subdivisions........     0970-AB85
1383         Head Start Appeal Timelines........................................................     0970-AB87
1384         Welfare-to-Work Data Collection....................................................     0970-AB92
1385         State Self Assessments To Determine Compliance With Federal Regulations............     0970-AB96
1386         Priority for Previously Selected Head Start Agencies...............................     0970-AB98
1387         Technical Revision of Head Start Regulations to Make Them Conform to Recent             0970-AC00
            Statutory Revisions.................................................................
1388         Assets for Independence Reserve Account............................................     0970-AC02
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1389         Temporary Assistance for Needy Families (TANF).....................................     0970-AB77
1390         Bonus to Reward Decrease in Illegitimacy Ratio.....................................     0970-AB79
1391         Implementation of AFCARS Corrective Action and Penalties and CAPTA Amendments......     0970-AB94
----------------------------------------------------------------------------------------------------------------


                                  Administration on Aging--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1392         Grants for State and Community Programs on Aging, Intrastate Funding Formulas;          0985-AA00
            Training, Research and Discretionary Programs; Vulnerable Elder Rights; and Grants
            to Indians and Native Hawaiians.....................................................
----------------------------------------------------------------------------------------------------------------

_______________________________________________________________________


Department of Health and Human Services (HHS)       Proposed Rule Stage


Office of the Secretary (OS)



_______________________________________________________________________




1093. CIVIL MONEY PENALTIES FOR MEDICARE+CHOICE ORGANIZATIONS AND 
MEDICAID MANAGED CARE ORGANIZATIONS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1320a-7a; 42 USC 1395mm; 42 USC 1395w-27; 42 
USC 1396b; 42 USC 1396u-2

CFR Citation: 42 CFR 1003

Legal Deadline: None

Abstract: This proposed rule would reflect OIG's authority to impose 
civil money penalties against health maintenance organizations and 
competitive medical plans that engage in certain abusive practices, 
including failure to provide medically necessary care and 
discriminatory enrollment procedures. This rule would specifically 
address the Medicare+Choice provisions set forth in Public Law 105-33 
(the Balanced Budget Act of 1997), and the Medicaid managed care 
provisions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Small Entities Affected: 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-AB03


_______________________________________________________________________



[[Page 64363]]

1094.  CIVIL MONEY PENALTY SAFE HARBOR TO PROTECT PAYMENT OF 
MEDICARE AND MEDIGAP PREMIUMS FOR ESRD BENEFICIARIES

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: Section 1128A(a)(5) of the Social Security Act

CFR Citation: 42 CFR 1003

Legal Deadline: None

Abstract: This proposed rule would set forth in the OIG's civil money 
penalty provisions in 42 CFR part 1003 a new safe harbor for unlawful 
inducements to beneficiaries to provide protection for independent 
dialysis facilities that pay, in whole or in part, premiums for 
Supplementary Medical Insurance (Medicare Part B) or Medicare 
Supplemental Health Insurance policies (Medigap) for financially needy 
Medicare beneficiaries with end-stage renal disease (ESRD). This safe 
harbor would specifically establish various standards and guidelines 
that, if met, would result in the particular arrangement being 
protected from civil sanctions under section 1128A(a)(5) of the Social 
Security Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Small Entities Affected: 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-AB04
_______________________________________________________________________




1095.  SAFE HARBOR FOR AMBULANCE RE-STOCKING

Priority: Substantive, Nonsignificant

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

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

CFR Citation: 42 CFR 1001

Legal Deadline: None

Abstract: This rule would set forth a new anti-kickback safe harbor to 
address certain re-stocking arrangements between municipal and non-
profit ambulance companies and hospitals.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Small Entities Affected: 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-AB05
_______________________________________________________________________




1096.  SAFE HARBOR FOR ARRANGEMENTS INVOLVING FEDERALLY 
QUALIFIED HEALTH CENTERS

Priority: Substantive, Nonsignificant

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

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

CFR Citation: 42 CFR 1001

Legal Deadline: None

Abstract: This rule would set forth a new anti-kickback safe harbor 
addressing remuneration between Federal Qualified Health Centers and 
certain service providers where a significant community benefit exists.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Small Entities Affected: 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-AB06
_______________________________________________________________________


Department of Health and Human Services (HHS)          Final Rule Stage


Office of the Secretary (OS)



_______________________________________________________________________




1097. 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 Public Law 100-93. Specifically, this 
rule modifies the original set of final safe harbor provisions (56 FR 
35952, July 29, 1991) to give greater clarity to the rulemaking's 
original intent. In addition, this rule sets forth an expanded listing 
of safe harbor

[[Page 64364]]

provisions designed to protect additional payment and business 
practices from criminal prosecution and civil sanctions under the anti-
kickback statute.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/21/93                    58 FR 49008
NPRM Comment Period End         11/22/93
Final Action                    11/00/99

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, 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-AA66
_______________________________________________________________________




1098. 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 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 written 
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              12/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Michael Herrell, Office of the Assistant Secretary for 
Planning and Evaluation, Department of Health and Human Services, 
Office of the Secretary, 200 Independence Avenue SW, Washington, DC 
20201
Phone: 202 690-5739

RIN: 0991-AA83
_______________________________________________________________________




1099. 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                    04/00/00

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-AA90
_______________________________________________________________________




1100. 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: 42 CFR 1001

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

Abstract: This interim final rule will establish a new statutory 
exception for risk-sharing arrangements under the Federal health care 
programs' anti-kickback provisions. The rule sets forth an exception 
from liability for remuneration between an eligible organization and an 
individual or entity providing items or services in accordance with a 
written agreement between these parties. The rule would 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              11/00/99

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 Inspector 
General (OCIG), 330 Independence Avenue SW, Washington, DC 20201
Phone: 202 619-0089

RIN: 0991-AA91


_______________________________________________________________________



[[Page 64365]]

1101. BLOCK GRANT PROGRAMS

Priority: Info./Admin./Other

Legal Authority: 42 USC 300w et seq; 42 USC 300x et seq; 42 USC 300y et 
seq; 42 USC 701 et seq; 42 USC 1243 et seq; 42 USC 1397 et seq; 42 USC 
8621 et seq; 42 USC 9901 et seq

CFR Citation: 45 CFR 96

Legal Deadline: None

Abstract: The rule amends the regulations governing the administration 
on block grants. It updates current regulations to reflect current name 
and statutory petitions. It establishes submission and completion dates 
for funding applications from LIHEAP, CSBG and SSSBG. It clarifies that 
the department may specify the form of an application where this is 
authorized by statute. It requires to submit a obligation and 
expenditure for all block grants.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/00/99

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Michael Herrell, Office of the Assistant Secretary for 
Planning and Evaluation, Department of Health and Human Services, 
Office of the Secretary, 200 Independence Avenue SW, Washington, DC 
20201
Phone: 202 690-5739

RIN: 0991-AA97
_______________________________________________________________________




1102. 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 final 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                            10/30/98                    63 FR 58341
NPRM Comment Period End         01/11/99
Final Rule                      11/26/99                    64 FR 57740

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, Office of Inspector 
General (OCIG), 330 Independence Avenue SW, Washington, DC 20201
Phone: 202 619-0089

RIN: 0991-AA98
_______________________________________________________________________




1103. PRIVACY ACT EXEMPT RECORD SYSTEM FROM THE HEALTHCARE INTEGRITY AND 
PROTECTION DATA BANK

Priority: Substantive, Nonsignificant

Legal Authority: 5 USC 552a

CFR Citation: 45 CFR 56

Legal Deadline: None

Abstract: This proposed rule would exempt the new system of records for 
the Healthcare Integrity and Protection Data Bank (HIPDB) from certain 
provisions of the Privacy Act (5 U.S.C. 552a). The proposed exemption 
being set forth would apply to investigative materials compiled for law 
enforcement purposes in anticipation of civil, criminal or 
administrative proceedings.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/26/99                    64 FR 57619
NPRM Comment Period End         11/26/99
Final Action                    04/00/00

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-AA99
_______________________________________________________________________




1104.  STANDARDS FOR PRIVACY OF INDIVIDUALLY INDENTIFIABLE 
HEALTH INFORMATION

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

RIN: 0991-AB08
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Office of the Secretary (OS)



_______________________________________________________________________




1105. 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                    07/22/99                    64 FR 39420

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0991-AA95


_______________________________________________________________________



[[Page 64366]]

1106. REVISION OF HHS FREEDOM OF INFORMATION ACT REGULATIONS

Priority: Other Significant

CFR Citation: 45 CFR 5

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM Comment Period End         05/26/99                    64 FR 14668
Final Rule                      10/26/99                    64 FR 57740

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Rosario Cirrincione
Phone: 202 690-7453

RIN: 0991-AB01
_______________________________________________________________________




1107.  FURTHER CLARIFICATIONS TO THE SAFE HARBOR PROVISIONS 
UNDER THE ANTI-KICKBACK STATUTE

Priority: Substantive, Nonsignificant

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

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

CFR Citation: 42 CFR 1001

Legal Deadline: None

Abstract: This proposed rule would address modifications to the OIG's 
initial safe harbor provisions codified in 1991. The rule would 
specifically seek revisions to the employee safe harbor and to space 
rental safe harbor. The proposed changes would give greater clarity to 
the rule's original intent and respond to an expressed preference for 
greater consistency among laws governing health care providers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       11/08/99

Regulatory Flexibility Analysis Required: No

Small Entities Affected: 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-AB07
_______________________________________________________________________


Department of Health and Human Services (HHS)       Proposed Rule Stage


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




1108. INTERSTATE SHIPMENT OF BIOLOGICAL MATERIALS THAT CONTAIN OR MAY 
CONTAIN INFECTIOUS SUBSTANCES

Priority: Other Significant

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

Legal Authority: 42 USC 264; 42 USC 271; 42 USC 262 note; 31 USC 9701; 
18 USC 3559; 18 USC 3571

CFR Citation: 42 CFR 72.6 (Renumbered); 42 CFR 72.7 (Renumbered); 42 
CFR 72.1-5 (Revision)

Legal Deadline: None

Abstract: The purpose of this NPRM is to update regulations governing 
the packaging, labeling, and shipment of infectious agents. Materials 
must be packaged in such a way as to prevent damage and leakage during 
transport in order to protect workers and the public from exposure.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Dr. Jonathan Y. Richmond, Director, Office on Health 
and Safety, Department of Health and Human Services, Centers for 
Disease Control, MS F05, 1600 Clifton Road NE, Atlanta, GA 30333
Phone: 404 639-2453

RIN: 0920-AA02
_______________________________________________________________________


Department of Health and Human Services (HHS)       Proposed Rule Stage


Departmental Management (HHSDM)



_______________________________________________________________________




1109. 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                     01/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Timothy M. White, Associate General Counsel, Business

[[Page 64367]]

and Administrative Law Division, Department of Health and Human 
Services, Room 5362, HHS Cohen Building, 330 Independence Avenue SW, 
Washington, DC 20201
Phone: 202 619-0150

RIN: 0990-AA02
_______________________________________________________________________


Department of Health and Human Services (HHS)             Prerule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________




1110. INVESTIGATIONAL USE NEW ANIMAL DRUG REGULATIONS (SECTION 610 
REVIEW)

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; 5 USC 610; 21 USC 351; 21 USC 352; 21 USC 
353; 21 USC 360b; 21 USC 371

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. In addition, FDA is initiating a review of this rule 
under section 610 of the Regulatory Flexibility Act. The purpose of the 
610 review is to determine if the rule should be amended to minimize 
adverse economic impacts on small entities. FDA will consider and 
solicit comments on the following: 1) the continued need for the rule; 
2) the nature of complaints or comments received concerning the rule; 
3) the complexity of the rule; 4) the extent to which the rule 
overlaps, duplicates, or conflicts with other Federal, State or local 
government rules; and 5) the degree to which technology, economic 
conditions or other factors have changed in the area affected by the 
rule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           11/21/96                    61 FR 59209
ANPRM Comment Period End        01/21/97
Begin Review                    01/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Marty Schoenemann, Department of Health and Human 
Services, Food and Drug Administration, HFV-126, Center for Veterinary 
Medicine, 7500 Standish Place, Rockville, MD 20855
Phone: 301 827-0220

RIN: 0910-AB02
_______________________________________________________________________




1111. 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; 21 USC 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: The advance notice of proposed rulemaking requests comments 
on requirements under consideration 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

________________________________________________________________________

ANPRM                           02/00/00

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, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB56
_______________________________________________________________________




1112.  SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED

Priority: Substantive, Nonsignificant

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: After determining that dioxins were present in some clays 
used as anti-caking agents in animal feeds, the Agency is considering 
proposing a rule that would prohibit the use of these clays unless they 
meet certain conditions under the Federal Food, Drug, and Cosmetic Act. 
At this time, it is not clear whether there are other types of mined 
clay products that contain dioxins or whether the relatively low 
concentrations found in recent samples of mined clay products would 
have a significant impact on the public health. Thus, the advance 
notice of proposed rulemaking will request further information 
regarding the presence of dioxins in mined clay products used in animal 
feeds or feed ingredients and the significance of these dioxins to the 
public health.

[[Page 64368]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           01/00/00

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Dr. Randall A Lovell, Veterinary Medical Officer, 
Department of Health and Human Services, Food and Drug Administration, 
7500 Standish Place, HFV-222, Center for Veterinary Medicine, 
Rockville, MD 20855
Phone: 301 827-0176
Fax: 301 594-1812
Email: [email protected]

RIN: 0910-AB90
_______________________________________________________________________


Department of Health and Human Services (HHS)       Proposed Rule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________




1113. 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 03/23/1982 (47 FR 12430)  NPRM 01/15/
1985 (50 FR 2172)  NPRM (Amendment) 08/07/1991 (56 FR 37622)  Final 
Action 08/16/1991 (56 FR 41008)

Alcohol (Oral) in OTC Drug Products  NPRM 10/21/1993 (58 FR 
54466)  Final Action 03/13/1995 (60 FR 13590)  NPRM (Amendment) 05/10/
1996 (61 FR 21392)  Final Action (Amendment) 11/18/1996 (61 FR 58629)

Anorectal Products  ANPRM 05/27/1980 (45 FR 35576)  NPRM 08/15/1988 (53 
FR 30756)  Final Action 08/03/1990 (55 FR 31776)  Final Action (LYCD) 
09/02/1993 (58 FR 46746)  Final Action (Witch Hazel) 06/03/1994 (59 FR 
28766)

Antacid Drug Products  ANPRM 04/05/1973 (38 FR 8714)  NPRM 11/12/1973 
(38 FR 31260)  Final Action 06/04/1974 (39 FR 9862)  NPRM (Amendment) 
(Overindulgence) 12/24/1991 (56 FR 66754)  Final Action (Amendment) 
(Warning) 08/26/1993 (58 FR 45204)  NPRM (Amendment) (Testing) 09/23/
1993 (58 FR 49826)  NPRM (Amendment)(Sodium Bicarb.) 02/02/1994 (59 FR 
5060)  Final Action (Technical Amendment) 11/25/1994 (59 FR 
60555)  Final Action (Amendment) (Testing) 02/08/1996 (61 FR 
4822)  Final Action (Amendment)(Sodium B.) 03/00/2000  Final Action 
(Amendment) (Overindulgence) 12/00/2001

Anthelmintic Products  ANPRM 09/09/1980 (45 FR 59541)  NPRM 08/24/1982 
(47 FR 37062)  Final Action 08/01/1986 (51 FR 27756)

Antibiotic First Aid Products  ANPRM 04/01/1977 (42 FR 17642)  NPRM 07/
09/1982 (47 FR 29986)  Final Action 12/11/1987 (52 FR 47312)  NPRM 
(Amendment) 08/18/1989 (54 FR 34188)  Final Action 03/15/1990 (55 FR 
9721)  NPRM (Amendment) 05/11/1990 (55 FR 19868)  NPRM (Amendment) 06/
08/1990 (55 FR 23450)  Final Action (Amendment) 10/03/1990 (55 FR 
40379)  Final Action (Amendment) 12/05/1990 (55 FR 50171)  NPRM 
(Amendment) (Warning) 02/14/1996 (61 FR 5918)  Final Action 
(Amendment)(Warning) 11/15/1996 (61 FR 58471)

Anticaries Products  ANPRM 03/28/1980 (45 FR 20666)  NPRM 09/30/1985 
(50 FR 39854)  NPRM 06/15/1988 (53 FR 22430)  Final Action 10/06/1995 
(60 FR 52474)  Final Action (Technical Amendment) 10/07/1996 (61 FR 
52285)

Antidiarrheal Products  ANPRM 03/21/1975 (40 FR 12924)  NPRM 04/30/1986 
(51 FR 16138)  NPRM (Amendment)(Trav. Diar.) 08/00/2000  Final Action 
08/00/2000

[[Page 64369]]

Antidotes, Toxic Ingestion Prdts (New Poison Treatment Prdts)  ANPRM 
01/05/1982 (47 FR 444)

Antiemetic Products  ANPRM 03/21/1975 (40 FR 12934)  NPRM 07/13/1979 
(44 FR 41064)  Final Action 04/30/1987 (52 FR 15886)  NPRM (Amendment) 
08/26/1993 (58 FR 45216)  Final Action 04/11/1994 (59 FR 16981)  NPRM 
(Amendment)(Warning) 08/29/1997 (62 FR 45767)

Antiflatulent Drug Products  NPRM 11/12/1973 (38 FR 31260)  Final 
Action 06/04/1974 (39 FR 19877)  NPRM (Amendment) 01/29/1988 (53 FR 
2716)  Final Action (Amendment) 03/05/1996 (61 FR 8836)

Antifungal (Topical) Products  ANPRM 03/23/1982 (47 FR 12480)  NPRM 12/
12/1989 (54 FR 51136)  NPRM (Amendment) (Diaper Rash) 06/20/1990 (55 FR 
25240)  Final Action (Amdt.)(Diaper Rash) 12/18/1992 (57 FR 
60430)  Final Action (Partial) 09/02/1993 (58 FR 46744)  Final Action 
09/23/1993 (58 FR 49890)  NPRM (Amendment) (Indications) 07/22/1999 (64 
FR 39452)

Antimicrobial Products  ANPRM 09/13/1974 (39 FR 33103)  NPRM 01/06/1978 
(43 FR 1210)  NPRM (Amendment) (Diaper Rash) 06/20/1990 (55 FR 
25246)  Final Action (Diaper Rash) 03/00/2004

Antiperspirant Products  ANPRM 10/10/1978 (43 FR 46694)  NPRM 08/20/
1982 (47 FR 36492)  Final Action 06/00/2000

Aphrodisiac Products  ANPRM 10/01/1982 (47 FR 43572)  NPRM 01/15/1985 
(50 FR 2168)  Final Action 07/07/1989 (54 FR 28780)

Aspirin (Heart Labeling Warning)  NPRM 11/16/1988 (53 FR 46204)  NPRM 
10/20/1993 (58 FR 54224)  NPRM (Amendment) 06/13/1996 (61 FR 
30002)  Final Action 06/00/2000

Aspirin (Heart Labeling)  Final Action 10/23/1998 (63 FR 56802)

Astringent (Wet Dressings) Prdts (Merged w/other rulemkg)  ANPRM 09/07/
1982 (47 FR 39436)

Benign Prostatic Hypertrophy Products  ANPRM 10/01/1982 (47 FR 
43566)  NPRM 02/20/1987 (52 FR 5406)  Final Action 02/27/1990 (55 FR 
6926)

Boil Ointments  ANPRM 06/29/1982 (47 FR 28306)  NPRM 01/26/1988 (53 FR 
2198)  Final Action 11/15/1993 (58 FR 60332)

Camphorated Oil Drug Products  ANPRM 09/26/1980 (45 FR 63869)  Final 
Action 09/21/1982 (47 FR 41716)

Cholecystokinetic Products  ANPRM 02/12/1980 (45 FR 9286)  NPRM 08/24/
1982 (47 FR 37068)  Final Action 06/10/1983 (48 FR 27004)  NPRM 
(Amendment) 08/15/1988 (53 FR 30786)  Final Action (Amendment) 02/28/
1989 (54 FR 8320)

Corn and Callus Remover Products  ANPRM 01/05/1982 (47 FR 522)  NPRM 
02/20/1987 (52 FR 5412)  Final Action 08/14/1990 (55 FR 33258)

Cough/Cold (Anticholinergic) Products  ANPRM 09/09/1976 (41 FR 
38312)  NPRM 07/09/1982 (47 FR 30002)  Final Action 11/08/1985 (50 FR 
46582)

Cough/Cold (Antihistamine) Products  ANPRM 09/09/1976 (41 FR 
38312)  NPRM 01/15/1985 (50 FR 2200)  NPRM (Amendment) 08/24/1987 (52 
FR 31892)  Final Action 12/09/1992 (57 FR 58356)  Final Action 
(Amendment)(Warning) 01/28/1994 (59 FR 4216)  NPRM 
(Amendment)(Diphenhydramine) 08/29/1997 (62 FR 45767)  Final Action 06/
00/2000

Cough/Cold (Antitussive) Products  ANPRM 09/09/1976 (41 FR 38312)  NPRM 
10/19/1983 (48 FR 48576)  Final Action 08/12/1987 (52 FR 30042)  NPRM 
(Amendment) (Warning) 07/06/1989 (54 FR 28442)  NPRM (Amendment) 10/02/
1989 (54 FR 40412)  Final Action (Amendment) (Warning) 07/06/1990 (55 
FR 27806)  Final Action (Amendment) 10/03/1990 (55 FR 40381)  NPRM 
(Amendment)(Warning) 06/19/1992 (57 FR 27666)  NPRM 
(Amendment)(Ingredients) 12/09/1992 (57 FR 58378)  Final Action 
(Amendment)(Warning) 10/20/1993 (58 FR 54232)  Final Action 
(Amdt.)(Ingredients) 06/03/1994 (59 FR 29172)  NPRM 
(Amendment)(Diphenhydramine) 08/29/1997 (62 FR 45767)  NPRM 
(Amendment)(Flammability) 07/20/1998 (63 FR 38762)  Final Action 
(Amendment)(Flammability) 03/00/2000

