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


Part VIII





Department of Health and Human Services





_______________________________________________________________________



Semiannual Regulatory Agenda

[[Page 22738]]



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 semiannual publication of an agenda 
outlining all current, projected and recently completed rulemakings. 
The Unified Agenda of Federal Regulatory and Deregulatory Actions 
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 November 22, 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 Administration's efforts to overhaul the Federal 
regulatory system so that it helps deliver important services to the 
American people while creating fewer burdens. These regulatory actions 
also are an indication of new policy mandates for HHS, affecting such 
national priorities as: securing the confidentiality of Americans' 
health records; establishing improved access to health services for 
children; assuring the safety of the American food supply; controlling 
the safety of clinical trials of emerging medical therapies; 
solidifying advances in welfare reform and health-insurance reform; and 
eliminating waste, fraud and abuse from the health care system. As 
backdrop to the Department's conduct of its regulatory responsibilities 
in all of the above-mentioned programmatic areas, there endures at HHS 
the focus and discipline which the principles of Executive Order 12866 
and the many subsequent regulatory-reform initiatives of the 
Administration have brought to 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, 5600 Fishers Lane, Room 1295, 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
----------------------------------------------------------------------------------------------------------------
916         Civil Money Penalties for Medicare+Choice Organizations and Medicaid Managed Care        0991-AB03
            Organizations.......................................................................
917         Civil Money Penalty Safe Harbor to Protect Payment of Medicare and Medigap Premiums      0991-AB04
            for ESRD Beneficiaries..............................................................
918         Safe Harbor for Ambulance Re-Stocking...............................................     0991-AB05
919         Safe Harbor for Arrangements Involving Federally Qualified Health Centers...........     0991-AB06
920         Revisions and Technical Corrections to 42 CFR Chapter V.............................     0991-AB09
----------------------------------------------------------------------------------------------------------------


[[Page 22739]]


                                    Office of the Secretary--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
921         Reproduction and Sale of Official Forms and Publications............................     0991-AA83
922         Revised OIG Civil Money Penalties Resulting From Public Law 104-191.................     0991-AA90
923         Shared Risk Exception to the Safe Harbor Provisions.................................     0991-AA91
924         Privacy Act Exempt Record System from the Healthcare Integrity and Protection Data       0991-AA99
            Bank................................................................................
925         Standards for Privacy of Individually Indentifiable Health Information..............     0991-AB08
----------------------------------------------------------------------------------------------------------------


                                   Office of the Secretary--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
926         Clarification of the Initial OIG Safe Harbor Provisions and Establishment of             0991-AA66
            Additional Safe Harbor Provisions Under the Anti-Kickback Statute...................
927         Block Grant Programs................................................................     0991-AA97
928         Health Care Fraud and Abuse Data Collection Program.................................     0991-AA98
----------------------------------------------------------------------------------------------------------------


                  Substance Abuse and Mental Health Services Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
929         Substance Abuse Prevention and Treatment Block Grant Applications Due Date Change        0930-AA04
            from March 31 to October 1 for FY 2001 and Beyond...................................
----------------------------------------------------------------------------------------------------------------


                          Centers for Disease Control and Prevention--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
930         Packaging and Handling of Infectious Substances and Select Agents...................     0920-AA02
931         Control of Communicable Diseases....................................................     0920-AA03
----------------------------------------------------------------------------------------------------------------


                                  Departmental Management--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
932         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
----------------------------------------------------------------------------------------------------------------
933         Investigational Use New Animal Drug Regulations (Section 610 Review)................     0910-AB02
934         Natural Rubber-Containing Drugs; User Labeling......................................     0910-AB56
935         Part 600 - Biological Products: General (Section 610 Review)........................     0910-AC06
----------------------------------------------------------------------------------------------------------------


[[Page 22740]]


                                Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
936         Hearing Aids; Professional and Patient Labeling; Conditions for Sale................     0910-AA39
937         Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution..     0910-AA49
938         Investigational New Drugs: Export Requirements for Unapproved New Drug Products.....     0910-AA61
939         Suspected Adverse Drug Reaction Reporting and Recordkeeping Requirements for             0910-AA86
            Marketed OTC Drugs..................................................................
940         Direct-to-Consumer Promotion Regulations............................................     0910-AA90
941         Labeling for Human Prescription Drugs; Revised Format...............................     0910-AA94
942         Suspected Adverse Drug Reaction Reporting Requirements for Human Drug and Biological     0910-AA97
            Products............................................................................
943         Radioactive Drugs for Basic Research................................................     0910-AB00
944         Administrative Practices and Procedures; Advisory Opinions and Guidelines...........     0910-AB14
945         Blood Initiative....................................................................     0910-AB26
946         Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based        0910-AB28
            Products............................................................................
947         Antibiotic Drug Approval and Exclusivity............................................     0910-AB33
948         Applications for FDA Approval to Market a New Drug; Complete Response Letter;            0910-AB34
            Amendments to Unapproved Applications...............................................
949         Expanded Access to Investigational Therapies........................................     0910-AB37
950         Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs...     0910-AB39
951         Electronic Submission of Adverse Drug Reaction Reports..............................     0910-AB42
952         Distinguishing Marks for Drug Products Containing Insulin...........................     0910-AB43
953         Pregnancy Labeling..................................................................     0910-AB44
954         Pharmacy and Physician Compounding of Drug Products.................................     0910-AB58
955         Drug Products That Present Demonstrable Difficulties for Compounding Because of          0910-AB59
            Reasons of Safety or Effectiveness..................................................
956         Discontinuation of a Life-Saving Product............................................     0910-AB60
957         Positron Emission Tomography Drugs; Current Good Manufacturing Practices............     0910-AB63
958         Presubmission Conferences...........................................................     0910-AB68
959         Current Good Manufacturing Practice for Medicated Feeds.............................     0910-AB70
960         Mandatory HACCP Regulations for Manufacturers of Rendered Products..................     0910-AB72
961         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.......................................................................
962         Antibiotic Resistance Labeling......................................................     0910-AB78
963         Fixed-Combination Prescription and Over-the-Counter Drugs for Human Use.............     0910-AB79
964         Repackaging Approval Requirements...................................................     0910-AB81
965         Stability Testing of Drugs..........................................................     0910-AB82
966         Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary        0910-AB88
            Supplements.........................................................................
967         Current Good Manufacturing Practice for Blood and Blood Components; Blood Labeling       0910-AB89
            Standards; Direct Final Rule........................................................
968         Submission in Electronic Format of Certain Labeling Information.....................     0910-AB91
969         Fees Relating to Drugs; Waiver and Reduction of Fees................................     0910-AB92
970         Skip Lot Testing....................................................................     0910-AB93
971         Food Additives: Food Contact Substances Notification System.........................     0910-AB94
972         Marking Requirements for and Prohibitions on the Reimportation of Imported Food          0910-AB95
            Products That Have Been Refused Admission into the United States....................
973         Requirements Pertaining to Sampling Services and Private Laboratories Used in            0910-AB96
            Connection with Imported Food.......................................................
974         State Certification of Mammography Facilities.......................................     0910-AB98
975         Medical Devices, Medical Device Establishment Registration and Listing Requirements;     0910-AB99
            Amendment...........................................................................
976         Availability for Public Disclosure and Submission to FDA for Public Disclosure of        0910-AC00
            Certain Data and Information Related to Gene Therapy or Xenotransplantation.........
977         Reporting Information Regarding Potential Research Misconduct.......................     0910-AC02
978         Examination of Administrative Record and Other Advisory Committee Records...........     0910-AC03
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
979         Over-the-Counter (OTC) Drug Review..................................................     0910-AA01
980         New Animal Drug Approval Process; Implementation of Title I of the Generic Animal        0910-AA02
            Drug and Patent Term Restoration Act (GADPTRA)......................................

[[Page 22741]]

 
981         Biological Products: Reporting of Biological Product Deviations in Manufacturing....     0910-AA12
982         Fruit and Vegetable Juices: Development of HACCP and Label Warning Statements for        0910-AA43
            Juices..............................................................................
983         Current Good Manufacturing Practice; Amendment of Certain Requirements for Finished      0910-AA45
            Pharmaceuticals.....................................................................
984         Bioavailability and Bioequivalence Requirements.....................................     0910-AA51
985         Drugs Used for Treatment of Narcotic Addicts........................................     0910-AA52
986         Reinventing FDA Food Regulations....................................................     0910-AA58
987         Investigational New Drug Applications; Clinical Holds for Drugs for Life-Threatening     0910-AA84
            Illnesses...........................................................................
988         Sterility Requirements for Aqueous-Based Drug Products for Oral Inhalation..........     0910-AA88
989         Determination That Informed Consent Is Infeasible or Is Contrary to the Best             0910-AA89
            Interest of Recipients..............................................................
990         Current Good Manufacturing Practice; Revision of Certain Labeling Controls..........     0910-AA98
991         Use of Ozone-Depleting Substances...................................................     0910-AA99
992         Veterinary Feed Directives..........................................................     0910-AB09
993         Exports; Notification and Recordkeeping Requirements................................     0910-AB16
994         Foreign Establishment Registration and Listing......................................     0910-AB21
995         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......................................................
996         Shell Eggs: Warning, Notice and Safe Handling Labeling Statements and Refrigeration      0910-AB30
            Requirements........................................................................
997         Supplements and Other Changes to Approved New Animal Drug Applications..............     0910-AB49
998         Revisions to the General Safety Requirements for Biological Products; Direct Final       0910-AB51
            Rule................................................................................
999         Bulk Drug Substances for Use in Pharmacy Compounding................................     0910-AB57
1000        Supplements and Other Changes to an Approved Application............................     0910-AB61
1001        Classification of Sheep as a Minor Species for All Data Collection Purposes.........     0910-AB69
1002        Citizen Petitions; Actions That Can Be Requested by Petition; Denials, Withdrawals,      0910-AB73
            and Referrals for Other Administrative Action.......................................
1003        180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications..............     0910-AB80
1004        Postmarketing Studies for Human Drugs and Licensed Biological Products: Status           0910-AB83
            Reports.............................................................................
1005        Amendment of Various Device Regulations to Reflect Current American Society for          0910-AB84
            Testing and Materials Citations.....................................................
1006        Addition to the List of Drug Products That Have Been Withdrawn From the Market for       0910-AC01
            Reasons of Safety or Effectiveness..................................................
1007        Efficacy Evidence Needed for Products To Be Used Against Toxic Substances When Human     0910-AC05
            Studies Are Unethical...............................................................
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1008        Infant Formula: Good Manufacturing Practice, Quality Control Procedures, Quality         0910-AA04
            Factors, Notification Requirements, and Records and Reports.........................
1009        Food Labeling Review................................................................     0910-AA19
1010        Medical Foods.......................................................................     0910-AA20
1011        Classification of Computer Software Programs That Are Medical Devices...............     0910-AA41
1012        Debarment Certification Regulations for Drug Applications...........................     0910-AA76
1013        Investigational New Drug Applications; Request for Information and Comments.........     0910-AA83
1014        Establishment Registration and Listing of Human Cellular and Tissue-Based Products..     0910-AB05
1015        Suitability Determination for Donors of Human Cellular and Tissue-Based Products....     0910-AB27
1016        Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed...............     0910-AB50
1017        Food Labeling: Trans Fatty Acids in Nutrition Labeling and Nutrient Content Claims..     0910-AB66
1018        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...........................................................
1019        Surgeon's and Patient Examination Gloves; Reclassification..........................     0910-AB74
1020        Substances Prohibited From Use in Animal Food or Feed...............................     0910-AB90
1021        Status Reports for Quantity Marketed Information for Animal Drug Products Used in        0910-AC04
            Food-Producing Animals..............................................................
----------------------------------------------------------------------------------------------------------------


[[Page 22742]]


                                 Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1022        Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992;           0910-AA08
            Policies, Requirements, and Administrative Procedures...............................
1023        Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition...     0910-AA74
1024        New Drug Applications; Drug Master File.............................................     0910-AA78
1025        New Drugs for Human Use; Clarification of Requirements for Patent Holder                 0910-AB12
            Notification........................................................................
1026        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.
1027        Medicated Feed Mill Licenses........................................................     0910-AB18
1028        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....................................................................
1029        Public Information; Communications With State and Foreign Government Officials......     0910-AB22
1030        Progestational Drug Products for Human Use; Requirements for Labeling Directed to        0910-AB45
            the Patient.........................................................................
1031        Pediatric Exclusivity...............................................................     0910-AB62
1032        Designated Journals.................................................................     0910-AB67
1033        Regulations on Statements Made for Dietary Supplements Concerning the Effect of the      0910-AB97
            Product on the Structure or Function of the Body....................................
----------------------------------------------------------------------------------------------------------------


                        Health Resources and Services Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1034        Designation of Medically Underserved Populations and Health Professional Shortage        0906-AA44
            Areas...............................................................................
1035        Compliance Alternatives for Provision of Uncompensated Services.....................     0906-AA52
1036        National Vaccine Injury Compensation Program: Revisions and Additions to the Vaccine     0906-AA55
            Injury Table........................................................................
----------------------------------------------------------------------------------------------------------------


                         Health Resources and Services Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1037        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
----------------------------------------------------------------------------------------------------------------
1038        National Practitioner Data Bank for Adverse Information on Physicians and Other          0906-AA41
            Health Care Practitioners: Medical Malpractice Payments Reporting Requirements......
----------------------------------------------------------------------------------------------------------------


                                   Indian Health Service--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1039        Contracts Under the Indian Self-Determination Act...................................     0917-AA04
----------------------------------------------------------------------------------------------------------------


[[Page 22743]]


                                     Indian Health Service--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1040        Indian Child Protection and Family Violence Prevention Act Minimum Standards of          0917-AA02
            Character...........................................................................
----------------------------------------------------------------------------------------------------------------


                               National Institutes of Health--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1041        National Institutes of Health AIDS Research Loan Repayment Program..................     0925-AA02
1042        Undergraduate Scholarship Program Regarding Professions Needed by the NIH...........     0925-AA10
1043        National Cancer Institute Clinical Cancer Education Program.........................     0925-AA17
1044        National Institutes of Health Loan Repayment Program for Research...................     0925-AA18
1045        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
----------------------------------------------------------------------------------------------------------------
1046        Traineeships........................................................................     0925-AA11
1047        Additional DHHS Protections for Pregnant Women and Human Fetuses Involved as             0925-AA14
            Subjects in Research, and Pertaining to Human In Vitro Fertilization................
1048        National Research Service Awards....................................................     0925-AA16
1049        National Institute of Child Health and Human Development Contraception and               0925-AA19
            Infertility Research Loan Repayment Program.........................................
1050        Federal Policy (Common Rule) for the Protection of Human Subjects...................     0925-AA21
1051        NIH Privacy Act System of Records, 09-25-0213, ``Administration: Investigative           0925-AA23
            Records''...........................................................................
----------------------------------------------------------------------------------------------------------------


                                National Institutes of Health--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1052        National Institutes of Health Construction Grants...................................     0925-AA04
1053        Service Fellowships.................................................................     0925-AA22
----------------------------------------------------------------------------------------------------------------


                            Office of Public Health and Science--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1054        Public Health Service Standards for the Protection of Research Misconduct                0940-AA01
            Whistleblowers......................................................................
----------------------------------------------------------------------------------------------------------------


                             Office of Public Health and Science--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1055        Standards of Compliance for Abortion-Related Services in Family Planning Service         0940-AA00
            Projects............................................................................
----------------------------------------------------------------------------------------------------------------


[[Page 22744]]


                               Health Care Financing Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1056        End Stage Renal Disease (ESRD) Conditions for Coverage (HCFA-3818-P) (Section 610        0938-AG82
            Review).............................................................................
1057        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
----------------------------------------------------------------------------------------------------------------
1058        Requirements for Establishing and Maintaining Medicare Billing Privileges (HCFA-6002-    0938-AH73
            P)..................................................................................
1059        Prospective Fee Schedule for Ambulance Services (HCFA-1002-NR)......................     0938-AI72
1060        Medicare/Medicaid and CLIA Programs: Clinical Laboratory Improvement Amendments of       0938-AJ47
            1988 Exemption of Laboratories in the State of California (HCFA-2245-N).............
1061        Medicare Program: Prospective Payment System for Inpatient Rehabilitation Hospital       0938-AJ55
            Services (HCFA-1069-P)..............................................................
1062        DME Surety Bonds (HCFA-6006-P)......................................................     0938-AJ64
1063        End Stage Renal Disease Bad Debt Payment (HCFA-1126-P)..............................     0938-AK02
----------------------------------------------------------------------------------------------------------------


                             Health Care Financing Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1064        Payment for Nursing and Allied Health Science Education (HCFA-1685-F)...............     0938-AE79
1065        Home Health Agency (HHA) Conditions of Participation (HCFA-3819-F)..................     0938-AG81
1066        Additional Supplier Standards (HCFA-6004-F).........................................     0938-AH19
1067        Requirements for Enrollment of Medicaid Recipients Under Cost Effective Employer-        0938-AH48
            Based Group Health Plans (HCFA-2047-FC).............................................
1068        Terms, Definitions, and Addresses: Technical Amendments (HCFA-9877-FC)..............     0938-AH53
1069        Standard Unique Health Care Provider Identifier (HCFA-0045-F).......................     0938-AH99
1070        Medicare Program; Adjustments to Cost Limits for Skilled Nursing Facility Inpatient      0938-AI14
            Routine Service Costs (HCFA-1896-FN)................................................
1071        State Child Health; Implementing Regulations for the State Children's Health             0938-AI28
            Insurance Program (HCFA-2006-F).....................................................
1072        Medicare Program; Medicare+Choice Program (HCFA-1030-2-F)...........................     0938-AI29
1073        Appeals of Carrier Determination That a Supplier Fails To Meet the Requirements for      0938-AI49
            Medicare Billing Privileges (HCFA-6003-P)...........................................
1074        Medicare Program; Prospective Payment System for Hospital Outpatient Services (HCFA-     0938-AI56
            1005-F).............................................................................
1075        Security Signature Standards (HCFA-0049-F)..........................................     0938-AI57
1076        Health Insurance Reform: Standards for Electronic Transactions (HCFA-0149-F)........     0938-AI58
1077        State Child Health; State Children's Health Insurance Program Allotments and             0938-AI65
            Payments to States (HCFA-2114-F)....................................................
1078        Medicaid Program; Home and Community-Based Services (HCFA-2010-FC)..................     0938-AI67
1079        Medicaid Managed Care; Regulatory Program To Implement Certain Medicaid Provisions       0938-AI70
            of the Balanced Budget Act of 1997 (HCFA-2001-F)....................................
1080        Coverage of Religious Non-Medical Health Care Institutions (HCFA-1909-IFC)..........     0938-AI93
1081        External Quality Review of Medicaid Managed Care Organizations (HCFA-2015-F)........     0938-AJ06
1082        Home Health Prospective Payment System (HCFA-1059-F)................................     0938-AJ24
1083        Protection for Women Who Elect Reconstruction After a Mastectomy (HCFA-2040-IFC)....     0938-AJ44
1084        Federal Enforcement in Group and Individual Health Insurance Markets (HCFA-2019-FC).     0938-AJ48
1085        The Children's Health Insurance Program: Implementing the Balanced Budget Act of         0938-AJ75
            1997 (HCFA-2006-F)..................................................................
1086        Application of Inherent Reasonableness to all Part B Services Other than Physician       0938-AJ97
            Services (HCFA-1908-F)..............................................................
1087        Flexibility in Payment Methods for Services of Hospitals, Nursing Facilities, and        0938-AK04
            Intermediate Care Facilities for the Mentally Retarded (HCFA-2004-F)................
----------------------------------------------------------------------------------------------------------------


[[Page 22745]]


                             Health Care Financing Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1088        Payment for Clinical Diagnostic Laboratory Tests (HCFA-1309-F)......................     0938-AB50
1089        Changes to Peer Review Organization Regulations (HCFA-3135-F).......................     0938-AD38
1090        ''Without Fault'' and Beneficiary Waiver of Recovery As It Applies to Medicare           0938-AD95
            Overpayment Liability (HCFA-1719-P).................................................
1091        Protection of Income and Resources for Community Spouses of Institutionalized            0938-AE12
            Individuals (HCFA-2023-P)...........................................................
1092        Survey Requirements and Alternative Sanctions for Home Health Agencies (HCFA-2169-F)     0938-AE39
1093        Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Services (HCFA-2028-     0938-AE72
            F)..................................................................................
1094        Coverage of Screening Pap Smears (HCFA-3705-F)......................................     0938-AE98
1095        Changes to the Long-Term Care Facility Survey Process (HCFA-3175-FC)................     0938-AF02
1096        Requirements for Certain Health Insuring Organizations and OBRA `90 Technical            0938-AF15
            Amendments (HCFA-1018-F)............................................................
1097        Provider Reimbursement Determinations and Appeals (HCFA-1727-P).....................     0938-AF28
1098        Alternative Sanctions for Psychiatric Hospitals (HCFA-2191-P).......................     0938-AF32
1099        Medicaid Payment for Covered Outpatient Drugs Under Rebate Agreements (HCFA-2046-FC)     0938-AF42
1100        Referral to Child Support Enforcement Agencies of Medicaid Families (HCFA-2051-F)...     0938-AF68
1101        Medicaid: Outstationed Intake Locations for Certain Low-Income Pregnant Women,           0938-AF69
            Infants, and Children Under Age 19 (HCFA-2052-F)....................................
1102        Assessing Interest Against Medicare Secondary Payer (MSP) Debts (HCFA-6108-P).......     0938-AF87
1103        Revised Medicaid Management Information Systems (HCFA-2038-FN)......................     0938-AG10
1104        Disclosure of Confidential PRO and ESRD Network Organization Information for             0938-AG33
            Research Purposes (HCFA-3208-P).....................................................
1105        Medicare Program: Limitations on Medicare Coverage of Intermittent Positive Pressure     0938-AG44
            Breathing Machine Therapy (HCFA-3781-FN)............................................
1106        Effect of Change of Ownership on Provider and Supplier Penalties, Sanctions,             0938-AG59
            Underpayments and Overpayments (HCFA-2215-P)........................................
1107        Medicaid: Optional Coverage of TB-Related Services for Individuals Infected With         0938-AG72
            Tuberculosis (HCFA-2082-P)..........................................................
1108        Revision of Medicare/Medicaid Hospital Conditions of Participation (HCFA-3745-F)....     0938-AG79
1109        Physicians' Referrals to Health Care Entities With Which They Have Financial             0938-AG80
            Relationships--Expanded to Designated Health Services (HCFA-1809-F).................
1110        Distinct Part Requirements for Nursing Homes and Prohibition of Financial Screening      0938-AG84
            of Applicants for Nursing Home Admission (HCFA-3815-P)..............................
1111        CLIA Program: Categorization of Waived Tests (HCFA-2225-FC).........................     0938-AG99
1112        Liability for Third Parties To Pay for Services (HCFA-2080-P).......................     0938-AH01
1113        Definition of Skilled Nursing Facility (SNF) for Coverage of Durable Medical             0938-AH16
            Equipment (DME) and Home Health (HCFA-1834-P).......................................
1114        State Plan Amendment (SPA) Reconsideration Process (HCFA-2096-P)....................     0938-AH24
1115        Hospice Care--Conditions of Participation (HCFA-3844-P).............................     0938-AH27
1116        Medicare Coverage of Services of Speech-Language Pathologists and Audiologists (HCFA-    0938-AH37
            1843-P).............................................................................
1117        Payment Amount if Customary Charges Are Less Than Reasonable Costs (HCFA-1860-FC)...     0938-AH49
1118        Limitations on Liability (HCFA-4859-FC).............................................     0938-AH51
1119        Medicaid; Estate Recoveries (HCFA-2083-P)...........................................     0938-AH63
1120        Medicaid Hospice Care (HCFA-2016-P).................................................     0938-AH65
1121        Medicare Technical Conforming Amendments (HCFA-1858-FC).............................     0938-AH67
1122        Elimination of Certain Requirements for Peer Review Organizations in the Utilization     0938-AH68
            and Quality Review Process and a Change in the Length of Peer Review Organization
            Contracts (HCFA-3235-FC)............................................................
1123        Determination of Substandard Care in SNFs and NFs (HCFA-2240-P).....................     0938-AH69
1124        Waiver of Staffing Requirements for End Stage Renal Disease (ESRD) Facilities            0938-AH72
            Participating in an Experiment (HCFA-2236-GNC)......................................
1125        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).........................................................
1126        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).............................................................................
1127        Revisions to Conditions for Coverage for Ambulatory Surgical Centers (HCFA-3887-P)..     0938-AH83
1128        Disclosure of Peer Review Organization Information in Response to Beneficiary            0938-AH85
            Complaints (HCFA-3241-P)............................................................
1129        National Standard for Identifiers of Health Plans (HCFA-4145-P).....................     0938-AH87
1130        Medicaid Program; Amendment to the Preadmission Screening and Annual Resident Review     0938-AH89
            Program (HCFA-2107-P)...............................................................
1131        Medically Needy Determinations Under Welfare Reform (HCFA-2109-IFC).................     0938-AH92
1132        Medicaid Program; Coverage and Payment for Federally Qualified Health Center             0938-AH95
            Services (HCFA-2043-P)..............................................................
1133        Portability and Nondiscrimination in the Group Health Insurance Market (HCFA-2890-F)     0938-AI08