Cough/Cold (Bronchodilator) Products  ANPRM 09/09/1976 (41 FR 
38312)  NPRM 10/26/1982 (47 FR 47520)  Final Action 10/02/1986 (51 FR 
35326)  NPRM (Amendment)(Warning) 06/19/1992 (57 FR 27662)  Final 
Action (Amendment)(Warning) 10/20/1993 (58 FR 54238)  NPRM 
(Amendment)(MDI) 03/09/1995 (60 FR 13014)  NPRM (Amendment)(Ephedrine) 
07/27/1995 (60 FR 38643)  Final Action (Amendment) (MDI) 05/20/1996 (61 
FR 25142)  NPRM (Amendment)(Ephedrine) 06/00/2000

Cough/Cold (Combination) Products  ANPRM 09/09/1976 (41 FR 38312)  NPRM 
08/12/1988 (53 FR 30522)  NPRM (Amendment)(DPH Combinations) 02/23/1995 
(60 FR 10286)  Final Action (Theophylline) 07/27/1995 (60 FR 
38636)  Final Action 03/00/2000  Final Action (Ephedrine Combo) 06/00/
2000

Cough/Cold (Diphenhydramine) Products  Final Action/Enforcement Policy 
04/09/1996 (61 FR 15700)

Cough/Cold (Expectorant) Products  ANPRM 09/09/1976 (41 FR 38312)  NPRM 
07/09/1982 (47 FR 30002)  Final Action 02/28/1989 (54 FR 8494)  Final 
Action (Technical Changes) 06/30/1992 (57 FR 29176)

Cough/Cold (Expectorant/Ipecac) Products  ANPRM 09/09/1976 (41 FR 
38312)  NPRM 07/09/1982 (47 FR 30002)  Final Action 09/14/1992 (57 FR 
41857)

Cough/Cold (Nasal Decongestant) Products  ANPRM 09/09/1976 (41 FR 
38312)  NPRM 01/15/1985 (50 FR 2220)  NPRM (Amendment) 06/19/1992 (57 
FR 27658)  Final Action 08/23/1994 (59 FR 43386)  Final Action; Partial 
Stay 03/08/1996 (61 FR 9570)  NPRM (Phenylpropanolamine) 12/00/2000

Dandruff, Seborrheic Dermatitis and Psoriasis Control Products  ANPRM 
12/03/1982 (47 FR 54646)  NPRM 07/30/1986 (51 FR 27346)  Final Action 
12/04/1991 (56 FR 63554)  NPRM (Amendment) 04/05/1993 (58 FR 
17554)  Final Action 01/28/1994 (59 FR 4000)

Daytime Sedatives  ANPRM 12/08/1975 (40 FR 57292)  NPRM 06/13/1978 (43 
FR 25544)  Final Action 06/22/1979 (44 FR 36378)

Diaper Rash Products (Merged w/other rulemkg)  ANPRM 09/07/1982 (47 FR 
39406)

Digestive Aid Products  ANPRM 01/05/1982 (47 FR 454)  NPRM 01/29/1988 
(53 FR 2706)  Final Action 10/21/1993 (58 FR 54450)

Eligibility Criteria for Additional Conditions  ANPRM 10/03/1996 (61 FR 
51625)  NPRM 12/00/1999

Emetic Products  ANPRM 03/21/1975 (40 FR 12939)  NPRM 09/05/1978 (43 FR 
39544)

Exocrine Pancreatic Insufficiency Products  ANPRM 12/21/1979 (44 FR 
75666)  NPRM 11/08/1985 (50 FR 46594)  NPRM (Reproposed) 07/15/1991 (56 
FR 32282)  Final Action 04/24/1995 (60 FR 20162)

[[Page 64370]]

External Analgesic Products  ANPRM 12/04/1979 (44 FR 69768)  NPRM 02/
08/1983 (48 FR 5852)  NPRM (Amendment) (Dandruff) 07/30/1986 (51 FR 
27360)  NPRM (Amendment) (Anorectal) 08/25/1988 (53 FR 32592)  NPRM 
(Amendment) (Poison Ivy) 10/03/1989 (54 FR 40818)  NPRM (Amendment) 
(Fvr Blister/Ext) 01/31/1990 (55 FR 3370)  NPRM (Amendment) 
(1%Hydrocortisone) 02/27/1990 (55 FR 6932)  NPRM (Amendment) (Diaper 
Rash) 06/20/1990 (55 FR 25234)  Final Action (Diaper Rash) 12/18/1992 
(57 FR 60426)  NPRM (Amendment)(Warning) 08/29/1997 (62 FR 
45767)  Final Action 12/00/2001

Fever Blister Products (Internal)  ANPRM 01/05/1982 (47 FR 502)  NPRM 
06/17/1985 (50 FR 25156)  Final Action 06/30/1992 (57 FR 29166)

First Aid Antiseptic  ANPRM 09/13/1974 (39 FR 33103)  NPRM 01/06/1978 
(43 FR 1210)  NPRM (Revised) 07/22/1991 (56 FR 33644)  Final Action 12/
00/2000

Fvr Blister/Cold Sore Prdts (Ext.) (To be merged w/other 
rulemkg)  ANPRM 09/07/1982 (47 FR 39436)

Hair Grower and Hair Loss Prevention Products  ANPRM 11/07/1980 (45 FR 
73955)  NPRM 01/15/1985 (50 FR 2190)  Final Action 07/07/1989 (54 FR 
28772)

Healthcare Antiseptic Products  ANPRM 09/13/1974 (39 FR 33103)  NPRM 
01/06/1978 (43 FR 1210)  NPRM (Revised) 06/17/1994 (59 FR 31402)

Hormone (Topical) Products  ANPRM 01/05/1982 (47 FR 430)  NPRM 10/02/
1989 (54 FR 40618)  Final Action 09/09/1993 (58 FR 57608)

Hypo/Hyperphosphatemia Products  ANPRM 12/09/1980 (45 FR 81154)  NPRM 
01/15/1985 (50 FR 2160)  Final Action 05/11/1990 (55 FR 19852)

Ingrown Toenail Relief Products  ANPRM 10/17/1980 (45 FR 69128)  NPRM 
09/03/1982 (47 FR 39120)  Final Action 09/09/1993 (58 FR 47602)

Insect Bite & Sting (Relief) Prdts (Merged w/other rulemkg)  ANPRM 09/
07/1982 (47 FR 39412)

Insect Repellent Drug Products (Internal)  ANPRM 01/05/1982 (47 FR 
424)  NPRM 06/10/1983 (48 FR 26986)  Final Action 06/17/1985 (50 FR 
25170)

Internal Analgesic Products  ANPRM 07/08/1977 (42 FR 35346)  NPRM 11/
16/1988 (53 FR 46204)  NPRM (Amendment) (Overindulgence) 12/24/1991 (56 
FR 66762)  NPRM (Amendment)(Sodium Bicarbonate) 02/02/1994 (59 FR 
5068)  NPRM (Prof. Labeling)(Acute MI) 06/13/1996 (61 FR 30002)  NPRM 
(Amendment)(Alcohol Warning) 11/14/1997 (62 FR 61041)  Final Action 
(Alcohol Warning) 10/23/1998 (63 FR 56789)  Final Action (Aspirin Prof 
Label) 10/23/1998 (63 FR 56802)  Final Action (Sodium Bicarbonate) 03/
00/2000  Final Action (Amendment)(Overindulgence) 12/00/2001

Internal Deodorant Products  ANPRM 01/05/1982 (47 FR 512)  NPRM 06/17/
1985 (50 FR 25162)  Final Action 05/11/1990 (55 FR 19862)

Labeling of Drug Products for OTC Human Use  NPRM (Sodium Labeling) 04/
25/1991 (56 FR 19222)  NPRM 04/05/1993 (58 FR 17553)  Final Action 01/
28/1994 (59 FR 3998)  NPRM (Do not mix drugs) 08/03/1994 (59 FR 
39499)  NPRM (Amendment) (Do not mix drugs) 10/04/1995 (60 FR 
52058)  NPRM (Unless a doctor tells you) 03/04/1996 (61 FR 8450)  Final 
Action (Sodium Labeling) 04/22/1996 (61 FR 17798)  NPRM (Calcium/
Magnesium/Potassium) 04/22/1996 (61 FR 17807)  Withdrawal (Unless a 
doctor tells you) 02/27/1997 (62 FR 9024)  Final Action (Format/
Examples) 03/17/1999 (64 FR 13254)  Final Action (Ca/Mg/K/Na) 01/00/
2000

Laxative Products  ANPRM 03/21/1975 (40 FR 12902)  NPRM 01/15/1985 (50 
FR 2124)  NPRM (Amendment) (Directions/Bulk) 10/01/1986 (51 FR 
35136)  NPRM (Amendment) (Docusate Salts) 09/02/1993 (58 FR 
46589)  NPRM (Amendment)(Sodium Phosphates) 03/31/1994 (59 FR 
15139)  NPRM (Phenolphthalein) 09/02/1997 (62 FR 46223)  Final Action 
(Sodium Phosphates) 05/21/1998 (63 FR 27836)  NPRM 
(Amendment)(Phosphates Label) 05/21/1998 (63 FR 27886)  NPRM 
(Amendment)(Stim. Laxative) 06/19/1998 (63 FR 33592)  Final Action; 
stay (Na Phos. Enema) 12/07/1998 (63 FR 67399)  Part. With. (Na Phos. 
Prof. Lab.) 12/09/1998 (63 FR 67817)  Final Action (Phenolphthalein) 
01/29/1999 (64 FR 4535)  Final Action 03/00/2000  Final Action (Stim. 
Laxative) 12/00/2003

Leg Muscle Cramps (Nocturnal Relief) Products  ANPRM 10/01/1982 (47 FR 
43562)  NPRM 11/08/1985 (50 FR 46588)  Final Action 08/22/1994 (59 FR 
43234)

Male Genital Desensitizer Products  ANPRM 09/07/1982 (47 FR 
39412)  NPRM 10/02/1985 (50 FR 40260)  Final Action 06/19/1992 (57 FR 
27654)

Menstrual Products  ANPRM 12/07/1982 (47 FR 55075)  NPRM 11/16/1988 (53 
FR 46194)  Final Action 12/00/2001

Mercurial (Topical) Products (To be merged w/other rulemkg)  ANPRM 01/
05/1982 (47 FR 436)

NDA Labeling Exclusivity  NPRM 11/09/1993 (58 FR 59622)

Nailbiting/Thumbsucking Deterrent Products  ANPRM 10/17/1980 (45 FR 
69122)  NPRM 09/03/1982 (47 FR 39096)  Final Action 09/02/1993 (58 FR 
46749)

Nighttime Sleep Aid Products  ANPRM 12/08/1975 (40 FR 57292)  NPRM 06/
13/1978 (43 FR 25544)  Final Action 02/14/1989 (54 FR 6814)  NPRM 
(Amendment) 08/26/1993 (58 FR 45217)  Final Action (Amendment) 04/11/
1994 (59 FR 16982)  NPRM (Amendment) (Warning) 08/29/1997 (62 FR 
45767)  Final Action 06/00/2000

Ophthalmic Products  ANPRM 05/06/1980 (45 FR 30002)  NPRM 06/28/1983 
(48 FR 29788)  Final Action 03/04/1988 (53 FR 7076)  Final Action 
(Anti-infective) 12/18/1992 (57 FR 60416)  NPRM (Amendment) (Warning) 
02/23/1998 (63 FR 8888)  Final Action 01/00/2000

Oral Discomfort (Relief) Products  ANPRM 05/25/1982 (47 FR 22712)  NPRM 
09/24/1991 (56 FR 48302)  Final Action 06/00/2002

Oral Health Care Products  ANPRM 05/25/1982 (47 FR 22760)  NPRM 01/27/
1988 (53 FR 2436)  NPRM (Amendment) (Antimicrobials) 02/09/1994 (59 FR 
6084)  ANPRM (Plaque/Gingivitis) 01/00/2000  NPRM 01/00/2001

Oral Wound Healing Products  ANPRM 11/02/1979 (44 FR 63270)  NPRM 07/
26/1983 (48 FR 33984)  Final Action 07/18/1986 (51 FR 26112)

Otic Products (Dry Water-Clogged Ears)  NPRM (Amendment) 08/17/1999 (64 
FR 44671)

Otic Products (Earwax)  NPRM 07/09/1982 (47 FR 30012)  Final Action 08/
08/1986 (51 FR 28656)

Otic Products (Swimmers Ear)  NPRM 07/30/1986 (51 FR 27366)  Final 
Action 02/15/1995 (60 FR 8916)  Final Action Partial Stay 08/16/1995 
(60 FR 42435)

[[Page 64371]]

Overindulgence Remedies  ANPRM 10/01/1982 (47 FR 43540)  NPRM 12/24/
1991 (56 FR 66742)  Final Action 12/00/2001

Overindulgence Remedies/Prevention of Inebriation  ANPRM 10/01/1982 (47 
FR 43540)  Final Action 07/19/1983 (48 FR 32872)

Pediculicide Products  ANPRM 06/29/1982 (47 FR 28312)  NPRM 04/03/1989 
(54 FR 13480)  Final Action 12/14/1993 (58 FR 65452)  NPRM (Labeling 
Amendment) 12/00/1999

Phenylpropanolamine Products (Labeling)  NPRM 02/14/1996 (61 FR 
3912)  Final Action 06/00/2000

Poison Ivy/Oak/Sumac Prevention (Merged w/other rulemkg)  ANPRM 09/07/
1982 (47 FR 39412)

Poison Treatment Products  NPRM 01/15/1985 (50 FR 2244)  Final Action 
06/00/2000  NPRM (Amendment) 12/00/2001

Quinine for Malaria  NPRM 04/19/1995 (60 FR 19650)  Final Action 03/20/
1998 (63 FR 13526)

Salicylate (Reye Syndrome)  NPRM (Amendment)(Warning) 05/05/1993 (58 FR 
26886)  ANPRM 10/20/1993 (58 FR 54228)  Final Action (Warning) 12/00/
1999

Skin Bleaching Products  ANPRM 11/03/1978 (43 FR 51546)  NPRM 09/03/
1982 (47 FR 39108)  NPRM (Reproposed) 01/00/2003

Skin Protectant Products  ANPRM 08/04/1978 (43 FR 34628)  NPRM 02/15/
1983 (48 FR 6820)  NPRM (Amendment) (Astringent) 04/03/1989 (54 FR 
13490)  NPRM (Amendment) (Poison Ivy) 10/03/1989 (54 FR 40808)  NPRM 
(Amendment) (Fvr Blister/Ext) 01/31/1990 (55 FR 3362)  NPRM (Amendment) 
(Diaper Rash) 06/20/1990 (55 FR 25204)  Final Action (Astringent) 10/
21/1993 (58 FR 54466)  Final Action (Witch Hazel) 06/03/1994 (59 FR 
28767)  Final Action (Poison Ivy) 12/00/1999  Final Action 12/00/1999

Smoking Deterrent Products  ANPRM 01/05/1982 (47 FR 490)  NPRM 07/03/
1985 (50 FR 27552)  Final Action 06/01/1993 (58 FR 31236)

Status of Certain Category II and III Ingredients  NPRM 05/16/1990 (55 
FR 20434)  Final Action 11/07/1990 (55 FR 46914)  NPRM 08/25/1992 (57 
FR 38568)  Final Action 05/10/1993 (58 FR 27636)  Final Action 04/22/
1998 (63 FR 19799)  Final Action 08/24/1998 (63 FR 44996)

Stimulant (Overindulgence) Products  NPRM (Amendment) 12/24/1991 (56 FR 
66758)  Final Action 12/00/2001

Stimulant Products  ANPRM 12/08/1975 (40 FR 57292)  NPRM 06/13/1978 (43 
FR 25544)  Final Action 02/29/1988 (53 FR 6100)

Stomach Acidifier Products  ANPRM 10/19/1979 (44 FR 60316)  NPRM 01/15/
1985 (50 FR 2184)  Final Action 08/17/1988 (53 FR 31270)

Sunscreen Products  ANPRM 08/25/1978 (43 FR 38206)  NPRM 05/12/1993 (58 
FR 28194)  NPRM (Amendment) 06/08/1994 (59 FR 29706)  NPRM 
(Amendment)(Avobenzone) 09/16/1996 (61 FR 48645)  Final Action 
(Avobenzone Enf. Pol.) 04/30/1997 (62 FR 23350)  Final Action 05/21/
1999 (64 FR 27666)

Sweet Spirits of Nitre  ANPRM 02/22/1980 (45 FR 11846)  Final Action 
06/27/1980 (45 FR 43400)

Topical Drug Products Containing Benzoyl Peroxide (Labeling)  NPRM 02/
17/1995 (60 FR 9554)  Final Action 07/00/2001

Vaginal Contraceptive Products  ANPRM 12/12/1980 (45 FR 82014)  NPRM 
02/03/1995 (60 FR 6892)  NPRM (Amendment) 03/00/2000

Vaginal Drug Products  ANPRM 10/13/1983 (48 FR 46694)  Withdrawal 02/
03/1995 (60 FR 5226)  NPRM (Douches) 12/00/2001

Vitamin/Mineral Products  ANPRM 03/16/1979 (44 FR 16126)  Withdrawal 
11/27/1981 (46 FR 57914)

Wart Remover Products  ANPRM 10/03/1980 (45 FR 65609)  NPRM 09/03/1982 
(47 FR 39102)  NPRM (Amendment) 03/27/1987 (52 FR 9992)  Final Action 
08/14/1990 (55 FR 33246)  NPRM (Amendment)(Directions) 01/28/1994 (59 
FR 4015)  Final Action (Amdt.)(Directions) 11/23/1994 (59 FR 60315)

Water Soluble Gums  NPRM 10/30/1990 (55 FR 45782)  Final Action 08/26/
1993 (58 FR 45194)

Weight Control Products  ANPRM 02/26/1982 (47 FR 8466)  NPRM 10/30/1990 
(55 FR 45788)  Final Action 08/08/1991 (56 FR 37792)  NPRM (Amendment) 
12/00/2000

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, HFD-105, Center for Drug Evaluation and 
Research, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2222

RIN: 0910-AA01
_______________________________________________________________________




1114. HEARING AIDS; PROFESSIONAL AND PATIENT LABELING; CONDITIONS FOR 
SALE

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

RIN: 0910-AA39
_______________________________________________________________________




1115. 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

[[Page 64372]]

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                            10/00/99

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, Room 15-74 
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-3380
Email: [email protected]

RIN: 0910-AA61
_______________________________________________________________________




1116. ADVERSE DRUG REACTION REPORTING AND RECORDKEEPING 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 358; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 
375; 21 USC 379; 42 USC 216

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

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

RIN: 0910-AA86
_______________________________________________________________________




1117. 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 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                            09/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0910-AA90
_______________________________________________________________________




1118. LABELING FOR HUMAN PRESCRIPTION DRUGS; REVISED FORMAT

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

RIN: 0910-AA94
_______________________________________________________________________




1119. SUSPECTED 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; 21 USC 371; 21 USC 374

CFR Citation: 21 CFR 310; 21 CFR 312; 21 CFR 314; 21 CFR 320; 21 CFR 
600; 21 CFR 601

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 suspected adverse drug reaction reports 
received by FDA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

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

RIN: 0910-AA97


_______________________________________________________________________



[[Page 64373]]

1120. 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 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 product 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                            09/01/99                    64 FR 47719
NPRM Comment Period End         11/30/99
Final Action                    12/00/00

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 
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA99
_______________________________________________________________________




1121. 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                            06/00/00
NPRM Comment Period End         08/00/00

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, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041

RIN: 0910-AB00
_______________________________________________________________________




1122. 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: NPRM, Statutory, July 1, 2000.

Abstract: This proposed rule would amend FDA regulations in 21 CFR part 
10 concerning advisory opinions and guidelines.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Andrea C. Masciale, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB14
_______________________________________________________________________




1123. 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                            05/14/99                    64 FR 26330

[[Page 64374]]

NPRM Comment Period Reopen      08/09/99
NPRM Comment Period End         10/08/99
Final Action                    05/00/00

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, Room 15-74 
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-3380
Email: [email protected]

RIN: 0910-AB21
_______________________________________________________________________




1124. BLOOD INITIATIVE

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 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, blood components, 
and 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 deferred donors; 
requirements for donor suitability and testing and infectious agent 
clearance. These actions are intended to help ensure the continued 
safety of the nation's blood supply.

Timetable:
________________________________________________________________________

Albumin (Human), Plasma Protein Fraction (Human) and Immune Globulin 
(Human); Rev. of Reqs.  Direct Final Rule 05/14/1999 (64 FR 
26282)  NPRM 05/14/1999 (64 FR 26344)

Gen. Reqs. for Blood, Blood Compon., and Plasma Derivatives; 
Notification of Deferred Donors  NPRM 08/19/1999 (64 FR 45355)  Final 
Action 10/00/2000

Infectious Agent Clearance  NPRM 04/00/2000

Plasma Derivatives and Other Blood-Derived Products; Reqs. for Tracking 
and Notification  ANPRM 08/19/1999 (64 FR 45383)  NPRM 10/00/2000

Reqs. for Testing Human Blood Donors for Evid. of Infection Due to 
Communicable Disease Agents  NPRM 08/19/1999 (64 FR 45340)  Final 
Action 10/00/2000

Rev. to the Requirements Applicable to Blood, Blood Components, and 
Source Plasma  Direct Final Rule 08/19/1999 (64 FR 45366)  NPRM 08/19/
1999 (64 FR 45375)  Final Action 10/00/2000

Suitability Reqs. for Whole Blood and Source Plasma Donors  NPRM 04/00/
2000

Regulatory Flexibility Analysis Required: No

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, Suite 200N (HFM-17), Center for Biologics Evaluation 
and Research, 1401 Rockville Pike, Rockville, MD 20852-1448
Phone: 301 827-6210
Email: [email protected]

RIN: 0910-AB26
_______________________________________________________________________




1125. 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                            09/30/99                    64 FR 52696
NPRM Comment Period End         12/29/99
Final Action                    10/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

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

RIN: 0910-AB27
_______________________________________________________________________




1126. 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

[[Page 64375]]

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                            03/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

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

RIN: 0910-AB28
_______________________________________________________________________




1127. 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 revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

Legal Authority: PL 105-115, sec 125

CFR Citation: 21 CFR 314

Legal Deadline: None

Abstract: The proposed rule would 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 are excepted under section 125(d) of the 
Food and Drug Administration Modernization Act of 1997 from certain 
provisions in section 505, including the exclusivity provisions under 
sections 505(c) and 505(j) of the Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Suite 3057 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB33
_______________________________________________________________________




1128. APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW 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 371; 21 USC 374; 21 USC 379e

CFR Citation: 21 CFR 312; 21 CFR 314

Legal Deadline: None

Abstract: The proposed rule would 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. The proposed rule would also 
amend the regulations on extension of the review clock because of 
amendments to applications.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/00

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, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041

RIN: 0910-AB34
_______________________________________________________________________




1129. EXPANDED ACCESS TO INVESTIGATIONAL THERAPIES

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 360bbb

CFR Citation: 21 CFR 312

Legal Deadline: None

Abstract: The proposed rule would 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                            06/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Joseph Griffin, Regulatory Counsel, Department of

[[Page 64376]]

Health and Human Services, Food and Drug Administration, (HFD-40), 
Center for Drug Evaluation and Research, 1451 Rockville Pike, Suite 
6021, Rockville, MD 20852
Phone: 301 594-6758
Fax: 301 594-5298

RIN: 0910-AB37
_______________________________________________________________________




1130. 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 290; 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 21 CFR parts 201, 329, and 369 by 
removing the requirement that certain habit-forming narcotics or 
hypnotics bear the statement ``Warning--May be habit forming.'' The 
rule would also revise 21 CFR part 290 to clarify that drugs that are 
controlled substances under the Federal Controlled Substances Act are 
prescription drugs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/00

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, Suite 3037 
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB39
_______________________________________________________________________




1131. 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; 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 set forth requirements 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                           11/05/98                    63 FR 59746
ANPRM Comment Period End        02/03/99
NPRM                            04/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Lee D. Korb, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB42
_______________________________________________________________________




1132. 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 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: The proposed rule would 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                            03/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Howard P. Muller, Regulatory Policy Staff, Department 
of Health and Human Services, Food and Drug Administration, Suite 3037 
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB43
_______________________________________________________________________




1133. PREGNANCY LABELING

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 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: The proposed rule would revise the regulatory requirements 
for the pregnancy labeling subsection of the labeling requirements for 
human drugs and biologics.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Virginia G. Beakes, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041

RIN: 0910-AB44


_______________________________________________________________________



[[Page 64377]]

1134. SUPPLEMENTAL MANUFACTURING CHANGES FOR NEW ANIMAL DRUGS

Priority: Other Significant

Legal Authority: 21 USC 356a

CFR Citation: 21 CFR 514.8

Legal Deadline: None

Abstract: Section 116 of the Food and Drug Administration Modernization 
Act of 1997 added a new section to the Federal Food, Drug, and Cosmetic 
Act that 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                            10/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: William Marnane, Department of Health and Human 
Services, Food and Drug Administration, HFV-140, Center for Veterinary 
Medicine, 7500 Standish Place, Rockville, MD 20855
Phone: 301 827-6966

RIN: 0910-AB49
_______________________________________________________________________




1135. PHARMACY AND PHYSICIAN COMPOUNDING OF DRUG PRODUCTS

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

RIN: 0910-AB58
_______________________________________________________________________




1136. 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 
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                            02/00/00

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, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041

RIN: 0910-AB59
_______________________________________________________________________




1137. 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 proposed rule would set forth 
requirements on issues related to the implementation of section 131, 
which requires that the sole manufacturer of certain 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

________________________________________________________________________

NPRM                            01/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Andrea C. Masciale, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB60
_______________________________________________________________________




1138. PEDIATRIC EXCLUSIVITY

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

[[Page 64378]]

in order to qualify for pediatric exclusivity.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/00

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 
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB62
_______________________________________________________________________




1139. 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                            02/00/00

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, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041

RIN: 0910-AB63
_______________________________________________________________________




1140. FOOD LABELING: TRANS FATTY ACIDS IN NUTRITION LABELING AND 
NUTRIENT CONTENT CLAIMS

Priority: Economically 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 permits foods to bear 
nutrient content claims for saturated fat (i.e., saturated fatty acids) 
and cholesterol only if they contain trans fatty acids below a 
specified level, and to define a ``trans fatty acids free'' nutrient 
content claim.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/99

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, HFS-165, Center for Food Safety 
and Applied, Nutrition, 200 C Street SW, Washington, DC 20204
Phone: 202 205-5587
Email: [email protected]

RIN: 0910-AB66
_______________________________________________________________________




1141. DESIGNATED JOURNALS

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 360b

CFR Citation: 21 CFR 510.95

Legal Deadline: None

Abstract: FDA intends to remove 21 CFR 510.95. 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                            01/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

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

RIN: 0910-AB67


_______________________________________________________________________



[[Page 64379]]

1142. 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                            06/00/00

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, HFV-100, 
Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD 
20855
Phone: 301 827-0205

RIN: 0910-AB68
_______________________________________________________________________




1143. 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 360b; 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                            07/00/00

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, 
HFV-220, Center for Veterinary Medicine, 7500 Standish Place, 
Rockville, MD 20855
Phone: 301 827-6651
Email: [email protected]

RIN: 0910-AB70
_______________________________________________________________________




1144. 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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/99

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, Room 15-74 
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-3380
Email: [email protected]

RIN: 0910-AB73
_______________________________________________________________________




1145. CGMPS FOR BLOOD AND BLOOD COMPONENTS: NOTIFICATION OF CONSIGNEES 
AND TRANSFUSION RECIPIENTS RECEIVING BLOOD AND BLOOD COMPONENTS AT 
INCREASED RISK OF TRANSMITTING HCV INFECTION

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

RIN: 0910-AB76
_______________________________________________________________________




1146. ANTIBIOTIC RESISTANCE LABELING

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 358; 21 USC 360; 21 USC 360b; 21 USC 371; 21 
USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; ...

CFR Citation: 21 CFR 201.57

Legal Deadline: None

Abstract: The proposed rule would require the inclusion of statements 
on antibiotic prescription drug labeling concerning inappropriate 
antibiotic use and the prevalence of drug resistant microorganisms.

[[Page 64380]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/00

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, Suite 3037 
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB78
_______________________________________________________________________




1147. FIXED-COMBINATION PRESCRIPTION AND OVER-THE-COUNTER DRUGS FOR 
HUMAN USE

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 
360b; 21 USC 361; 21 USC 371

CFR Citation: 21 CFR 300.50; 21 CFR 330.10

Legal Deadline: None

Abstract: The proposed rule would amend 21 CFR 300.50 and 21 CFR 
330.10(a)(4)(iv), which state the conditions under which two or more 
drugs (for a prescription drug) or active ingredients (for an over-the-
counter drug) may be combined in a single dosage form. The proposed 
rule would state how this provision will apply to products derived from 
natural sources, including animal and botanical raw materials.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/00

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, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041

RIN: 0910-AB79
_______________________________________________________________________




1148. REPACKAGING APPROVAL REQUIREMENTS

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 371; 21 USC 374; 21 USC 379e

CFR Citation: 21 CFR 314

Legal Deadline: None

Abstract: The proposed rule would set forth requirements for FDA prior 
approval of certain types of repackaging of approved drug products by 
persons who are not holders of approved applications for the products. 
The proposed rule would ensure that FDA approves changes to drug 
product containers and closure systems by both application holders and 
repackagers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/00

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, Suite 3037 
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB81
_______________________________________________________________________




1149. STABILITY TESTING OF 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 371; 21 USC 374; 21 USC 379e

CFR Citation: 21 CFR 314

Legal Deadline: None

Abstract: The proposed rule would specify required stability data that 
must be submitted with new drug applications.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/00

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, Suite 3037 
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB82
_______________________________________________________________________




1150. POSTMARKETING STUDIES FOR HUMAN DRUGS AND LICENSED BIOLOGICAL 
PRODUCTS: STATUS REPORTS

Priority: Other Significant

Legal Authority: PL 105-115

CFR Citation: 21 CFR 314.81; 21 CFR 601.70

Legal Deadline: Other, Statutory, October 1, 2001, Section 130(b) 
requires the FDA to report by 10/01/01 to the House and Senate 
committees summarizing submitted postmarketing study reports evaluating 
sponsor performance and the timeliness of FDA review.

Abstract: Section 130(a) of the Food and Drug Administration 
Modernization Act of 1997 adds a new section 506B to the Federal Food, 
Drug, and Cosmetic Act requiring a drug sponsor that has agreed to 
conduct a postmarketing study to submit within one year after the 
drug's approval and annually thereafter until the study's conclusion, a 
progress report, or an explanation of why the sponsor has not conducted 
the study. Any information pertaining to postmarketing study reports 
will be considered public to identify the sponsor or explain the status 
of the study, including why it has not been carried out. FDA is 
required to publish annually in the Federal Register a report 
concerning the status of postmarketing studies that sponsors have 
agreements to conduct.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/99

[[Page 64381]]

Regulatory Flexibility Analysis Required: No

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, 
Suite 200N (HFM-17), Center for Biologics Evaluation and Research, 1401 
Rockville Pike, Rockville, MD 20852-1448
Phone: 301 827-6210

RIN: 0910-AB83
_______________________________________________________________________




1151. AMENDMENT OF VARIOUS FOOD ADDITIVE AND DEVICE REGULATIONS TO 
REFLECT CURRENT AMERICAN SOCIETY FOR TESTING AND MATERIALS CITATIONS

Priority: Routine and Frequent

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 341; 21 USC 342; 21 USC 
343; 21 USC 346; 21 USC 348; 21 USC 351; 21 USC 352; 21 USC 360i; 21 
USC 360j; 21 USC 371; 21 USC 373; 21 USC 374; 21 USC 379e

CFR Citation: 21 CFR 172.210; 21 CFR 172.250; 21 CFR 172.615; 21 CFR 
172.862; 21 CFR 172.864; 21 CFR 172.882; 21 CFR 173.25; 21 CFR 175.250; 
21 CFR 175.270; 21 CFR 175.300; 21 CFR 176.170; 21 CFR 176.180; 21 CFR 
177.1040; 21 CFR 177.1200; 21 CFR 177.1210; ...

Legal Deadline: None

Abstract: The proposed rule would amend various food additive and 
medical device regulations. The amendments would update the references 
in those regulations to various standards of the American Society for 
Testing and Materials (ASTM) to reflect the current standards 
designations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

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

RIN: 0910-AB84
_______________________________________________________________________




1152.  CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, 
PACKING, OR HOLDING DIETARY SUPPLEMENTS

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

RIN: 0910-AB88
_______________________________________________________________________




1153.  CURRENT GOOD MANUFACTURING FOR BLOOD AND BLOOD 
COMPONENTS; BLOOD LABELING STANDARDS; DIRECT FINAL RULE

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 360; 21 USC 
360j; 21 USC 371; 21 USC 374; 42 USC 216; 42 USC 262; 42 USC 263a; 42 
USC 264; 21 USC 355; 42 USC 216; 42 USC 262; 42 USC 263a; 42 USC 264

CFR Citation: 21 CFR 606.121; 21 CFR 606.122

Legal Deadline: None

Abstract: The direct final rule and companion proposed rule would amend 
the regulations governing labeling for human biologic products under 21 
CFR 606.121 and 606.122. The rule or revised regulations would 
eliminate reference to an outdated guidance document on uniform 
labeling. The rule would also provide for updating the labeling 
requirements regarding testing and results for communicable disease 
agents. The regulations currently require that certain information, 
e.g., product name, donor classification statement, etc., be printed on 
the label in solid red. The rule would provide the alternative for 
printing this information in solid red or solid black. This alternative 
will make it unnecessary for manufacturers to seek an alternative 
exception under 21 CFR 640.120.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/00
Direct Final Rule               04/00/00

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0910-AB89
_______________________________________________________________________




1154.  SUBMISSION IN ELECTRONIC FORMAT OF CERTAIN LABELING 
INFORMATION

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 350; 21 USC 351; 21 USC 
353; 21 USC 355; 21 USC 371; 21 USC 374; 21 USC 379e; ...

CFR Citation: 21 CFR 314.50; 21 CFR 314.81; 21 CFR 314.94

Legal Deadline: None

Abstract: The Food and Drug Administration is proposing to amend its 
regulations governing the format in which certain required labeling 
information in new drug applications, abbreviated new drug 
applications, supplements, and annual reports is required to be 
submitted. The proposal would require that the labeling information 
described under 201.56 and 201.57 be submitted to FDA in electronic 
format as a portable document format file.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/00

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Lee D. Korb, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB91


_______________________________________________________________________



[[Page 64382]]

1155.  FEES RELATING TO DRUGS; WAIVER AND REDUCTION OF FEES

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 379g; 21 USC 379h

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: Sections 735 and 736 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. sections 379g and 379h) require FDA to assess and 
collect fees related to human drug applications. Section 736(d) of the 
act (21 U.S.C. 379h(d) authorizes the agency to grant a waiver or 
reduction of such fees in certain circumstances. This proposed rule 
would establish FDA's criteria for determining whether to grant a 
waiver or reduction of fees.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/00

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Andrea C. Masciale, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB92
_______________________________________________________________________




1156.  SKIP LOT TESTING

Priority: Substantive, Nonsignificant. 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 
360(b); 21 USC 371; 21 USC 374; ...

CFR Citation: 21 CFR 211.165

Legal Deadline: None

Abstract: The proposed rule requests comments on when certain tests 
used to determine satisfactory conformance to final specifications of a 
batch of drug product may be performed on a periodic basis.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/00

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Carol Drew, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB93
_______________________________________________________________________




1157.  FOOD ADDITIVES: FOOD CONTACT SUBSTANCES NOTIFICATION 
SYSTEM

Priority: Substantive, Nonsignificant

Legal Authority: 5 USC 550 and 552; 21 USC 321-393, 1401-1403; 18 USC 
1905; 17 USC 2531-2582; 5 USC 552; 40 CFR 1500-1508; 42 USC 
241,242,242a, 242i, 242n, 243, 262, 263, 263b-264a, 265, 4321, 4332, 
216; EO 11524, 3 CFR 1971 Comp. 0531-533 as amended by EO 11991; 42 FR 
26967; 42 USC 300a-300e, 300aa-1; ...

CFR Citation: 21 CFR 25.20; 21 CFR 25.32; 21 CFR 20.100; 21 CFR 58.3; 
21 CFR 170.3; 21 CFR 170.100; 21 CFR 170.101; 21 CFR 170.102; 21 CFR 
170.103; 21 CFR 170.104; 21 CFR 170.105; 21 CFR 171.1; 21 CFR 171.4; 21 
CFR 174.5; 21 CFR 179.25; 21 CFR 170.106; ...

Legal Deadline: None

Abstract: In November of 1997 the U.S. Congress amended the Federal 
Food, Drug, and Cosmetic Act (FFD&C) to establish a notification 
process whereby manufactures and suppliers of components of food 
contact materials may notify FDA 120 days prior to marketing a new food 
contact substance. If FDA does not object to the notification within 
120 days, the substance may be marketed with the same status as a 
regulated food additive. FDA is authorized to publish regulations 
outlining the information required to be submitted in premarket 
notifications for food-contact substances, submitted to the agency. FDA 
is also authorized to publish regulations that identify when a food 
additive petition in lieu of a premarket notification is required. FDA 
is not required to accept a premarket notification in any fiscal year 
for which an appropriation is not specifically made for this program. 
FDA expects that the majority of food-contact substances that are 
currently the subject of food additive petitions will be the subject of 
premarket notifications once the process is in place. FDA also expects 
that substances currently reviewed under the agency's threshold of 
regulation process will be reviewed as premarket notifications under 
the new process. Unlike food additive regulations, premarket 
notifications will be specific to the notifier. The proposed use of a 
similar or identical substance produced by another manufacturer will 
require a separate premarket notification submission. Also unlike food 
additive petitions, the existence of the notification and any otherwise 
releasable data within the notification is not publicly available until 
the 120-day period has expired. FDA expects to keep a publicly 
available list of effective premarket notifications to assist 
manufacturers, distributors, and users of food packaging and other 
food-contact materials. FDA also expects to publish a proposed rule on 
the notification process for food contact substances by early FY 2000. 
FDA will provide a period for comments on the proposed rule and will 
need to address any comments in a final rule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/00

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Mitchell Alan Cheeseman, Team Leader, Department of 
Health and Human Services, Food and Drug Administration, HFS-215, 
Center for Food Safety and Applied Nutrition, 200 C Street, S.W., 
Washington, DC 20204
Phone: 202 418-3083
Fax: 202 418-3131
Email: [email protected]

RIN: 0910-AB94

[[Page 64383]]

_______________________________________________________________________


Department of Health and Human Services (HHS)          Final Rule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________




1158. 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 12/17/1991 (56 FR 65544)  NPRM 
00/00/0000

Reporting Requirements for Marketed Animal Drugs  NPRM 12/17/1991 (56 
FR 65581)  Final Action 12/00/1999

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, 301 827-6642. 
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: Claire Lathers, Director, Office of New Animal Drug 
Evaluation, Department of Health and Human Services, Food and Drug 
Administration, HFV-100, Center for Veterinary Medicine, 7500 Standish 
Place, Rockville, MD 20855
Phone: 301 594-1620

RIN: 0910-AA02
_______________________________________________________________________




1159. PRESCRIPTION DRUG MARKETING ACT OF 1987; POLICY INFORMATION, 
GUIDANCE, AND CLARIFICATIONS

Priority: Other Significant

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

CFR Citation: 21 CFR 203

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/14/94                    59 FR 11842
NPRM Comment Period End         08/01/94
Final Action                    12/00/99

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Organizations

Government Levels Affected: Federal, State

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, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041

[[Page 64384]]

Fax: 301 827-5562

RIN: 0910-AA08
_______________________________________________________________________




1160. BIOLOGICAL PRODUCT: POST-MARKETING SURVEILLANCE REPORTS OF 
INFORMATION AFFECTING BIOLOGICAL PRODUCT SAFETY AND QUALITY

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                    06/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD67.