[[Page 22746]]

 
1134        Medicare Program; Medicare Integrity Program (HCFA-7020-F)..........................     0938-AI09
1135        Medicare Program; Improvements to the Appeals Process for Medicare Beneficiaries         0938-AI11
            Enrolled in HMOs, CMPs, and HCPPs (HCFA-4024-P).....................................
1136        Medicaid: Medical Child Support (HCFA-2081-P).......................................     0938-AI21
1137        Medicare/Medicaid Program; User Fees for Information, Products, and Services (HCFA-      0938-AI46
            6021-P).............................................................................
1138        Surety Bond Requirements for Comprehensive Outpatient Rehab. Facilities, Rehab.          0938-AI48
            Agencies, Community Mental Health Centers, and Independent Diagnostic Testing
            Facilities (HCFA-6005-P)............................................................
1139        National Standard Employer Identifier (HCFA-0047-F).................................     0938-AI59
1140        State Plan Requirements for Durable Medical Equipment Providers (HCFA-2007-P).......     0938-AI63
1141        Elimination of Application of Federal Financial Participation Limits (HCFA-2111-IFC)     0938-AI73
1142        Medicaid Program; Changes to Eligibility of Non-U.S. Citizens (HCFA-2108-P).........     0938-AI74
1143        Medicare Program; Advance Refunding of Debt and Methodology for Repayment of Loan        0938-AI75
            (HCFA-1777-P).......................................................................
1144        Revision of Procedures for Requesting Exceptions to Cost Limits for SNFs and             0938-AI80
            Elimination of Reclassifications (HCFA-1883-P)......................................
1145        Medicare Program; Medicare Coverage of and Payment for Bone Mass Measurements (HCFA-     0938-AI89
            3004-F).............................................................................
1146        Health Insurance Reform Universal Health Care Identifier (HCFA-0048-NOI)............     0938-AI91
1147        Medicare Program; Coverage and Administrative Policies for Clinical Diagnostic           0938-AI92
            Laboratory Tests (HCFA-3250-P)......................................................
1148        Peer Review Organization Contracts: Solicitation of Statements of Interest From In-      0938-AI99
            State Organizations (HCFA-3009-N)...................................................
1149        HHS' Recognition of NAIC Model Standards for Regulation of Medigap Policy (HCFA-2025-    0938-AJ07
            N)..................................................................................
1150        Reporting Outcome and Assessment Information Set (OASIS) Data as Part of the             0938-AJ10
            Conditions of Participation for Home Health Agencies (HCFA-3006-IFC)................
1151        Medicare Program; Criteria and Standards for Evaluating Intermediary and Carrier         0938-AJ15
            Performance: Millennium Compliance (HCFA-4002-GNC)..................................
1152        Rural Health Clinics: Amendments to Participation Requirements and Payment               0938-AJ17
            Provisions, and Establishment of a Quality Assessment and Improvement Program (HCFA-
            1910-P).............................................................................
1153        Hospital Conditions of Participation: Laboratory Services (HCFA-3 014-P)............     0938-AJ29
1154        Medicare Hospice Care Amendments (HCFA-1022-P)......................................     0938-AJ36
1155        Emergency Medical Treatment and Labor Act (EMTALA) (HCFA-1063-P)....................     0938-AJ39
1156        Decision on the Funding for the AIDS Healthcare Foundation START Program, (HCFA-2041-    0938-AJ43
            N)..................................................................................
1157        Medicare Program: Criteria for Making National Coverage Decision (HCFA-3432-P2).....     0938-AJ54
1158        Schedules of Per Visit and Per Beneficiary Limitation on Home Health Agency Cost         0938-AJ57
            (HCFA-1060-NC)......................................................................
1159        Medicare Program; Sustainable Growth Rate for Fiscal Year 2000 (HCFA-1110-N)........     0938-AJ60
1160        Medicare and Medicaid Programs; Programs for All-Inclusive Care for the Elderly          0938-AJ63
            (PACE) (HCFA-1903-F)................................................................
1161        State Health Insurance Assistance Program (SHIP) (HCFA-4005-IFC)....................     0938-AJ67
1162        Reapplication of the Community Health Accreditation Program, Incorporated (CHAP) for     0938-AJ69
            Continued Approval of Deeming Authority for Health Care Agencies (HHAs) (HCFA-2059-
            F)..................................................................................
1163        Clinical Social Worker Services (HCFA-1088-P).......................................     0938-AJ71
1164        State Allotments for Payments of Medicare Part B Premiums for Qualified Individuals:     0938-AJ72
            Federal Fiscal Year 2000 (HCFA-2063-N)..............................................
1165        Medicaid Disproportionate Share Hospital Payments -- Institutions for Mental Disease     0938-AJ74
            (HCFA-2062-N).......................................................................
1166        Children's Health Insurance Program; Final Allotments to States, Commonwealths and       0938-AJ77
            Territories for FY 98 and FY 99 (HCFA-2064-N).......................................
1167        Announcement of Additional Applications from Hospitals Requesting Waivers for Organ      0938-AJ79
            Procurement Service Areas (HCFA-1055-N).............................................
1168        Monthly Actuary Rates and Monthly Supplementary Medical Insurance Premium Rates          0938-AJ80
            Beginning January 1, 2000 (HCFA-8006-N).............................................
1169        HHA Surety Bond (HCFA-6001-P).......................................................     0938-AJ81
1170        Payment for Upgraded Durable Medical Equipment (HCFA-1084-P)........................     0938-AJ82
1171        Inpatient Hospital Deductible and Extended Care Services for Coinsurance Amounts for     0938-AJ83
            FY 2000 (HCFA-8005-N)...............................................................
1172        Part A Premium for FY 2000 for the Uninsured, Aged and for Certain Disabled              0938-AJ84
            Individuals Who Have Exhausted Other Entitlements (HCFA-8004-N).....................
1173        Medicare Program Update of Ambulatory Surgical Center Payment Rates Effective for        0938-AJ86
            Services On or After October 1, 1999 (HCFA-1085-N)..................................
1174        Coverage of, and Payment of, Paramedic Intercept Ambulance Services (HCFA-1813-F)...     0938-AJ87
1175        Criteria and Standards for Evaluating Intermediary and Carrier Performance During FY     0938-AJ88
            2000 (HCFA-4009-GNC)................................................................
1176        Medicare Graduate Medical Education Consortia (HCFA-1094-P).........................     0938-AJ89
1177        Sustainable Growth Rate for FY 2000 (HCFA-1110-N)...................................     0938-AJ90

[[Page 22747]]

 
1178        Medicare Program; Medicare Disproportionate Share (DSH) Adjustment Calculation:          0938-AJ92
            Change in the Treatment of Days in States with 1115 Expansion Waivers (HCFA-1124-
            IFC)................................................................................
1179        Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities--     0938-AJ93
            Update (HCFA-1112-P)................................................................
1180        State Children's Health Insurance Program; Final Allotments to States,                   0938-AJ94
            Commonwealths, and Territories for Fiscal Year 2000 (HCFA-2067-N)...................
1181        Use of Restraint and Seclusion in Residential Treatment Facilities Providing             0938-AJ96
            Inpatient Psychiatric Services to Individuals Under Age 21 (HCFA-2065-IFC)..........
1182        Supplier Standards Related to Requirements for Oxygen, Orthotics and Prosthetics         0938-AJ98
            (HCFA-1129-P).......................................................................
1183        Conditions of Participation for Intermediate Care Facilities for the Mentally            0938-AJ99
            Retarded............................................................................
1184        Non-Federal Governmental Plans Exempt From HIPAA (HCFA-2033-IFC)....................     0938-AK00
1185        Process for Requesting Recognition of New Technologies and Certain Drugs,                0938-AK01
            Biologicals and Medical Devices for Special Payment under Hospital Outpatient PPS
            (HCFA-1128-N).......................................................................
1186        Schedules of Per Visit and Per Beneficiary Limitations on Home Health Agency Cost        0938-AK03
            for Cost Reporting Periods Beginning on or After October 1, 2000 (HCFA-1108-NC).....
1187        Reporting Quality Assurance and Performance Improvement Data as Part of the              0938-AK05
            Conditions for Coverage for End Stage Renal Disease Facilities. (HCFA-3048-N).......
----------------------------------------------------------------------------------------------------------------


                             Health Care Financing Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1188        Omnibus Nursing Home Reform Requirements (HCFA-3488-F)..............................     0938-AD81
1189        Alternative Sanctions for Renal Dialysis Facilities (HCFA-3204-P)...................     0938-AG31
1190        Description of HCFA's Evaluation Methodology for the Peer Review Organizations Fifth     0938-AG32
            Scope of Work Contracts (HCFA-3207-N)...............................................
1191        Telephone Requests for Review of Part B Initial Claim Determinations (HCFA-4121-FC).     0938-AG48
1192        CLIA Program; Cytology Proficiency Testing (HCFA-2233-N)............................     0938-AH35
1193        Medicare Secondary Payer Clarifications and Amendments (HCFA-1865-P)................     0938-AH52
1194        Revision to Accrual Basis of Accounting Policy (HCFA-1876-F)........................     0938-AH61
1195        Utilization Control and Discontinued Review Activities; Medicaid (HCFA-2101-FC).....     0938-AH64
1196        Provider and Supplier Billing When Medicare Is Secondary Payor to Liability              0938-AH66
            Insurance (HCFA-1848-P).............................................................
1197        Revision to the Definition of an Unemployed Parent (HCFA-2106-FC)...................     0938-AH98
1198        Medicare Program; Physician Fee Schedule Conversion Factor for Calendar Year 1998        0938-AI16
            and Sustainable Growth Rate for Fiscal Year 1998 (HCFA-1893-FN).....................
1199        Medicare Program: Physicians' Referrals; Issuance of Advisory Opinions (HCFA-1902-F)     0938-AI38
1200        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)............................................................................
1201        Medicare Hospice Care (HCFA-1022-P).................................................     0938-AI77
1202        Solvency Standards for Provider-Sponsored Organizations (HCFA-1011-F)...............     0938-AI83
1203        Replacement of Reasonable Charge Methodology by Fee Schedules (HCFA-1010-P).........     0938-AJ00
1204        Suggestions Program on Methods to Improve Medicare Efficiency (HCFA-4000-FC)........     0938-AJ30
1205        Medicare Program; Procedures for Making Medical Services National Coverage Decisions     0938-AJ31
            (HCFA-3432-P).......................................................................
1206        Medicare Program; Special Payment Limits for Certain Durable Medical Equipment and       0938-AJ34
            Prosthetic Devices (HCFA-1050-PN)...................................................
1207        Accelerated Payments to Providers Furnishing Services Under Medicare Part A and Part     0938-AJ45
            B and Advance Payments to Suppliers Furnishing Items or Services Under Medicare Part
            B (HCFA-1066-FC)....................................................................
1208        Changes to the Hospital Inpatient Prospective Payment System and Fiscal Year 2000        0938-AJ50
            Rates (HCFA-1053-F) (Section 610 Review)............................................
1209        Appeal of Loss of Nurse Aide Training Programs (HCFA-2054-IFC)......................     0938-AJ59
1210        Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities-      0938-AJ65
            Update (HCFA-1056-N)................................................................
1211        Reapplication of the American Osteopathic Association (AOA) for Continued Approval       0938-AJ66
            of Deeming Authority for Hospitals (HCFA-2057-FN)...................................
1212        Reapplication of the Joint Commission for Accreditation of Health Care Organizations     0938-AJ68
            (JCAHO) for Continued Approval of Deeming Authority for Home Health Agencies (HHAs)
            (HCFA-2058-F).......................................................................
----------------------------------------------------------------------------------------------------------------


[[Page 22748]]


                          Administration for Children and Families--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1213        Child Support Enforcement for Indian Tribes.........................................     0970-AB73
1214        Family Child Care Program Option for Head Start Programs............................     0970-AB90
1215        Program Performance Standards for the Operation of Head Start Programs..............     0970-AB99
1216        Safeguarding Child Support and Expanded FPLS Information............................     0970-AC01
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1217        Standards for Safe Transportation...................................................     0970-AB24
1218        Construction of Head Start Facilities...............................................     0970-AB54
1219        Methodology for Determining Whether an Increase in a State's Child Poverty Rate is       0970-AB65
            the Result of the TANF Program......................................................
1220        Bonus To Reward High Performance States Under the Temporary Assistance for Needy         0970-AB66
            Families Block Grant................................................................
1221        Child Support Enforcement Program Omnibus Conforming Regulation.....................     0970-AB81
1222        Incentive Payments and Audit Penalties to States and Political Subdivisions.........     0970-AB85
1223        State Self-Assessments To Determine Compliance With Federal Regulations.............     0970-AB96
1224        National Medical Support Notice.....................................................     0970-AB97
1225        Technical Revision of Head Start Regulations to Make Them Conform to Recent              0970-AC00
            Statutory Revisions.................................................................
1226        Runaway and Homeless Youth Program..................................................     0970-AC04
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1227        Title IV-E Foster Care Eligibility Reviews and Child and Family Services State Plan      0970-AA97
            Reviews, MEPA Implementation, and ASFA Implementation...............................
1228        Requirements for the Tribal Programs................................................     0970-AB78
1229        Refugee Resettlement Program: Refugee Cash and Medical Assistance Programs..........     0970-AB83
1230        Head Start Appeal Timelines.........................................................     0970-AB87
1231        Welfare-to-Work Data Collection.....................................................     0970-AB92
1232        Priority for Previously Selected Head Start Agencies................................     0970-AB98
1233        Assets for Independence Reserve Account.............................................     0970-AC02
----------------------------------------------------------------------------------------------------------------


                                  Administration on Aging--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1234        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.....................................................
----------------------------------------------------------------------------------------------------------------


[[Page 22749]]

_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




916. 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 Medicare+Choice organizations 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                            10/00/00
NPRM Comment Period End         12/00/00

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
_______________________________________________________________________




917. 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                            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-AB04
_______________________________________________________________________




918. 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                            05/00/00
NPRM Comment Period End         07/00/00

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
_______________________________________________________________________




919. 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                            10/00/00
NPRM Comment Period End         12/00/00

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

[[Page 22750]]

_______________________________________________________________________




920.  REVISIONS AND TECHNICAL CORRECTIONS TO 42 CFR CHAPTER V

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 1320a-7; 42 USC 1320a-7a; 42 USC 
1320a-7b; 42 USC 1320a-7d(b); 42 USC 1395u

CFR Citation: 42 CFR 1001; 42 CFR 1003; 42 CFR 1008

Legal Deadline: None

Abstract: This proposed rule sets forth several miscellaneous revisions 
and technical corrections to the OIG regulations codified in 42 CFR 
chapter V. Among other revisions, this rule proposes revisions or 
clarifications to the term ``item or service'' contained in part 1003 
of this chapter, to the reinstatement procedures relating to exclusions 
resulting from the default on health education or scholarship 
obligations set forth in part 1001, and to the statute of limitations 
for the OIG to impose an exclusion under part 1001.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

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

RIN: 0991-AB09
_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




921. 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              06/00/00

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
_______________________________________________________________________




922. 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                    05/00/00

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
_______________________________________________________________________




923. 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.

[[Page 22751]]

Abstract: This final rule establishes 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 allows 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              11/19/99                    64 FR 63504
Final Rule                      08/00/00

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-AA91
_______________________________________________________________________




924. 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 final rule exempts 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                    06/00/00

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
_______________________________________________________________________




925. STANDARDS FOR PRIVACY OF INDIVIDUALLY INDENTIFIABLE HEALTH 
INFORMATION

Priority: Economically Significant. Major under 5 USC 801.

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

Legal Authority: 42 USC 1320d-2; 42 USC 1320d-4; PL 104-191, sec 264

CFR Citation: 45 CFR 160; 45 CFR 164

Legal Deadline: Final, Statutory, February 21, 2000.

Abstract: The proposed rule would implement part of the Administrative 
Simplification requirements of Public Law 104-191 by establishing 
standards for health plans, health care clearinghouses and certain 
health care providers to protect the privacy of individually 
identifiable health information.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/03/99                    64 FR 59967
Final Action                    08/00/00

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Tribal, Federal

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Roxanne Gibson, Senior Administrative Assistant, 
Department of Health and Human Services, Office of the Secretary, Room 
G-322A, Attention: Privacy-P, 200 Independence Avenue SW, Washington, 
DC 20201
Phone: 202 260-5083

RIN: 0991-AB08
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Office of the Secretary (OS)



_______________________________________________________________________




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

Priority: Other Significant

CFR Citation: 42 CFR 1001

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/19/99                    64 FR 63518

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0991-AA66
_______________________________________________________________________




927. BLOCK GRANT PROGRAMS

Priority: Info./Admin./Other

CFR Citation: 45 CFR 96

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/15/99                    64 FR 55843

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Michael Herrell
Phone: 202 690-5739

RIN: 0991-AA97

[[Page 22752]]

_______________________________________________________________________




928. HEALTH CARE FRAUD AND ABUSE DATA COLLECTION PROGRAM

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 61 (New)

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      11/26/99                    64 FR 57740

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0991-AA98
_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




929.  SUBSTANCE ABUSE PREVENTION AND TREATMENT BLOCK GRANT 
APPLICATIONS DUE DATE CHANGE FROM MARCH 31 TO OCTOBER 1 FOR FY 2001 AND 
BEYOND

Priority: Routine and Frequent

Legal Authority: Not Yet Determined

CFR Citation: 45 CFR 96; 45 CFR 96.122(d); 45 CFR 96.130(e); 45 CFR 
96.134(d)

Legal Deadline: None

Abstract: The Substance Abuse and Mental Health Services Administration 
(SAMHSA) (formerly, the Alcohol,Drug Abuse and Mental Health 
Administration (ADAMHA)) has permitted applicants for its Substance 
Abuse Prevention and Treatment (SAPT) Block Grant program to submit an 
application for a grant as late as March 31 of the fiscal year for 
which it is applying. Starting with the fiscal year 2001 applications, 
SAMHSA is proposing a new date for receipt of the applications for SAPT 
Block Grants of October 1 of the fiscal year for which Block Grant 
funding is being requested. However, the deadline for two application 
components required to be submitted by that due date may be extended 
for a limited period, not to extend beyond December 31 of the same 
fiscal year when good cause is demonstrated.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/04/00                     65 FR 5474
NPRM Comment Period End         03/20/00


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Thomas Reynolds, Department of Health and Human 
Services, Substance Abuse and Mental Health Services Administration, 
5600 Fishers Lane, Room 13C-20, Parklawn, Rockville, MD 20857
Phone: 301 443-0179

RIN: 0930-AA04
_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




930. PACKAGING AND HANDLING OF INFECTIOUS SUBSTANCES AND SELECT AGENTS

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                            10/28/99                    64 FR 58022


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Federalism:  Undetermined

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

RIN: 0920-AA02
_______________________________________________________________________




931.  CONTROL OF COMMUNICABLE DISEASES

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

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

CFR Citation: 21 CFR 1240

Legal Deadline: None

Abstract: CDC proposes to recodify certain regulatory responsibilities 
of 21 CFR part 1240, that relate to interstate quarantine of persons, 
following transfer of these responsibilities from FDA to CDC. 
Department officials have agreed to transfer this authority, which has 
rested with FDA since 1983. Once transferred, the authority will be 
updated through rulemaking.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule                       To Be                       Determined

[[Page 22753]]

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: State

Federalism:  Undetermined

Agency Contact: Teresa Durden, Senior Program Analyst, Department of 
Health and Human Services, Centers for Disease Control and Prevention, 
MS D23, 1600 Clifton Road NE, Atlanta, GA 30333
Phone: 404 639-7070
Fax: 404 639-7171
Email: [email protected]

RIN: 0920-AA03
_______________________________________________________________________


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


Departmental Management (HHSDM)



_______________________________________________________________________




932. 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                     05/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0990-AA02
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)             Prerule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________




933. 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: 5 USC 610; 21 USC 321; 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 that would result in less regulatory burden upon 
industry and FDA while maintaining the 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 
section 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                    04/00/00

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  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

[[Page 22754]]

_______________________________________________________________________




934. 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                           11/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  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
_______________________________________________________________________




935.  PART 600 - BIOLOGICAL PRODUCTS: GENERAL (SECTION 610 
REVIEW)

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

Unfunded Mandates: Undetermined

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

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: Parts 600 through 680 (21 CFR parts 600 through 680) describe 
regulations applicable to biological products. Part 600 describes 
regulations for general establishment standards, establishment 
inspections, and the reporting of adverse experiences applicable to 
manufacturers of licensed biological products. FDA is initiating a 
review under section 610 of the Regulatory Flexibility Act for the 
regulations in part 600. The purpose of this review is to determine if 
any of the regulations in part 600 should be continued without change, 
or should be amended or rescinded, to minimize adverse economic impacts 
on small entities. FDA will consider, and solicit comments on the 
following: 1) the continued need for a regulation in part 600; 2) the 
nature of complaints or comments received concerning a regulation in 
part 600; 3) the complexity of a regulation in part 600; 4) the extent 
to which a regulation in part 600 overlaps, duplicates, or conflicts 
with other Federal, State, or government rules; and 5) the degree to 
which technology, economic conditions or other factors have changed in 
the area affected by a regulation in part 600.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review of Current 
Regulation                      04/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

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
Fax: 301 594-1944
Email: [email protected]

RIN: 0910-AC06
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




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

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

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

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

CFR Citation: 21 CFR 801.420; 21 CFR 801.421

Legal Deadline: None

Abstract: FDA is considering revising its present regulation governing 
the labeling and conditions for sale of hearing aids. The present rule 
requires an examination by a physician before purchase of a hearing 
aid, but permits an informed adult to waive that requirement. There is 
some evidence that this waiver provision is being misused.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Additional Information: Previously reported under RIN 0905-AE46.

Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department 
of

[[Page 22755]]

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-AA39
_______________________________________________________________________




937. 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 requirements for registration and listing, and to 
consolidate and reorganize the regulation. The proposal would also 
require the electronic submission of establishment registration and 
product listing information.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  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
_______________________________________________________________________




938. 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 371; 21 USC 381; 21 USC 382; 21 USC 393; 42 USC 
241; 42 USC 243; 42 USC 262

CFR Citation: 21 CFR 312.110

Legal Deadline: None

Abstract: The proposed rule would amend the regulations on the 
exportation of unapproved new drug products, including biological 
products, for investigational use. In general, the proposed rule would 
provide four different routes for exporting an unapproved new drug 
product for investigational use. One route would permit exportation, if 
the drug is the subject of an investigational new drug application 
(IND) and is being exported for use in the investigation. A second 
route would permit exportation, without prior Food and Drug 
Administration (FDA) approval and without an IND, if the product is to 
be exported for use in a clinical investigation and has received 
marketing authorization in certain developed countries. The third route 
would permit exportation, without prior FDA approval and without an 
IND, if the product is to be exported for use in a clinical 
investigation in certain specified developed countries. The fourth 
route would permit exportation without an IND, to any country provided 
that the exporter sends a written certification to FDA at the time the 
drug is first exported. Drugs exported under any of the first three 
routes would, however, be subject to certain statutory requirements, 
such as not conflicting with the foreign country's laws and not being 
sold or offered for sale in the United States. Drugs exported under 
either the second or third routes would be subject to additional 
statutory requirements, such as being in substantial conformity with 
the current good manufacturing practices and certain labeling 
requirements. These provisions would implement recent changes in FDA's 
export authority resulting from the FDA Export Reform and Enhancement 
Act of 1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/00

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-AA61
_______________________________________________________________________




939. SUSPECTED 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                            09/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  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

[[Page 22756]]

Phone: 301 594-2041

RIN: 0910-AA86
_______________________________________________________________________




940. 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 type of 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                            12/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Federalism:  Undetermined

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
_______________________________________________________________________




941. LABELING FOR HUMAN PRESCRIPTION DRUGS; REVISED FORMAT

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

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

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

CFR Citation: 21 CFR 201

Legal Deadline: None

Abstract: The proposed regulation would amend the regulations governing 
the format and content of professional labeling for human prescription 
drug and biologic products, 21 CFR 201.56 and 201.57. The proposal 
would require that professional labeling include a section containing 
highlights of prescribing information and a section containing an index 
to prescribing information, reorder currently required information and 
make minor changes to its content, and establish minimum graphical 
requirements for professional labeling. The proposal would also 
eliminate certain unnecessary statements that are currently required to 
appear on prescription drug labels and move certain information to 
professional labeling.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Additional Information: Legal Authority continued: 42 USC 216; 42 USC 
241; 42 USC 262; 42 USC 264

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

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-AA94
_______________________________________________________________________




942. 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                            08/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  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 22757]]

_______________________________________________________________________




943. 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                            10/00/00
NPRM Comment Period End         01/00/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  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
_______________________________________________________________________




944. ADMINISTRATIVE PRACTICES AND PROCEDURES; ADVISORY OPINIONS AND 
GUIDELINES

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

Unfunded Mandates: Undetermined

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

CFR Citation: 21 CFR 10; 21 CFR 808

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  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
_______________________________________________________________________




945. 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 
amending 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 05/14/99 (64 FR 26282)  NPRM 
05/14/99 (64 FR 26344)  Final Action 12/00/00

Gen. Reqs. for Blood, Blood Compon., and Plasma Derivatives; 
Notification of Deferred Donors  NPRM 08/19/99 (64 FR 45355)  Final 
Action 12/00/00

Infectious Agent Clearance  NPRM 12/00/00

Plasma Derivatives and Other Blood-Derived Products; Reqs. for Tracking 
and Notification  ANPRM 08/19/99 (64 FR 45383)  NPRM 03/00/01

Reqs. for Testing Human Blood Donors for Evid. of Infection Due to 
Communicable Disease Agents  NPRM 08/19/99 (64 FR 45340)  Final Action 
12/00/00

Rev. to the Requirements Applicable to Blood, Blood Components, and 
Source Plasma  Direct Final Rule 08/19/99 (64 FR 45366)  NPRM 08/19/99 
(64 FR 45375)  Final Action 12/00/00

Suitability Reqs. for Whole Blood and Source Plasma Donors  NPRM 12/00/
00

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

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
Fax: 301 594-1944
Email: [email protected]

RIN: 0910-AB26

[[Page 22758]]

_______________________________________________________________________




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

Priority: Other Significant

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

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

CFR Citation: 21 CFR 1271

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/00

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

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
Email: [email protected]

RIN: 0910-AB28
_______________________________________________________________________




947. 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                            01/24/00                     65 FR 3623
NPRM Comment Period End         04/24/00
Final Action                    11/00/00

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: 301 827-8041
Email: [email protected]

RIN: 0910-AB33
_______________________________________________________________________




948. 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                            07/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  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
_______________________________________________________________________




949. 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

[[Page 22759]]

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                            11/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  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-AB37
_______________________________________________________________________




950. 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, 
361, 606, and 610 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 
drugs 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                            04/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Christine Rogers, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Suite 3059 
(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
_______________________________________________________________________




951. 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                            09/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  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
_______________________________________________________________________




952. 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                            09/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  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
_______________________________________________________________________




953. 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

[[Page 22760]]

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                            10/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  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
_______________________________________________________________________




954. PHARMACY AND PHYSICIAN COMPOUNDING OF DRUG PRODUCTS

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 353a; 21 
USC 355; 21 USC 360; 21 USC 371

CFR Citation: 21 CFR 216

Legal Deadline: None

Abstract: Section 503A of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 353a) describes the circumstances under which 
compounded drugs may qualify for exemption from three requirements of 
the act: (1) That a drug be manufactured according to current good 
manufacturing practice, (2) that a drug have adequate directions for 
use, and (3) that a marketing application be approved by FDA before a 
new drug product is introduced for sale (i.e., sections 501(a)(2)(B), 
502(f)(1), and 505 of the act (21 U.S.C. 351(a)(2)(B), 352(f)(1), and 
355)). To qualify for the exemption, a pharmacist or physician must 
meet statutory conditions for compounding, including the following: (1) 
There generally must be a prescription for an identified individual 
patient before compounding. (2) Compounding before receiving a 
prescription is allowed only under limited circumstances. (3) The 
quantity of drugs that may be shipped out of state is limited and may 
vary depending on whether the compounder is located in a state that has 
entered into a memorandum of understanding (MOU) with FDA. (4) Drug 
products may only be compounded using a bulk drug substance (which is 
essentially the active ingredient) that is listed in the United States 
Pharmacopoeia (USP) or National Formulary (NF); or a bulk drug 
substance that is a component of an FDA-approved drug product; or a 
bulk drug substance that is listed in the regulation as one that FDA 
has found to be suitable for compounding. (5) The bulk drug substance 
must be made in a facility registered with FDA and the bulk drug 
substance must be accompanied by a certificate of analysis. (6) Limited 
quantities of copies of commercially manufactured drug products may be 
compounded only in special circumstances. (7) Drug products may not be 
compounded if they are listed in a regulation as having been removed 
from the market or had their FDA-approval withdrawn because they were 
found to be not safe or not effective. (8) Drug products that are 
listed in the regulations as ``demonstrably difficult to compound'' may 
not be compounded. The regulations will amplify and explain the 
statutory requirements as well as execute tasks Congress assigned FDA 
in section 503A. This proposed rule will be one of several rulemakings 
implementing section 503A. Related regulatory initiatives are described 
below: (1) FDA has issued a final rule listing drug products that may 
not be compounded because they were found to be not safe or not 
effective and were removed from the market or had their FDA approval 
withdrawn; (2) FDA has also issued a proposed rule and is preparing a 
final rule listing drugs that are not the subject of a USP or NF 
monograph, and are not components of an FDA-approved drug product but 
are suitable for compounding; (3) FDA is currently preparing a proposed 
rule listing those drugs that are demonstrably difficult to compound 
and are not allowed to be compounded; and (4) FDA has published a 
Federal Register notice announcing the availability of a draft MOU 
between FDA and State boards of pharmacy.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/00

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal, State

Federalism:  Undetermined

Additional Information: See RINs 0910-AB57, 0910-AB59

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: 301 827-8041
Email: [email protected]

RIN: 0910-AB58
_______________________________________________________________________




955. 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                            08/00/00

[[Page 22761]]

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  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-AB59
_______________________________________________________________________




956. 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                            08/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  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
_______________________________________________________________________




957. 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                            08/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  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
_______________________________________________________________________




958. 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

Federalism:  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
_______________________________________________________________________




959. CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS

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 351; 21 USC 352; 21 USC 360b; 21 USC 371; 21 
USC 374

CFR Citation: 21 CFR 225

Legal Deadline: None

Abstract: This 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                            12/00/00

[[Page 22762]]

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

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
_______________________________________________________________________




960. 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

Federalism:  Undetermined

Agency Contact: Daniel G. McChesney, Deputy Director, Office of 
Surveillance and Compliance, Department of Health and Human Services, 
Food and Drug Administration, HFV-200, Center for Veterinary Medicine, 
7500 Standish Place, Rockville, MD 20855
Phone: 301 827-6648

RIN: 0910-AB72
_______________________________________________________________________




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

Priority: Economically Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
353; 21 USC 355; 21 USC 360; 21 USC 371; 21 USC 374; 42 USC 216; 42 USC 
262; 42 USC 263; 42 USC 263a; 42 USC 264; 42 USC 300aa-25

CFR Citation: 21 CFR 606; 21 CFR 610

Legal Deadline: None

Abstract: This rulemaking is one of a number of actions being taken to 
amend the biologics regulations to remove, revise, or update the 
regulations applicable to blood, blood components, and blood 
derivatives. These actions are based on a comprehensive review of the 
regulations performed by FDA, and are 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, and the Institute of Medicine, as well as 
public comments. In this rulemaking, FDA will propose to amend the 
biologics regulations to require that blood establishments prepare and 
follow written procedures for appropriate action when it is determined 
that blood and blood components pose an increased risk for transmitting 
hepatitis C virus (HCV) infection because they have been collected from 
a donor who, at a later date, tested repeatedly reactive for evidence 
of HCV.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/00

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: See RIN 0910-AB26.

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
Fax: 301 594-1944
Email: [email protected]

RIN: 0910-AB76
_______________________________________________________________________




962. 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 201.24

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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Christine Rogers, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Suite 3059 
(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

[[Page 22763]]

_______________________________________________________________________




963. 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                            07/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  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
_______________________________________________________________________




964. 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                            12/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Christine Rogers, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Suite 3059 
(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
_______________________________________________________________________




965. 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                            09/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Christine Rogers, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Suite 3059 
(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
_______________________________________________________________________




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

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 21 USC 342; 21 USC 371; 21 USC 374; 42 USC 264

CFR Citation: 21 CFR 111

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) announced in an 
advance notice of proposed rulemaking (ANPRM) of February 6, 1997 (62 
FR 5700), its plans to consider developing regulations establishing 
current good manufacturing practices (CGMP) for dietary supplements and 
dietary ingredients. The ANPRM was published in order for FDA to 
solicit comments on whether it should initiate action to establish CGMP 
regulations and if so, what constitutes CGMP for these products. FDA 
announced that this effort was in response to the section of the 
Federal Food, Drug, and Cosmetic Act (the act) that provides authority 
to the Secretary of Health and Human Services to promulgate CGMP 
regulations and to a submission from the dietary supplement industry 
asking that FDA consider an industry-proposed CGMP framework as a basis 
for CGMP regulations. The ANPRM also responds to concerns that such 
regulations are necessary to ensure that consumers are provided with 
dietary supplement products which have not been adulterated as a result 
of manufacturing, packing, or holding; which have the identity and 
provide the quantity of dietary ingredients declared in labeling; and 
which meet the quality specifications that the supplements are 
represented to meet.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           02/06/97                     62 FR 5700
ANPRM Comment Period End        06/06/97
NPRM                            09/00/00

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

[[Page 22764]]

Federalism:  Undetermined

Agency Contact: Karen Strauss, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, (HFS-820), 200 
C Street SW, Washington, DC 20204
Phone: 202 205-5372
Fax: 202 260-8957
Email: [email protected]

RIN: 0910-AB88
_______________________________________________________________________




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

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
355; 21 USC 360; 21 USC 360j; 21 USC 371; 21 USC 374; 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 exception under 
21 CFR 640.120.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/00
Direct Final Rule               12/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Sharon Carayiannis, Consumer Safety Officer, Department 
of Health and Human Services, Food and Drug Administration, Suite 400S 
(HFM-17), Center for Biologics Evaluation and Research, 1401 Rockville 
Pike, Rockville, MD 20852-1448
Phone: 301 827-6210

RIN: 0910-AB89
_______________________________________________________________________




968. 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 labeling in new drug 
applications, abbreviated new drug applications, supplements, and 
annual reports is required to be submitted. The proposal would require 
that the labeling described under sections 201.56 and 201.57 be 
submitted to FDA in electronic format.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/00

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  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
_______________________________________________________________________




969. 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                            08/00/00

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  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
_______________________________________________________________________




970. 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                            11/00/00

[[Page 22765]]

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  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
_______________________________________________________________________




971. 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 manufacturers 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 is required in lieu of a premarket notification. 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. 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 expects to publish a 
proposed rule on the notification process for food contact substances 
during FY 2000.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/00

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 SW, 
Washington, DC 20204
Phone: 202 418-3083
Fax: 202 418-3131
Email: [email protected]

RIN: 0910-AB94
_______________________________________________________________________




972. MARKING REQUIREMENTS FOR AND PROHIBITIONS ON THE REIMPORTATION OF 
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 for safety reasons 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                            08/00/00

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
_______________________________________________________________________




973. REQUIREMENTS PERTAINING TO SAMPLING SERVICES AND PRIVATE 
LABORATORIES USED IN CONNECTION WITH IMPORTED FOOD

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 sampling

[[Page 22766]]

services and private laboratories in connection with imported food. 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 imported food. 
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                            02/00/01

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
_______________________________________________________________________




974.  STATE CERTIFICATION OF MAMMOGRAPHY FACILITIES

Priority: Other Significant

Legal Authority: 21 USC 360(i); 21 USC 360(nn); 21 USC 374(e); 42 USC 
263(b)

CFR Citation: 21 CFR 900.2; 21 CFR 900.20; 21 CFR 900.21; 21 CFR 
900.22; 21 CFR 900.23; 21 CFR 900.24; 21 CFR 900.25

Legal Deadline: None

Abstract: FDA is considering regulations to implement section (q) of 
the Mammography Quality Standards Act of 1992 (the MQSA). This section 
permits FDA to authorize individual States to certify mammography 
facilities, to conduct the inspection of the facilities, to enforce the 
MQSA quality standards, and to administer other related functions. FDA 
retains oversight responsibility for the activities of the States to 
which this authority has been delegated and mammography facilities 
certified by those States must continue to meet the quality standards 
established by FDA for mammography facilities nationwide. The rule 
would include procedures for application, approval, evaluation, and 
withdrawal of approval of States as Certification Agencies. It also 
would include standards to be met by States receiving this authority.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/30/00                    65 FR 16847
NPRM Comment Period End         06/28/00
Final Rule                       To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Ruth Fischer, Office of Health and Industry Programs, 
Department of Health and Human Services, Food and Drug Administration, 
HFZ-240, Center for Devices and Radiological Health, 1350 Piccard 
Drive, Rockville, MD 20850
Phone: 301 594-3332

RIN: 0910-AB98
_______________________________________________________________________




975.  MEDICAL DEVICES, MEDICAL DEVICE ESTABLISHMENT REGISTRATION 
AND LISTING REQUIREMENTS; AMENDMENT

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 360; 21 USC 
360c; 21 USC 360e; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC 374

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: FDA is considering revising its present establishment 
registration and device listing regulations. More particularly, FDA is 
considering whether to (1) merge establishment registration and device 
listing into a single system and single reporting form, (2) encourage 
the electronic submission of the establishment registration and device 
listing information, (3) require premarket submission application 
numbers, (4) amend time frames for providing and updating registration 
and listing data, (5) shift registration and listing responsibilities 
to parent company level, and (6) require notification of transfer of 
ownership for premarket notifications.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Bryan H. Benesch, Special Assistant to the Director, 
Office of Compliance, Department of Health and Human Services, Food and 
Drug Administration, HFZ-300, Center for Devices and Radiological 
Health, 2094 Gaither Road, Rockville, MD 20850
Phone: 301 549-4699
Fax: 301 594-4715
Email: [email protected]

RIN: 0910-AB99
_______________________________________________________________________




976.  AVAILABILITY FOR PUBLIC DISCLOSURE AND SUBMISSION TO FDA 
FOR PUBLIC DISCLOSURE OF CERTAIN DATA AND INFORMATION RELATED TO GENE 
THERAPY OR XENOTRANSPLANTATION

Priority: Other Significant

Legal Authority: 5 USC 552; 21 USC 331(j); 21 USC 505

CFR Citation: 21 CFR 20.100; 21 CFR 312.42; 21 CFR 312.130; 21 CFR 
601.50; 21 CFR 601.51; 21 CFR 601.52; 21 CFR 601.53

Legal Deadline: None

Abstract: The proposed regulation would require sponsors of human 
trials involving human gene therapy or xenotransplantation to submit a 
redacted version of the original for public disclosure, with an 
investigational New Drug Application (IND), an amendment to an IND, or 
other related documents. The submission would be redacted to exclude 
trade secret information and personal information, the disclosure of 
which would constitute a clearly unwarranted invasion of personal 
privacy. FDA would then make the redacted documents available to the 
general public and the information may be discussed in open session at 
scientic advisory committee meetings and at other suitable fora.

[[Page 22767]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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
Fax: 301 594-1944
Email: [email protected]

RIN: 0910-AC00
_______________________________________________________________________




977.  REPORTING INFORMATION REGARDING POTENTIAL RESEARCH 
MISCONDUCT

Priority: Substantive, Nonsignificant

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 355(i)

CFR Citation: 21 CFR 312.3; 21 CFR 312.56; 21 CFR 812.3; 21 CFR 812.46

Legal Deadline: None

Abstract: The proposed rule would require sponsors to submit 
information in their possession indicating that research misconduct may 
have been committed by a person involved in proposing, designing, 
conducting, recording, or reporting human subject trials.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

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-AC02
_______________________________________________________________________




978.  EXAMINATION OF ADMINISTRATIVE RECORD AND OTHER ADVISORY 
COMMITTEE RECORDS

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 321

CFR Citation: 21 CFR 14.75

Legal Deadline: None

Abstract: FDA is amending its administrative regulations in 21 CFR 
14.75(a) to state that written information for consideration by an 
advisory committee at an advisory committee meeting is available for 
public disclosure, whenever practicable, before or at the time of the 
meeting.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/00
Direct Final Rule               06/00/00

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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-AC03
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




979. 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 331; 21 USC 351; 21 USC 352; 21 
USC 353; 21 USC 355; 21 USC 360; 21 USC 360a; 21 USC 360b; 21 USC 361; 
21 USC 371; 21 USC 371a

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

Legal Deadline: None

Abstract: The OTC drug review establishes conditions under which OTC 
drugs are considered generally recognized as safe and effective and not 
misbranded. After a final monograph (i.e., final rule) is issued, only 
OTC drugs meeting the conditions of the monograph, or having an 
approved new drug application, may be legally marketed. NOTE: NPRM for 
``Antidotes, Toxic Ingestion Products'' was combined with NPRM for 
``Emetic Products'' and reproposed as ``Poison Treatment Products.'' 
NPRM for ``Astringent (Wet Dressings) Products'' was included in the 
NPRM for ``Skin Protectant Products.'' NPRM for ``Diaper Rash 
Products'' was included in NPRMs for ``Antifungal,'' ``Antimicrobial,'' 
``External Analgesic'' and ``Skin Protectant Products.'' NPRM for 
``Fever Blister/Cold Sore Products (External)'' was included in NPRMs 
for ``External Analgesic'' and ``Skin Protectant Products.'' NPRM for 
``Insect Bites and Stings (Relief) Products'' was included in NPRMs for 
``External Analgesic'' and ``Skin Protectant Products.'' ``Poison Ivy/
Oak/Sumac Prevention'' was included in NPRMs for ``External Analgesic'' 
and ``Skin Protectant Products.'' NPRM for ``Mercurial (Topical) 
Products'' was included in revised NPRM for ``Antimicrobial Products.'' 
NPRM for ``Alcohol (Topical) Products'' was included in revised NPRM 
for ``Antimicrobial Products.'' The NPRM for ``Antimicrobial Products'' 
was updated and split into two sections: First Aid Products and Health 
Care Antiseptic Products.
SMALL ENTITIES AFFECTED: The effects, if any, vary depending on the 
individual rulemaking. However, the Agency anticipates that the rules 
would not have a significant economic impact on a substantial number of 
small entities as defined by the Regulatory Flexibility Act.