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

RIN: 0910-AA12
_______________________________________________________________________




1161. FRUIT AND VEGETABLE JUICES: DEVELOPMENT OF HACCP AND LABEL WARNING 
STATEMENTS FOR JUICES

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

RIN: 0910-AA43
_______________________________________________________________________




1162. 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                    06/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Federal

Agency Contact: Howard P. Muller, Regulatory Policy Staff, Department 
of Health and Human Services, Food and Drug Administration, Suite 3037 
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA45
_______________________________________________________________________




1163. 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 
371

CFR Citation: 21 CFR 320

Legal Deadline: None

Abstract: The final rule revises and clarifies certain sections of part 
320 and eliminates duplication and inconsistencies.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/19/98                    63 FR 64222
NPRM Comment Period End         02/02/99
Final Action                    03/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

[[Page 64385]]

Agency Contact: Christine Rogers, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Suite 3037 
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA51
_______________________________________________________________________




1164. 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 final 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 final rule will provide 
for a transition period for programs operating under the existing 
regulatory system.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/22/99                    64 FR 39810
Final Action                    01/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Ellsworth Dory, Associate Director for International 
and Domestic Drug Control, Department of Health and Human Services, 
Food and Drug Administration, HFY-342, Center for Drug Evaluation and 
Research, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-7264

RIN: 0910-AA52
_______________________________________________________________________




1165. ALUMINUM IN LARGE AND SMALL VOLUME PARENTERALS USED IN TOTAL 
PARENTERAL NUTRITION

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321; 21 USC 360b; 21 USC 360gg-360ss; 21 USC 
331; 21 USC 351 to 353; 21 USC 355; 21 USC 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 201.323

Legal Deadline: None

Abstract: The rule will establish a maximum level of aluminum permitted 
in large volume parenterals and require that this maximum level be 
stated on the immediate container label of all large volume 
parenterals; require that the maximum aluminum content present at the 
time of release be stated on the immediate container label of 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                    02/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Agency Contact: Leanne Cusumano, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA74
_______________________________________________________________________




1166. 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; 
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                    01/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Lee D. Korb, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA78
_______________________________________________________________________




1167. 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 371; 42 USC 262

[[Page 64386]]

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                    02/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Andrea C. Masciale, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA84
_______________________________________________________________________




1168. STERILITY REQUIREMENTS FOR AQUEOUS-BASED DRUG PRODUCTS FOR ORAL 
INHALATION

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; 
21 USC 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 aqueous-based drug products 
for oral inhalation 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                    12/00/99

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, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA88
_______________________________________________________________________




1169. 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, published December 21, 1990, 55 FR 52814, 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                            10/05/99                    64 FR 53960
Interim Final Rule              10/05/99                    64 FR 54180
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal

Agency Contact: Bonnie M. Lee, Senior Policy Analyst, Office of the 
Executive Secretariat, Department of Health and Human Services, Food 
and Drug Administration, (HF-40), Office of the Commissioner, 5600 
Fishers Lane, Rockville, MD 20857
Phone: 301 827-4450

RIN: 0910-AA89
_______________________________________________________________________




1170. 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 
360b; 21 USC 371; 21 USC 374

CFR Citation: 21 CFR 210; 21 CFR 211

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/29/97                    62 FR 40489
NPRM Comment Period End         10/27/97
Final Action                    03/00/00

Regulatory Flexibility Analysis Required: Undetermined

[[Page 64387]]

Government Levels Affected: Undetermined

Agency Contact: Howard P. Muller, Regulatory Policy Staff, Department 
of Health and Human Services, Food and Drug Administration, Suite 3037 
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA98
_______________________________________________________________________




1171. VETERINARY FEED DIRECTIVES

Priority: Other Significant

Legal Authority: PL 104-250

CFR Citation: 21 CFR 510; 21 CFR 514; 21 CFR 558

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, for 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 final 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                            07/02/99                    64 FR 35966
Final Action                    07/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

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

RIN: 0910-AB09
_______________________________________________________________________




1172. 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; 
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                    04/00/00

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 
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB12
_______________________________________________________________________




1173. 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 final 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                            04/02/99                    64 FR 15944
Extension                       06/17/99                    64 FR 32442
NPRM Comment Period End         07/16/99
Final Action                    03/00/00

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, Room 15-74 
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-3380
Email: [email protected]

RIN: 0910-AB16
_______________________________________________________________________




1174. MEDICATED FEED MILL LICENSES

Priority: Other Significant

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

[[Page 64388]]

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 
regulation implements the requirements for feed mill licensing set 
forth in the ADAA. Under this regulation, 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                    12/00/99

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, HFV-200, 
Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD 
20855
Phone: 301 827-6652
Fax: 301 594-4512

RIN: 0910-AB18
_______________________________________________________________________




1175. PUBLIC INFORMATION; COMMUNICATIONS WITH STATE AND FOREIGN 
GOVERNMENT OFFICIALS

Priority: Info./Admin./Other

Legal Authority: 5 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 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 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 Action                    11/00/99

Regulatory Flexibility Analysis Required: No

Small Entities Affected: 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, Room 15-74 
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-3380
Email: [email protected]

RIN: 0910-AB22
_______________________________________________________________________




1176. 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 rule would establish reporting and recordkeeping 
requirements to implement sections 801(d)(3) and 801(d)(4) of the 
Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food 
and Drug Administration (FDA) Export Reform and Enhancement Act of 
1996. Section 801(d)(3) of the act provides that, under prescribed 
conditions, drug and device components, food and color additives, and 
dietary supplements may be imported if they are to be further processed 
or incorporated into products that are to be exported from the United 
States in accordance with sections 801(e) or 802 of the act or section 
351(h) of the Public Health Service (PHS) Act. Section 801(d)(4) of the 
act provides that blood, blood components, source plasma, or source 
leukocytes, or a component, accessory, or part thereof, may not be 
imported under section 801(d)(3) of the act unless the importation 
complies with section 351(a) of the PHS Act or FDA permits the 
importation under FDA-determined appropriate circumstances and 
conditions. Additionally, section 801(d)(4) of the act prohibits the 
importation of tissue or a component or part of tissue under section 
801(d)(3) of the act unless the importation complies with section 361 
of the PHS Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/24/98                    63 FR 64930
NPRM Comment Period End         02/08/99
Final Action                    03/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

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

RIN: 0910-AB24
_______________________________________________________________________




1177. SHELL EGGS: WARNING, NOTICE AND SAFE HANDLING LABELING STATEMENTS 
AND REFRIGERATION REQUIREMENTS

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

RIN: 0910-AB30


_______________________________________________________________________



[[Page 64389]]

1178. PROGESTATIONAL DRUG PRODUCTS FOR HUMAN USE; REQUIREMENTS FOR 
LABELING DIRECTED TO THE PATIENT

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 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: The final rule revokes 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 revoking this labeling requirement 
because of changes in the currently available scientific information.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/13/99                    64 FR 17985
NPRM Comment Period End         07/12/99
Final Action                    11/00/99

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, Suite 3037 
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB45
_______________________________________________________________________




1179. 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
Final Action                    04/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: RFA: N

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

RIN: 0910-AB51
_______________________________________________________________________




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 Pharmacopia (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 compunding under section 
127 unless such substances are covered by USP or NF monograph or are 
components of approved drugs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/07/99                      64 FR 996
NPRM Comment Period End         03/23/99
Final Action                    01/00/00

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, Suite 3057 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB57
_______________________________________________________________________




1181. MANUFACTURING CHANGES FOR DRUGS

Priority: Other Significant

Legal Authority: 21 USC 356a

CFR Citation: 21 CFR 314

Legal Deadline: None

[[Page 64390]]

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 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 rule would 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                            06/28/99                    64 FR 34608
Final Action                    04/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Howard P. Muller, Regulatory Policy Staff, Department 
of Health and Human Services, Food and Drug Administration, Suite 3037 
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB61
_______________________________________________________________________




1182. 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/26/99                    64 FR 40321
Final Action                    08/00/00

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, HFV-130, 
Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD 
20855
Phone: 301 827-7581

RIN: 0910-AB69
_______________________________________________________________________




1183. 180-DAY GENERIC DRUG EXCLUSIVITY FOR ABBREVIATED NEW DRUG 
APPLICATIONS

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 371; 21 USC 374; 21 USC 379e

CFR Citation: 21 CFR 314.107

Legal Deadline: None

Abstract: The proposed rule would amend regulations governing 180-day 
generic drug exclusivity to clarify existing eligibility requirements 
and conditions for abbreviated new drug application sponsors, to modify 
current eligibility requirements, and to impose new eligibility 
conditions. These revisions are the result of a court decision in Mova 
Pharmaceutical v. Shalala, 140 F. 3d 1060 (D.C. Cir. 1998), 
invalidating an eligibility requirement for exclusivity.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/06/99                    64 FR 42873
NPRM Comment Period End         10/04/99
Final Action                    09/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Virginia G. Beakes, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041

RIN: 0910-AB80
_______________________________________________________________________




1184.  STRUCTURE/FUNCTION

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

Legal Authority: 21 USC 343(r)(6); 21 USC 321(g); 21 USC 371(a)

CFR Citation: 21 CFR 101.93(g)

Legal Deadline: Final, Statutory.

Abstract: The Food and Drug Administration (FDA) is issuing final 
regulations defining the types of statements that can be made 
concerning the effect of a dietary supplement on the structure or 
function of the body. The regulations also establish criteria for 
determining when a statement about a dietary supplement is a claim to 
diagnose, cure, mitigate, treat, or prevent disease. This action is 
intended to clarify what types of claims may be made for dietary 
supplements without prior review by FDA and what types of claims 
require prior authorization as health claims or prior approval as drug 
claims. Final rule establishing criteria for the types of statements 
that may be made for dietary supplements under 21 USC 343(r)(6) without 
prior FDA review.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/29/98                    63 FR 23624
Notice of Public Meeting; 
Reopen. of comment period       07/08/99                    64 FR 36824
Final Action                    01/00/00

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Ann Marlin Witt, Department of Health and Human 
Services, Food and Drug Administration, Office of the Commissioner, HF-
11, 5600 Fishers Lane, Parklawn Bldg. rm. 14-101, Rockville, MD
Phone: 301 827-3360
Email: [email protected]

RIN: 0910-AB97

[[Page 64391]]

_______________________________________________________________________


Department of Health and Human Services (HHS)         Long-Term Actions


Food and Drug Administration (FDA)



_______________________________________________________________________




1185. INFANT FORMULA: GOOD MANUFACTURING PRACTICE, QUALITY CONTROL 
PROCEDURES, QUALITY FACTORS, NOTIFICATION REQUIREMENTS, AND RECORDS AND 
REPORTS

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 343; 21 USC 350a; 21 USC 371

CFR Citation: 21 CFR 106; 21 CFR 107

Legal Deadline: None

Abstract: The agency published a proposed rule on July 9, 1996 that 
would 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 1986 Amendments to the Infant 
Formula Act of 1980. Two final rules will be published: one, on Quality 
Factors and the second, on Good Manufacturing Practice, Quality Control 
Procedures Notification Requirements, and Records and Reports.

Timetable:
________________________________________________________________________

Current Good Mfg. Practices; Qual. Control Proc.  NPRM 07/09/1996 (61 
FR 36154)  NPRM Comment Period End 12/06/1996  Final Action 00/00/0000

Infant Form Cons Comp, Micro Test & Recd Retention Req  NPRM 01/26/1989 
(54 FR 3783)  NPRM Comment Period End 03/27/1989  Final Rule 12/24/1991 
(56 FR 66566)

Infant Formula Quality Factors  NPRM 07/09/1996 (61 FR 36154)  NPRM 
Comment Period End 12/06/1996  Final Action 00/00/0000

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AC46.

Agency Contact: Darla Danford, Supervisory Nutritionist, Department of 
Health and Human Services, Food and Drug Administration, HFS-456, 
Center for Food Safety and Applied Nutrition, 200 C Street SW, 
Washington, DC 20204
Phone: 202 205-5365

RIN: 0910-AA04
_______________________________________________________________________




1186. 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 implementing 
the provisions for exemptions from nutrition labeling 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, implementing the 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 on the voluntary declaration of nutrition 
labeling for raw produce and fish.

Timetable:
________________________________________________________________________

Amend Standard of Identity for Grain Products (Folic Acid)  NPRM 10/14/
1993 (58 FR 53305)  Final Action 03/05/1996 (61 FR 8781)

Health Claims and Label Statements  NPRM Folic Acid and Neural Tube Def 
10/14/1993 (58 FR 53254)  Final Action 03/05/1996 (61 FR 8752)

Misleading Containers; Nonfunctional Slack Fill  NPRM 01/06/1993 (58 FR 
2957)  Final Action 12/06/1993 (58 FR 64123)

Nutrient Content Claims and Health Claims; Restaurant Foods  NPRM 06/
15/1993 (58 FR 33055)  Final Action 08/02/1996 (61 FR 40320)

Nutrient Content, Definition of the Term, Healthy  NPRM 01/06/1993 (58 
FR 2944)  Final Action 05/10/1994 (59 FR 24232)

Placement of Nutrition Facts Panel  NPRM 08/18/1993 (58 FR 
44091)  Final Action 04/05/1995 (60 FR 17202)  Final Action Effective 
05/05/1995  Final Action Correction 06/12/1995 (60 FR 30788)

Protein Hydrolysates; Broth in Tuna; and/or Labeling  NPRM (Declaration 
of Ingredients) 01/06/1993 (58 FR 2950)  Final Action (Dec. of 
Ingredients) 00/00/0000

Reference Daily Intakes  NPRM 01/04/1994 (59 FR 427)  Final Action 12/
28/1995 (60 FR 67164)

Small Business Exemption, Nutrition Labeling  NPRM 03/14/1994 (59 FR 
11872)  Final Action 08/07/1996 (61 FR 40963)

Voluntary Guidelines for Nutrition Labeling Produce  NPRM 07/18/1994 
(59 FR 36379)  Final Action 08/16/1996 (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: Gerard L. McCowin, Acting Deputy Director, Office of 
Food Labeling, Department of Health and Human Services, Food and Drug 
Administration, HFS-150, Center for Food Safety and Applied, Nutrition,

[[Page 64392]]

200 C Street SW, Washington, DC 20204
Phone: 202 205-4561

RIN: 0910-AA19
_______________________________________________________________________




1187. MEDICAL FOODS

Priority: Other Significant

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

CFR Citation: Not Yet Determined

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           11/29/96                    61 FR 60661
ANPRM Comment Period End        04/28/97
NPRM                             To Be                       Determined

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, HFS-456, 
Center for Food Safety and Applied, Nutrition, 200 C Street SW, 
Washington, DC 20204
Phone: 202 205-4605

RIN: 0910-AA20
_______________________________________________________________________




1188. 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                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE58.

Agency Contact: Charles S. Furfine, Regulatory Review Scientist/
Software Expert, Department of Health and Human Services, Food and Drug 
Administration, HFZ-143, Center for Devices and Radiological, Health, 
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 443-2536

RIN: 0910-AA41
_______________________________________________________________________




1189. 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 
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                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Howard P. Muller, Regulatory Policy Staff, Department 
of Health and Human Services, Food and Drug Administration, Suite 3037 
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA49
_______________________________________________________________________




1190. 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,''

[[Page 64393]]

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 06/12/1996 (61 FR 
29701)  Comment Period Ended 10/10/1996  NPRM 00/00/0000

Food Standards of Identity, Quality, and Fill of Container  ANPRM 12/
29/1995 (60 FR 67492)  Comment Period Ended 06/28/1996  NPRM 00/00/0000

Food, Color, and GRAS; Simult. Pet. Rev. by USDA (Meat/Poultry)  NPRM 
12/29/1995 (60 FR 67490)  Comment Period Ended 03/14/1996  Extension of 
Comment Period 06/03/1996  Final Action 00/00/0000

Notification Procedures for Independent GRAS Determinations  NPRM 04/
17/1997 (62 FR 18938)  NPRM Comment Period Ended 07/16/1997  Final 
Action 00/00/0000

Revocation of Certain Food Labeling and Cosmetic Regulations  NPRM 06/
12/1996 (61 FR 29708)  Comment Period Ended 08/26/1996  Final Rule 08/
12/1997 (62 FR 43071)

Revocation of Lower Fat Milk Standards  NPRM 11/09/1995 (60 FR 
56541)  Comment Period Ended 01/23/1996  Partial Final 11/20/1996 (61 
FR 58991)  Confirmation of Effective Date 02/24/1997 (62 FR 8163)

Revocation of Lower Fat Yogurt Standards  NPRM 11/09/1995 (60 FR 
56541)  Confirmation of Effective Date 00/00/0000  Final Action 
(Yogurt) 00/00/0000

Revocation of Obsolete Regulations  NPRM 10/13/1995 (60 FR 
53480)  Comment Period Ended 01/11/1996  Final Rule 06/03/1996 (61 FR 
27771)  Confirmation of Eff. Date 08/27/1996 (61 FR 43963)

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

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

RIN: 0910-AA58
_______________________________________________________________________




1191. 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 to 335c; 21 USC 351 to 353; 21 USC 355; 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                             To Be                       Determined

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, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA76


_______________________________________________________________________



[[Page 64394]]

1192. 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; 
21 USC 371; 42 USC 262

CFR Citation: 21 CFR 56; 21 CFR 312

Legal Deadline: None

Abstract: The 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                            To Be                       Determined

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, (HFD-40), 
Center for Drug Evaluation and Research, 1451 Rockville Pike, Suite 
6021, Rockville, MD 20852
Phone: 301 594-6758
Fax: 301 594-5298

RIN: 0910-AA83
_______________________________________________________________________




1193. ESTABLISHMENT REGISTRATION AND LISTING OF HUMAN CELLULAR AND 
TISSUE-BASED PRODUCTS

Priority: Other Significant

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

Legal Authority: 42 USC 264

CFR Citation: 21 CFR 207; 21 CFR 807; 21 CFR 1271

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/14/98                    63 FR 26744
NPRM Comment Period End         08/12/98
Final Action                    10/00/00

Regulatory Flexibility Analysis Required: No

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, 
Suite 200N (HFM-17), Center for Biologics Evaluation and Research, 1401 
Rockville Pike, Rockville, MD 20852-1448
Phone: 301 827-6210

RIN: 0910-AB05
_______________________________________________________________________




1194. 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 non-tobacco product names and other identification on tobacco 
products and would modify the list of established names for smokeless 
tobacco products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Anne M. Kirchner, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Room 12A-55 
(HF-13), Office of Tobacco Programs, 5600 Fishers Lane, Rockville, MD 
20857
Phone: 301 827-5321

RIN: 0910-AB17
_______________________________________________________________________




1195. 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.

[[Page 64395]]

Timetable:
________________________________________________________________________

Group 1  NPRM 02/19/1997 (62 FR 7390)  NPRM Comment Period End 06/23/
1997  Final Rule 11/28/1997 (62 FR 63271)

Group 2  NPRM 00/00/0000

Groups 1 and 2  Notice 11/07/1996 (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, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Room 12A-55 
(HF-13), Office of Tobacco Programs, 5600 Fishers Lane, Rockville, MD 
20857
Phone: 301 827-5321

RIN: 0910-AB19
_______________________________________________________________________




1196. REQUIREMENTS FOR LIQUID MEDICATED FEED AND FREE-CHOICE MEDICATED 
FEED

Priority: Substantive, Nonsignificant

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

CFR Citation: 21 CFR 558.5; 21 CFR 510.455

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: William D. Price, Special Assistant, Department of 
Health and Human Services, Food and Drug Administration, HFV-200, 
Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD 
20855
Phone: 301 827-6652
Fax: 301 594-4512

RIN: 0910-AB50
_______________________________________________________________________




1197. IMPLEMENTATION OF THE IMPORT TOLERANCE PROVISIONS OF THE ANIMAL 
DRUG AVAILABILITY ACT OF 1996 AND THE SAFE LEVEL PROVISIONS OF THE 
ANIMAL MEDICINAL DRUG USE 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) permits the Secretary of HHS to establish 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 
food safety criteria used by the Secretary 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 Use 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 the Secretary finds that there is a reasonable probability 
that an extralabel use may present a risk to the public health.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

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

RIN: 0910-AB71
_______________________________________________________________________




1198. 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 part 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 part 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 
part 589 by promulgating mandatory HACCP regulations for renderers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Daniel G. McChesney, Team Leader, Feed Safety Team,

[[Page 64396]]

Department of Health and Human Services, Food and Drug Administration, 
HFV-222, Center for Veterinary Medicine, 7500 Standish Place, 
Rockville, MD 20855
Phone: 301 827-6653

RIN: 0910-AB72
_______________________________________________________________________




1199. SURGEON'S AND PATIENT EXAMINATION GLOVES; RECLASSIFICATION

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 352; 21 USC 357; 
21 USC 360; 21 USC 360c; 21 USC 360e; 21 USC 360i; 21 USC 360j; 21 USC 
360l; 21 USC 371; 21 USC 374

CFR Citation: 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. FDA 
is also considering requiring additional labeling concerning powder and 
protein levels for these devices.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/30/99                    64 FR 41710
Final Action                     To Be                       Determined

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, HFZ-215, 
Center for Devices and Radiological Health, 1350 Piccard Drive, 
Rockville, MD 20850
Phone: 301 827-2974

RIN: 0910-AB74
_______________________________________________________________________




1200.  MARKING REQUIREMENTS FOR IMPORTED FOOD PRODUCTS THAT HAVE 
BEEN REFUSED ADMISSION INTO THE UNITED STATES

Priority: Routine and Frequent

Legal Authority: 15 USC 1453, 1454, 1455; 21 USC 321, 343, 352, 355, 
360b, 362, 371, 374, 381, 382, 393; 42 USC 216, 241, 243, 262, 264

CFR Citation: 21 CFR 1.98

Legal Deadline: None

Abstract: The proposed rule would require food products which are 
refused entry into the United States to be marked,``United States 
Refused Entry.'' The proposed rule is intended to protect the public 
health against contaminated or unsafe imported food products and to 
facilitate FDA's examination of imported products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0910-AB95
_______________________________________________________________________




1201.  REQUIREMENTS FOR PERSONS USING PRIVATE LABORATORIES 
REGARDING ACTIONS TAKEN BY THE FOOD AND DRUG ADMINISTRATION

Priority: Routine and Frequent

Legal Authority: 21 USC 331; 21 USC 333; 21 USC 334; 21 USC 335b; 21 
USC 335c; 21 USC 342; 21 USC 343; 21 USC 351; 21 USC 352; 21 USC 361; 
21 USC 362; 21 USC 371; 21 USC 372; 21 USC 374; 21 USC 376; 21 USC 381

CFR Citation: 21 CFR 59

Legal Deadline: None

Abstract: The proposed rule would establish requirements for importers 
and other persons who use private laboratories with regard to a FDA 
regulatory action. For example, the proposal would pertain to persons 
who use sample collection services and private laboratories and would 
describe some responsibilities for such persons, sample collection 
services, and private laboratories. These responsibilities might 
include recordkeeping requirements to ensure that the correct sample is 
collected and analyzed and a notification requirement if a person 
intends to use a private laboratory in connection with a FDA regulatory 
action. The proposed rule is intended to help insure the integrity and 
scientific validity of data and results submitted to FDA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

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

RIN: 0910-AB96

[[Page 64397]]

_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Food and Drug Administration (FDA)



_______________________________________________________________________




1202. DIETARY SUPPLEMENT REGULATIONS IN RESPONSE TO DSHEA

Priority: Other Significant

CFR Citation: 21 CFR 101

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule-Nutrient Labeling and 
Ingredient Labeling; Dietary 
Supplements                     06/05/98                    63 FR 30615

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: Federal, State

Agency Contact: Elizabeth A. Yetley
Phone: 202 205-4168

RIN: 0910-AA59
_______________________________________________________________________




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

Priority: Other Significant

CFR Citation: 21 CFR 201; 21 CFR 330

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      03/17/99                    64 FR 13254