[[Page 22768]]

Timetable:
________________________________________________________________________

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

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

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

Antacid Drug Products  ANPRM 04/05/73 (38 FR 8714)  NPRM 11/12/73 (38 
FR 31260)  Final Action 06/04/74 (39 FR 9862)  NPRM (Amendment) 
(Overindulgence) 12/24/91 (56 FR 66754)  Final Action (Amendment) 
(Warning) 08/26/93 (58 FR 45204)  NPRM (Amendment) (Testing) 09/23/93 
(58 FR 49826)  NPRM (Amendment)(Sodium Bicarb.) 02/02/94 (59 FR 
5060)  Final Action (Technical Amendment) 11/25/94 (59 FR 60555)  Final 
Action (Amendment) (Testing) 02/08/96 (61 FR 4822)  Final Action 
(Amendment)(Sodium B.) 12/00/00  Final Action (Amendment) 
(Overindulgence) 12/00/01

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

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

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

Antidiarrheal Products  ANPRM 03/21/75 (40 FR 12924)  NPRM 04/30/86 (51 
FR 16138)  NPRM (Amendment)(Trav. Diar.) 12/00/00  Final Action 12/00/
00

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

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

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

Antifungal (Topical) Products  ANPRM 03/23/82 (47 FR 12480)  NPRM 12/
12/89 (54 FR 51136)  NPRM (Amendment) (Diaper Rash) 06/20/90 (55 FR 
25240)  Final Action (Amdt.)(Diaper Rash) 12/18/92 (57 FR 60430)  Final 
Action (Partial) 09/02/93 (58 FR 46744)  Final Action 09/23/93 (58 FR 
49890)  NPRM (Amendment) (Indications) 07/22/99 (64 FR 39452)  Final 
Action 06/00/00  NPRM (Amendment) Clotrimazole 08/00/00

Antimicrobial Products  ANPRM 09/13/74 (39 FR 33103)  NPRM 01/06/78 (43 
FR 1210)  NPRM (Amendment) (Diaper Rash) 06/20/90 (55 FR 25246)  Final 
Action (Diaper Rash) 03/00/04

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

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

Aspirin (Heart Labeling)  Final Action 10/23/98 (63 FR 56802)

Aspirin (OTC Professional Use Warning)  NPRM 11/16/88 (53 FR 
46204)  NPRM 10/20/93 (58 FR 54224)  NPRM (Amendment) 06/13/96 (61 FR 
30002)

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

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

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

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

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

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

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

Cough/Cold (Antihistamine) Products  ANPRM 09/09/76 (41 FR 38312)  NPRM 
01/15/85 (50 FR 2200)  NPRM (Amendment) 08/24/87 (52 FR 31892)  Final 
Action 12/09/92 (57 FR 58356)  Final Action (Amendment)(Warning) 01/28/
94 (59 FR 4216)  NPRM (Amendment)(Diphenhydramine) 08/29/97 (62 FR 
45767)  Final Action 12/00/00

Cough/Cold (Antitussive) Products  ANPRM 09/09/76 (41 FR 38312)  NPRM 
10/19/83 (48 FR 48576)  Final Action 08/12/87 (52 FR 30042)  NPRM 
(Amendment) (Warning) 07/06/89 (54 FR 28442)  NPRM (Amendment) 10/02/89 
(54 FR 40412)  Final Action (Amendment) (Warning) 07/06/90 (55 FR 
27806)  Final Action (Amendment) 10/03/90 (55 FR 40381)  NPRM 
(Amendment)(Warning) 06/19/92 (57 FR 27666)  NPRM 
(Amendment)(Ingredients) 12/09/92 (57 FR 58378)  Final Action 
(Amendment)(Warning) 10/20/93 (58 FR 54232)  Final Action 
(Amdt.)(Ingredients) 06/03/94 (59 FR 29172)  NPRM 
(Amendment)(Diphenhydramine) 08/29/97 (62 FR 45767)  NPRM 
(Amendment)(Flammability) 07/20/98 (63 FR 38762)  Final Action 
(Amendment)(Flammability) 10/00/00

Cough/Cold (Bronchodilator) Products  ANPRM 09/09/76 (41 FR 
38312)  NPRM 10/26/82 (47 FR 47520)  Final Action 10/02/86 (51 FR 
35326)  NPRM (Amendment)(Warning) 06/19/92 (57 FR 27662)  Final Action 
(Amendment)(Warning) 10/20/93 (58 FR 54238)  NPRM (Amendment)(MDI) 03/
09/95 (60 FR 13014)  NPRM (Amendment)(Ephedrine) 07/27/95 (60 FR 
38643)  Final Action (Amendment) (MDI) 05/20/96 (61 FR 25142)  Final 
Action (Amendment) (Ephedrine) 10/00/00

[[Page 22769]]

Cough/Cold (Combination) Products  ANPRM 09/09/76 (41 FR 38312)  NPRM 
08/12/88 (53 FR 30522)  NPRM (Amendment)(DPH Combinations) 02/23/95 (60 
FR 10286)  Final Action (Theophylline) 07/27/95 (60 FR 38636)  NPRM 
(Amendment) (Ephedrine Combo) 10/00/00  Final Action 12/00/00

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

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

Cough/Cold (Expectorant/Ipecac) Products  ANPRM 09/09/76 (41 FR 
38312)  NPRM 07/09/82 (47 FR 30002)  Final Action 09/14/92 (57 FR 
41857)

Cough/Cold (Nasal Decongestant) Products  ANPRM 09/09/76 (41 FR 
38312)  NPRM 01/15/85 (50 FR 2220)  NPRM (Amendment) 06/19/92 (57 FR 
27658)  Final Action 08/23/94 (59 FR 43386)  Final Action; Partial Stay 
03/08/96 (61 FR 9570)  NPRM (Phenylpropanolamine) 12/00/00

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

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

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

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

Eligibility Criteria for Additional Conditions  ANPRM 10/03/96 (61 FR 
51625)  NPRM 12/20/99 (64 FR 71062)  Final Action 10/00/00

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

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

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

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

First Aid Antiseptic  ANPRM 09/13/74 (39 FR 33103)  NPRM 01/06/78 (43 
FR 1210)  NPRM (Revised) 07/22/91 (56 FR 33644)  Final Action 12/00/01

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

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

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

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

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

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

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

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

Internal Analgesic Products  ANPRM 07/08/77 (42 FR 35346)  NPRM 11/16/
88 (53 FR 46204)  NPRM (Amendment) (Overindulgence) 12/24/91 (56 FR 
66762)  NPRM (Amendment)(Sodium Bicarbonate) 02/02/94 (59 FR 
5068)  NPRM (Prof. Labeling)(Acute MI) 06/13/96 (61 FR 30002)  NPRM 
(Amendment)(Alcohol Warning) 11/14/97 (62 FR 61041)  Final Action 
(Alcohol Warning) 10/23/98 (63 FR 56789)  Final Action (Aspirin Prof. 
Label) 10/23/98 (63 FR 56802)  Final Action (Sodium Bicarbonate) 12/00/
00  Final Action (Amendment)(Overindulgence) 12/00/01

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

Labeling of Drug Products for OTC Human Use  NPRM (Sodium Labeling) 04/
25/91 (56 FR 19222)  NPRM 04/05/93 (58 FR 17553)  Final Action 01/28/94 
(59 FR 3998)  NPRM (Do not mix drugs) 08/03/94 (59 FR 39499)  NPRM 
(Amendment) (Do not mix drugs) 10/04/95 (60 FR 52058)  NPRM (Unless a 
doctor tells you) 03/04/96 (61 FR 8450)  Final Action (Sodium Labeling) 
04/22/96 (61 FR 17798)  NPRM (Calcium/Magnesium/Potassium) 04/22/96 (61 
FR 17807)  Withdrawal (Unless a doctor tells you) 02/27/97 (62 FR 
9024)  Final Action (Format/Examples) 03/17/99 (64 FR 13254)  Final 
Action (Technical Amendment) 01/03/00 (65 FR 7)  Final Action (Ca/Mg/K/
Na) 12/00/00

Laxative Products  ANPRM 03/21/75 (40 FR 12902)  NPRM 01/15/85 (50 FR 
2124)  NPRM (Amendment) (Directions/Bulk) 10/01/86 (51 FR 35136)  NPRM 
(Amendment) (Docusate Salts) 09/02/93 (58 FR 46589)  NPRM 
(Amendment)(Sodium Phosphates) 03/31/94 (59 FR 15139)  NPRM 
(Phenolphthalein) 09/02/97 (62 FR 46223)  Final Action (Sodium 
Phosphates) 05/21/98 (63 FR 27836)  NPRM (Amendment)(Phosphates Label) 
05/21/98 (63 FR 27886)  NPRM (Amendment)(Stim. Laxative) 06/19/98 (63 
FR 33592)  Final Action; stay (Na Phos. Enema) 12/07/98 (63 FR 
67399)  Part. With. (Na Phos. Prof. Lab.) 12/09/98 (63 FR 67817)  Final 
Action (Phenolphthalein) 01/29/99 (64 FR 4535)  Final Action 12/00/
00  Final Action (Stim. Laxative) 12/00/03

[[Page 22770]]

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

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

Menstrual Products  ANPRM 12/07/82 (47 FR 55075)  NPRM 11/16/88 (53 FR 
46194)  Final Action 12/00/01

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

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

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

Nighttime Sleep Aid Products  ANPRM 12/08/75 (40 FR 57292)  NPRM 06/13/
78 (43 FR 25544)  Final Action 02/14/89 (54 FR 6814)  NPRM (Amendment) 
08/26/93 (58 FR 45217)  Final Action (Amendment) 04/11/94 (59 FR 
16982)  NPRM (Amendment) (Warning) 08/29/97 (62 FR 45767)  Final Action 
03/00/01

Ophthalmic Products  ANPRM 05/06/80 (45 FR 30002)  NPRM 06/28/83 (48 FR 
29788)  Final Action 03/04/88 (53 FR 7076)  Final Action (Anti-
infective) 12/18/92 (57 FR 60416)  NPRM (Amendment) (Warning) 02/23/98 
(63 FR 8888)  Final Action 06/00/00

Oral Discomfort (Relief) Products  ANPRM 05/25/82 (47 FR 22712)  NPRM 
09/24/91 (56 FR 48302)  Final Action 06/00/02

Oral Health Care Products  ANPRM 05/25/82 (47 FR 22760)  NPRM 01/27/88 
(53 FR 2436)  NPRM (Amendment) (Antimicrobials) 02/09/94 (59 FR 
6084)  ANPRM (Plaque/Gingivitis) 10/00/00  NPRM 01/00/01

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

Otic Products (Dry Water-Clogged Ears)  NPRM (Amendment) 08/17/99 (64 
FR 44671)  Final Action 08/00/00

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

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

Overindulgence Remedies  ANPRM 10/01/82 (47 FR 43540)  NPRM 12/24/91 
(56 FR 66742)  Final Action 12/00/01

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

Pediculicide Products  ANPRM 06/29/82 (47 FR 28312)  NPRM 04/03/89 (54 
FR 13480)  Final Action 12/14/93 (58 FR 65452)  NPRM (Labeling 
Amendment) 09/00/00

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

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

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

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

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

Skin Bleaching Products  ANPRM 11/03/78 (43 FR 51546)  NPRM 09/03/82 
(47 FR 39108)  NPRM (Reproposed) 01/00/03

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

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

Status of Certain Category II and III Ingredients  NPRM 05/16/90 (55 FR 
20434)  Final Action 11/07/90 (55 FR 46914)  NPRM 08/25/92 (57 FR 
38568)  Final Action 05/10/93 (58 FR 27636)  Final Action 04/22/98 (63 
FR 19799)  Final Action 08/24/98 (63 FR 44996)

Stimulant (Overindulgence) Products  NPRM (Amendment) 12/24/91 (56 FR 
66758)  Final Action 12/00/01

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

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

Sunscreen Products  ANPRM 08/25/78 (43 FR 38206)  NPRM 05/12/93 (58 FR 
28194)  NPRM (Amendment) 06/08/94 (59 FR 29706)  NPRM 
(Amendment)(Avobenzone) 09/16/96 (61 FR 48645)  Final Action 
(Avobenzone Enf. Pol.) 04/30/97 (62 FR 23350)  Final Action 05/21/99 
(64 FR 27666)

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

Topical Drug Products Containing Benzoyl Peroxide (Labeling)  NPRM 02/
17/95 (60 FR 9554)  Final Action 07/00/01

Vaginal Contraceptive Products  ANPRM 12/12/80 (45 FR 82014)  NPRM 02/
03/95 (60 FR 6892)  NPRM (Amendment) 12/00/00

Vaginal Drug Products  ANPRM 10/13/83 (48 FR 46694)  Withdrawal 02/03/
95 (60 FR 5226)  NPRM (Douches) 12/00/01

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

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

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

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

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

[[Page 22771]]

_______________________________________________________________________




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

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

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

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

CFR Citation: 21 CFR 514

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

Abstract: On December 17, 1991, the Agency published a proposed 
revision of the existing regulations that is consistent with the 
current procedural regulations for human drugs, where appropriate. The 
New Animal Drug Application (NADA) revisions articulate general 
requirements in regulations containing performance standards and would 
complement these regulations through detailed 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 the safety and effectiveness of new animal drugs and 
enable a more streamlined animal drug application review and approval 
process which will result in less regulatory burden upon industry and 
FDA. The Agency also proposes to amend its regulations to implement 
title I of the Generic Animal Drug and Patent Term Restoration Act, 
which established new standards for marketing approval of generic 
copies of animal drugs approved after 1962.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Reporting Requirements for Marketed Animal Drugs  NPRM 12/17/91 (56 FR 
65581)  Final Action 09/00/00

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.
The federalism implications for the New Animal Drug Approval Process 
are 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-AA02
_______________________________________________________________________




981. BIOLOGICAL PRODUCTS: REPORTING OF BIOLOGICAL PRODUCT DEVIATIONS IN 
MANUFACTURING

Priority: Other Significant

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

CFR Citation: 21 CFR 600; 21 CFR 606

Legal Deadline: None

Abstract: FDA is amending the regulations that require licensed 
manufacturers of biological products to report biological product 
deviations 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 biological product deviations reporting by 
unlicensed registered blood establishments and transfusion services 
currently reporting on a voluntary basis. The reporting requirements 
will expedite reporting of biological product deviations 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 manufacturing deviations 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                    09/00/00

[[Page 22772]]

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

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
Email: [email protected]

RIN: 0910-AA12
_______________________________________________________________________




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

Priority: Economically Significant. Major under 5 USC 801.

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

CFR Citation: 21 CFR 120

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) announced its plans to 
consider the development of regulations establishing requirements for a 
new comprehensive food safety assurance program that would be based on 
the principles of Hazard Analysis Critical Control Points (HACCP) in an 
advance notice of proposed rulemaking on August 4, 1994. The new food 
safety program would respond to new challenges, such as new food 
processing and packaging technologies, new food distribution and 
consumption patterns, exposure to industrial chemicals and chemical 
waste, the increasing importation of foods, new microbial pathogens, 
and resource constraints. Current information shows that the most 
serious of these challenges is presented by food-borne pathogens. The 
number of recognized food-borne pathogens has broadened considerably, 
as has the awareness of long-term complications from certain food-borne 
illnesses--such as arthritis, heart disease, and kidney and 
neurological damage. To meet such challenges, FDA intends to shift the 
focus of its food safety assurance program away from periodic visual 
inspection and end-product testing and toward prevention of food safety 
risks and problems, utilizing the state-of-the-art HACCP preventive 
approach. A first step was taken when FDA published a HACCP regulation 
for fish and fishery products on December 18, 1995. Consistent with 
FDA's HACCP efforts, USDA published a HACCP regulation for meat and 
poultry on July 25, 1996. FDA proposed on April 24, 1998 to adopt a 
HACCP regulation for the processing of juice. The agency simultaneously 
proposed to require a warning statement on the labels or in labeling 
for juice products that have not been processed to reduce, control, or 
eliminate the presence of harmful bacteria; the warning statement rule 
was finalized in July. Such labeling serves to reduce the risk of food-
borne illness, pending development of a final HACCP rule for juice. As 
part of the development of the HACCP proposal, FDA considered 
information obtained during agency HACCP pilot activities, and comments 
and scientific and technological information relating to fresh juices 
provided during and after an agency public meeting on juice held on 
December 16 and 17, 1996. FDA held two technical scientific workshops, 
one November 12, 1998, in Lake Alfred, Florida and the other November 
29, 1998, in Irvine, California, to discuss and clarify issues related 
to the implementation of the agency's rule requiring a warning 
statement for certain juice products. The workshops addressed citrus 
juice production and the methods for measuring and validating such 
systems. On December 8 and 9, 1999, the National Advisory Committee on 
Microbiological Criteria for Foods (NACMCF) met to consider performance 
criteria for fresh juice. FDA specifically requested the NACMCF to make 
recommendations about the efficacy of surface treatments in ensuring 
the safety of citrus juices.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           08/04/94                    59 FR 39888
ANPRM Comment Period End        12/02/94
Economic Analysis for Juice HACCP and Labeling  PRIA 05/01/98 (63 FR 
24254)  PRIA Comment Period End 06/22/98

HACCP for Juice  NPRM 04/24/98 (63 FR 20450)  NPRM Comment Period End 
08/07/98  NPRM Comment Period Reopened 12/17/98 (63 FR 69579)  NPRM 
Reopened Comment Period End 01/19/99  Final Action 09/00/00

Label Warning Statements for Juice  Notice of Intent 08/28/97 (62 FR 
45593)  NPRM 04/24/98 (63 FR 20496)  NPRM Comment Period End 06/21/
98  Final Action 07/08/98 (63 FR 37029)

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Additional Information: Previously reported under RIN 0905-AE60.

Agency Contact: Shellee Anderson, Food Technologist, Department of 
Health and Human Services, Food and Drug Administration, HFS-306, 
Center for Food Safety and Applied Nutrition, 200 C Street SW, 
Washington, DC 20204
Phone: 202 205-5023
Email: [email protected]

RIN: 0910-AA43
_______________________________________________________________________




983. 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

[[Page 22773]]

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                    11/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

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
_______________________________________________________________________




984. 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 
parts 314 and 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                    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 3059 
(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
_______________________________________________________________________




985. DRUGS USED FOR TREATMENT OF NARCOTIC ADDICTS

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 355; 21 USC 371; 21 USC 823; 42 USC 241; 42 USC 
257a; 42 USC 290; 42 USC 300

CFR Citation: 21 CFR 291; 42 CFR 8

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                    10/00/00

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Federalism:  This action may have federalism implications as defined in 
EO 13132.

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
_______________________________________________________________________




986. REINVENTING FDA FOOD REGULATIONS

Priority: Substantive, Nonsignificant

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

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

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

Legal Deadline: None

Abstract: In response to President Clinton's memorandum to heads of 
departments and agencies entitled ``Regulatory Reinvention 
Initiative,'' FDA has initiated rulemaking to retain, revise, or revoke 
certain of its regulations for food. FDA published an advance notice of 
proposed rulemaking (ANPRM) on December 29, 1995, requesting 
information on the need to retain, revise, or revoke its food standards 
of identity regulations and its common or usual name regulations. In 
the same issue of the Federal Register, FDA proposed to improve the 
coordination of the food additive, GRAS, and color additive approval 
process with USDA for substances used in meat and poultry products. FDA 
proposed to revoke several lower fat milk standards on November 9, 
1995. On June 12, 1996, FDA published an ANPRM announcing its intention 
to review: (1) its human food labeling regulations pertaining to the 
exemption for soft drinks from requirements for the type size and 
placement of certain information on the information panel, requirements 
for listing ``statements of identity,'' and requirements for flavor 
labeling; (2) its infant formula regulations to ensure that they fully 
reflect the Federal Food, Drug, and Cosmetic Act; (3) its regulations 
pertaining to the discharge of waste aboard casino ships, passenger 
ships,

[[Page 22774]]

and ferries; and (4) its food additive regulations to consolidate 
certain existing regulations. In the same June 12 issue of the Federal 
Register, FDA published a second ANPRM seeking public comment on 
possible ways to streamline various food additive regulations. FDA also 
proposed on June 12, 1996, to revoke certain food labeling regulations 
pertaining to labeling of food with number of servings and labeling 
Kosher and Kosher-style foods and to revoke the agency's voluntary 
filing of cosmetic product experiences. The latter was published August 
12, 1997.
On October 13, 1995, FDA proposed to revoke certain agency regulations 
that were obsolete or no longer necessary to achieve public health 
goals. The final rule (pertaining to food regulations only) was 
published on June 3, 1996. A confirmation of effective date (CED) on 
those regulations, promulgated under the formal rulemaking procedures 
of section 701(e) of the Federal Food, Drug, and Cosmetic Act (21 USC 
371(e)), pertaining to diabetic labeling (21 CFR 105.67) and sodium 
intake labeling (21 CFR 105.69), was published on August 27, 1996.
In the Federal Register of April 17, 1997 (62 FR 18938), FDA proposed 
to establish a notification procedure for companies to use to inform 
FDA of a company's determination that use of a substance in food is 
generally recognized as safe (GRAS).

Timetable:
________________________________________________________________________

Exempt Infant Formula; Plan for Revisions  ANPRM 06/12/96 (61 FR 
29701)  Comment Period Ended 10/10/96  NPRM To Be Determined

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

Food, Color, and GRAS; Simult. Pet. Rev. by USDA (Meat/Poultry)  NPRM 
12/29/95 (60 FR 67490)  Comment Period Ended 03/14/96  Extension of 
Comment Period 06/03/96  Final Action 08/00/00

Notification Procedures for Independent GRAS Determinations  NPRM 04/
17/97 (62 FR 18938)  NPRM Comment Period Ended 07/16/97  Final Action 
To Be Determined

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

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

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

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

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Additional Information: Federalism: Yes for Food Standards of Identity, 
Quality, and Fill of Container

Agency Contact: L. Robert Lake, Director, Office of Regulations and 
Policy, Department of Health and Human Services, Food and Drug 
Administration, (HFS-4), Center for Food Safety and Applied, Nutrition, 
200 C Street SW, Washington, DC 20204
Phone: 202 205-4561

RIN: 0910-AA58
_______________________________________________________________________




987. 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

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                    05/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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
_______________________________________________________________________




988. 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                    06/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

[[Page 22775]]

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
_______________________________________________________________________




989. DETERMINATION THAT INFORMED CONSENT IS INFEASIBLE OR IS CONTRARY TO 
THE BEST INTEREST OF RECIPIENTS

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 346; 21 USC 346a; 21 USC 348; 21 
USC 352; 21 USC 353; 21 USC 355; 21 USC 360; 21 USC 360c; 21 USC 360d; 
21 USC 360e; 21 USC 360f; 21 USC 360h; 21 USC 360i; 21 USC 360j; 21 USC 
371; 21 USC 379e; 21 USC 381; 42 USC 216; 42 USC 241; 42 USC 262; 42 
USC 263b; 42 USC 263c; 42 USC 263d; 42 USC 263e; 42 USC 263f; 42 USC 
263g; 42 USC 263h; 42 USC 263i; 42 USC 263j; 42 USC 263k; 42 USC 263l; 
42 USC 263m; 42 USC 263n

CFR Citation: 21 CFR 50; 21 CFR 312

Legal Deadline: None

Abstract: The Food and Drug Administration is planning to publish a 
final rule that would finalize its 1999 interim final rule (64 FR 
54180) that (1) revoked its December 21, 1990, interim final 
regulations that permitted the Commissioner to determine that obtaining 
informed consent from military personnel for the use of investigational 
products is not feasible in certain military combat situations; and (2) 
established strengthened criteria and standards for the President to 
apply in making a determination that informed consent is not feasible 
or is contrary to the best interest of military personnel engaged in 
specific military operations. The agency is taking this final 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 
and its 1999 interim final regulation soliciting comments on this 
action, and in light of the enactment of the Strom Thurmond National 
Defense Authorization Act for Fiscal Year 1999 under which the 
President is authorized to waive the Federal Food, Drug, and Cosmetic 
Act's informed consent requirements in military operations if the 
President finds that obtaining consent is infeasible or contrary to the 
best interests of recipients and on an additional ground that obtaining 
consent is contrary to national security interests.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              10/05/99                    64 FR 54180
Final Action                    09/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal

Agency Contact: Bonnie M. Lee, Health Issues Analyst, Division of 
Compliance Policy, Office of Enforcement, Department of Health and 
Human Services, Food and Drug Administration, HFC-230, Office of 
Regulatory Affairs, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-0415

RIN: 0910-AA89
_______________________________________________________________________




990. 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                    09/00/00

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-AA98
_______________________________________________________________________




991. USE OF OZONE-DEPLETING SUBSTANCES

Priority: Other Significant. Major status under 5 USC 801 is 
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 amending 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 amending 
the regulations to better conform to other statutes and regulations 
relating to ozone-depleting substances to eliminate potential confusion 
and conflicts. FDA is eliminating out-of-date transitional provisions 
and making other nonsubstantive housekeeping changes to its regulations 
on ozone-depleting substances. The intended effect of the 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: No

Government Levels Affected: None

Agency Contact: Leanne Cusumano, Regulatory Counsel, Regulatory Policy

[[Page 22776]]

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
_______________________________________________________________________




992. 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

Small Entities Affected: Businesses

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
_______________________________________________________________________




993. EXPORTS; NOTIFICATION 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 1.101

Legal Deadline: None

Abstract: The final rule would establish the notification recordkeeping 
requirements for persons exporting human drugs, animal drugs, 
biological products, 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                    08/00/00

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
_______________________________________________________________________




994. FOREIGN ESTABLISHMENT REGISTRATION AND 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 final rule would amend the establishment registration and 
product listing regulations for human drugs, biological products, 
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
NPRM Comment Period Reopen      08/09/99
NPRM Comment Period End         10/08/99
Final Action                    09/00/00

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
_______________________________________________________________________




995. 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 final 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,

[[Page 22777]]

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                    09/00/00

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-AB24
_______________________________________________________________________




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

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

Legal Authority: 21 USC 321; 42 USC 264

CFR Citation: 21 CFR 101.17(g); 21 CFR 115.50; 21 CFR 16.5

Legal Deadline: None

Abstract: There have been numerous foodborne outbreaks of 
salmonellosis, principally due to Salmonella Enteritidis (SE), that 
have been traced to the consumption of temperature abused and/or 
undercooked shell eggs. The Food and Drug Administration has received 
petitions from Rose Acres Farm, Inc., and the Center for Science in the 
Public Interest that request, in part, that FDA establish safe handling 
statements for shell eggs. FDA intends to require safe handling 
statements on labeling of shell eggs that have not been treated to 
destroy Salmonella microorganisms that may be present. In accordance 
with amendments to the Egg Products Inspection Act, USDA published on 
August 27, 1998, a final rule to require that shell eggs be stored at 
an ambient temperature of 7.2 degrees Celsius (45 degrees Fahrenheit). 
However, the USDA rulemaking does not include refrigeration at retail. 
FDA intends to mandate that shell eggs be stored for retail sale at 7.2 
degrees Celsius (45 degrees Fahrenheit) or less. FDA is requiring these 
measures to ensure that shell eggs are handled in a manner to decrease 
the possible growth of any SE that may be present in shell eggs. All of 
these actions are intended to reduce the occurrence of illnesses and 
deaths associated with the consumption of improperly cooked shell eggs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           05/19/98                    63 FR 27502
ANPRM Comment Period End        08/17/98
Economic Analysis for Refrigeration and Labeling of Shell Eggs  NPRM 
07/06/99 (64 FR 36492)  NPRM Comment Period End 09/20/99 (64 FR 
36492)  Final Action 07/00/00

Refrigeration and Labeling of Shell Eggs  NPRM 07/06/99 (64 FR 
36492)  NPRM Comment Period End 09/20/99 (64 FR 36492)  Final Action 
07/00/00

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Geraldine A. June, Consumer Safety Officer, Department 
of Health and Human Services, Food and Drug Administration, (HFS-822), 
Center for Food Safety and Applied, Nutrition, 200 C Street SW, 
Washington, DC 20204
Phone: 202 205-5099
Email: [email protected]

RIN: 0910-AB30
_______________________________________________________________________




997. SUPPLEMENTS AND OTHER CHANGES TO APPROVED NEW ANIMAL DRUG 
APPLICATIONS

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 (21 USC 356a). 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 establish 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 amending the regulations 
regarding supplementary new animal drug regulations to incorporate the 
requirements of section 116.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/01/99                    64 FR 53281
Final Rule                      09/00/00

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  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

[[Page 22778]]

_______________________________________________________________________




998. 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                    08/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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
_______________________________________________________________________




999. BULK DRUG SUBSTANCES FOR USE IN PHARMACY COMPOUNDING

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

Unfunded Mandates: Undetermined

Legal Authority: PL 105-115, sec 127

CFR Citation: 21 CFR 216

Legal Deadline: None

Abstract: Section 127 of the Food and Drug Administration Modernization 
Act of 1997 (Pub. L. 105-115) added section 503A to the Food, Drug, and 
Cosmetic Act (21 USC 353a). Section 503A governs the application of 
Federal law to the practice of pharmacy compounding. Section 
503A(b)(1)(A) directs FDA to issue by regulation a list of bulk drug 
substances that may be used in compounding that are not covered by a 
United States Pharmacopeia (USP) or National Formulary (NF) monograph 
and are not components of FDA-approved drugs. Bulk drug substances that 
do not appear on the list may not be used in 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                    06/00/00

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: 301 827-8041
Email: [email protected]

RIN: 0910-AB57
_______________________________________________________________________




1000. SUPPLEMENTS AND OTHER CHANGES TO AN APPROVED APPLICATION

Priority: Other Significant

Legal Authority: 21 USC 356a

CFR Citation: 21 CFR 314

Legal Deadline: None

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 four 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. A second category of changes may be made if 
FDA has not notified the company within 30 days after the submission of 
a supplement that prior approval is required. A third category of 
changes may be made upon submission of a supplement to the Agency. 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                    06/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

[[Page 22779]]

_______________________________________________________________________




1001. 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: No

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
_______________________________________________________________________




1002. CITIZEN PETITIONS; ACTIONS THAT CAN BE REQUESTED BY PETITION; 
DENIALS, WITHDRAWALS, AND REFERRALS 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 final 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 final rule would also revise 
the content requirements for citizen petitions and would allow the 
agency to take various administrative actions in response to 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                            11/30/99                    64 FR 66822
NPRM Comment Period End         02/28/00
Final Action                    01/00/01

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-AB73
_______________________________________________________________________




1003. 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 final rule will 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
_______________________________________________________________________




1004. 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.

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                            12/01/99                    64 FR 67207
NPRM Comment Period End         02/14/00
Final Action                    10/00/00

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

[[Page 22780]]

Additional Information: Description of Legal Deadline continued... of 
FDA review.

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
Email: [email protected]

RIN: 0910-AB83
_______________________________________________________________________




1005. AMENDMENT OF VARIOUS 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 351; 21 USC 352; 21 USC 
360i; 21 USC 360j; 21 USC 371; 21 USC 374

CFR Citation: 21 CFR 801.410; 21 CFR 801.430

Legal Deadline: None

Abstract: The proposed rule would amend various 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                            01/24/00                     65 FR 3627
Final Rule                      06/00/00

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-AB84
_______________________________________________________________________




1006.  ADDITION TO THE LIST OF DRUG PRODUCTS THAT HAVE BEEN 
WITHDRAWN FROM THE MARKET FOR REASONS OF SAFETY OR EFFECTIVENESS

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 353a

CFR Citation: 21 CFR 216.24

Legal Deadline: None

Abstract: The final rule will amend 21 CFR 216.24 by adding two drug 
products, aminopyrine and astemizole, to the list of drug products that 
may not be used for pharmacy compounding under the exemptions provided 
by section 503A of the Federal Food, Drug, and Cosmetic Act because 
they have had their approval withdrawn or were removed from the market 
because the drug product or its components have been found to be unsafe 
or not effective.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/04/00                    65 FR 00256
NPRM Comment Period End         03/20/00
Final Action                    05/00/00

Regulatory Flexibility Analysis Required: No

Small Entities Affected: 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: 301 827-8041
Email: [email protected]

RIN: 0910-AC01
_______________________________________________________________________




1007.  EFFICACY EVIDENCE NEEDED FOR PRODUCTS TO BE USED AGAINST 
TOXIC SUBSTANCES WHEN HUMAN STUDIES ARE UNETHICAL

Priority: Other Significant

Legal Authority: 15 USC 1451-1561; 21 USC 321; 21 USC 331; 21 USC 351; 
21 USC 352; 21 USC 353; 21 USC 355; 21 USC 360; 21 USC 360c; 21 USC 
360d; 21 USC 360e; 21 USC 360f; 21 USC 360h; 21 USC 360i; 21 USC 360j; 
21 USC 371; 21 USC 374; 21 USC 379e; 21 USC 381; 42 USC 216; 42 USC 
241; 42 USC 262; 42 USC 263b; PL 105-115, sec 122, 111 stat 2322 (21 
USC 355 note)

CFR Citation: 21 CFR 314; 21 CFR 601

Legal Deadline: None

Abstract: The Agency plans to publish a final rule that would amend its 
new drug and biological product regulations to identify the information 
needed to provide substantial evidence of the efficacy of new drug and 
biological products used to reduce or prevent the toxicity of chemical, 
biological, radiological, or nuclear substances when adequate and well-
controlled efficacy studies in humans cannot be ethically conducted 
because they would involve administering a potentially lethal or 
permanently disabling toxic substance or organism to healthy human 
volunteers without a proven treatment and field trials (assessment of 
use of the product after accidental or hostile exposure to the 
substance) are not feasible. FDA is taking this action because it 
recognized the importance of improving medical response capabilities to 
the use of lethal or permanently disabling chemical, biological, 
radiological, and nuclear substances in order to protect individuals 
exposed to these substances.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/05/99                    64 FR 53960
Final Action                    09/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Bonnie M. Lee, Health Issues Analyst, Division of 
Compliance Policy, Office of Enforcement, Department of Health and 
Human Services, Food and Drug Administration, HFC-230, Office of 
Regulatory Affairs, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-0415

RIN: 0910-AC05

[[Page 22781]]

_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




1008. 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 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 07/09/96 (61 FR 
36154)  NPRM Comment Period End 12/06/96  Final Action To Be Determined

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

Infant Formula Quality Factors  NPRM 07/09/96 (61 FR 36154)  NPRM 
Comment Period End 12/06/96  Final Action To Be Determined

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-800), 
Center for Food Safety and Applied Nutrition, 200 C Street SW, 
Washington, DC 20204
Phone: 202 205-5365

RIN: 0910-AA04
_______________________________________________________________________




1009. 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/
93 (58 FR 53305)  Final Action 03/05/96 (61 FR 8781)

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

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

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

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

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

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

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

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

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

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Additional Information: Previously reported under RIN 0905-AD89. 
Federalism: Yes for Protein Hydrolysates; Broth in Tuna; and/or 
Labeling

[[Page 22782]]

Agency Contact: Christine L. Lewis, Acting Director, Office of 
Nutritional Products, Labeling and Dietary Supplements, Department of 
Health and Human Services, Food and Drug Administration, (HFS-800), 
Center for Food Safety and Applied, Nutrition, 200 C Street SW, 
Washington, DC 20204
Phone: 202 205-4934

RIN: 0910-AA19
_______________________________________________________________________




1010. 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

Federalism:  Undetermined

Additional Information: Previously reported under RIN 0905-AD91.

Agency Contact: Sue A. Anderson, Department of Health and Human 
Services, Food and Drug Administration, (HFS-831), Center for Food 
Safety and Applied, Nutrition, 200 C Street SW, Washington, DC 20204
Phone: 202 205-4240

RIN: 0910-AA20
_______________________________________________________________________




1011. 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
_______________________________________________________________________




1012. 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

Federalism:  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
_______________________________________________________________________




1013. 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

[[Page 22783]]

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

Federalism:  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
_______________________________________________________________________




1014. 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 regulatory 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                    10/00/01

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
Email: [email protected]

RIN: 0910-AB05
_______________________________________________________________________




1015. 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 requiring 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 amending 
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                    10/00/01

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

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
Email: [email protected]

RIN: 0910-AB27
_______________________________________________________________________




1016. 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

[[Page 22784]]

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                            06/00/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  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
_______________________________________________________________________




1017. 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. FDA issued final regulations implementing these 
provisions in 1993. FDA subsequently received a citizen petition 
requesting that FDA amend its regulations on food labeling to require 
that the amount of trans fatty acids be listed in the nutrition label 
and be limited wherever saturated fat limits are placed on nutrient 
content claims, health claims, or disqualifying levels and disclosure 
levels. In response to this petition and based on new evidence, FDA 
proposed the actions requested in the petition on November 17, 1999 (64 
FR 62746). In addition, FDA proposed to define the claim ``trans fat 
free.''

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/17/99                    64 FR 62746
Final Rule                       To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Susan Thompson, Chemist, Department of Health and Human 
Services, Food and Drug Administration, (HFS-832), Center for Food 
Safety and Applied, Nutrition, 200 C Street SW, Washington, DC 20204
Phone: 202 205-5587
Email: [email protected]

RIN: 0910-AB66
_______________________________________________________________________




1018. 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 (ADAA) 
(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 (AMDUCA) (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. This rule would implement the provisions in ADAA and 
AMDUCA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  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
_______________________________________________________________________




1019. 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 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 801.437; 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.

[[Page 22785]]

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
_______________________________________________________________________




1020. 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           06/00/01

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: State

Federalism:  Undetermined

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: 301 827-1484
Email: [email protected]

RIN: 0910-AB90
_______________________________________________________________________




1021.  STATUS REPORTS FOR QUANTITY MARKETED INFORMATION FOR 
ANIMAL DRUG PRODUCTS USED IN FOOD-PRODUCING ANIMALS

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 360(b)

CFR Citation: 21 CFR 524

Legal Deadline: None

Abstract: After approving a new animal drug application, the Food and 
Drug Administration (FDA) requires the sponsor to submit adverse 
experience and use information on the product. The currently submitted 
distribution data are insufficient to provide the use information 
needed by FDA. Because of concern about the effect of the use of 
antimicrobial drugs in food-producing animals on the development rate 
and extent of resistance in human pathogens, FDA published a document 
describing a proposed framework for evaluating and protecting human 
health. The Framework Document describes the need for more detailed 
drug distribution information to permit the evaluation of a correlation 
between changes in resistance and the use of antimicrobial drugs in 
food-producing animals. The regulatory proposal would require the 
reporting of the total number of distributed units of each size, 
strength, or potency (distribution data or quantity marketed data) and 
provide FDA with the more detailed information needed to assess the 
correlation between resistance in human pathogens and the use of 
antimicrobial drugs in food-producing animals.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/01

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: William Keller, Division Director, Division of 
Epidemiology and Surveillance, Department of Health and Human Services, 
Food and Drug Administration, (HFV-210), Center for Veterinary 
Medicine, 7500 Standish Place, Rockville, MD 20855
Phone: 301 827-6642

RIN: 0910-AC04
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Food and Drug Administration (FDA)



_______________________________________________________________________




1022. PRESCRIPTION DRUG MARKETING ACT OF 1987; PRESCRIPTION DRUG 
AMENDMENTS OF 1992; POLICIES, REQUIREMENTS, AND ADMINISTRATIVE 
PROCEDURES

Priority: Other Significant

CFR Citation: 21 CFR 203

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/03/99                    64 FR 67720

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: Federal, State

Agency Contact: Lee D. Korb
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA08
_______________________________________________________________________




1023. ALUMINUM IN LARGE AND SMALL VOLUME PARENTERALS USED IN TOTAL 
PARENTERAL NUTRITION

Priority: Other Significant

CFR Citation: 21 CFR 201.323

[[Page 22786]]

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      01/26/00                     65 FR 4103

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

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

RIN: 0910-AA74
_______________________________________________________________________




1024. NEW DRUG APPLICATIONS; DRUG MASTER FILE

Priority: Substantive, Nonsignificant

CFR Citation: 21 CFR 314

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/12/00                     65 FR 1776

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Lee D. Korb
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA78
_______________________________________________________________________




1025. NEW DRUGS FOR HUMAN USE; CLARIFICATION OF REQUIREMENTS FOR PATENT 
HOLDER NOTIFICATION

Priority: Substantive, Nonsignificant

CFR Citation: 21 CFR 314

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       03/08/00                    65 FR 12154

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0910-AB12
_______________________________________________________________________




1026. 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

CFR Citation: 21 CFR 897

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       03/21/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Anne M. Kirchner
Phone: 301 827-5321

RIN: 0910-AB17
_______________________________________________________________________




1027. MEDICATED FEED MILL LICENSES

Priority: Other Significant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/19/99                    64 FR 63195

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: William D. Price
Phone: 301 827-6652
Fax: 301 594-4512

RIN: 0910-AB18
_______________________________________________________________________




1028. 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

CFR Citation: 21 CFR 808

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Revocation of Final Rule (Group 
I)                              03/31/00                    65 FR 17135
Withdrawn                       03/21/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Local

Agency Contact: Anne M. Kirchner
Phone: 301 827-5321

RIN: 0910-AB19
_______________________________________________________________________




1029. PUBLIC INFORMATION; COMMUNICATIONS WITH STATE AND FOREIGN 
GOVERNMENT OFFICIALS

Priority: Info./Admin./Other

CFR Citation: 21 CFR 20.88; 21 CFR 20.89

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/07/00                    65 FR 11881

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

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

RIN: 0910-AB22
_______________________________________________________________________




1030. PROGESTATIONAL DRUG PRODUCTS FOR HUMAN USE; REQUIREMENTS FOR 
LABELING DIRECTED TO THE PATIENT

Priority: Other Significant

CFR Citation: 21 CFR 310

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/16/99                    64 FR 62110

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0910-AB45
_______________________________________________________________________




1031. PEDIATRIC EXCLUSIVITY

Priority: Other Significant

CFR Citation: 21 CFR 314

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn--No action will be 
taken                           02/28/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0910-AB62
_______________________________________________________________________




1032. DESIGNATED JOURNALS

Priority: Substantive, Nonsignificant

CFR Citation: 21 CFR 510.95

[[Page 22787]]

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/10/99                    64 FR 69209
Direct Final Rule               12/10/99                    64 FR 69188
Final Action                    03/31/00                    65 FR 17134

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Claire Lathers
Phone: 301 594-1620

RIN: 0910-AB67
_______________________________________________________________________




1033. REGULATIONS ON STATEMENTS MADE FOR DIETARY SUPPLEMENTS CONCERNING 
THE EFFECT OF THE PRODUCT ON THE STRUCTURE OR FUNCTION OF THE BODY

Priority: Other Significant

CFR Citation: 21 CFR 101.93(g)

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/06/00                    65 FR 00999

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Ann Marlin Witt
Phone: 301 827-3360
Email: [email protected]

RIN: 0910-AB97
_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1034. 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 the NPRM, dated September 1, 
1998.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/01/98                    63 FR 46538
NPRM Comment Period End         01/04/99
Second NPRM                     10/00/00
NPRM Comment Period End         01/00/01

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
_______________________________________________________________________




1035. COMPLIANCE ALTERNATIVES FOR PROVISION OF UNCOMPENSATED SERVICES

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 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 proposed 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
_______________________________________________________________________




1036.  NATIONAL VACCINE INJURY COMPENSATION PROGRAM: REVISIONS 
AND ADDITIONS TO THE VACCINE INJURY TABLE

Priority: Substantive, Nonsignificant

Legal Authority: PL 106-170

CFR Citation: 42 CFR 100

Legal Deadline: None

Abstract: This NPRM proposes several changes to the Vaccine Injury 
Table (Table) (42 CFR 100.3), which will have an effect upon petitions 
for compensation under the National Childhood Vaccine Injury 
Compensation Program including the following: 1) amending the Table by 
adding the injury of intussusception to the Table for vaccines 
containing live, oral, rhesus-based rotavirus, a category

[[Page 22788]]

of rotavirus vaccines; 2) removing residual seizure disorder and early 
onset Hib disease from the Table's Qualifications and Aids to 
Interpretation; 3) removing hemophilus influenzae type b polysaccharide 
vaccines from and adding pneumococcal conjugate vaccines to the Table; 
and 4) changing certain dates of coverage under the Table.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/00

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Geoffrey Evans, Medical Director, Divison of Vaccine 
Injury Compensation, BHPr, HRSA/DHHS, Department of Health and Human 
Services, Health Resources and Services Administration, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 443-4198
Email: [email protected]

RIN: 0906-AA55
_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1037. 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 underserved 
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                    09/00/00

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)



_______________________________________________________________________




1038. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON 
PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: MEDICAL MALPRACTICE 
PAYMENTS REPORTING REQUIREMENTS

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 by the amount of the payment.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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


Next Action Undetermined

[[Page 22789]]

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)       Proposed Rule Stage


Indian Health Service (IHS)



_______________________________________________________________________




1039. 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                            02/01/00                     65 FR 4797
NPRM Comment Period End         04/03/00
Final Rule                      07/00/00

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)



_______________________________________________________________________




1040. 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                    06/00/00

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)       Proposed Rule Stage


National Institutes of Health (NIH)



_______________________________________________________________________




1041. NATIONAL INSTITUTES OF HEALTH AIDS RESEARCH LOAN REPAYMENT PROGRAM

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 68

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Additional Information: Previously reported under RIN 0905-AD18.
RFA: N

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-AA02

[[Page 22790]]

_______________________________________________________________________




1042. 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                            09/00/00

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
_______________________________________________________________________




1043. 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                            09/00/00

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-AA17
_______________________________________________________________________




1044. 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 to qualified health professionals who agree 
to conduct research as employees of the National Institutes of Health.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/00

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
_______________________________________________________________________




1045. SCIENTIFIC PEER REVIEW OF RESEARCH GRANT APPLICATIONS AND RESEARCH 
AND DEVELOPMENT CONTRACT PROJECTS

Priority: Substantive, Nonsignificant

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

Legal Authority: 42 USC 216; 42 USC 282(b)(6); 42 USC 284(c)(3); 42 USC 
289a; 42 USC 290aa-3

CFR Citation: 42 CFR 52h

Legal Deadline: None

Abstract: NIH staff have been reexamining the peer review process as 
part of its reinvention initiatives and have found ambiguities, 
misstatements, and voids in the existing regulations. These 
regulations, which govern the first level of review, are being amended 
to reflect current policies and procedures.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/00

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

[[Page 22791]]

_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




1046. TRAINEESHIPS

Priority: Info./Admin./Other

Legal Authority: 42 USC 216; 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 Rule                      06/00/00

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
_______________________________________________________________________




1047. 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 Rule                      09/00/00

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
_______________________________________________________________________




1048. 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 be 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 Rule                      06/00/00

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
_______________________________________________________________________




1049. NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT 
CONTRACEPTION AND INFERTILITY RESEARCH LOAN REPAYMENT PROGRAM