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Debra Bowen
Phone: 301 827-2222

RIN: 0910-AA79
_______________________________________________________________________




1204. DEFINITION OF SUBSTANTIAL EVIDENCE

Priority: Other Significant

CFR Citation: 21 CFR 514.4

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      07/28/99                    64 FR 40746

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Gail Schmerfeld
Phone: 301 827-0205

RIN: 0910-AB08
_______________________________________________________________________




1205. 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

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      10/20/99                    64 FR 56441

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Robert A. Yetter
Phone: 301 827-0373

RIN: 0910-AB29
_______________________________________________________________________




1206. RADIOPHARMACEUTICALS USED FOR IN VIVO DIAGNOSIS AND MONITORING

Priority: Other Significant

CFR Citation: 21 CFR 315; 21 CFR 601

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      05/17/99                    64 FR 26657

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Steven F. Falter
Phone: 301 827-6210
Email: [email protected]
Brian L. Pendleton
Phone: 301 594-2041

RIN: 0910-AB52
_______________________________________________________________________




1207.  REQUIREMENTS FOR TESTING HUMAN BLOOD DONORS FOR EVIDENCE 
OF INFECTION DUE TO COMMUNICABLE DISEASE AGENTS

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Merged With 0910-AB26           09/20/99

RIN: 0910-AB85
_______________________________________________________________________




1208.  GENERAL REQUIREMENTS FOR BLOOD, BLOOD COMPONENTS, AND 
BLOOD DERIVATIVES; NOTIFICATION OF DEFERRED DONORS

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Merged With 0910-AB26           09/20/99

RIN: 0910-AB86
_______________________________________________________________________




1209.  REVISIONS TO THE REQUIREMENTS APPLICABLE TO BLOOD, BLOOD 
COMPONENTS, AND SOURCE PLASMA

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Merged With 0910-AB26           09/20/99

RIN: 0910-AB87

[[Page 64398]]

_______________________________________________________________________


Department of Health and Human Services (HHS)       Proposed Rule Stage


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1210. 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). This NPRM will address 
issues raised by comments received in NPRM dated 9/1/98.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/01/98                    63 FR 46538
NPRM Comment Period End         01/04/99
Second NPRM                     02/00/00
NPRM Comment Period End         05/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Richard C. 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
_______________________________________________________________________




1211.  COMPLIANCE ALTERNATIVES FOR PROVISION OF UNCOMPENSATED 
SERVICES

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 300s(3)

CFR Citation: 42 CFR part 124,   subpart F

Legal Deadline: None

Abstract: The proposed rules apply to facilities obligated under the 
Hospital Survey and Construction Act, commonly known as the Hill-Burton 
Act. The proposed rules would revise a compliance alternative that 
provides more flexible compliance standards for facilities that 
principally serve nonpaying patient populations by reducing the amount 
of time needed to qualify for certification under the alternative and 
by providing for provisional certification, where a facility is unable 
to qualify for full certification. The propose rules would also provide 
a compliance alternative for facilities histories of uncompensated 
services deficits, to enable them to make up the deficits on a timely 
basis. These revisions would have the effect of making it easier for 
facilities with an uncompensated services obligation to meet that 
obligation, while still ensuring the availability of uncompensated 
services to persons unable to pay.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/00
NPRM Comment Period End         06/00/00
Final Action                    12/00/00

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Mr. Eulas Dortch, Deputy Director, Division of 
Facilities Compliance and Recovery, OSP, Department of Health and Human 
Services, Health Resources and Services Administration, Room 10-C16, 
5600 Fishers Lane, Rockville, MD 20857
Phone: 301 443-5656
Fax: 301 443-0619
Email: [email protected]

RIN: 0906-AA52
_______________________________________________________________________


Department of Health and Human Services (HHS)          Final Rule Stage


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1212.  FINAL RULE FOR THE HEALTH PROFESSIONS, NURSING, PUBLIC 
HEALTH, AND ALLIED HEALTH TRAINING GRANT PROGRAMS UNDER 42 CFR PARTS 57 
AND 58

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 105-392

CFR Citation: 42 CFR 57; 42 CFR 58

Legal Deadline: None

Abstract: This final rule rescinds and removes various Public Health 
Service health professions, nursing, public health, and allied health 
training grant regulations from the CFR at 42 CFR parts 57 and 58. The 
existing training grant regulations are fundamentally and extensively 
inconsistent with the new law, Health Professions Education 
Partnerships Act of 1998 (Pub. L. 105-392), enacted November 13, 1998. 
There are structural problems in implementing the new statute under the 
current program regulations. The general focus of this legislation is 
to reauthorize and consolidate 44 different Federal health professions 
training programs currently authorized under titles VII and VIII, PHS 
Act. These 44 programs are consolidated into seven general categories 
of authorities and offer more flexibility for program implementation. 
These categories are designed to train health practitioners most 
inclined to enter practice in rural and other medically undeserved 
areas. Because the statute always take precedence over regulations, and 
the existing regulations are inconsistent with the new law which takes 
an interdisciplinary approach (and thus inhibits the achievement of the 
statute's clustered objectives), we are removing the grant regulations 
from the Code of Federal Regulations. Program specific guidance and 
information for preparing applications are now provided in the grant 
application materials (which makes them now self-contained).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/00/00

[[Page 64399]]

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Steve Tise, Acting Chief, Planning, Evaluation and 
Legislation Branch/ORP, BHPr/HRSA/DHHS, Department of Health and Human 
Services, Health Resources and Services Administration, Room 8-67 
Parklawn Buidling, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 443-2381
Email: [email protected]

RIN: 0906-AA53
_______________________________________________________________________


Department of Health and Human Services (HHS)         Long-Term Actions


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1213. 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 
medical malpractice actions or claims, 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.

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 was made.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/24/98                    63 FR 71255
NPRM Comment Period End         02/22/99


Next Action Undetermined

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

RIN: 0906-AA41
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1214.  NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION 
ON PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: REPORTING ADVERSE AND 
NEGATIVE ACTIONS

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Duplicate of 0906-AA43          09/09/99

RIN: 0906-AA51

[[Page 64400]]

_______________________________________________________________________


Department of Health and Human Services (HHS)       Proposed Rule Stage


Indian Health Service (IHS)



_______________________________________________________________________




1215.  CONTRACTS UNDER THE INDIAN SELF-DETERMINATION ACT

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 2003; 25 USC 13

CFR Citation: 42 CFR 36.201-237

Legal Deadline: None

Abstract: The Department of Health and Human Services and the 
Department of the Interior published, on June 24, 1996, joint 
regulations implementing section 107 of the Indian Self-Determination 
Act, as amended. This joint rule 25 CFR part 900 replaced 42 CFR 
sections 36.201 through 36.237 among other parts.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/99

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, Suite 450, 12300 
Twinbrook Parkway, Rockville, MD 20857
Phone: 301 443-1116
Email: [email protected]

RIN: 0917-AA04
_______________________________________________________________________


Department of Health and Human Services (HHS)          Final Rule Stage


Indian Health Service (IHS)



_______________________________________________________________________




1216. 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, Public Law 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                            03/25/99                    64 FR 14559
NPRM Comment Period End         07/26/99
Final Action                    01/00/00

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)         Completed Actions


Indian Health Service (IHS)



_______________________________________________________________________




1217. CURRENTLY EFFECTIVE INDIAN HEALTH SERVICE ELIGIBILITY REGULATIONS

Priority: Info./Admin./Other

CFR Citation: 42 CFR 36

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      10/28/99                    64 FR 58318

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Tribal

Agency Contact: Betty J. Penn
Phone: 301 443-1116
Email: [email protected]

RIN: 0917-AA03
_______________________________________________________________________


Department of Health and Human Services (HHS)       Proposed Rule Stage


National Institutes of Health (NIH)



_______________________________________________________________________




1218. 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                            03/00/00

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, Room 601 MSC 
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606

[[Page 64401]]

Email: [email protected]

RIN: 0925-AA02
_______________________________________________________________________




1219. 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                            03/00/00

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, Room 601 MSC 
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Email: [email protected]

RIN: 0925-AA10
_______________________________________________________________________




1220. NATIONAL CANCER INSTITUTE CLINICAL CANCER EDUCATION PROGRAM

Priority: Info./Admin./Other

Legal Authority: 42 USC 216

CFR Citation: 42 CFR 52d

Legal Deadline: None

Abstract: Current regulations relating to the National Cancer Institute 
(NCI) Clinical Cancer Education Program will be amended to update 
various aspects of the regulation.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/99

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, Room 601 MSC 
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Email: [email protected]

RIN: 0925-AA17
_______________________________________________________________________




1221. 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                            03/00/00

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, Room 601 MSC 
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Email: [email protected]

RIN: 0925-AA18
_______________________________________________________________________




1222. 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                            11/00/99

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, Room 601 MSC 
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Email: [email protected]

RIN: 0925-AA19
_______________________________________________________________________




1223. 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

[[Page 64402]]

to reflect current policies and procedures.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/00

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, Room 601 MSC 
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Email: [email protected]

RIN: 0925-AA20
_______________________________________________________________________


Department of Health and Human Services (HHS)          Final Rule Stage


National Institutes of Health (NIH)



_______________________________________________________________________




1224. TRAINEESHIPS

Priority: Info./Admin./Other

Legal Authority: 42 USC 216; 42 USC 282(b)(B); 42 USC 284(b)(1)(C); 42 
USC 285a-2(b)(3); 42 USC 286b-3; 42 USC 287c-21(a)

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                            10/30/98                    63 FR 58336
Final Action                    03/00/00

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, Room 601 MSC 
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Email: [email protected]

RIN: 0925-AA11
_______________________________________________________________________




1225. 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                            05/20/98                    63 FR 27794
Final Action                    02/00/00

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, MSC 7507 Suite 3B01, Office for Protection from Research 
Risks, 6100 Executive Boulevard, Rockville, MD 20892-7507
Phone: 301 435-5649

RIN: 0925-AA14
_______________________________________________________________________




1226. 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 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                            06/30/99                    64 FR 35119
Final Action                    03/00/00

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, Room 601 MSC 
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Email: [email protected]

RIN: 0925-AA16
_______________________________________________________________________




1227. 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:  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

[[Page 64403]]

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              03/00/00

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, MSC 7507 Suite 3B01, Office for Protection from Research 
Risks, 6100 Executive Boulevard, Rockville, MD 20892-7507
Phone: 301 435-5649

RIN: 0925-AA21
_______________________________________________________________________




1228. 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 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                    11/00/99

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, Room 601 MSC 
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Email: [email protected]

RIN: 0925-AA22
_______________________________________________________________________




1229.  NIH PRIVACY ACT SYSTEM OF RECORDS, 09-25-0213, 
``ADMINISTRATION: INVESTIGATIVE RECORDS''

Priority: Info./Admin./Other

Legal Authority: 5 USC 301; 5 USC 552a

CFR Citation: 45 CFR 5b

Legal Deadline: None

Abstract: The Department of Health and Human Services is exempting a 
new system of records, 09-25-0213, ``Administration: Investigative 
Records, HHS/NIH/OM/OA/OMA,'' from certain requirements of the Privacy 
Act to protect records compiled in the course of an inquiry and/or 
investigation and to protect the identity of confidential sources who 
furnish information to the Government under an express promise that the 
identity of such source would be held in confidence.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/09/99                    64 FR 37081
NPRM Comment Period End         08/09/99
Final Action                    12/00/99

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Timothy Wheeles, NIH Privacy Act Officer, Department of 
Health and Human Services, National Institutes of Health, 6011 
Executive Boulevard, Room 601, Rockville, MD 20852
Phone: 301 402-5347
Fax: 301 402-0169

RIN: 0925-AA23
_______________________________________________________________________


Department of Health and Human Services (HHS)         Long-Term Actions


National Institutes of Health (NIH)



_______________________________________________________________________




1230. 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-3; 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; 42 USC 285a-2; 42 USC 285b-3; 42 USC 285b-4

CFR Citation: 42 CFR 52b

Legal Deadline: None

Abstract: Regulations concerning NCI construction grants will be 
amended to make them generally applicable to all NIH extramural 
programs with construction grant authority. Additionally, the 
regulations will be amended to show new administrative and technical 
requirements, add new procedures for the recovery of grant funds for 
facilities no longer used for biomedical research, show new Public 
Health Service Act section numbers, and update the listing of other HHS 
regulations relevant to construction grants.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/06/95                    60 FR 35266
NPRM Comment Period End         09/05/95
Final Action                    11/00/00

[[Page 64404]]

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, Room 601 MSC 
7669, 6011 Executive Boulevard, Rockville, MD 20852
Phone: 301 496-4606
Email: [email protected]

RIN: 0925-AA04
_______________________________________________________________________


Department of Health and Human Services (HHS)       Proposed Rule Stage


Office of Public Health and Science (OPHS)



_______________________________________________________________________




1231. 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 a 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 respond 
adequately 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                            05/00/00
NPRM Comment Period End         07/00/00

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State

Agency Contact: Barbara Bullman, Policy Analyst, Department of Health 
and Human Services, Office of Public Health and Science, Suite 700, 
5515 Security Lane, Rockville, MD 20852
Phone: 301 443-5300
Fax: 301 443-5351

RIN: 0940-AA01
_______________________________________________________________________


Department of Health and Human Services (HHS)         Long-Term Actions


Office of Public Health and Science (OPHS)



_______________________________________________________________________




1232. 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                     To Be                       Determined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Additional Information: Previously reported under RIN 0905-AE03.

Agency Contact: Denese Shervington M.D., M.P., Department of Health and 
Human Services, Office of Public Health and Science, Suite 200, West 
Tower Bldg., East-West Towers, 4350 East-West Highway, Bethesda, MD 
20814
Phone: 301 594-4001

RIN: 0940-AA00
_______________________________________________________________________


Department of Health and Human Services (HHS)             Prerule Stage


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1233. END STAGE RENAL DISEASE (ESRD) CONDITIONS FOR COVERAGE (HCFA-3818-
F) (SECTION 610 REVIEW)

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 rule would revise the current conditions for coverage 
for end stage renal disease (ESRD) facilities approved to provide ESRD 
service

[[Page 64405]]

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. We will also 
review for the requirements of Section 610c of the Regulatory 
Flexibility Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review                    12/00/99
End Review                      06/00/00

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Additional Information: HCFA-3818

Agency Contact: Robert Miller, Department of Health and Human Services, 
Health Care Financing Administration, S3-04-25, Department of Health 
and Human Services, Office of Clinical Standards and Quality, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6797

RIN: 0938-AG82
_______________________________________________________________________




1234. CRITERIA FOR MEDICARE COVERAGE OF HEART, LIVER, AND LUNG 
TRANSPLANTS (HCFA-3835-ANPRM)

Priority: Other Significant

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

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This notice lists various options related to the criteria for 
Medicare coverage of heart, liver, and lung transplants and seeks 
public comment on those options.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           12/00/99

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: HCFA-3835-PN

Agency Contact: Kathy Linstromberg, Department of Health and Human 
Services, Health Care Financing Administration, Department of Health 
and Human Services, Health Care Financing Administration, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-8279

RIN: 0938-AH17
_______________________________________________________________________


Department of Health and Human Services (HHS)       Proposed Rule Stage


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1235. MEDICARE PROGRAM; QUALIFICATIONS FOR ESTABLISHING AND MAINTAINING 
MEDICARE BILLING PRIVILEGES (HCFA-6002-P)

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

RIN: 0938-AH73
_______________________________________________________________________




1236. NATIONAL STANDARD FOR IDENTIFIERS OF HEALTH PLANS (HCFA-4145-P)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1320d-2

CFR Citation: 45 CFR 142

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

Abstract: This rule would implement a standard identifier to identify 
health plans that process and pay certain electronic health care 
transactions. It would implement one of the requirements for 
administrative simplification in section 262 of the Health Insurance 
Portability and Accountability Act of 1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/99

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

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 Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-3342

RIN: 0938-AH87
_______________________________________________________________________




1237. STATE CHILD HEALTH; IMPLEMENTING REGULATIONS FOR THE STATE 
CHILDREN'S HEALTH INSURANCE PROGRAM (HCFA-2006-P)

Priority: Economically Significant

Legal Authority: PL 105-33; 42 USC 1396

CFR Citation: 42 CFR 457

Legal Deadline: None

Abstract: This proposed regulation will implement all programmatic 
provisions for the new State Children's Health Insurance Program (CHIP) 
under 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/99

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: Federal, State, Local

Agency Contact: Cheryl Austein-Casnoff, Department of Health and Human 
Services, Health Care Financing Administration, 200 Independence Avenue 
SW., Washington, DC 20201
Phone: 410 786-4196

RIN: 0938-AI28


_______________________________________________________________________



[[Page 64406]]

1238. APPEALS OF CARRIER DETERMINATION THAT A SUPPLIER FAILS TO MEET THE 
REQUIREMENTS FOR MEDICARE BILLING PRIVILEGES (HCFA-6003-P)

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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/99

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 Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-6140

RIN: 0938-AI49
_______________________________________________________________________




1239. PROSPECTIVE FEE SCHEDULE FOR AMBULANCE SERVICES (HCFA-1002-NR)

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

RIN: 0938-AI72
_______________________________________________________________________




1240. MEDICARE PROGRAM; COVERAGE AND ADMINISTRATIVE POLICIES FOR 
CLINICAL DIAGNOSTIC LABORATORY TESTS; INTENT TO FORM NEGOTIATED 
RULEMAKING COMMITTEE (HCFA-3250-P)

Priority: Other Significant

Unfunded Mandates: This action may affect State, Local or Tribal 
Governments.

Legal Authority: PL 105-33, sec 4554(b)(1)

CFR Citation: 42 CFR ch 410

Legal Deadline: Final, Statutory, January 1, 1999, BBA Section 4106.

Abstract: This proposed rule would establish national coverage and 
administrative policies for clinical diagnostic laboratory services 
payable under Medicare Part B to promote Medicare program integrity and 
national uniformity, and simplify administrative requirements for 
clinical diagnostic laboratory services. A Negotiated Rulemaking 
Committee (the Committee) developed the proposed policies as directed 
by section 4554(b)(1) of the Balanced Budget Act of 1997 (the BBA).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice of Intent to Negotiate   06/03/98                    63 FR 30166
NPRM                            12/00/99

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: State

Agency Contact: Jacqueline Sheridan, Office of Clinical Standards & 
Quality, Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4635

RIN: 0938-AI92
_______________________________________________________________________




1241. DECISION ON THE FUNDING FOR THE AIDS HEALTHCARE FOUNDATION START 
PROGRAM, (HCFA-2041-N)

Priority: Info./Admin./Other

Legal Authority: PL 105-33, sec 1110

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This notice announces the award of a grant in the sum of $2 
million to the AIDS Healthcare Foundation of Los Angeles, California, 
for a demonstration project entitled, ``START PROGRAM: Success Through 
Anti-Retroviral Therapy.''