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 288-2

CFR Citation: 42 CFR 68c

Legal Deadline: None

Abstract: Section 487B of the Public Health Service Act creates a 
program through which appropriately qualified health professionals may 
obtain federally funded repayment of education loans by conducting 
research with respect to contraception and/or infertility.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/10/99                    64 FR 69213
Final Rule                      06/00/00

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-AA19
_______________________________________________________________________




1050. 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

[[Page 22792]]

Policy by: (1) prohibiting any executive branch agency from engaging in 
classified research involving human subjects unless the agency has 
adopted the Federal Policy and the interim final rule; (2) eliminating 
the availability of waiver of informed consent and expedited review for 
classified research involving human subjects; (3) enhancing the 
informed consent requirements and allowing for disclosure of classified 
information if necessary; and (4) changing the composition of the 
institutional review board (IRB) and establishing a process for 
individual IRB approvals of classified research.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              09/00/00

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
_______________________________________________________________________




1051. 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 Rule                      05/00/00

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)         Completed Actions


National Institutes of Health (NIH)



_______________________________________________________________________




1052. NATIONAL INSTITUTES OF HEALTH CONSTRUCTION GRANTS

Priority: Other Significant

CFR Citation: 42 CFR 52b

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      11/22/99                    64 FR 63721

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Jerry Moore
Phone: 301 496-4606
Email: [email protected]

RIN: 0925-AA04
_______________________________________________________________________




1053. SERVICE FELLOWSHIPS

Priority: Other Significant

CFR Citation: 42 CFR 61, subpart B

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      11/10/99                    64 FR 61218

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Jerry Moore
Phone: 301 496-4606
Email: [email protected]

RIN: 0925-AA22
_______________________________________________________________________


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


Office of Public Health and Science (OPHS)



_______________________________________________________________________




1054. 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

[[Page 22793]]

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)



_______________________________________________________________________




1055. 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)



_______________________________________________________________________




1056. END STAGE RENAL DISEASE (ESRD) CONDITIONS FOR COVERAGE (HCFA-3818-
P) (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 of 
end stage renal disease (ESRD) facilities approved to provide ESRD 
service under Medicare. It would update the conditions to reflect 
developments in technology and equipment, emphasize the total patient 
experience and develop performance expectations for the facility that 
result in quality, comprehensive care for the dialysis patient. We will 
also review for the requirements of Section 610c of the Regulatory 
Flexibility Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review                    04/00/00
End Review                      06/00/00

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

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

RIN: 0938-AG82
_______________________________________________________________________




1057. 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 rule 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                           05/00/00

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

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

RIN: 0938-AH17

[[Page 22794]]

_______________________________________________________________________


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


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1058. REQUIREMENTS FOR ESTABLISHING AND MAINTAINING MEDICARE BILLING 
PRIVILEGES (HCFA-6002-P)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 424

Legal Deadline: None

Abstract: This rule would establish a requirement that all providers 
and suppliers (other than physicians who have entered into a private 
contract with a beneficiary) must complete an enrollment form, submit 
specified information to us, and periodically update and certify the 
accuracy of the enrollment information in order to receive and maintain 
billing privileges in the Medicare program. The information must 
clearly identify the provider or supplier and its place of business, 
provide documentation that it is qualified to perform the services for 
which it is billing, and assure that it is not currently excluded from 
the Medicare program. If we determine the information submitted is 
incomplete, invalid, or insufficient to meet Medicare requirements, we 
would reject, deny, inactivate, or revoke billing privileges.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Federalism:  Undetermined

Additional Information: Formerly known as HCFA-1023-P

Agency Contact: Michael Collett, OFM, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6121

RIN: 0938-AH73
_______________________________________________________________________




1059. PROSPECTIVE FEE SCHEDULE FOR AMBULANCE SERVICES (HCFA-1002-NR)

Priority: Other Significant

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

Legal Authority: PL 105-33, sec 4531(b)

CFR Citation: 42 CFR 410

Legal Deadline: Final, Statutory, January 1, 2000.

Abstract: The Balanced Budget Act of 1997 requires that the Secretary 
establish a fee schedule for ambulance services through negotiated 
rulemaking. The fee schedule is to be effective beginning with services 
furnished on or after January 1, 2000. In addition to setting the 
payment rates, the Secretary is to ensure that the aggregate amount of 
payment made for ambulance services in 2000 may not exceed the amount 
of payment that would have been made absent the fee schedule. This is a 
cap on payment, not a budget neutrality adjustment. The Secretary is to 
consult with national organizations representing individuals and 
entities that furnish and regulate ambulance services and share 
relevant data with these organizations. This provision will be met 
through the negotiated rulemaking process.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice of Intent to Negotiate   01/22/99                     64 FR 3474
NPRM                            05/00/00

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Nancy Edwards, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, C5-06-27, 7500 Security Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-4531
Email: [email protected]

Robert Niemann, Program Analyst, Division of Special Payment Programs, 
Department of Health and Human Services, Health Care Financing 
Administration, 1-A-5, ELR, 6325 Security Boulevard, Baltimore, MD 
21207
Phone: 301 966-4569

RIN: 0938-AI72
_______________________________________________________________________




1060. 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 notice 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                            06/00/00

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
_______________________________________________________________________




1061. MEDICARE PROGRAM: PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT 
REHABILITATION HOSPITAL SERVICES (HCFA-1069-P)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: PL 105-33, sec 4421; 42 USC 1395ww(j)

CFR Citation: None

Legal Deadline: NPRM, Statutory, October 1, 2000.

Abstract: This rule would implement the new prospective payment system 
for rehabilitation facilities as added by section 4421 of the BBA and 
as amended by section 125 of the Balanced Budget Refinement Act of 
1999.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/00

[[Page 22795]]

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Laurence Wilson, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-7-04, 7500 Security Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-4603

RIN: 0938-AJ55
_______________________________________________________________________




1062. DME SURETY BONDS (HCFA-6006-P)

Priority: Economically Significant

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

Legal Authority: PL 105-33, sec 4312(a); 42 USC 1395m(a)(16)

CFR Citation: 42 CFR 424.57

Legal Deadline: NPRM, Statutory, January 1, 1998.

Abstract: This rule would implement the provision of the Balanced 
Budget Act of 1997 that requires a Medicare supplier of durable medical 
equipment (DME) to furnish HCFA with a surety bond.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/00

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

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-AJ64
_______________________________________________________________________




1063.  END STAGE RENAL DISEASE BAD DEBT PAYMENT (HCFA-1126-P)

Priority: Other Significant

Legal Authority: Section 1861(v)(1)(A); 42 USC 1395x(v)(1)(A)

CFR Citation: 42 CFR 413.178

Legal Deadline: None

Abstract: This rule would remove the cap on end stage renal disease bad 
debts as stated in 42 CFR 413.178, which limits reimbursement of 
medicare bad debts to the end stage renal disease facility's uncovered 
costs. A final rule would be effective for cost reporting periods 
beginning on or after January 1, 2000.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Katie Walker, Office of Hospital Policy, Department of 
Health and Human Services, Health Care Financing Administration, C5-03-
03, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-7278

RIN: 0938-AK02
_______________________________________________________________________


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


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1064. 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: None

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
Final Rule                      05/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Rebecca Hirshorn, Health Insurance Specialist, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-06-06, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3411

RIN: 0938-AE79
_______________________________________________________________________




1065. 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 1395bbb

CFR Citation: 42 CFR 484

Legal Deadline: None

Abstract: This rule will revise home health agency conditions of 
participation to center on the patient,

[[Page 22796]]

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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/10/97                    62 FR 11005
NPRM Comment Period End         06/09/97
Final Rule                      09/00/00

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Federalism:  Undetermined

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

Janice Stevenson, Office of Clinical Standards and Quality, Department 
of Health and Human Services, Health Care Financing Administration, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4882

RIN: 0938-AG81
_______________________________________________________________________




1066. 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                    11/00/00

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

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-AH19
_______________________________________________________________________




1067. REQUIREMENTS FOR ENROLLMENT OF MEDICAID RECIPIENTS UNDER COST 
EFFECTIVE EMPLOYER-BASED GROUP HEALTH PLANS (HCFA-2047-FC)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1396a(a)(10); 42 USC 1396a(u)(1); 42 USC 
1396d(a); 42 USC 1396a(a)(25); 42 USC 1396a(e); 42 USC 1396e

CFR Citation: 42 CFR 435; 42 CFR 436

Legal Deadline: None

Abstract: This rule amends our regulations to incorporate a statutory 
action 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 rule 
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 rule 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                    10/00/00

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
_______________________________________________________________________




1068. 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 rule 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 Action                    05/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Luisa V. Iglesias, Division of Regulation and 
Issuances,

[[Page 22797]]

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
_______________________________________________________________________




1069. STANDARD UNIQUE HEALTH CARE PROVIDER IDENTIFIER (HCFA-0045-F)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1320d-2

CFR Citation: 42 CFR 160; 42 CFR 162

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/07/98                    63 FR 25320
NPRM Comment Period End         07/06/98
Final Action                    06/00/00

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Additional Information: None

Agency Contact: Patricia Peyton, Office of Information Services, 
Department of Health and Human Services, Health Care Financing 
Administration, N3-20-05, 7500 Security Boulevard, Baltimore, MD 21224-
1850
Phone: 410 786-1812

RIN: 0938-AH99
_______________________________________________________________________




1070. MEDICARE PROGRAM; ADJUSTMENTS TO COST LIMITS FOR SKILLED NURSING 
FACILITY INPATIENT ROUTINE SERVICE COSTS (HCFA-1896-FN)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1320

CFR Citation: 42 CFR 1001

Legal Deadline: None

Abstract: This notice eliminates an adjustment that is made to Medicaid 
cost limits for skilled nursing facility routine services, when the 
final rate of change in the market basket index for a calendar year, is 
used to set the limits that differ from the estimated rate of change 
and the index by at least 0.3 percentage points.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/01/97                    62 FR 51551
NPRM Comment Period End         12/01/97
Final Action                    04/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: This RIN was incorrectly reported as 
``Completed'' in the October 1997 edition of the Unified Agenda.

Agency Contact: Richard Strauss, Deputy Director, Division of Financial 
Management, Department of Health and Human Services, Health Care 
Financing Administration, S3-13-15, 7500 Security Boulevard, Baltimore, 
MD 21244-1850
Phone: 410 786-2019
Email: [email protected]

RIN: 0938-AI14
_______________________________________________________________________




1071. STATE CHILD HEALTH; IMPLEMENTING REGULATIONS FOR THE STATE 
CHILDREN'S HEALTH INSURANCE PROGRAM (HCFA-2006-F)

Priority: Economically Significant

Legal Authority: PL 105-33; 42 USC 1396

CFR Citation: 42 CFR 457

Legal Deadline: None

Abstract: This rule 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                            11/08/99                    64 FR 60882
NPRM Comment Period End         01/07/00
Final Action                    09/00/00

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: Federal, State, Local

Federalism:  Undetermined

Agency Contact: Cheryl Austein-Casnoff, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4196

RIN: 0938-AI28
_______________________________________________________________________




1072. MEDICARE PROGRAM; MEDICARE+CHOICE PROGRAM (HCFA-1030-2-F)

Priority: Other Significant

Legal Authority: PL 105-33, section 400; 42 USC 1395w-21 to 1395w-27

CFR Citation: 42 CFR 417; 42 CFR 422

Legal Deadline: None

Abstract: This rule responds to comments on the June 26, 1998, interim 
final rule that implemented the Medicare+Choice (M+C) program and makes 
revisions to those regulations where warranted.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/26/98                    63 FR 34968
NPRM Comment Period End         09/24/98
Limited Final Rule              02/17/99                     64 FR 7968
Final Action                    06/00/00

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Tony Culotta, Department of Health and Human Services, 
Health Care Financing Administration, 7500 Security Boulevard, 
Baltimore, MD 21244

[[Page 22798]]

Phone: 410 786-4661

RIN: 0938-AI29
_______________________________________________________________________




1073. 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                            10/25/99                    64 FR 57431
Final Action                    05/00/00

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

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
_______________________________________________________________________




1074. MEDICARE PROGRAM; PROSPECTIVE PAYMENT SYSTEM FOR HOSPITAL 
OUTPATIENT SERVICES (HCFA-1005-F)

Priority: Economically Significant. Major under 5 USC 801.

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

Legal Authority: PL 105-33, sec 4521; PL 105-33, sec 4522; PL 105-33, 
sec 4523; PL 99-509, sec 9343(c)

CFR Citation: 42 CFR 409.10; 42 CFR 410.2; 42 CFR 410.27; 42 CFR 
410.28; 42 CFR 410.30; 42 CFR 411.15; 42 CFR 412.50; 42 CFR 413.118; 42 
CFR 413.122; 42 CFR 413.124; 42 CFR 413.130; 42 CFR 413; 42 CFR 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) (Pub. L. 105-33), 
enacted on August 5, 1997, provides for implementation of a Prospective 
Payment System (PPS) for hospital outpatient services (and for part B 
services furnished to inpatients who have no part A coverage) furnished 
on or after January 1, 1999. In the proposed rule published on 
September 8, 1998, HCFA indicated that, implementation of the system 
would be delayed because of systems concerns. 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 
weight 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 weights and the projected volume of services for 
each group. In addition, this rule would establish the requirements for 
designating certain entities as provider-based or as a department of a 
hospital.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/08/98                    63 FR 47551
Correction Notice               06/30/99                    64 FR 35258
NPRM Comment Period End         07/30/99
Final Action                    06/00/00

Regulatory Flexibility Analysis Required: Yes

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-AI56
_______________________________________________________________________




1075. SECURITY SIGNATURE STANDARDS (HCFA-0049-F)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: PL 104-191; 42 USC 1320d-2

CFR Citation: 45 CFR 162

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

Abstract: This rule implements some of the requirements of the 
Administrative Simplification subtitle of the Health Insurance 
Portability and Accountability Act of 1996. It establishes standards 
for the security of health information used by health plans, health 
care clearinghouses, and certain health care providers. These entities 
would use the security standards to develop and maintain the security 
of all electronic health information.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/12/98                    63 FR 43242
Final Action                    05/00/00

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State, Local, Tribal, Federal

Federalism:  Undetermined

Agency Contact: Barbara Clark, Office of Information Services, 
Department of Health and Human Services, Health Care Financing 
Administration, N2-14-10, 7500 Security Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-3017

RIN: 0938-AI57
_______________________________________________________________________




1076. HEALTH INSURANCE REFORM: STANDARDS FOR ELECTRONIC TRANSACTIONS 
(HCFA-0149-F)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1320d-2

CFR Citation: 45 CFR 160; 45 CFR 162

[[Page 22799]]

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

Abstract: This rule puts in place code-set standards and standards for 
eight electronic transactions to be used by health plans, certain 
health care providers, and health care clearinghouses. It would 
implement requirements for administrative simplification in section 262 
and 264 of the Health Insurance Portability and Accountability Act of 
1996. The standards will significantly reduce costs for processing 
health care transactions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

Federalism:  Undetermined

Agency Contact: Joy Glass, Office of Information Systems, Department of 
Health and Human Services, Health Care Financing Administration, N2-14-
26, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-6125

RIN: 0938-AI58
_______________________________________________________________________




1077. STATE CHILD HEALTH; STATE CHILDREN'S HEALTH INSURANCE PROGRAM 
ALLOTMENTS AND PAYMENTS TO STATES (HCFA-2114-F)

Priority: Other Significant

Legal Authority: PL 105-33, sec 2104; PL 105-33, sec 2105

CFR Citation: 42 CFR 447.88; 42 CFR 457.200; 42 CFR 457.202; 42 CFR 
457.204; 42 CFR 457.206; 42 CFR 457.208; 42 CFR 457.210; 42 CFR 
457.212; 42 CFR 457.216; 42 CFR 457.218; 42 CFR 457.220; 42 CFR 
457.222; 42 CFR 457.224; 42 CFR 457.226; 42 CFR 457.228; ...

Legal Deadline: None

Abstract: This rule sets forth the methodologies and procedures to 
determine the Federal fiscal year allotments of Federal funds available 
to individual States, Commonwealths and Territories for the new State 
Children's Health Insurance Program (CHIP), established under title XX1 
of the Social Security Act. This rule also specifies the allotment, 
payment, and grant award process that will be used for the States, the 
Commonwelaths and Territories to claim and receive Federal Financial 
Participation (FFP) for expenditures under the State Children's Health 
Insurance Program and related Medicaid program provisions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/07/99                    64 FR 12404
Final Action                    04/00/00

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: Federal, State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Additional Information: This RIN was incorrectly reported as 
``Completed'' in the April 1999 edition of the Unified Agenda.

Agency Contact: Richard Strauss, Deputy Director, Division of Financial 
Management, Department of Health and Human Services, Health Care 
Financing Administration, S3-13-15, 7500 Security Boulevard, Baltimore, 
MD 21244-1850
Phone: 410 786-2019
Email: [email protected]

RIN: 0938-AI65
_______________________________________________________________________




1078. MEDICAID PROGRAM; HOME AND COMMUNITY-BASED SERVICES (HCFA-2010-FC)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 1396n(c)(5)

CFR Citation: 42 CFR 440; 42 CFR 441

Legal Deadline: None

Abstract: This rule 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                    06/00/00

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
_______________________________________________________________________




1079. MEDICAID MANAGED CARE; REGULATORY PROGRAM TO IMPLEMENT CERTAIN 
MEDICAID PROVISIONS OF THE BALANCED BUDGET ACT OF 1997 (HCFA-2001-F)

Priority: Other Significant. Major under 5 USC 801.

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

Legal Authority: PL 105-33, sec 4701 to 4710

CFR Citation: 42 CFR 438; 42 CFR 430; 42 CFR 431; 42 CFR 434; 42 CFR 
435; 42 CFR 438; 42 CFR 440; 42 CFR 447

Legal Deadline: None

Abstract: This rulemaking establishes rules for Medicaid managed care 
programs that involve quality of care and services under Medicaid 
managed care programs. It implements certain provisions in sections 
4701 through 4710 of the Balanced Budget Act of 1997 (BBA) (Pub. L. 
105-33).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/29/98                    63 FR 52021
NPRM Comment Period End         11/30/98
Final Action                    06/00/00

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses, Organizations, Governmental 
Jurisdictions

Government Levels Affected: Federal, Tribal, State, Local

Federalism:  Undetermined

Agency Contact: Michael Fiore, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Boulevard, Baltimore, MD 21244

[[Page 22800]]

Phone: 410 786-0623

RIN: 0938-AI70
_______________________________________________________________________




1080. 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 rule 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 non-medical health 
care institutions in their place. This change permits any religious 
organization to apply to be paid for furnishing non-medical 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 non-medical health care institution for purposes of receiving 
payment for services furnished under Medicare and Medicaid.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              11/30/99                    64 FR 67028
Final Action                    05/00/00

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

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
_______________________________________________________________________




1081. EXTERNAL QUALITY REVIEW OF MEDICAID MANAGED CARE ORGANIZATIONS 
(HCFA-2015-F)

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 rule amends the regulation to conform with the 
provisions of section 4705 of the Balanced Budget Act of 1997. It also 
requires 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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/01/99                    64 FR 67223
NPRM Comment Period Ended       01/31/00
Final Action                    08/00/00

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

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
_______________________________________________________________________




1082. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM (HCFA-1059-F)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: PL 105-33, sec 4603

CFR Citation: 42 CFR ch IV

Legal Deadline: Final, Statutory, October 1, 2000.

Abstract: This rule will establish requirements for the new prospective 
payment system (PPS) for home health agencies as governed by section 
4603 of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/28/99                    64 FR 58134
Final Action                    06/00/00

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: 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-AJ24
_______________________________________________________________________




1083. 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 rule 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

________________________________________________________________________

Interim Final Rule              12/00/00

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  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 22801]]

_______________________________________________________________________




1084. 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 not enforce the 
requirements. It also specifies how the Government will impose civil 
money penalties on health insurance issuers in those states and states, 
and specifies appeal rights and procedures.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/00/00

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: State

Federalism:  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
_______________________________________________________________________




1085. THE CHILDREN'S HEALTH INSURANCE PROGRAM: IMPLEMENTING THE BALANCED 
BUDGET ACT OF 1997 (HCFA-2006-F)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1396; PL 105-33

CFR Citation: 42 CFR 457

Legal Deadline: None

Abstract: This regulation establishes rules for the new Children's 
Health Insurance Program (CHIP). It implements sections 4901 and 4911 
of the Balanced Budget Act (BBA) of 1997.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/08/99                    64 FR 60881
NPRM Comment Period End         01/07/00
Final Action                    09/00/00

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Organizations

Government Levels Affected: State, Local

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Cheryl Austein-Casnoff, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4196

RIN: 0938-AJ75
_______________________________________________________________________




1086.  APPLICATION OF INHERENT REASONABLENESS TO ALL PART B 
SERVICES OTHER THAN PHYSICIAN SERVICES (HCFA-1908-F)

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

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This rule implements section 4316 of the Balanced Budget Act 
of 1997. It revises the process for establishing a realistic and 
equitable payment amount for all Medicare part B services (other than 
physician services) when the existing payment amounts are inherently 
unreasonable because they are either grossly excessive or deficient. In 
addition, this rule imposes special payment limits, for five items of 
durable medical equipment and one prosthetic device, to replace the 
current fee schedule amounts for these items. This rule describes the 
factors HCFA (or its carrier) will consider and the procedures it will 
follow in establishing realistic and equitable payment amounts.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: William J. Long, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-12-18, 7500 Security Boulevard, Baltimore, MD 21228
Phone: 410 786-5655
Email: [email protected]

RIN: 0938-AJ97
_______________________________________________________________________




1087.  FLEXIBILITY IN PAYMENT METHODS FOR SERVICES OF HOSPITALS, 
NURSING FACILITIES, AND INTERMEDIATE CARE FACILITIES FOR THE MENTALLY 
RETARDED (HCFA-2004-F)

Priority: Other Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 1302; 42 USC 1396a(a)(13); 42 USC 1396d(o)(3); 
42 USC 1396r-4

CFR Citation: 42 CFR 447.205; 42 CFR 447.250; 42 CFR 447.251; 42 CFR 
447.252; 42 CFR 447.253; 42 CFR 447.254; 42 CFR 447.255; 42 CFR 
447.256; 42 CFR 447.257; 42 CFR 447.271; 42 CFR 447.272; 42 CFR 447.280

Legal Deadline: None

Abstract: This rule proposes to amend the Medicaid regulations that 
deal with payment for the services of hospitals and long-term care 
facilities. It proposes to remove all references to sections 447.253 
and 447.255 (the Boren Amendment), and to add more flexible rules for 
States changing rates or payment methodologies for hospitals and long-
term care facilities. These revisions will conform the regulations to 
the Social Security Act, as revised by section 4711 of the Balanced 
Budget Act of 1997.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/06/99                    64 FR 54263
Final Rule                      05/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: State

Federalism:  Undetermined

Agency Contact: Marge Lee, Health Insurance Specialist, Department of

[[Page 22802]]

Health and Human Services, Health Care Financing Administration, S2-01-
16, 7500 Security Boulevard, Baltimore, MD
Phone: 410 786-4361