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/04/99                    64 FR 10479
Notice                          11/00/99

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Wayne Smith Ph.D., CMSO, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6762

RIN: 0938-AJ43
_______________________________________________________________________




1242. PROTECTION FOR WOMEN WHO ELECT RECONSTRUCTION AFTER A MASTECTOMY 
(HCFA-2040-IFC)

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

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 300gg-6

CFR Citation: 45 CFR 146; 45 CFR 148

Legal Deadline: None

Abstract: This IFC will implement the requirements of the Women's 
Health and Cancer Rights Act of 1998 (WHCRA). It will provide 
protection for patients who elect breast reconstruction following a 
mastectomy.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/99

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Michael Bussacca, Center for Health Plans and 
Providers, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-4602

RIN: 0938-AJ44


_______________________________________________________________________



[[Page 64407]]

1243. ACCELERATED PAYMENTS TO PROVIDERS FURNISHING SERVICES UNDER 
MEDICARE PART A AND PART B AND ADVANCE PAYMENTS TO SUPPLIERS FURNISHING 
ITEMS OR SERVICES UNDER MEDICARE PART B (HCFA-1066-FC)

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

Unfunded Mandates: Undetermined

Legal Authority: PL 91-190; 42 USC 1302; 42 USC 1395g; 42 USC 1395l; 42 
USC 1395hh

CFR Citation: 42 CFR 412.116; 42 CFR 413.64; 42 CFR 421.214

Legal Deadline: None

Abstract: This proposed rule would ensure continued payments to 
providers and suppliers in the event of a national, regional, or a 
local emergency, such as national disasters including fire, flood, 
earthquake and the year 2000 computer system difficulties and related 
breakdowns. The intent of the proposed rule is to give HCFA broad 
discretion in implementing procedures to provide appropriate payments 
to providers and suppliers in the event of a national, regional, or a 
local emergency that may prevent the submission or processing of 
Medicare claims.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/99

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Geraldine Nicholson, CHPP, Department of Health and 
Human Services, Health Care Financing Administration, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6967

RIN: 0938-AJ45
_______________________________________________________________________




1244. MEDICARE/MEDICAID AND CLIA PROGRAMS: CLINICAL LABORATORY 
IMPROVEMENT AMENDMENTS OF 1988 EXEMPTION OF LABORATORIES IN THE STATE OF 
CALIFORNIA (HCFA-2245-N)

Priority: Other Significant

Legal Authority: 42 USC 263a

CFR Citation: 42 CFR 493

Legal Deadline: None

Abstract: This NPRM grants all State-licensed or approved laboratories 
in California exemption from the requirements of the Clinical 
Laboratory Improvement Amendments of 1998, based on the State's 
demonstrated compliance with all the exemption requirements.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/99

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal, State

Agency Contact: Jim Cometa, CMSO, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6720

RIN: 0938-AJ47
_______________________________________________________________________




1245. FEDERAL ENFORCEMENT IN GROUP AND INDIVIDUAL HEALTH INSURANCE 
MARKETS (HCFA-2019-FC)

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

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 300gg

CFR Citation: 45 CFR 150

Legal Deadline: None

Abstract: This rule adds more specific requirements for enforcing 
legislative requirements concerning the portability and availability of 
health insurance. It specifies the Federal Government's role in 
enforcing the insurance requirements in States that do no enforce the 
requirements. It also specifies how the government will impose civil 
money penalties on health insurance issuers in those states and states 
appeal rights and procedures.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/99

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Rochelle Shevitz, CMSO, Department of Health and Human 
Services, Health Care Financing Administration, S3-16-26, 7500 Security 
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-1570

RIN: 0938-AJ48
_______________________________________________________________________




1246.  MEDICARE PROGRAM: PROSPECTIVE PAYMENT SYSTEM FOR 
INPATIENT REHABILITATION HOSPITAL SERVICES (HCFA-1069-P)

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

RIN: 0938-AJ55
_______________________________________________________________________




1247.  DME SURETY BONDS (HCFA-6006-P)

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

RIN: 0938-AJ64
_______________________________________________________________________




1248.  REAPPLICATION OF THE JOINT COMMISSION FOR ACCREDITATION 
OF HEALTH CARE ORGANIZATIONS JCAHO (HCFA-2058-PN)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1395(bb)

CFR Citation: None

Legal Deadline: None

Abstract: This NPRM announces the receipt of a reapplication from JCAHO 
for recognition as a national accreditation program for home health 
agencies (HHA's) that wish to participate in the Medicare or Medicaid 
programs. The Social Security Act requires that the Secretary publish a 
notice identifying the national accreditation body making the request 
for approval describing the nature of the request and providing a 30-
day public comment period.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/99

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Joan Berry, Center for Medicaid and State Operations, 
Department of Health and Human Services, Health Care Financing

[[Page 64408]]

Administration, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-7233
Email: [email protected]

RIN: 0938-AJ68
_______________________________________________________________________




1249.  REAPPLICATION OF THE COMMUNITY HEALTH ACCREDITATION 
PROGRAM, INCORPORATED (CHAP FOR CONTINUED APPROVAL OF DEEMING AUTHORITY 
FOR WHOM HEALTH CARE AGENCIES HCFA-2059-PN)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1395(bb)

CFR Citation: None

Legal Deadline: None

Abstract: This NPRM announces the receipt of a reapplication from CHAP 
for recognition as a national accreditation program for home health 
agencies (HHA's) that wish to participate in the Medicare or Medicaid 
programs. The Social Security Act requires that the Secretary publish a 
notice identifying the national accrediatation body making the request 
for approval describing the nature of the request and providing a 30-
day comment period.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/99

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0938-AJ69
_______________________________________________________________________




1250.  HHA SURETY BOND (HCFA-6001-P)

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

RIN: 0938-AJ81
_______________________________________________________________________


Department of Health and Human Services (HHS)          Final Rule Stage


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1251. ADDITIONAL SUPPLIER STANDARDS (HCFA-6004-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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/20/98                     63 FR 2926
Final Action                    11/00/99

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: HCFA-1864

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

RIN: 0938-AH19
_______________________________________________________________________




1252. 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 final rule with comment period amends our regulations to 
incorporate an optional statutory requirement that States may require, 
as a condition of Medicaid eligibility, enrollment of certain Medicaid 
eligibles in employer-based group health plans determined cost-
effective by States under guidelines approved by HCFA. If this option 
is elected by the State, it also requires States to pay all premiums, 
deductibles, coinsurance, and other cost-sharing obligations under 
these group health plans for services otherwise covered under the 
approved Medicaid State plans. In addition, this final rule with 
comment period provides for Medicaid payment of premiums for certain 
individuals who are entitled to elect continuation coverage provided 
for in the Consolidated Omnibus Budget Reconciliation Act of 1985 
(``COBRA''), Public Law 99-272, under a group health plan provided by 
an employer with 75 or more employees.

This final rule with comment period conforms our regulations to 
sections 4402 and 4713 of the Omnibus Budget Reconciliation Act of 1990 
and section 4741 of 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                    10/00/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

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, S2-15-27, 7500 Security Boulevard, Baltimore, 
MD 21244-1850
Phone: 410 786-5928
Email: [email protected]

RIN: 0938-AH48


_______________________________________________________________________



[[Page 64409]]

1253. 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 revise text in the CFR to reduce burden or 
duplication, or streamline requirements.

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 With Comment Period       12/00/99

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 Building, 200 
Independence Avenue SW, Washington, DC
Phone: 202 690-6383

RIN: 0938-AH53
_______________________________________________________________________




1254. UTILIZATION CONTROL AND DISCONTINUED REVIEW ACTIVITIES; MEDICAID 
(HCFA-2101-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                    12/00/99

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

Additional Information: MB-101

Agency Contact: Pamela Butler, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6776

RIN: 0938-AH64
_______________________________________________________________________




1255. UPDATE OF RATESETTING METHODOLOGY, PAYMENT RATES AND THE LIST OF 
COVERED SURGICAL PROCEDURES FOR AMBULATORY SURGICAL CENTERS EFFECTIVE 
FOR CALENDAR YEAR 2000 (HCFA-1885-F)

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 final 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
Final Action                    12/00/99

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: BPD-885

Agency Contact: Joan H. Sanow, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Boulevard, C4-11-16, Baltimore, MD 21244
Phone: 410 786-5763

RIN: 0938-AH81
_______________________________________________________________________




1256. NATIONAL STANDARD HEALTH CARE PROVIDER IDENTIFIER (HCFA-0045-F)

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

RIN: 0938-AH99
_______________________________________________________________________




1257. MEDICARE PROGRAM; MEDICARE+CHOICE PROGRAM (HCFA-1030-2-F)

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

RIN: 0938-AI29
_______________________________________________________________________




1258. MEDICARE PROGRAM; PROSPECTIVE PAYMENT SYSTEM FOR HOSPITAL 
OUTPATIENT SERVICES (HCFA-1005-F)

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

RIN: 0938-AI56


_______________________________________________________________________



[[Page 64410]]

1259. SECURITY AND ELECTRONIC SIGNATURE STANDARDS (HCFA-0049-F)

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

RIN: 0938-AI57
_______________________________________________________________________




1260. HEALTH INSURANCE REFORM: STANDARDS FOR ELECTRONIC TRANSACTIONS 
(HCFA-0149-F)

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

RIN: 0938-AI58
_______________________________________________________________________




1261. NATIONAL STANDARD EMPLOYER IDENTIFIER (HCFA-0047-F)

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

RIN: 0938-AI59
_______________________________________________________________________




1262. 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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/00/99

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 Boulevard, Baltimore, MD 21244
Phone: 410 786-5921

RIN: 0938-AI67
_______________________________________________________________________




1263. 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. 46 in Part II of this issue of 
the Federal Register.

RIN: 0938-AI70
_______________________________________________________________________




1264. COVERAGE OF RELIGIOUS NON-MEDICAL HEALTH CARE INSTITUTIONS (HCFA-
1909-IFC)

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 403; 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, BBA Section 4106.

Abstract: This final rule with comment period implements section 4454 
of the Balanced Budget Act of 1997 (BBA 1997), which amended section 
1861 of the Social Security Act (the Act) and added a new section 1821 
to the Act. Section 4454 of BBA 1997 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. Section 4454 also 
authorizes payment for such services as an option benefit under State 
Medicaid plans. 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 and Medicaid.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/00/00

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 Boulevard, Baltimore, MD 21244
Phone: 410 786-3508

RIN: 0938-AI93
_______________________________________________________________________




1265. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM (HCFA-1059-P)

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

RIN: 0938-AJ24
_______________________________________________________________________




1266. ESTABLISHMENT OF A PROGRAM TO COLLECT SUGGESTIONS FOR IMPROVING 
MEDICARE PROGRAM EFFICIENCY AND TO REWARD SUGGESTORS (HCFA-4000-FC)

Priority: Other Significant

Legal Authority: PL 104-191, sec 203(c)1; 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 420.410

Legal Deadline: None

Abstract: This rule establishes a suggestion program as a means of (1) 
encouraging individuals to submit suggestions and (2) rewarding 
individuals who make suggestions for improving the efficiency of the 
Medicare program in those instances in which HCFA deems that it is 
appropriate and when a reward is not otherwise provided by law. The 
rule describes the program, lists information requirements and 
eligibility criteria, establishes an upper limit for payments, and 
outlines the process and time limitations for obtaining a reward.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/00/99

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Sam Della Vecchia, CBS, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4481

RIN: 0938-AJ30


_______________________________________________________________________



[[Page 64411]]

1267.  THE CHILDREN'S HEALTH INSURANCE PROGRAM: IMPLEMENTING THE 
BALANCED BUDGET ACT OF 1997 (HCFA-2006-P)

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

RIN: 0938-AJ75
_______________________________________________________________________


Department of Health and Human Services (HHS)         Long-Term Actions


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1268. 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-3

Agency Contact: Cathy Black, Center for Medicaid and State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4544

RIN: 0938-AB50
_______________________________________________________________________




1269. CHANGES TO PEER REVIEW ORGANIZATION REGULATIONS (HCFA-3135-F)

Priority: Substantive, Nonsignificant

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

Legal Authority: 42 USC 1320c; 42 USC 1396a(a)(30); 42 USC 1395cc(a)

CFR Citation: 42 CFR 400.200; 42 CFR 411.15; 42 CFR 431.630; 42 CFR 
433.15; 42 CFR 462.1; 42 CFR 462.101; 42 CFR 462.102; 42 CFR 462.106; 
42 CFR 462.107; 42 CFR 466.1; 42 CFR 466.71; 42 CFR 466.76; 42 CFR 
466.78; 42 CFR 466.83

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: HSQ-135

Agency Contact: William 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-
1850
Phone: 410 786-0433

RIN: 0938-AD38
_______________________________________________________________________




1270. 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 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

[[Page 64412]]

NPRM Comment Period End         04/06/92


Next Action Undetermined

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 & Quality, 
Department of Health and Human Services, Health Care Financing 
Administration, S3-05-27, 7500 Security Boulevard, Baltimore, MD 21244-
1850
Phone: 401 786-0596

RIN: 0938-AD81
_______________________________________________________________________




1271. ``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-71

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 
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-4475

RIN: 0938-AD95
_______________________________________________________________________




1272. 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: Local, State

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-
1850
Phone: 410 786-3417

RIN: 0938-AE12
_______________________________________________________________________




1273. 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: Local, State, Federal

Additional Information: HSQ-169

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, S2-19-14, 7500 Security Boulevard, Baltimore, 
MD 21244-1850
Phone: 410 786-6780

RIN: 0938-AE39
_______________________________________________________________________




1274. EARLY AND PERIODIC SCREENING, DIAGNOSTIC, AND TREATMENT (EPSDT) 
SERVICES (HCFA-2028-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

[[Page 64413]]

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: Local, State

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-
1850
Phone: 410 786-5916

RIN: 0938-AE72
_______________________________________________________________________




1275. 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 and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-4539

RIN: 0938-AE79
_______________________________________________________________________




1276. COVERAGE OF SCREENING PAP SMEARS (HCFA-3705-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


Next Action Undetermined

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 Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-4619

RIN: 0938-AE98
_______________________________________________________________________




1277. 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 rule 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

[[Page 64414]]

Small Entities Affected: No

Government Levels Affected: None

Additional Information: HSQ-175

This regulation may be published only with the concurrence of the U.S. 
District Court in Smith v. Shalala.

Agency Contact: Helene Fredeking, Director, Division of Outcomes and 
Improvements, Department of Health and Human Services, Health Care 
Financing Administration, S2-21-28, 7500 Security Boulevard, Baltimore, 
MD 21244-1850
Phone: 410 786-7304

RIN: 0938-AF02
_______________________________________________________________________




1278. 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: Betty Stanton, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, S2-25-13, 7500 Security Boulevard, Baltimore, 
MD 21244-1850
Phone: 410 786-3247

RIN: 0938-AF15
_______________________________________________________________________




1279. 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: Morton 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-
1850
Phone: 410 786-4477

RIN: 0938-AF28
_______________________________________________________________________




1280. 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: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Organizations

Government Levels Affected: State, Federal

Additional Information: HSQ-191

RIN: 0938-AF32
_______________________________________________________________________




1281. 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

[[Page 64415]]

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


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: State

Additional Information: HCFA-2046-FC

Agency Contact: Peggy Rahn, Department of Health and Human Services, 
Health Care Financing Administration, Department of Health and Human 
Services, Health Care Financing Adminsitration, 7500 Security Blvd., 
Baltimore, MD 21244
Phone: 410 786-3284

RIN: 0938-AF42
_______________________________________________________________________




1282. 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


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Additional Information: HCFA-2051

Agency Contact: Robert Nakielny, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, S2-14-26, 7500 Security Boulevard, Baltimore, 
MD 21244-1850
Phone: 410 786-4466

RIN: 0938-AF68
_______________________________________________________________________




1283. 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
Effective Date                  10/24/94
Comment Period End              11/22/94


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Additional Information: HCFA-2052

Agency Contact: Robert Tomlinson Jr., Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, S2-08-24, 7500 Security Boulevard, Baltimore, 
MD 21244-1850
Phone: 410 786-4463

RIN: 0938-AF69
_______________________________________________________________________




1284. 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 W. Albert, Office of Financial Management, 
Department of Health and Human Services, Health Care Financing 
Administration, S3-02-26, 7500 Security Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-7457

RIN: 0938-AF87
_______________________________________________________________________




1285. REVISED MEDICAID MANAGEMENT INFORMATION SYSTEMS (HCFA-2038-FN)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1396b(r)

CFR Citation: Not Yet Determined

Legal Deadline: None

[[Page 64416]]

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


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: State

Additional Information: MB-038

Agency Contact: Richard H. 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
_______________________________________________________________________




1286. 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 sanction as an alternative to 
terminating coverage of the facilities services when an end-stage renal 
dialysis (ESRD) facility is not in substantial compliance with the 
conditions for coverage, but its deficiencies do not pose immediate 
jeopardy to patient health or safety. Before section 1881 of the Social 
Security Act was amended by section 12 of the Medicare and Medicaid 
Patient and Program Protection Act of 1987 (Public Law 100-93), HCFA 
was authorized to impose alternative sanctions only when an ESRD 
facility failed to cooperate in the goals and activities of the ESRD 
network for the area in which the facility is located.

Timetable: 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 21244-1850
Phone: 410 786-6829

RIN: 0938-AG31
_______________________________________________________________________




1287. 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)(2)

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


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Additional Information: HSQ-207-NC

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-
1850
Phone: 410 786-9352

RIN: 0938-AG32
_______________________________________________________________________




1288. 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: 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-
1850
Phone: 410 786-6940

RIN: 0938-AG33


_______________________________________________________________________



[[Page 64417]]

1289. MEDICARE PROGRAM: LIMITATIONS ON MEDICARE COVERAGE OF INTERMITTENT 
POSITIVE PRESSURE BREATHING MACHINE THERAPY (HCFA-3781-FN)

Priority: Substantive, Nonsignificant

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

CFR Citation: 45 CFR 500

Legal Deadline: None

Abstract: Intermittent positive pressure breathing (IPPB) machine 
therapy is currently covered under Medicare as durable medical 
equipment for patients whose ability to breathe is severely impaired. 
Based on an Office of Health Technology Assessment recommendation, we 
will place limitations on Medicare coverage of IPPB machine therapy.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Notice                 06/29/94                    59 FR 33520
Comment Period End              08/29/94


Next Action Undetermined

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 21244-1850
Phone: 410 786-4614

RIN: 0938-AG44
_______________________________________________________________________




1290. 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


Next Action Undetermined

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-
1850
Phone: 410 786-6972

RIN: 0938-AG48
_______________________________________________________________________




1291. 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-
1850
Phone: 410 786-6813

RIN: 0938-AG59
_______________________________________________________________________




1292. MEDICAID: OPTIONAL COVERAGE OF TB-RELATED SERVICES FOR INDIVIDUALS 
INFECTED WITH TUBERCULOSIS (HCFA-2082-P)

Priority: Economically 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: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Local

Additional Information: HCFA-2082

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 21244-1850

[[Page 64418]]

Phone: 410 786-4461

RIN: 0938-AG72
_______________________________________________________________________




1293. 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

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-
1850
Phone: 410 786-4656

RIN: 0938-AG79
_______________________________________________________________________




1294. 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

CFR Citation: 42 CFR 411.1; 42 CFR 411.350 to 411.361; 42 CFR 424.22; 
42 CFR 435.1002; 42 CFR 435.1012; 42 CFR 455.100 to 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


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

Additional Information: BPD-1809-

Agency Contact: Joanne Sinsheimer, Technical Assistant, CHPPS, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4620

RIN: 0938-AG80
_______________________________________________________________________




1295. HOME HEALTH AGENCY (HHA) CONDITIONS OF PARTICIPATION (HCFA-3819-F)

Priority: Other Significant

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

Legal Authority: 42 USC 1302; 42 USC 1395x; 42 USC 1395cc(a); 42 USC 
1395hh; 42 USC 1395bb

CFR Citation: 42 CFR 484

Legal Deadline: None

Abstract: This final rule will revise home health agency conditions of 
participation to center on the patient, using outcome-oriented 
measures. Most of the current HHA conditions of participation have 
remained unchanged since home health services became a Medicare benefit 
in 1966. Some limited modifications have been made over the years to 
comply with legislative changes. As a result, most of the conditions of 
participation continue to be structure and process oriented. In 
addition, this final rule will require that HHAs use a standard core 
assessment data set, the ``Outcome and Assessment Information Set'' 
(OASIS), when evaluating adult, 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

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-
1850
Phone: 410 786-6940

RIN: 0938-AG81


_______________________________________________________________________



[[Page 64419]]

1296. 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: Nancy Archer, Office of Clinical Standards & Quality, 
Department of Health and Human Services, Health Care Financing 
Administration, S3-05-27, 7500 Security Boulevard, Baltimore, MD 21244-
1850
Phone: 401 786-0596

RIN: 0938-AG84
_______________________________________________________________________




1297. CLIA PROGRAM: CATEGORIZATION OF WAIVED TESTS (HCFA-2225-FC)

Priority: Other Significant. Major under 5 USC 801.