RIN: 0938-AK04
_______________________________________________________________________


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


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1088. 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: Businesses

Government Levels Affected: None

Federalism:  Undetermined

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
_______________________________________________________________________




1089. 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

Federalism:  Undetermined

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
_______________________________________________________________________




1090. ``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

Federalism:  Undetermined

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

[[Page 22803]]

_______________________________________________________________________




1091. PROTECTION OF INCOME AND RESOURCES FOR COMMUNITY SPOUSES OF 
INSTITUTIONALIZED INDIVIDUALS (HCFA-2023-P)

Priority: Other Significant

Legal Authority: 42 USC 1396r-5; 42 USC 1302

CFR Citation: 42 CFR 435.650 to 674; 42 CFR 435.750 to 754

Legal Deadline: None

Abstract: This rule would interpret statutory changes made in 1988, 
1989, 1990 and 1993 that allocate income and resources between an 
institutionalized spouse and the spouse remaining in the community. It 
would also provide special post-eligibility rules for institutionalized 
individuals who have spouses in the community to retain more income to 
meet living expenses.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Local, State

Federalism:  Undetermined

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
_______________________________________________________________________




1092. 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

Federalism:  Undetermined

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
_______________________________________________________________________




1093. 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

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

Federalism:  Undetermined

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
_______________________________________________________________________




1094. 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

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

Sharon Lappalainen, Health Insurance Specialist, Department of Health 
and

[[Page 22804]]

Human Services, Health Care Financing Administration, 7500 Security 
Boulevard, Baltimore, MD 2108
Phone: 410 786-9262

RIN: 0938-AE98
_______________________________________________________________________




1095. 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

Small Entities Affected: No

Government Levels Affected: None

Federalism:  Undetermined

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
_______________________________________________________________________




1096. 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 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

Federalism:  Undetermined

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
_______________________________________________________________________




1097. 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 
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: Businesses

Government Levels Affected: None

Federalism:  Undetermined

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
_______________________________________________________________________




1098. 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 rule would provide an alternative to terminating a 
psychiatric hospital's participation in the Medicare and Medicaid 
programs for facilities

[[Page 22805]]

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

Federalism:  Undetermined

Agency Contact: Shirley Eldridge, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security 
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-6836

RIN: 0938-AF32
_______________________________________________________________________




1099. 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 rule will incorporate section 4401 of OBRA '90 to add 
specific requirements for Medicaid payment for covered outpatient 
drugs. The requirements concern: denial of Federal financial 
participation unless rebate agreements and drug use review are in 
effect; prohibiting some State plan drug access limitations for drugs 
covered under a rebate agreement; and the content of the rebate 
agreements. (The drug rebate agreement was previously published in the 
Federal Register on February 21, 1991 (56 FR 7049)). This rule will 
reflect statutory revisions mandated by the Veteran's Health Care Act 
of 1992 and OBRA '93. Revision of the drug rebate dispute resolution 
process is part of the Department's regulatory reinvention initiative.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/19/95                    60 FR 48442
NPRM Comment Period End         11/20/95


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: State

Federalism:  Undetermined

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

Kellie Gomez, Health Insurance Specialist, Department of Health and 
Human Services, Health Care Financing Administration, S2-06-25, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7969

RIN: 0938-AF42
_______________________________________________________________________




1100. 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

Federalism:  Undetermined

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
_______________________________________________________________________




1101. 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 that 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, Public Law 101-508.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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


Next Action Undetermined

[[Page 22806]]

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Federalism:  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-AF69
_______________________________________________________________________




1102. 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 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

Federalism:  Undetermined

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
_______________________________________________________________________




1103. 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

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

Federalism:  Undetermined

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
_______________________________________________________________________




1104. 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

Federalism:  Undetermined

Agency Contact: Alfreda Staton, Program Analyst, Health Standards and 
Quality Bureau, Department of Health and Human Services, Health Care 
Financing Administration, 2-D-2 Meadows East Building, 6300 Security 
Boulevard, Baltimore, MD 21207
Phone: 410 786-6940

RIN: 0938-AG33
_______________________________________________________________________




1105. 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

[[Page 22807]]

Government Levels Affected: None

Federalism:  Undetermined

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
_______________________________________________________________________




1106. EFFECT OF CHANGE OF OWNERSHIP ON PROVIDER AND SUPPLIER PENALTIES, 
SANCTIONS, UNDERPAYMENTS AND OVERPAYMENTS (HCFA-2215-P)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 1395f(b); 42 USC 1395g(a); 42 USC 
1395hh; 42 USC 1395ii; 42 USC 1395oo; 42 USC 1395xx; 42 USC 1395x(v); 
42 USC 13951; 42 USC 405; 42 USC 1395ww

CFR Citation: 42 CFR 405.1803; 42 CFR 405.1811; 42 CFR 405.1835; 42 CFR 
405.1843; 42 CFR 405.1805; 42 CFR 489.2; 42 CFR 489.18

Legal Deadline: None

Abstract: This rule would amend the regulations on provider and certain 
supplier agreements by clarifying the effect a change of ownership has 
on penalties and sanctions incurred by the former provider or supplier. 
It also would clarify our policy on changes involving leased 
departments.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

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
_______________________________________________________________________




1107. 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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/10/99                    64 FR 49121


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Local

Federalism:  Undetermined

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-AG72
_______________________________________________________________________




1108. 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 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

Federalism:  Undetermined

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

Stephanie Dyson, Health Insurance Specialist, Department of Health and 
Human Services, Health Care Financing Administration, S3-06-25, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-9226

RIN: 0938-AG79
_______________________________________________________________________




1109. 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 455.103; 42 CFR 
455.108; 42 CFR 455.109

[[Page 22808]]

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

Federalism:  Undetermined

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
_______________________________________________________________________




1110. 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 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 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

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
_______________________________________________________________________




1111. 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

Federalism:  Undetermined

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
_______________________________________________________________________




1112. 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 433.154

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 an 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

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

[[Page 22809]]

_______________________________________________________________________




1113. 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 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

Federalism:  Undetermined

Agency Contact: Thomas E. Hoyer, 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
Phone: 410 786-4605

RIN: 0938-AH16
_______________________________________________________________________




1114. 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 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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  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-AH24
_______________________________________________________________________




1115. 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 rule would revise the Medicare conditions of 
participation for hospices to help ensure the provision of quality care 
through an emphasis on patient-centered outcomes. Areas of change would 
include, among others, assessment of patient needs, clarification of 
physician roles, coordination of care for hospice patients residing in 
nursing homes, clarification of nursing roles, patient rights, and 
provision of services.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Mary Rossi Coajou, Health Insurance Specialist, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6051

RIN: 0938-AH27
_______________________________________________________________________




1116. 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 rule would implement SSA `94 provisions to provide 
coverage for speech-language pathology services furnished by a 
qualified pathologist.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Federalism:  Undetermined

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

[[Page 22810]]

_______________________________________________________________________




1117. 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 references the following aspects of the Medicare program: 
(1) the Lower of Cost or Charges (LCC) carryover provision (this 
provision was removed from HCFA regulations several years ago); (2) 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); and (3) other content that was 
previously removed. This regulation also clarifies several portions of 
section 413.13 and removes obsolete provisions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

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
_______________________________________________________________________




1118. 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 rule will implement section 1879 (h) of the Social 
Security Act, which limits beneficiary liability for certain medical 
equipment and supplies. This rulemaking is part of the Reinventing 
Government effort. We are working with industry representatives to 
develop guidelines that will streamline requirements, reduce burden and 
duplication, and give beneficiaries the opportunity to make informed 
consumer decisions regarding certain medical equipment and supplies.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: None

Federalism:  Undetermined

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
_______________________________________________________________________




1119. MEDICAID; ESTATE RECOVERIES (HCFA-2083-P)

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

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 1302; 42 USC 1396p(b)

CFR Citation: 42 CFR 433

Legal Deadline: None

Abstract: This rule is being developed as a result of the OBRA 1993 
provisions that mandated States to seek adjustment or recovery from the 
estates of Medicaid beneficiaries for amounts correctly spent by 
Medicaid on permanently institutionalized individuals (any age) and 
individuals age 55 or older for certain services. The OBRA 1993 
provision also defines ``estate,'' and further requires States to 
establish hardship procedures, in accordance with standards specified 
by the Secretary for waiver of recovery in cases where undue hardship 
would result.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: State

Federalism:  Undetermined

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
_______________________________________________________________________




1120. 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 rule would provide for optional Medicaid coverage of 
hospice care for terminally ill recipients who elect to receive care 
from a participating hospice, establish eligibility requirements, 
covered services, reimbursement procedures, and conditions that a 
hospice must meet to provide services to Medicaid recipients. It would 
make conforming technical revisions to the Medicare regulations 
governing hospice care.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Local

[[Page 22811]]

Federalism:  Undetermined

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
_______________________________________________________________________




1121. 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 rule will update our regulations to reflect that payment 
for durable medical equipment is on a fee-based schedule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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
Phone: 410 786-4605

RIN: 0938-AH67
_______________________________________________________________________




1122. 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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

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
_______________________________________________________________________




1123. 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 rule would revise the definition of ``substandard 
quality of care'' as it applies to skilled nursing facilities in the 
Medicare program, and nursing facilities in the Medicaid program. 
``Substandard quality of care'' is one type of noncompliance with 
Federal participation requirements that carries with it statutory 
consequences to facilities providing such care. The purpose of this 
proposed revision is to improve the definition of substandard quality 
of care so that the process can make a more meaningful distinction 
between facility noncompliance that warrants the consequences mandated 
by the statute for a finding of substandard quality of care and 
noncompliance that does not.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: Federal, State, Local

Federalism:  Undetermined

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
_______________________________________________________________________




1124. 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 notice will announce 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

[[Page 22812]]

quality of care standards are not being compromised.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                           To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

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
_______________________________________________________________________




1125. INDIVIDUAL MARKET HEALTH INS. REFORM: PORTABILITY FROM GROUP TO 
INDIV. COVERAGE; FEDERAL RULES FOR ACCESS IN THE INDIV. MARKET; STATE 
ALTERNATIVE MECHANISMS TO FEDERAL RULES (HCFA-2882-F)

Priority: Other Significant. Major under 5 USC 801.

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

Legal Authority: 42 USC 300gg-41 et seq

CFR Citation: 45 CFR 148

Legal Deadline: None

Abstract: This rule will address comments received on the interim final 
rule published on April 8, 1997, and further clarifies the Departmental 
position on Public Health Service Act insurance reform 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

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: Federal, State, Local

Federalism:  Undetermined

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
_______________________________________________________________________




1126. 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 rule discusses several policy changes affecting coverage 
of and payment for Ambulatory Surgical Center (ASC) facility services, 
as provided under sections 1833(i)(1)(A) and (i)(2)(A) 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                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Bob Cereghino, Program Analyst, Alternative Delivery 
Organizations Branch, Department of Health and Human Services, Health 
Care Financing Administration, Room 401, EHR, 6325 Security Boulevard, 
Baltimore, MD 21207
Phone: 410 966-4637

RIN: 0938-AH81
_______________________________________________________________________




1127. 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 rule would revise the ambulatory surgical center 
conditions for coverage to reflect current innovations in healthcare 
delivery, quality assessment, and performance improvement. The focus 
would be to improve outcomes of health care and satisfaction for 
Medicare beneficiaries, while streamlining structural and procedural 
requirements where possible.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

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
_______________________________________________________________________




1128. 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; 42 USC 1320c-3(a)(14)

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 rule would change our policy regarding the disclosure of 
peer review organization (PRO) information in responding to beneficiary 
complaints

[[Page 22813]]

about physicians, other practitioners, and other institutional and non-
institutional providers of health care, including Health Maintenance 
Organizations and Competitive Medical Plans. Under the proposal, we 
would permit the disclosure of PRO information about physicians and 
other individual practitioners without their permission to the extent 
necessary to comply with section 1154(a)(14) of the Social Security 
Act. This section requires PROs to conduct reviews of beneficiary 
complaints about the quality of services that do not meet 
professionally recognized standards of health care and inform each 
beneficiary of the final disposition of his or her complaint.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Alfreda Staton, Program Analyst, Office of Clinical 
Standards and Quality, Department of Health and Human Services, Health 
Care Financing Administration, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-1910

RIN: 0938-AH85
_______________________________________________________________________




1129. 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                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  This action may have federalism implications as defined in 
EO 13132.

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
_______________________________________________________________________




1130. 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 1302

CFR Citation: 42 CFR 405; 42 CFR 431; 42 CFR 433; 42 CFR 441; 42 CFR 
483

Legal Deadline: None

Abstract: This 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 rule would also 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

Federalism:  Undetermined

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
_______________________________________________________________________




1131. MEDICALLY NEEDY DETERMINATIONS UNDER WELFARE REFORM (HCFA-2109-
IFC)

Priority: Substantive, Nonsignificant

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

Legal Authority: 42 USC 1302; 42 USC 1396a(a)(10)(C)

CFR Citation: 42 CFR 435; 42 CFR 436

Legal Deadline: None

Abstract: This rule will revise our rules to allow States to include 
individuals who are described as categorically needy to be covered as 
medically needy. The State must specify the income and resources 
criteria for the medically needy group in the State plan. If an 
individual is also described as categorically needy, the individual 
would receive Medicaid as categorically needy if the State elected to 
cover the categorically needy group into which the individual fits. If 
the State has not elected to cover that group, the individual would be 
medically needy. This change will allow more individuals to become 
eligible for Medicaid as medically needy and eliminate an inequity in 
current regulations. This revision also allows some individuals who 
would otherwise lose their Medicaid benefits to retain their 
eligibility.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule               To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: State

Federalism:  Undetermined

Agency Contact: Jackie Wilder, Center for Medicaid and State 
Operations,

[[Page 22814]]

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
_______________________________________________________________________




1132. 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 rule would incorporate and interpret 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, Public Law 105-33.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Tribal

Federalism:  Undetermined

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
_______________________________________________________________________




1133. PORTABILITY AND NONDISCRIMINATION IN THE GROUP HEALTH INSURANCE 
MARKET (HCFA-2890-F)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 300gg et seq

CFR Citation: 45 CFR 146

Legal Deadline: None

Abstract: This 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 to group 
health plans and health insurance issuers offering group health 
insurance coverage. A group health plan or health insurance issuer 
offering group health coverage may provide greater rights to 
participants and beneficiaries than those currently provided. This rule 
will include the following: (1) limitations on preexisting condition 
exclusion periods; (2) certification and disclosure of previous 
coverage; (3) special enrollment periods for individuals (and 
dependents) losing other coverage; (4) use of affiliation period by 
HMOs as alternative to preexisting condition exclusion; (5) prohibited 
discrimination against individual participants and beneficiaries based 
on health status; (6) guaranteed availability in the small group 
market; and (7) guaranteed renewability in the large and small group 
markets.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/08/97                    62 FR 16894
Interim Final Rule Effective    06/07/97
Interim Final Rule Comment 
Period End                      07/07/97
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: Federal

Federalism:  Undetermined

Additional Information: None

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
_______________________________________________________________________




1134. MEDICARE PROGRAM; MEDICARE INTEGRITY PROGRAM (HCFA-7020-F)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: PL 104-191; PL 104-191, sec 202

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                            05/20/98                    63 FR 13590


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

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
_______________________________________________________________________




1135. 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 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

[[Page 22815]]

enrollees in HMOs and CMPs. This rule would reduce time lines for non-
urgent 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: Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Beverly Sgroi, Department of Health and Human Services, 
Health Care Financing Administration, 7500 Security Boulevard, 
Baltimore, MD 21244-1850
Phone: 410 786-7638

RIN: 0938-AI11
_______________________________________________________________________




1136. 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; 42 CFR 433.135; 42 CFR 433.170

Legal Deadline: None

Abstract: This 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 (Pub. L. 
103-66), commonly cited as OBRA 1993. The medical child support laws 
that the States must have in effect are set forth in second 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

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
_______________________________________________________________________




1137. MEDICARE/MEDICAID PROGRAM; USER FEES FOR INFORMATION, PRODUCTS, 
AND SERVICES (HCFA-6021-P)

Priority: Substantive, Nonsignificant

Legal Authority: 31 USC 9701

CFR Citation: 42 CFR 401

Legal Deadline: None

Abstract: This 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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Federalism:  Undetermined

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
_______________________________________________________________________




1138. 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; 42 USC 
1395x(cc)(2); 42 USC 1395x(p)

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 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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

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
_______________________________________________________________________




1139. NATIONAL STANDARD EMPLOYER IDENTIFIER (HCFA-0047-F)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: PL 104-191; 42 USC 1320d-2

CFR Citation: 45 CFR 162

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

Abstract: This rule institutes the employer identification number (EIN) 
as the standard for identifying employers for purposes of 
administrative simplification, as required by the Health Insurance 
Portability and Accountability Act of 1996 (HIPAA). Use of one standard 
in the health care industry will reduce the cost of identifying 
employers in electronic health care transactions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/16/98                    63 FR 32784

[[Page 22816]]

NPRM Comment Period End         08/17/98
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

Federalism:  This action may have federalism implications as defined in 
EO 13132.

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-AI59
_______________________________________________________________________




1140. 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 rule would establish 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 
rule would implement section 4724(g) of the Balanced Budget Act of 
1997.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Governmental Jurisdictions, Businesses

Government Levels Affected: State, Local, Tribal

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
_______________________________________________________________________




1141. ELIMINATION OF APPLICATION OF FEDERAL FINANCIAL PARTICIPATION 
LIMITS (HCFA-2111-IFC)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 1396a(r)(2); 42 USC 1396b(f)

CFR Citation: 42 CFR 435

Legal Deadline: None

Abstract: This rule would eliminate the requirement that limits the 
extent to which states may use methodologies that are less restrictive 
than those of the relevant cash assistance programs in determining 
Medicaid income eligibility for certain optional categorically needy 
groups and the medically needy. The rule would result in consistent 
treatment of the circumstances under which a state may use more liberal 
income methodologies, whether in the low-income families and children 
group (established by Welfare Reform), which is not subject to FFP 
limits, or in those groups that are subject to those limits.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Federalism:  Undetermined

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
_______________________________________________________________________




1142. 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; 8 USC 81611-1613

CFR Citation: 42 CFR 435; 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). We are 
proposing to conform our regulations with the law to clarify that, 
unless otherwise considered to be SSI recipients, qualified aliens in 
those States that cover only SSI recipients would not be eligible for 
Medicaid. We would seek comments on whether there is any statutory 
basis to Medicaid coverage for these individuals.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Federalism:  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
_______________________________________________________________________




1143. 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 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

[[Page 22817]]

portion of the loan on which expense is allowable. This rule would also 
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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

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
_______________________________________________________________________




1144. 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 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 
SNFs and HHAs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/11/98                    63 FR 42797


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  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
_______________________________________________________________________




1145. 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 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

Federalism:  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
_______________________________________________________________________




1146. 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 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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                           To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  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
_______________________________________________________________________




1147. MEDICARE PROGRAM; COVERAGE AND ADMINISTRATIVE POLICIES FOR 
CLINICAL DIAGNOSTIC LABORATORY TESTS (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.

[[Page 22818]]

Abstract: This 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


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: State, Local, Tribal

Federalism:  Undetermined

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
_______________________________________________________________________




1148. 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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                           To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: None

Federalism:  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: Udo Nwachukwu, Office of Clinical Standards and 
Quality, Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7234

RIN: 0938-AI99
_______________________________________________________________________




1149. 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                          12/04/98                    63 FR 67078


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Federalism:  Undetermined

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
_______________________________________________________________________




1150. 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 rule 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 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, Local, Tribal

Federalism:  Undetermined

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

[[Page 22819]]

_______________________________________________________________________




1151. 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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                           To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  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: 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
_______________________________________________________________________




1152. 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 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, and would prohibit commercial 
use, the use of RHC space or equipment, and other RHC resources by 
another entity. The rule also requires establishment of a quality 
assessment and performance improvement program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

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
_______________________________________________________________________




1153. 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 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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Organizations

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Mary Collins, OCSQ, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-3189

RIN: 0938-AJ29
_______________________________________________________________________




1154. 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 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 rule would clarify other current policies.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

[[Page 22820]]

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Federalism:  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
_______________________________________________________________________




1155. EMERGENCY MEDICAL TREATMENT AND LABOR ACT (EMTALA) (HCFA-1063-P)

Priority: Other Significant

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 1395cc; 42 USC 1395dd

CFR Citation: 42 CFR 489.24

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  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
_______________________________________________________________________




1156. 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                           To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Organizations

Government Levels Affected: Undetermined

Federalism:  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
_______________________________________________________________________




1157.  MEDICARE PROGRAM: CRITERIA FOR MAKING NATIONAL COVERAGE 
DECISION (HCFA-3432-P2)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This rule would set forth the general criteria we propose to 
use to make coverage decisions. It also would set forth the basis for 
the development of more specific guidance documents in which we would 
explain the application of these general criteria to specific sectors 
of medical care, such as surgical procedures, medical devices, or 
durable medical equipment.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

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-AJ54
_______________________________________________________________________




1158.  SCHEDULES OF PER VISIT AND PER BENEFICIARY LIMITATION ON 
HOME HEALTH AGENCY COST (HCFA-1060-NC)

Priority: Other Significant

Legal Authority: 42 USC 1395x(u)(1)(L)

CFR Citation: 42 CFR 413.30

Legal Deadline: None

Abstract: This rule sets forth revised schedules of limitations on home 
health agency costs that may be paid under the Medicare program for 
cost reporting periods beginning on or after October 1, 1999, and 
portions of cost reporting periods beginning before October 1, 2000.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          08/05/99                    64 FR 42766


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  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-AJ57
_______________________________________________________________________




1159.  MEDICARE PROGRAM; SUSTAINABLE GROWTH RATE FOR FISCAL YEAR 
2000 (HCFA-1110-N)

Priority: Substantive, Nonsignificant

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

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This notice announces the methodology for calculating the 
sustainable growth rate.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

[[Page 22821]]

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Federalism:  Undetermined

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-AJ60
_______________________________________________________________________




1160.  MEDICARE AND MEDICAID PROGRAMS; PROGRAMS FOR ALL-
INCLUSIVE CARE FOR THE ELDERLY (PACE) (HCFA-1903-F)

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

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This rule establishes requirements for Programs of All-
Inclusive Care for the Elderly (PACE) under Medicare and Medicaid. 
These are pre-paid, capitated programs for beneficiaries who meet 
special eligibility requirements and who elect to enroll. Programs must 
apply for approval and are evaluated in terms of specific criteria. 
Only a limited number of programs can be approved. Priority 
consideration will be given to applicants that have been operating 
under ongoing PACE demonstration projects.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Janet Samen, Center for Health Plans and Policy, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-08-15, 7500 Security Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-9161