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

Legal Authority: 42 USC 263a

CFR Citation: 42 CFR 493.2; 42 CFR 493.7; 42 CFR 493.8; 42 CFR 493.9; 
42 CFR 493.15; 42 CFR 493.20; 42 CFR 493.25; 42 CFR 493.35; 42 CFR 
493.37; 42 CFR 493.39; 42 CFR 493.45; 42 CFR 493.47; 42 CFR 493.49; 42 
CFR 493.53; 42 CFR 493.1775

Legal Deadline: None

Abstract: As part of the CLIA program (see RIN: 0938-AE47), this rule 
will revise our current process of evaluating tests against generic 
criteria. A waiver will be granted to any test that meets the statutory 
criteria, provided that scientifically valid data are submitted 
verifying that the criteria were met.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/13/95                    60 FR 47534
NPRM Comment Period End         11/13/95


Next Action Undetermined

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 Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-3531

RIN: 0938-AG99
_______________________________________________________________________




1298. LIABILITY FOR THIRD PARTIES TO PAY FOR SERVICES (HCFA-2080-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 individual's right 
to payment by a third party.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal, State

Additional Information: MB-08

Agency Contact: Robert Nakielny, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, S2-14-26, 7500 Security Boulevard, Baltimore, 
MD 21244-1850
Phone: 410 786-4466

RIN: 0938-AH01
_______________________________________________________________________




1299. 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 E. Hoyer, Center for Health Plans and Providers,

[[Page 64420]]

Department of Health and Human Services, Health Care Financing 
Administration, C4-02-16, 7500 Security Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-4605

RIN: 0938-AH16
_______________________________________________________________________




1300. STATE PLAN AMENDMENT (SPA) RECONSIDERATION PROCESS (HCFA-2096-P)

Priority: Substantive, Nonsignificant

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

Legal Authority: 42 USC 1316; 42 USC 1396a(a)

CFR Citation: 42 CFR 430.18; 42 CFR 430.60

Legal Deadline: None

Abstract: This proposed rule would revise and streamline the State Plan 
Amendment (SPA) reconsideration process. Currently, when a State 
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

Agency Contact: Robert Tomlinson Jr., Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, S2-08-24, 7500 Security Boulevard, Baltimore, 
MD 21244-1850
Phone: 410 786-4463

RIN: 0938-AH24
_______________________________________________________________________




1301. 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 Clinical Standard & 
Quality, Department of Health and Human Services, Health Care Financing 
Administration, S3-04-25, 7500 Security Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-4652

RIN: 0938-AH27
_______________________________________________________________________




1302. CLIA PROGRAM; CYTOLOGY PROFICIENCY TESTING (HCFA-2233-N)

Priority: Other Significant

Legal Authority: 42 USC 263a(f)(4)(B)(iv)

CFR Citation: 42 CFR 493.855

Legal Deadline: None

Abstract: This notice announces the withdrawal of a proposed rule on 
cytology proficiency testing that was published in the Federal Register 
November 30, 1995, and instead, announces a supplement to the 
rulemaking record of a final rule published February 28, 1992. In 
publishing the proposed rule, HHS complied with a Federal court order 
requiring publication of a proposal that would require that cytology 
proficiency testing be conducted to the extent practicable, under 
normal working conditions. As required, we proposed to revise 
regulations to require that proficiency testing be conducted at a pace 
corresponding to the maximum workload rate for individuals examining 
slides. We also solicited comments on the use of computer facsimile 
representations of cytology specimens, as an alternative to glass-slide 
proficiency testing. After the proposed rule was published, the appeals 
court revised the lower court's order, allowing us to withdraw the 
proposed rule and supplement the record to the final rule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/30/95                    60 FR 61509
NPRM Comment Period End         01/29/96


Next Action Undetermined

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 S. Whalen, Senior Health Scientist, Department 
of Health and Human Services, Health Care Financing Administration, MS 
F, 4770 Buford Highway NE, 11, Atlanta, GA 30341-3724
Phone: 770 488-8155

RIN: 0938-AH35
_______________________________________________________________________




1303. 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

[[Page 64421]]

provide coverage for speech-language pathology services furnished by a 
qualified pathologist.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: BPD-843

Agency Contact: Jacqueline Gordon, Division of Cost Reporting, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-07-14, 7500 Security Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-4517

RIN: 0938-AH37
_______________________________________________________________________




1304. 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: In accordance with HCFA's regulatory burden reduction 
program, this technical regulation modifies or removes from regulations 
language that reference the following aspects of the Medicare program:

o The Lower of Cost or Charges (LCC) carryover provision; this 
provision was removed from HCFA regulations several years ago.

o The application of the LCC principle to durable medical equipment 
(DME) furnished by home health agencies (HHAs); these items are now 
paid in accordance with a fee schedule.

o Other content that was previously removed. This final regulation also 
clarifies several portions of section 413.13 and removes obsolete 
provisions.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Additional Information: BPD-86

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 21244-1850
Phone: 410 786-4528

RIN: 0938-AH49
_______________________________________________________________________




1305. 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-85

Agency Contact: Denis M. Garrison, Division of Beneficiary Protections, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-06-21, 7500 Security Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-5643

RIN: 0938-AH51
_______________________________________________________________________




1306. 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                             To Be                       Determined

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 21244-1850
Phone: 410 786-4474

RIN: 0938-AH52
_______________________________________________________________________




1307. REVISION TO ACCRUAL BASIS OF ACCOUNTING POLICY (HCFA-1876-F)

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 cost 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

[[Page 64422]]

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

Agency Contact: John Eppinger Jr., Center for Health Plans and 
Providers, Department of Health and Human Services, Health Care 
Financing Administration, C5-03-18, 7500 Security Boulevard, Baltimore, 
MD 21244-1850
Phone: 410 786-4518

RIN: 0938-AH61
_______________________________________________________________________




1308. 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

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 21244-1850
Phone: 410 786-4461

RIN: 0938-AH63
_______________________________________________________________________




1309. MEDICAID HOSPICE CARE (HCFA-2016-P)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1395hh; 42 USC 1302

CFR Citation: 42 CFR 418.24; 42 CFR 418.28; 42 CFR 418.98; 42 CFR 
440.167; 42 CFR 440.250(q); 42 CFR 441; 42 CFR 447

Legal Deadline: None

Abstract: This proposed rule would provide for optional Medicaid 
coverage of hospice care for terminally ill recipients who elect to 
receive care from a participating hospice, establish eligibility 
requirements, covered services, reimbursement procedures, and 
conditions that a hospice must meet to provide services to Medicaid 
recipients. It would make conforming technical revisions to the 
Medicare regulations governing hospice care.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Local

Additional Information: HCFA-2016

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
_______________________________________________________________________




1310. 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 & Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-04-27, 7500 Security Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-4486

RIN: 0938-AH66
_______________________________________________________________________




1311. 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: Next Action Undetermined

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-
1850

[[Page 64423]]

Phone: 410 786-4605

RIN: 0938-AH67
_______________________________________________________________________




1312. 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.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: HSQ-235-FC

Agency Contact: William 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-
1850
Phone: 410 786-0433

RIN: 0938-AH68
_______________________________________________________________________




1313. 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: Federal, State, Local

Additional Information: HSQ-24

Agency Contact: Patricia 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 21244-1850
Phone: 410 786-6780

RIN: 0938-AH69
_______________________________________________________________________




1314. 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, 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-
1850
Phone: 410 786-0433

RIN: 0938-AH72
_______________________________________________________________________




1315. INDIVIDUAL MARKET HEALTH INS. REFORM PORTABILITY FROM GROUP TO 
INDIV. COVERAGE; FEDERAL RULES FOR ACCESS IN THE INDIV. MARKET; STATE 
ALTERNATIVE MECHANISMS TO FEDERAL RULES (HCFA-2882-F)

Priority: Other Significant. Major under 5 USC 801.

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

Legal Authority: 42 USC 300gg-41 et seq

CFR Citation: 45 CFR 148

Legal Deadline: None

Abstract: This final rule will address comments received on the interim 
final rule published on April 8, 1997 and further clarifies the 
Departmental position on HIPAA requirements in the individual market.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/08/97                    62 FR 16985
Interim Final Rule Effective 
Date                            04/08/97
Interim Final Rule Comment 
Period End                      07/07/97


Next Action Undetermined

[[Page 64424]]

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: Federal, State, Local

Additional Information: BPD-882

Agency Contact: Gertrude Saunders, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5888
Email: [email protected]

RIN: 0938-AH75
_______________________________________________________________________




1316. 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, S2-199.06, 7500 Security Boulevard, Baltimore, MD 
21244-1850
Phone: 410 786-6747

RIN: 0938-AH83
_______________________________________________________________________




1317. 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: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: HSQ-241

Agency Contact: William 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-
1850
Phone: 410 786-0433

RIN: 0938-AH85
_______________________________________________________________________




1318. 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: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State

Additional Information: HCFA-2107

Agency Contact: Jan Earle, Center for Medicaid and State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, S2-15-10, 7500 Security Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-9004

RIN: 0938-AH89
_______________________________________________________________________




1319. 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

[[Page 64425]]

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: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: State

Additional Information: MB-1

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 21244-1850
Phone: 410 786-4579
Email: [email protected]

RIN: 0938-AH92
_______________________________________________________________________




1320. MEDICAID PROGRAM; COVERAGE AND PAYMENT FOR FEDERALLY QUALIFIED 
HEALTH CENTER SERVICES (HCFA-2043-P)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1396a(a)(13); 42 USC 1396d(a)

CFR Citation: 42 CFR 431; 42 CFR 440; 42 CFR 441; 42 CFR 447

Legal Deadline: None

Abstract: This proposed rule would incorporate and interpret in 
regulations coverage and payment requirements for services furnished by 
a federally qualified health center (FQHC) under the Medicaid program. 
This rule will include changes in the payment provisions to FQHCS made 
by section 4712 of the Balanced Budget Act of 1997 PL-105-33.

Timetable: 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 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 21244-1850
Phone: 410 786-5919

RIN: 0938-AH95
_______________________________________________________________________




1321. 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

________________________________________________________________________

Final Rule With Comment Period  08/07/98                    63 FR 42270


Next Action Undetermined

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, S2-08-05, 7500 Security Boulevard, Baltimore, 
MD 21244-1850
Phone: 410 786-4462

RIN: 0938-AH98
_______________________________________________________________________




1322. PORTABILITY AND NONDISCRIMINATION IN THE GROUP HEALTH INSURANCE 
MARKET (HCFA-2890-F)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 300gg et seq

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


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

[[Page 64426]]

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 Boulevard, Baltimore, MD 21244
Phone: 410 786-1564

RIN: 0938-AI08
_______________________________________________________________________




1323. 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; 
competitive requirements; 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                            05/19/98


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: Brenda Thew, OICS, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4889

RIN: 0938-AI09
_______________________________________________________________________




1324. 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: Beverly Sgroi, Department of Health and Human Services, 
Health Care Financing Administration, Department of Health and Human 
Services, Health Care Financing Administratin, 7500 Security Blvd, 
Baltimore, MD 21244-1850
Phone: 410 786-7638

RIN: 0938-AI11
_______________________________________________________________________




1325. 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 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 C, Department of Health and 
Human Services, Health Care Financing Administration, 7500 Security 
Boulevard, C4-10-26, Baltimore, MD 21244
Phone: 410 786-4497

RIN: 0938-AI16
_______________________________________________________________________




1326. 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 that 
would result in greater enrollment opportunities for children 
facilitate the filing of claims by custodial parents and establish new 
payment disbursement criteria.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State

Additional Information: HCFA-2081

[[Page 64427]]

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
_______________________________________________________________________




1327. MEDICARE PROGRAM: PHYSICIANS' REFERRALS; ISSUANCE OF ADVISORY 
OPINIONS (HCFA-1902-F)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1395nn(g)(6); 42 USC 1302; 42 USC 1395hh

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 Boulevard, Baltimore, MD 21244
Phone: 410 786-4620

RIN: 0938-AI38
_______________________________________________________________________




1328. MEDICARE/MEDICAID PROGRAM; USER FEES FOR INFORMATION, PRODCUTS, 
AND SERVICES (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 Boulevard, Baltimore, MD 21244
Phone: 410 786-5401

RIN: 0938-AI46
_______________________________________________________________________




1329. SURETY BOND REQUIREMENTS FOR COMPREHENSIVE OUTPATIENT REHAB. 
FACILITIES, REHAB. AGENCIES, COMMUNITY MENTAL HEALTH CENTERS, AND 
INDEPENDENT DIAGNOSTIC TESTING FACILITIES (HCFA-6005-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 Boulevard, Baltimore, MD 21244
Phone: 410 786-4870
Email: [email protected]

RIN: 0938-AI48
_______________________________________________________________________




1330. 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 1396a(a)(65)(B)

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, S2-26-12, 7500 Security Boulevard, Baltimore, 
MD 21244-1850
Phone: 410 786-2011
Email: [email protected]

RIN: 0938-AI63
_______________________________________________________________________




1331. 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

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

[[Page 64428]]

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 program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/11/98                    63 FR 48735


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

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

RIN: 0938-AI69
_______________________________________________________________________




1332. 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, S2-17-18, 7500 Security Boulevard, Baltimore, 
MD 21244-1850
Phone: 410 786-4579
Email: [email protected]

RIN: 0938-AI73
_______________________________________________________________________




1333. 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: Robert Tomlinson Jr., Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, S2-08-24, 7500 Security Boulevard, Baltimore, 
MD 21244-1850
Phone: 410 786-4463

RIN: 0938-AI74
_______________________________________________________________________




1334. 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 Boulevard, Baltimore, MD 21244
Phone: 410 786-4516
Email: [email protected]

RIN: 0938-AI75
_______________________________________________________________________




1335. MEDICARE HOSPICE CARE (HCFA-1022-P)

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

Unfunded Mandates: Undetermined

Legal Authority: PL 105-33, sec 4441(a); PL 105-33, sec 4442 to 4446; 
PL 105-33, sec 4448

CFR Citation: 42 CFR 418

Legal Deadline: None

Abstract: This proposed rule would implement section 4441(a), 4442-
4446, and 4448 of the Balanced Budget Act

[[Page 64429]]

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 Boulevard, Baltimore, MD 21244
Phone: 410 786-5909
Email: [email protected]

RIN: 0938-AI77
_______________________________________________________________________




1336. 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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/11/98                    63 FR 42797


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Steve Raitzyk, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4599

RIN: 0938-AI80
_______________________________________________________________________




1337. SOLVENCY STANDARDS FOR PROVIDER-SPONSORED ORGANIZATIONS (HCFA-
1011-F)

Priority: Other Significant

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 final rule establishes solvency standards for provider-
sponsored organizations (PSOs) under the new Medicare+Choice Program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              05/07/98                    63 FR 25360
Interim Final Rule Effective    05/07/98
Interim Final Rule Comment 
Period End                      07/06/98


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Greg Snyder, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0329

RIN: 0938-AI83
_______________________________________________________________________




1338. MEDICARE PROGRAM; MEDICARE COVERAGE OF AND PAYMENT FOR BONE MASS 
MEASUREMENTS (HCFA-3004-F)

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 final rule provides for uniform coverage of, and payment 
for, bone mass measurements for qualified Medicare beneficiaries for 
services furnished on or after July 1, 1998. It implements provisions 
in section 4106(a) of the Balanced Budget Act of 1997.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              06/24/98                    63 FR 34320

Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: William Larson, Office of Communications & Operations 
Support, Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4639

RIN: 0938-AI89
_______________________________________________________________________




1339. 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, BBA Section 4106.

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

[[Page 64430]]

health data standards and health information privacy that will support 
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, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Boulevard, N2-12-22, Baltimore, MD 21244
Phone: 410 786-7065
Email: [email protected]

RIN: 0938-AI91
_______________________________________________________________________




1340. 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-of-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 Boulevard, Baltimore, MD 21244
Phone: 410 786-7234

RIN: 0938-AI99
_______________________________________________________________________




1341. 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 Boulevard, Baltimore, MD 21244
Phone: 410 786-4499

RIN: 0938-AJ00
_______________________________________________________________________




1342. 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 related to the 
quality of care provided by these managed care organizations and 
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: Sharon Gilles, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1177

RIN: 0938-AJ06
_______________________________________________________________________




1343. HHS' RECOGNITION OF NAIC MODEL STANDARDS FOR REGULATION OF MEDIGAP 
POLICY (HCFA-2025-N)

Priority: Other Significant

Legal Authority: 42 USC 1395ss

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                    63 FR 67078


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

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 Boulevard, Baltimore, MD 21244
Phone: 410 786-5903

RIN: 0938-AJ07


_______________________________________________________________________



[[Page 64431]]

1344. 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 HHAs 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 generated by 
the OASIS.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/25/99                     64 FR 3748


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: State

Agency Contact: Tracey Mummert, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Boulevard, Baltimore, MD
Phone: 410 786-3398

RIN: 0938-AJ10
_______________________________________________________________________




1345. 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 Boulevard, Baltimore, MD 21244
Phone: 410 786-7409

RIN: 0938-AJ15
_______________________________________________________________________




1346. 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 requirements. 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 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 21244-1850
Phone: 410 786-5919

RIN: 0938-AJ17
_______________________________________________________________________




1347. HOSPITAL CONDITIONS OF PARTICIPATION: LABORATORY SERVICES (HCFA-3 
014-P)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 482.27

Legal Deadline: None

Abstract: This proposed rule would require hospitals that transfuse 
blood and blood products to (1) prepare and follow written procedures 
for appropriate action when it is determined that blood and blood 
products are at increased risk for transmitting hepatitis C virus 
(HCV); (2) quarantine prior collections from a donor who is at 
increased risk for transmitting HCV infection; (3) notify transfusion 
recipients, as appropriate, of the need for HCV testing and counseling; 
and (4) maintain records for at least 10 years.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Organizations

Government Levels Affected: None

Agency Contact: Mary Collins, OCSQ, Department of Health and Human

[[Page 64432]]

Services, Health Care Financing Administration, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-3189

RIN: 0938-AJ29
_______________________________________________________________________




1348. MEDICARE PROGRAM; PROCEDURES FOR MAKING MEDICAL SERVICES NATIONAL 
COVERAGE DECISIONS (HCFA-3432-GN)

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

Legal Authority: 42 USC 1302; 40 USC 1395hh

CFR Citation: None

Legal Deadline: None

Abstract: This notice withdraws the proposed rule that we published in 
the Federal Register on January 30, 1989 (54 FR 4302), in which we 
proposed to establish in regulations generally applicable criteria and 
procedures for HCFA decisions regarding whether and under what 
circumstances specific health care technologies could be considered 
``reasonable'' and ``necessary'' and, therefore, covered under 
Medicare. We are withdrawing the proposed rule and announcing our 
intention to issue a new notice of proposed rulemaking concerning the 
criteria to be used in making national coverage decisions.

This notice also describes the procedures we use for making national 
decisions regarding the coverage of a payment for specific medical 
items and services under Medicare.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0938-AJ31
_______________________________________________________________________




1349. MEDICARE PROGRAM; SPECIAL PAYMENT LIMITS FOR CERTAIN DURABLE 
MEDICAL EQUIPMENT AND PROSTHETIC DEVICES (HCFA-1050-PN)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1395m; 42 USC 1395u

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This notice proposes special payment limits, for five items 
of durable medical equipment and one prosthetic device, to replace the 
current fee schedule amounts for these items.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

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 Boulevard, Baltimore, MD 21244
Phone: 410 786-4499

RIN: 0938-AJ34
_______________________________________________________________________




1350. MEDICARE HOSPICE CARE AMENDMENTS (HCFA-1022-P)

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

Unfunded Mandates: Undetermined

Legal Authority: PL 105-33, sec 4441(a); PL 105-33, sec 4442 to 4446; 
PL 105-33, sec 4448

CFR Citation: 42 CFR 418

Legal Deadline: None

Abstract: This proposed rule would implement sections 4441(a), 4442 to 
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 provided in non-urbanized areas, and 
extending the period for physician certification of an individual's 
terminal illness. Additionally, the proposed rule would 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 Boulevard, Baltimore, MD 21244
Phone: 410 786-5909
Email: [email protected]

RIN: 0938-AJ36
_______________________________________________________________________




1351. EMERGENCY MEDICAL TREATMENT AND LABOR ACT (EMTALA) (HCFA-1063-FC)

Priority: Other Significant

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 1395cc, sec 1866; 42 USC 1395dd

CFR Citation: 42 CFR 489.24

Legal Deadline: None

Abstract: This final rule with comment period clarifies the extent of 
the Emergency Medical Treatment and Labor Act (EMTALA) application.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: George Morey, CHPP, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4653

RIN: 0938-AJ39
_______________________________________________________________________




1352. CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEM AND 
FISCAL YEAR 2000 RATES (HCFA-1053-P) (SECTION 610 REVIEW)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 412; 42 CFR 413; 42 CFR 483; 42 CFR 485

[[Page 64433]]

Legal Deadline: NPRM, Statutory, April 1, 1999.
Final, Statutory, August 1, 1999.

Abstract: We are proposing to revise the Medicare hospital inpatient 
prospective payment systems for operating costs and capital-related 
costs to implement changes arising from our continuing experience with 
the systems. In addition, in the addendum to this proposed rule, we are 
describing proposed changes in the amounts and factors necessary to 
determine rates for Medicare hospital inpatient services for operating 
costs and capital-related costs. These changes would be applicable to 
discharges occurring on or after October 1, 1999. We are also setting 
forth proposed rate-of-increase limits as well as proposed policy 
changes for hospitals and hospital unites excluded from the prospective 
payment systems. Finally, we are proposing changes to the policies 
governing payment to hospitals for the direct costs of graduate medical 
education. We will also review for the requirements of Section 610c of 
the Regulatory Flexibility Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/07/99                    64 FR 24715
NPRM Comment Period End         07/06/99
Final Action                    07/30/99                    64 FR 41490


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Tzvi Hefter, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, C5-08-27, 7500 Security Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-1304

RIN: 0938-AJ50
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1353. CASE MANAGEMENT (HCFA-2027-F)

Priority: Other Significant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       09/01/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Local, State

RIN: 0938-AF07
_______________________________________________________________________




1354. ADJUSTMENT IN PAYMENT AMOUNTS FOR NEW TECHNOLOGY INTRAOCULAR 
LENSES (HCFA-3831-F)

Priority: Economically Significant

CFR Citation: 42 CFR 416

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/16/99                    64 FR 32198

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Claude Mone
Phone: 410 786-5666

RIN: 0938-AH15
_______________________________________________________________________




1355. MEDICARE AND MEDICAID PROGRAMS; QUARTERLY LISTING OF PROGRAM 
ISSUANCES AND COVERAGE DECISIONS--SECOND QUARTER, 1998 (HCFA-9002-N)

Priority: Routine and Frequent

CFR Citation: 42 CFR ch IV

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NOTICE                          12/09/98                    63 FR 67899

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Kristy Nishimoto
Phone: 410 786-8517
Email: knishimotochcfa.gov

RIN: 0938-AI13
_______________________________________________________________________




1356. GME: INCENTIVE PAYMENTS UNDER PLANS FOR VOLUNTARY REDUCTION IN 
NUMBER OF RESIDENTS (HCFA-1001-F)

Priority: Other Significant

CFR Citation: 42 CFR 413

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              08/18/99                    64 FR 44841
Interim Final Rule Comment 
Period End                      10/18/99

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: Federal, State, Local

Agency Contact: Marc Hartstein
Phone: 410 786-4539

RIN: 0938-AI27
_______________________________________________________________________




1357. MEDICARE PROGRAM; PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED 
BILLING FOR SKILLED NURSING FACILITIES. (HCFA-1913-IFC)

Priority: Economically Significant

CFR Citation: 42 CFR 409; 42 CFR 410; 42 CFR 411; 42 CFR 413; 42 CFR 
483; 42 CFR 489

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/30/99                    64 FR 41644
Final Action Effective          09/28/99

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: Federal

Agency Contact: Laurence Wilson
Phone: 410 786-4603

RIN: 0938-AI47
_______________________________________________________________________




1358. MEDICARE AND MEDICAID PROGRAMS; QUARTERLY LISTING OF PROGRAM 
ISSUANCES -- FIRST QUARTER 1998 (HCFA-9879-N)

Priority: Routine and Frequent

CFR Citation: 42 CFR ch IV

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          09/16/98                    63 FR 49598

[[Page 64434]]

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Kristy Nichimoto
Phone: 410 786-8517

RIN: 0938-AJ12
_______________________________________________________________________




1359. MEDICARE PROGRAM STATE ALLOTMENTS FOR PAYMENTS OF MEDICARE PART B 
PREMIUM FOR QUALIFYING INDIVIDUALS: FEDERAL FISCAL YEAR FOR 1999 (HCFA-
2032-N)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: Not Yet Determined

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          03/29/99                    64 FR 14931

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal, State

Agency Contact: Miles McDermott
Phone: 410 786-3722
Email: [email protected]

RIN: 0938-AJ28
_______________________________________________________________________




1360. MEDICAID PROGRAM; CIVIL MONEY PENALTIES FOR NURSING HOMES (SNF/
NF), CHANGE IN NOTICE REQUIREMENTS, AND EXPANSION OF DISCRETIONARY 
REMEDY (HCFA-2035-FC)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 488.402; 42 CFR 488.408; 42 CFR 488.430; 42 CFR 
488.432; 42 CFR 488.434; 42 CFR 488.438; 42 CFR 488.440; 42 CFR 
488.442; 42 CFR 488.454; 42 CFR 435.1001(c)

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule with Comment         03/28/99                    64 FR 13354

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Fred Galdden
Phone: 410 786-3033

RIN: 0938-AJ35
_______________________________________________________________________




1361. MEDICARE AND MEDICAID PROGRAMS; QUARTERLY LISTING OF PROGRAM 
ISSUANCES -- THIRD QUARTER, 1998 (HCFA-9000-N)

Priority: Routine and Frequent

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          05/11/99                    64 FR 25351

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Kristy Nishimoto
Phone: 410 786-8517
Email: knishimotochcfa.gov

RIN: 0938-AJ37
_______________________________________________________________________




1362. RECOGNITION OF THE JOINT COMMISSION FOR ACCREDITATION OF 
HEALTHCARE ORGANIZATIONS (JCAHO) FOR HOSPICES (HCFA-2039-FN)

Priority: Routine and Frequent

CFR Citation: 42 CFR ch IV

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          06/18/99                    64 FR 32881

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Joan C. Berry
Phone: 410 786-7233
Email: [email protected]

RIN: 0938-AJ41
_______________________________________________________________________




1363. RECOGNITION OF THE COMMUNITY HEALTH ACCREDITATION PROGRAM, INC. 
(CHAP) FOR HOSPICES (HCFA-2029-FN)

Priority: Routine and Frequent

CFR Citation: 42 CFR ch IV

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          04/20/99                    64 FR 19376

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Joan C. Berry
Phone: 410 786-7233
Email: [email protected]

RIN: 0938-AJ42
_______________________________________________________________________




1364.  PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR 
HOME HEALTH AGENCIES (HCFA-1059-P)

Priority: Other Significant

Legal Authority: PL 105-33

CFR Citation: None

Legal Deadline: None

Abstract: This proposed rule will establish requirements for the new 
prospective payment system from home health agencies as governed by 
section 4603 of the Balanced Budget Act of 1997.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Duplicate of 0938-AJ24          10/20/99

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Robert Wardell, Chief, Home & Community Based Waiver 
Branch, Department of Health and Human Services, Health Care Financing 
Administration, 4th Floor, EHR, 6325 Security Boulevard, Baltimore, MD 
21207
Phone: 301 966-5659

Robert Wardwell, Center for Health Plans and Providers, Department of 
Health and Human Services, Health Care Financing Administration, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3254

RIN: 0938-AJ51
_______________________________________________________________________




1365.  MEDICARE AND MEDICAID PROGRAMS: HOSPITAL CONDITIONS OF 
PARTICIPATION; PATIENTS' RIGHTS (HCFA-3018-IFC)

Priority: Economically Significant. Major under 5 USC 801.

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

Legal Authority: PL 105-33, sec 4521; PL 105-33, sec 4522; PL 99-509, 
sec 9343(c)

CFR Citation: 42 CFR 409.10; 42 CFR 410.2; 42 CFR 410.27; 42 CFR 
410.410.28; 42 CFR 410.30; 42 CFR 411.15; 42 CFR 412.50; 42 CFR 
413.118; 42 CFR 413.122; 42 CFR 413.124; 42 CFR 413.130; 42 CFR 413; 42 
CFR

[[Page 64435]]

489.20; 42 CFR 1003.101 to 102; 42 CFR 1003.105

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

Abstract: The Balanced Budget Act of 1997 (BBA) (Public Law 105-33), 
enacted on August 5, 1997, provides for implementation of a Prospective 
Payment System (PPS) for hospital outpatient servies (and for Part B 
services furnished to inpatient who have no Part A coverage) furnished 
on or after January 1, 1999. This system will also apply to partial 
hospitalization services furnished by community mental health centers. 
The BBA also requires a new method for calculating beneficiary 
copayments for the hospital outpatient services included under the PPS. 
The PPS will consist of about 340 groups of services, called 
``Ambulatory Payment Classifications'' or APCs, that are related 
clinically and in terms of their resource use. We will assign a group 
wright to each group, based on the median cost (operating and capital) 
of the services included in the group. We will convert the weights for 
each group to payment rates using a national conversion factor, taking 
into account group weightts and the projected volume of services for 
each group. In addition, this rule would establish in regulations the 
requirements for designating certain entities as provider based or as a 
department of a hospital.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/06/98                    63 FR 47551
NPRM Comment Period End         07/30/99
Duplicate of 0938-AI56          10/20/99

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Janet Wellham, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4510

RIN: 0938-AJ56
_______________________________________________________________________




1366.  MEDICARE PROGRAM: PROSPECTIVE PAYMENT SYSTEM AND 
CONSOLIDATED BILLING FOR SKILLED NURSING FACILITIES UPDATE

Priority: None

Legal Deadline: None

Abstract:   

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       10/28/99

Regulatory Flexibility Analysis Required:    

RIN: 0938-AJ58
_______________________________________________________________________




1367.  REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE 
SCHEDULE FOR CALENDAR YEAR 2000 (HCFA-1065-P)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1395w(4); PL 105-33, sec 4103; PL 105-33, sec 
4505; PL 105-33, sec 4511; PL 105-33, sec 4512; PL 105-33, sec 4513

CFR Citation: 42 CFR 410; 42 CFR 411; 42 CFR 414; 42 CFR 415

Legal Deadline: Final, Statutory, January 1, 2000.

Abstract: This final rule will update physician payments by Medicare as 
required by section 1848 of the Social Security Act (the Act). It 
includes a provision to change the method of determining malpractice 
insurance relative value units (RVUs) from the current charge-based 
system to a resource-based system and continues the refinement of the 
practice expense RVUs that are transitioning from charge-based to 
resource-based. New and revised procedure codes for 2000 are also 
addressed. Provisions of the Balanced Budget Act of 1997 (BBA) 
concerning the coverage of prostate screening tests and removal of the 
x-ray requirement as a prerequisite for chiropractic manipulation, and 
policy changes concerning discontinuous anesthesia time, payment for 
diagnostic tests, physician pathology services and independent 
laboratories and nurse practitioner qualifications are also included in 
this rule. A discussion of the next 5 year review of work RVUs is also 
included.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/22/99                    64 FR 39608
NPRM Comment Period End         09/20/99
Final Action                    11/02/99                    64 FR 59739

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0938-AJ61
_______________________________________________________________________




1368.  MEDICAID MANAGED CARE; REGULATORY PROGRAM TO IMPLEMENT 
CERTAIN MEDICAID PROVISIONS OF THE BALANCED BUDGET ACT OF 1997

Priority: Other Significant

Legal Authority: PL 105-33; 42 USC 1396w

CFR Citation: 42 CFR 438

Legal Deadline: None

Abstract: This final rule establishes rules for Medicaid managed care 
programs. It implements certain provisions in sections 4710 of the 
Balanced Budget Act of 1997 (Pub. L. 105-33).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Duplicate of 0938-AI70          10/20/99

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Tribal, Federal

Agency Contact: David Cade, Family & Children's Health Programs Group, 
Center for Medicaid and State Operati, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-3870

RIN: 0938-AJ73

[[Page 64436]]

_______________________________________________________________________


Department of Health and Human Services (HHS)       Proposed Rule Stage


Administration for Children and Families (ACF)



_______________________________________________________________________




1369. BONUS TO REWARD HIGH PERFORMANCE STATES UNDER THE TEMPORARY 
ASSISTANCE FOR NEEDY FAMILIES BLOCK GRANT

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: 42 USC 603(a)(4)

CFR Citation: 45 CFR 270 (New)

Legal Deadline: None

Abstract: The Administration for Children and Families, in consultation 
with the National Governor's Association and the American Public Human 
Services Association (formerly the American Public Welfare 
Association), will propose specific performance measures and a funds 
allocation 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                            12/00/99

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 West, 370 L'Enfant Promenade SW, 
Washington, DC 20447
Phone: 202 401-9220

RIN: 0970-AB66
_______________________________________________________________________




1370. CHILD SUPPORT ENFORCEMENT FOR INDIAN TRIBES

Priority: Other Significant

Legal Authority: 42 USC 655(f)

CFR Citation: 45 CFR 309

Legal Deadline: None

Abstract: This NPRM proposes to specify how tribes can obtain direct 
payments from the Department of Health and Human Services for provision 
of child support enforcement services if they submit a plan meeting the 
objectives of title IV-D, including establishment of paternity, 
modification and enforcement of support orders, and location of absent 
parents.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Tribal

Agency Contact: Paige Biava, Division of Policy and Planning, 
Department of Health and Human Services, Administration for Children 
and Families, Office of Child Support Enforcement, 370 L'Enfant 
Promenade SW, Washington, DC 20447
Phone: 202 401-5635
Email: [email protected]

RIN: 0970-AB73
_______________________________________________________________________




1371. FAMILY CHILD CARE PROGRAM OPTION FOR HEAD START PROGRAMS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 9801 et seq

CFR Citation: 45 CFR 1304; 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/00

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, Department of Health and Human Services, Administration for 
Children and Families, 330 C Street SW, Washington, DC 20447
Phone: 202 205-8569

RIN: 0970-AB90
_______________________________________________________________________




1372. NATIONAL MEDICAL SUPPORT NOTICE

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 652(f); 42 USC 666(a)(19)

CFR Citation: 45 CFR 303.32

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

________________________________________________________________________

NPRM                            12/00/99

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal, State, Local, Tribal

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

RIN: 0970-AB97
_______________________________________________________________________




1373. PROGRAM PERFORMANCE STANDARDS FOR THE OPERATION OF HEAD START 
PROGRAMS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 9831 et seq; sec 641A of the Head Start Act

CFR Citation: 45 CFR 1304

Legal Deadline: None

Abstract: The education component of the Head Start Performance 
Standards will be revised to ensure the school readiness of children 
participating in a Head Start program and to assure that Head Start 
children have certain understandings in the areas of language and 
numeracy.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/00

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: None

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start, Department of Health and Human Services, Administration for 
Children and Families, 330 C Street SW, Washington, DC 20447
Phone: 202 205-8569

RIN: 0970-AB99


_______________________________________________________________________



[[Page 64437]]

1374. SAFEGUARDING CHILD SUPPORT AND EXPANDED FPLS INFORMATION

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 652; 42 USC 653; 42 USC 653A; 42 USC 654; 42 
USC 654A; 42 USC 663

CFR Citation: 45 CFR 303.21

Legal Deadline: None

Abstract: The Personal Responsibility and Work Opportunity 
Reconciliation Act of 1996 made far-reaching amendments to title IV-D 
of the Social Security Act, which governs the child support enforcement 
program. The Balanced Budget Act of 1997, the Adoption and Safe 
Families Act of 1997 and the Child Support Performance and Incentive 
Act of 1998 further amended title IV-D. A significant result of this 
legislation is an expansion in the scope of information available to 
State IV-D child support enforcement agencies. The legislation has 
rendered obsolete or inconsistent several regulations at 45 CFR chapter 
III, Office of Child Support Enforcement, including the regulations on 
the Federal Parent Locator Service, the State Parent Locator Services, 
offset of Federal payments for purposes of collecting child support, 
and safeguarding of information. This regulation would update various 
sections in 45 CFR chapter III to reflect the statutory changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Local

Agency Contact: Eileen C. Brooks, Program Specialist, DHHS/OCSE, 
Department of Health and Human Services, Administration for Children 
and Families, 4th Floor East, OCSE DPP, 370 L'Enfant Promenade SW, 
Washington, DC 20447
Phone: 202 401-5369
Email: [email protected]

RIN: 0970-AC01
_______________________________________________________________________


Department of Health and Human Services (HHS)          Final Rule Stage


Administration for Children and Families (ACF)



_______________________________________________________________________




1375. TITLE IV-E FOSTER CARE ELIGIBILITY REVIEWS AND CHILD AND FAMILY 
SERVICES STATE PLAN REVIEWS, MEPA IMPLEMENTATION, AND ASFA 
IMPLEMENTATION

Priority: Other Significant

Legal Authority: 42 USC 622; 42 USC 671; 42 USC 1302; 42 USC 1320a-2a

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 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 as well as Adoption and Safe Families Act requirements 
related to State plan issues. 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 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                    12/00/99

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
_______________________________________________________________________




1376. 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                    08/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Local, Tribal

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start, Department of Health and Human Services, Administration for 
Children and Families, 330 C Street SW, Washington, DC 20447
Phone: 202 205-8569

RIN: 0970-AB24
_______________________________________________________________________




1377. 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 rule establishes procedures to be used by Head Start 
agencies in requesting to use Head Start grant funds to construct or 
renovate a Head Start facility.

[[Page 64438]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/08/99                     64 FR 6013
NPRM Comment Period End         04/09/99
Final Action                    06/00/00

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, Department of Health and Human Services, Administration for 
Children and Families, 330 C Street SW, Washington, DC 20447
Phone: 202 205-8569

RIN: 0970-AB54
_______________________________________________________________________




1378. 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                    04/00/00

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 West, 370 L'Enfant Promenade SW, 
Washington, DC 20447
Phone: 202 401-9220

RIN: 0970-AB65
_______________________________________________________________________




1379. 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 establishment 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                    01/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal, State, Tribal

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
Email: [email protected]

RIN: 0970-AB78
_______________________________________________________________________




1380. 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              02/09/99                     64 FR 6237
Final Action                    05/00/00

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, MS 
OCSE, DPP, 370 L'Enfant Promenade SW, Washington, DC 20447
Phone: 202 401-5366
Email: [email protected]

RIN: 0970-AB81
_______________________________________________________________________




1381. REFUGEE RESETTLEMENT PROGRAM: REFUGEE CASH AND MEDICAL ASSISTANCE 
PROGRAMS

Priority: Other Significant

Legal Authority: 8 USC 1522(a)(9)

CFR Citation: 45 CFR 400

Legal Deadline: None

Abstract: This regulation will give States flexibility to establish the 
refugee cash assistance program as a public/private partnership between 
States and local resettlement agencies, make several revisions to the 
Refugee Medical Assistance Program, and other technical changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/08/99                     64 FR 1159
NPRM Comment Period End         03/09/99
Final Action                    02/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Gayle Smith, Division of Refugee Self-Sufficiency, 
Department

[[Page 64439]]

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
_______________________________________________________________________




1382. INCENTIVE PAYMENTS AND AUDIT PENALTIES TO STATES AND POLITICAL 
SUBDIVISIONS

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 proposes to implement the requirements in 42 
U.S.C. 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 would also implement a new incentive 
system, enacted under Public Law 105-200. Based on 42 U.S.C. 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                            10/08/99                    64 FR 55074
Final Action                    10/00/00

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, MS OCSE, DPP, 370 L'Enfant Promenade SW, Washington, DC 
20447
Phone: 202 401-5374
Email: [email protected]

RIN: 0970-AB85
_______________________________________________________________________




1383. HEAD START APPEAL TIMELINES

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 9801 et seq

CFR Citation: 45 CFR 1303

Legal Deadline: None

Abstract: This 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                    01/00/00

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Local, Tribal

Additional Information: RFA: N

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start, Department of Health and Human Services, Administration for 
Children and Families, 330 C Street SW, Washington, DC 20447
Phone: 202 205-8569

RIN: 0970-AB87
_______________________________________________________________________




1384. WELFARE-TO-WORK DATA COLLECTION

Priority: Other Significant

Legal Authority: 42 USC 611

CFR Citation: 45 CFR 276

Legal Deadline: None

Abstract: This final rule specifies the data elements that grantees 
must report for the Welfare-to-Work program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              10/29/98                    63 FR 57919
Final Action                    05/00/00

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 West, 370 L'Enfant Promenade SW, 
Washington, DC 20447
Phone: 202 401-9220

RIN: 0970-AB92
_______________________________________________________________________




1385. STATE SELF ASSESSMENTS 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: The rule would require States to conduct annual reviews on 
certain aspects of the State Title IV-D Programs and provide a report 
to the Secretary.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/08/99                    64 FR 55102
Final Action                    10/00/00

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Jan Rothstein, Program Specialist, Office of Child 
Support Enforcement/DHHS, Department of Health and Human Services, 
Administration for Children and Families, Office of Child Support 
Enforcement, 370 L'Enfant Promenade SW, Washington, DC 20447
Phone: 202 401-5073
Email: [email protected]

RIN: 0970-AB96
_______________________________________________________________________




1386. PRIORITY FOR PREVIOUSLY SELECTED HEAD START AGENCIES

Priority: Other Significant

Legal Authority: 42 USC 9801 et seq

CFR Citation: 45 CFR 1302.12

Legal Deadline: None

Abstract: The final rule proposes to amend 45 CFR part 1302 by removing 
section 1302.12 for clarification purposes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/24/99                    64 FR 14202
NPRM Comment Period End         05/24/99
Final Action                    02/00/00

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Local, Tribal

Agency Contact: James Kolb, Head Start Bureau, ACYF, Department of

[[Page 64440]]

Health and Human Services, Administration for Children and Families, 
330 C Street SW, Washington, DC 20201
Phone: 202 205-8580

RIN: 0970-AB98
_______________________________________________________________________




1387. TECHNICAL REVISION OF HEAD START REGULATIONS TO MAKE THEM CONFORM 
TO RECENT STATUTORY REVISIONS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 9831 et seq

CFR Citation: 45 CFR 1301; 45 CFR 1302; 45 CFR 1303; 45 CFR 1308

Legal Deadline: None

Abstract: This rule will correct several Head Start regulations which 
define Head Start programs as ``non-profit'' agencies. Recent statutory 
changes now allow ``for-profit'' agencies to receive Head Start grant 
funds.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              06/00/00

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: None

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start, Department of Health and Human Services, Administration for 
Children and Families, 330 C Street SW, Washington, DC 20447
Phone: 202 205-8569

RIN: 0970-AC00
_______________________________________________________________________




1388. ASSETS FOR INDEPENDENCE RESERVE ACCOUNT

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 604 Note

CFR Citation: 45 CFR Part 1000

Legal Deadline: None

Abstract: The Office of Community Services (OCS) is administering a new 
demonstration project that will establish, support, and participate in 
the evaluation of Individual Development Accounts (IDA) for lower 
income individuals and families, as enacted in Title IV, Human Services 
Reauthorization Act of 1998 (P.L. 105-285). Section 407(b)(2) of Title 
IV, Human Services Reauthorization Act of 1998 (P.L. 105-285), states 
that the Secretary is to prescribe regulations on accounting for 
amounts in the IDA reserve fund. This regulation would address that 
requirement.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              02/00/00

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Richard Saul, Program Specialist, Department of Health 
and Human Services, Administration for Children and Families, 5th 
Floor, OCS, 370 L'Enfant Promenade SW, Washington, DC 20447
Phone: 202 401-9341
Email: [email protected]

RIN: 0970-AC02
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Administration for Children and Families (ACF)



_______________________________________________________________________




1389. TEMPORARY ASSISTANCE FOR NEEDY FAMILIES (TANF)

Priority: Other Significant

CFR Citation: 45 CFR 260 to 265 (New)

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      04/12/99                    64 FR 17720

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal, State, Tribal

Agency Contact: Mack A. Storrs
Phone: 202 401-9289
Email: [email protected]

RIN: 0970-AB77
_______________________________________________________________________




1390. BONUS TO REWARD DECREASE IN ILLEGITIMACY RATIO

Priority: Other Significant

CFR Citation: 45 CFR 283 (New)

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      04/14/99                    64 FR 18484

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Kelleen Kaye
Phone: 202 401-6634
Email: [email protected]

RIN: 0970-AB79
_______________________________________________________________________




1391. IMPLEMENTATION OF AFCARS CORRECTIVE ACTION AND PENALTIES AND CAPTA 
AMENDMENTS

Priority: Other Significant

CFR Citation: 45 CFR 1355; 45 CFR 1356; 45 CFR 1340

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       10/01/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Kathleen McHugh
Phone: 202 401-5789
Email: [email protected]

RIN: 0970-AB94

[[Page 64441]]

_______________________________________________________________________


Department of Health and Human Services (HHS)       Proposed Rule Stage


Administration on Aging (AOA)



_______________________________________________________________________




1392. GRANTS FOR STATE AND COMMUNITY PROGRAMS ON AGING, INTRASTATE 
FUNDING FORMULAS; TRAINING, RESEARCH AND DISCRETIONARY PROGRAMS; 
VULNERABLE ELDER RIGHTS; AND GRANTS TO INDIANS AND 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

Abstract: 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 proposed earlier 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 2000 to implement 
the provisions to the next reauthorization of the Older Americans Act, 
if necessary.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/99

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Tribal

Agency Contact: Edwin Walker, Director, Office of Program Operations 
and Development, Department of Health and Human Services, 
Administration on Aging, Room 4733, 330 Independence Avenue SW, Cohen 
Building, Washington, DC 20201
Phone: 202 619-0011

RIN: 0985-AA00
[FR Doc. 99-27967 Filed 11-19-99; 8:45 am]
BILLING CODE 4150-04-F