RIN: 0938-AJ63
_______________________________________________________________________




1161.  STATE HEALTH INSURANCE ASSISTANCE PROGRAM (SHIP) (HCFA-
4005-IFC)

Priority: Info./Admin./Other

Legal Authority: 42 USC 1935w-7

CFR Citation: 42 CFR 403.502; 42 CFR 403.504; 42 CFR 403.508

Legal Deadline: None

Abstract: This rule modifies several terms and conditions that apply to 
State Medicare beneficiary counseling and assistance grants and 
implements several minor technical clarifications affecting programs 
compliance. This rule also specifies our policies regarding the 
treatment of other funds associated with the management of this 
program, including user fee assessments not in effect when prior 
regulations were issued.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule               To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: State, Local

Federalism:  Undetermined

Agency Contact: Eric Lang, Health Insurance Specialist, Office of 
Beneficiary Services, Department of Health and Human Services, Health 
Care Financing Administration, Room 600, EHR, 6325 Security Boulevard, 
Baltimore, MD 21207
Phone: 410 966-3193

RIN: 0938-AJ67
_______________________________________________________________________




1162. REAPPLICATION OF THE COMMUNITY HEALTH ACCREDITATION PROGRAM, 
INCORPORATED (CHAP) FOR CONTINUED APPROVAL OF DEEMING AUTHORITY FOR 
HEALTH CARE AGENCIES (HHAS) (HCFA-2059-F)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1395(bb)

CFR Citation: None

Legal Deadline: None

Abstract: This rule announces the receipt of a reapplication from CHAP 
for recognition as a national accreditation program for home health 
agencies (HHAs) 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 comment period.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/10/99                    64 FR 49198


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Federalism:  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-AJ69
_______________________________________________________________________




1163.  CLINICAL SOCIAL WORKER SERVICES (HCFA-1088-P)

Priority: Substantive, Nonsignificant

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

Legal Authority: 42 USC 1395x

CFR Citation: 42 CFR 410

Legal Deadline: None

Abstract: This rule would permit clinical social workers to bill 
Medicare part B separately for services rendered to residents in 
skilled nursing facilities.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Paul Kim, Health Insurance Specialist, Department of 
Health and Human Services, Health Care Financing Administration, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7410

RIN: 0938-AJ71

[[Page 22822]]

_______________________________________________________________________




1164.  STATE ALLOTMENTS FOR PAYMENTS OF MEDICARE PART B PREMIUMS 
FOR QUALIFIED INDIVIDUALS: FEDERAL FISCAL YEAR 2000 (HCFA-2063-N)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1396a(a)(10)(E); 42 USC 1396x

CFR Citation: None

Legal Deadline: None

Abstract: This rule announces the Federal fiscal year 2000 allotments 
that are available for State agencies to pay Medicare part B premiums 
for two specific eligibility groups of low-income Medicare 
beneficiaries, referred to as qualifying individuals. The Social 
Security Act provides for the Medicaid program to pay all or part of 
the Medicare part B premiums for 5 years (Federal Fiscal Year 1998 
through 2000) for these eligibility groups.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Federalism:  Undetermined

Agency Contact: Miles McDermott, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3722
Email: [email protected]

RIN: 0938-AJ72
_______________________________________________________________________




1165.  MEDICAID DISPROPORTIONATE SHARE HOSPITAL PAYMENTS -- 
INSTITUTIONS FOR MENTAL DISEASE (HCFA-2062-N)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1396r-4(a)(2); 42 USC 1396(f); 42 USC 1396(h); 
PL 105-33

CFR Citation: None

Legal Deadline: None

Abstract: This rule announces the Federal share disproportionate share 
hospital (DSH) allotments for Federal fiscal years (FFYs) 1998 through 
2002. It also describes the methodology for calculating the Federal 
share DSH allotments for FFY 2003 and thereafter, and announces the FFY 
2000 and 2001 limitations on aggregate DSH payments that States may 
make to institutions for mental disease (IMDs) and other mental health 
facilities. In addition, it adds rules regarding the annual DSH report 
mandated by the Balanced Budget Act of 1997 (BBA '97). The Federal DSH 
allotments apply to FFYs beginning October 1, 1997 and thereafter. The 
IMD limitations published in this notice apply to Medicaid DSH payments 
made in FFY 2000 and FFY 2001. The provisions concerning DSH annual 
reporting apply to DSH expenditures reported annually beginning with 
FFY 1999. The annual report for FFY 1999 is due by 3/1/00.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Federalism:  Undetermined

Agency Contact: Christine Hinds, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Boulevard, S2-05-27, Baltimore, 
MD 21244
Phone: 410 786-4578

RIN: 0938-AJ74
_______________________________________________________________________




1166.  CHILDREN'S HEALTH INSURANCE PROGRAM; FINAL ALLOTMENTS TO 
STATES, COMMONWEALTHS AND TERRITORIES FOR FY 98 AND FY 99 (HCFA-2064-N)

Priority: Other Significant

Legal Authority: PL 105-33, sec 4901

CFR Citation: None

Legal Deadline: None

Abstract: This rule provides notification of the final fiscal year (FY) 
1998 and FY 1999 allotments available to provide Federal funding to 
individual States, Commonwealths, and Territories for expenditures in 
the Children's Health Insurance Program (CHIP). The final allotments 
published in this notice are the same as the reserved allotments 
previously published on February 8, 1999 in the Federal Register. The 
allotments were originally published as reserved because not all 
States, Commonwealths, and Territories had submitted and approved child 
health plans. Final allotments may only be provided to those with 
approved plans. For purposes of planning and budgeting, the reserved FY 
98 and FY 99 allotments were calculated as if all States, Commonwealths 
and Territories had approved child health plans.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: State, Local

Federalism:  Undetermined

Agency Contact: Richard Strauss, Deputy Director, Division of Financial 
Management, Department of Health and Human Services, Health Care 
Financing Administration, S3-13-15, 7500 Security Boulevard, Baltimore, 
MD 21244-1850
Phone: 410 786-2019
Email: [email protected]

RIN: 0938-AJ77
_______________________________________________________________________




1167.  ANNOUNCEMENT OF ADDITIONAL APPLICATIONS FROM HOSPITALS 
REQUESTING WAIVERS FOR ORGAN PROCUREMENT SERVICE AREAS (HCFA-1055-N)

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

Legal Authority: 42 USC 13206-8

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This rule announces additional applications that we have 
received from hospitals requesting waivers from entering into 
agreements with their designated organ procurement organizations. 
Section 1138(a)(2) of the Social Security Act allows the Secretary of 
the Department of Health and Human Services to grant waivers to 
hospitals that want to enter into an agreement with a specific OPO that 
is not the designated OPO for the hospital's service area. This notice 
requests comments from OPOs and the general public for our 
consideration in

[[Page 22823]]

determining whether these waivers should be granted.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/09/99                    64 FR 43198


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Mark Horney, CHPP, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4554

RIN: 0938-AJ79
_______________________________________________________________________




1168.  MONTHLY ACTUARY RATES AND MONTHLY SUPPLEMENTARY MEDICAL 
INSURANCE PREMIUM RATES BEGINNING JANUARY 1, 2000 (HCFA-8006-N)

Priority: Routine and Frequent

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: Other, Statutory, January 1, 2000, Notice reg. section 
4611(e)(3) of BBA of 1997.

Abstract: In accordance with section 1839 of the Social Security Act, 
this rule announces the monthly actuarial rates for aged (age 65 or 
over) and disabled (under age 65) enrollees in the Medicare 
Supplementary Medical Insurance (SMI) program for 2000. It also 
announces the monthly SMI premium rate to be paid by all enrollees 
during 2000.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Federalism:  Undetermined

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

RIN: 0938-AJ80
_______________________________________________________________________




1169. HHA SURETY BOND (HCFA-6001-P)

Priority: Economically Significant

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

Legal Authority: PL 105-33, sec 431ff; PL 105-33, sec 4724ff; PL 105-
33, sec 1861(o)(8); PL 105-33, sec 1861(v)(1); PL 105-33, sec 
1866(b)(2); PL 105-33, sec 1891(b); PL 105-33, sec 1902(a)(10)(D); PL 
105-33, sec 1903(I); PL 105-33, sec 1905(a)(7)

CFR Citation: 42 CFR 413; 42 CFR 440; 42 CFR 441; 42 CFR 489

Legal Deadline: NPRM, Statutory, June 15, 2000.

Abstract: This rule would amend our regulations to require an HHA 
surety bond of $50,000. We would remove the 15 percent provision based 
on concerns expressed by the Congress, the home health industry, surety 
association representatives, and comments published in a report by the 
General Accounting Office. This rule would require that HHAs obtain a 
surety bond by October 1, 2000. Although the bond must be effective 
January 1, 1998, we are proposing not to hold sureties liable for 
excessive interim payments attributable to the implementation of the 
interim payment systems made between October 1, 1997 and September 30, 
2000. Other suggestions recommended by GAO were to require a single 
$50,000 bond for both the Medicare and Medicaid programs and provide an 
exemption of those HHAs that demonstrate fiscal responsibility. 
However, these recommendations require Congressional action. The final 
recommendation was to eliminate the HHA's option for substituting a 
Treasury note, U.S. bond, or other Federal public debt obligation for a 
surety bond. We generally agree with these recommendations except for 
the elimination of substituting a Treasury note, etc., for a surety 
bond.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Organizations

Government Levels Affected: None

Additional Information: RIN 0938-AJ08 in the October 1998 Unified 
Agenda provides information about rulemaking actions taken and 
withdrawn in 1998 concerning surety bond requirements for home health 
agencies.

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-AJ81
_______________________________________________________________________




1170.  PAYMENT FOR UPGRADED DURABLE MEDICAL EQUIPMENT (HCFA-
1084-P)

Priority: Substantive, Nonsignificant

Legal Authority: Section 1834(a) of the Act

CFR Citation: 42 CFR 414.225 (New)

Legal Deadline: None

Abstract: This rule allows beneficiaries to buy or rent upgraded 
durable medical equipment (DME). HCFA will pay to the supplier an 
amount equal to the Medicare allowance for standard DME, less the 
deductible and coinsurance. The rule also provides beneficiary 
safeguards from abusive suppliers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: William J. Long, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-12-18, 7500 Security Boulevard, Baltimore, MD 21228
Phone: 410 786-5655
Email: [email protected]

RIN: 0938-AJ82

[[Page 22824]]

_______________________________________________________________________




1171.  INPATIENT HOSPITAL DEDUCTIBLE AND EXTENDED CARE SERVICES 
FOR COINSURANCE AMOUNTS FOR FY 2000 (HCFA-8005-N)

Priority: Economically Significant. Major under 5 USC 801.

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

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This rule announces the inpatient hospital deductible and the 
hospital and extended care services coinsurance amounts for services 
furnished in calendar year 2000 under Medicare's hospital insurance 
program (Medicare part A). The Medicare statute specifies the formulae 
used to determine these amounts.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: State, Local, Tribal

Federalism:  Undetermined

Agency Contact: Clare McFarland, OACT, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6390

RIN: 0938-AJ83
_______________________________________________________________________




1172.  PART A PREMIUM FOR FY 2000 FOR THE UNINSURED, AGED AND 
FOR CERTAIN DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER ENTITLEMENTS 
(HCFA-8004-N)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This rule announces the hospital insurance premium for 
calendar year 2000 under Medicare's hospital insurance program (part A) 
for the uninsured aged and for certain disabled individuals who have 
exhausted other entitlement. The monthly Medicare part A premium for 
the 12 months beginning January 1, 2000 for these individuals is $301. 
The reduced premium for certain other individuals as described in this 
rule is $166. Section 1818(d) of the Social Security Act specifies the 
method to be used to determine these amounts.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State

Federalism:  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: Clare McFarland, OACT, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6390

RIN: 0938-AJ84
_______________________________________________________________________




1173.  MEDICARE PROGRAM UPDATE OF AMBULATORY SURGICAL CENTER 
PAYMENT RATES EFFECTIVE FOR SERVICES ON OR AFTER OCTOBER 1, 1999 (HCFA-
1085-N)

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

Legal Authority: Section 1832(a)(2)(F) of SSA; Section 1833(i)(1) of 
SSA; Section 1833(i)(2) of SSA

CFR Citation: Not Yet Determined

Legal Deadline: Other, Statutory, October 1, 1999, Section 4201(c)(I) 
of BBA of 1997.

Abstract: This rule implements section 1833(i)(2)(C) of the Social 
Security Act, which mandates an inflation adjustment to Medicare 
payment amounts for ambulatory surgical center (ASC) facility services 
during the years when the payment amounts are not updated based on a 
survey of the audited costs incurred by ASCs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Bob Cereghino, Program Analyst, Alternative Delivery 
Organizations Branch, Department of Health and Human Services, Health 
Care Financing Administration, Room 401, EHR, 6325 Security Boulevard, 
Baltimore, MD 21207
Phone: 410 966-4637

RIN: 0938-AJ86
_______________________________________________________________________




1174.  COVERAGE OF, AND PAYMENT OF, PARAMEDIC INTERCEPT 
AMBULANCE SERVICES (HCFA-1813-F)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This rule implements section 4531(c) of the Balanced Budget 
Act of 1997 concerning Medicare coverage of, and payment for, paramedic 
intercept ambulance services in rural communities. It also sets forth 
the BBRA definition of ``rural area.''

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: State, Local

Federalism:  Undetermined

Agency Contact: Robert Niemann, Program Analyst, Division of Special 
Payment Programs, Department of Health and Human Services, Health Care 
Financing Administration, 1-A-5, ELR, 6325 Security Boulevard, 
Baltimore, MD 21207
Phone: 301 966-4569

RIN: 0938-AJ87
_______________________________________________________________________




1175.  CRITERIA AND STANDARDS FOR EVALUATING INTERMEDIARY AND 
CARRIER PERFORMANCE DURING FY 2000 (HCFA-4009-GNC)

Priority: Routine and Frequent

Unfunded Mandates: Undetermined

[[Page 22825]]

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This rule sets out the criteria HCFA will use in evaluating 
their contractors in 2000.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

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-AJ88
_______________________________________________________________________




1176.  MEDICARE GRADUATE MEDICAL EDUCATION CONSORTIA (HCFA-1094-
P)

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This rule announces the solicitation for applications for the 
Medicare Graduate Medical Education (GME) Consortia demonstration, to 
study how teaching hospitals and affiliated organizations respond to 
the incentive of shared direct GME payments. HCFA is especially 
interested in the participation of newly formed partnerships as well as 
already existing GME consortia. HCFA plans to conduct the demonstration 
with a limited number of consortia, to be chosen through a competitive 
application process.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Sid Mazumdar, Health Insurance Specialist, Department 
of Health and Human Services, Health Care Financing Administration, C4-
17-27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6673

RIN: 0938-AJ89
_______________________________________________________________________




1177.  SUSTAINABLE GROWTH RATE FOR FY 2000 (HCFA-1110-N)

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

Unfunded Mandates: Undetermined

Legal Authority: PL 106-11, SEC 211

CFR Citation: Not Yet Determined

Legal Deadline: Other, Statutory, February 29, 2000, Notice.

Abstract: This rule specifies the formula for establishing yearly SGR 
targets for physician's services under Medicare. The use of SGR targets 
is intended to control the actual growth in Medicare expenditures for 
physician services.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

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-AJ90
_______________________________________________________________________




1178.  MEDICARE PROGRAM; MEDICARE DISPROPORTIONATE SHARE (DSH) 
ADJUSTMENT CALCULATION: CHANGE IN THE TREATMENT OF DAYS IN STATES WITH 
1115 EXPANSION WAIVERS (HCFA-1124-IFC)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1395ww(d)(5)(F)(vi)(II)

CFR Citation: 42 CFR 412

Legal Deadline: None

Abstract: This rule implements a change to the Medicare DSH adjustment 
calculation policy to allow hospitals to include the patient days of 
all populations eligible for Medicaid matching payments in a State's 
section 1115 waiver in calculating the adjustment.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule Comment 
Period End                      01/20/00                     65 FR 3136


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  This action may have federalism implications as defined in 
EO 13132.

Agency Contact: Stephen Phillips, CHPP, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4548

RIN: 0938-AJ92
_______________________________________________________________________




1179.  PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR 
SKILLED NURSING FACILITIES--UPDATE (HCFA-1112-P)

Priority: Economically Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 411; 42 CFR 489

Legal Deadline: None

Abstract: This rule sets forth updates for the forthcoming fiscal year 
to the payment rates used under the prospective payment system for 
skilled nursing facilities. Annual updates to the prospective payment 
system rates are required by section 4432 of the Balanced Budget Act of 
1997, and as amended by the Medicare, Medicaid and State Child Health 
Insurance Program Balanced Budget Refinement Act of 1999, related to 
Medicare payments and consolidated billing for skilled nursing 
facilities. In addition, this rule sets forth certain conforming 
revisions to the regulations that are necessary in order to implement 
section 103 of the Medicare, Medicaid and

[[Page 22826]]

State Child Health Insurance Program Balanced Budget Refinement Act of 
1999.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Susan Burris, Health Insurance Specialist, Department 
of Health and Human Services, Health Care Financing Administration, C5-
06-27, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-6655
Email: [email protected]

RIN: 0938-AJ93
_______________________________________________________________________




1180.  STATE CHILDREN'S HEALTH INSURANCE PROGRAM; FINAL 
ALLOTMENTS TO STATES, COMMONWEALTHS, AND TERRITORIES FOR FISCAL YEAR 
2000 (HCFA-2067-N)

Priority: Other Significant

Legal Authority: PL 105-33; PL 106-113

CFR Citation: None

Legal Deadline: None

Abstract: This rule sets forth the final allotments of Federal funding 
available to each State, Commonwealth and Territory for fiscal year 
(FY) 2000 under title XXI of the Social Security Act (the Act). 
Established by section 4901 of the Balanced Budget Act (BBA)of 1997 
(Pub. L. 105-33), title XXI of the Act authorizes payment of Federal 
matching funds to States, Commonwealths and Territories to initiate and 
expand health insurance coverage to uninsured, low-income children 
through a State Children's Health Insurance Program (SCHIP), an 
expansion of a State Medicaid program, or a combination of both. Recent 
legislation, the Medicare, Medicaid and SCHIP Balanced Budget 
Refinement Act (BBRA) of 1999 (Pub. L. 106-113, enacted November 29, 
1999), amended the SCHIP statute in part by modifying the SCHIP 
allotment formula effective with the FY 2000 allotments. The FY 2000 
SCHIP allotments contained in this rule were determined under the new 
allotment formula.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State

Federalism:  Undetermined

Agency Contact: Sharon Brown, Health Insurance Specialist, Department 
of Health and Human Services, Health Care Financing Administration, C4-
14-21, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0673
Email: [email protected]

RIN: 0938-AJ94
_______________________________________________________________________




1181.  USE OF RESTRAINT AND SECLUSION IN RESIDENTIAL TREATMENT 
FACILITIES PROVIDING INPATIENT PSYCHIATRIC SERVICES TO INDIVIDUALS UNDER 
AGE 21 (HCFA-2065-IFC)

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

Unfunded Mandates: Undetermined

Legal Authority: The Social Security Act, sec 1905(a)(16); The Social 
Security Act, sec 1905(h)

CFR Citation: 42 CFR 441; 42 CFR 483

Legal Deadline: None

Abstract: This rule establishes a new condition of participation that 
psychiatric residential treatment facilities that are not hospitals 
must meet to provide, or to continue to provide the Medicaid inpatient 
psychiatric services benefit to individuals under age 21. Specifically, 
this rule establishes standards for the use of restraint or seclusion 
that residential treatment facilities must have in place to protect the 
health and safety of residents. This new COP acknowledges a resident's 
right to be free from restraint or seclusion except in emergency safety 
situations. We also are requiring residential facilities to notify a 
resident and his or her parent or legal guardian of the facility's 
policy regarding the use of restraint or seclusion during an emergency 
safety situation that occurs while the resident is in the program. We 
believe these added requirements will provide minimum safeguards to 
protect residents against the inappropriate use of restraint or 
seclusion.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule               To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Mary Kay Mullen, Health Insurance Specialist, 
Department of Health and Human Services, Health Care Financing 
Administration, S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-5480

RIN: 0938-AJ96
_______________________________________________________________________




1182.  SUPPLIER STANDARDS RELATED TO REQUIREMENTS FOR OXYGEN, 
ORTHOTICS AND PROSTHETICS (HCFA-1129-P)

Priority: Substantive, Nonsignificant

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 424.57

Legal Deadline: None

Abstract: As required by the BBA, this rule proposes service standards 
for oxygen providers. In addition, as recommended by the OIG, it 
proposes training standards for suppliers of customized orthotics and 
prosthetics, including diabetic footwear.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

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-AJ98

[[Page 22827]]

_______________________________________________________________________




1183.  CONDITIONS OF PARTICIPATION FOR INTERMEDIATE CARE 
FACILITIES FOR THE MENTALLY RETARDED

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

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 1302

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This rule would revise the conditions of participation for 
ICFs/MR. It would set forth these requirements that ICFs/MR must meet 
to adhere to current trends in the field of developmental disabilities.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

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-AJ99
_______________________________________________________________________




1184.  NON-FEDERAL GOVERNMENTAL PLANS EXEMPT FROM HIPAA (HCFA-
2033-IFC)

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

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: 45 CFR 146

Legal Deadline: None

Abstract: This rule amends 45 CFR part 146, as promulgated at 62 FR 
16894 April 8, 1997 (BPD-890-IFC). This rule makes a technical 
correction to 45 CFR 146.150, Guaranteed Availability of Coverage for 
Employers in the Small Group Market.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule               To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

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-AK00
_______________________________________________________________________




1185.  PROCESS FOR REQUESTING RECOGNITION OF NEW TECHNOLOGIES 
AND CERTAIN DRUGS, BIOLOGICALS AND MEDICAL DEVICES FOR SPECIAL PAYMENT 
UNDER HOSPITAL OUTPATIENT PPS (HCFA-1128-N)

Priority: Other Significant

Legal Authority: 42 USC 1395l(e) of the SS Act

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: We expect to implement a prospective payment system for 
hospital outpatient services for the Medicare program on July 1, 2000. 
This system will recognize new technology as discrete payment groups 
within the ambulatory payment classification (APC) system. This payment 
system will also provide for additional payments to hospitals at 
amounts higher than the amounts that would otherwise be paid for 
certain specified items, such as: orphan drugs; drugs, biologic agents, 
and brachytherapy devices used for the treatment of cancer; 
radiopharmaceutical drugs and biologic products; and certain new or 
innovative medical devices. We have identified items or services for 
inclusion in the new technology APC groups, as well as items 
potentially eligible for special additional payments. This rule 
addresses the process that interested parties must use to submit 
additional items for consideration.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

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-AK01
_______________________________________________________________________




1186.  SCHEDULES OF PER VISIT AND PER BENEFICIARY LIMITATIONS ON 
HOME HEALTH AGENCY COST FOR COST REPORTING PERIODS BEGINNING ON OR AFTER 
OCTOBER 1, 2000 (HCFA-1108-NC)

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

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This rule will update the cost limitations that are currently 
in effect. The cost limitations must be published by August 1, 2000.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  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-AK03
_______________________________________________________________________




1187.  REPORTING QUALITY ASSURANCE AND PERFORMANCE IMPROVEMENT 
DATA AS PART OF THE CONDITIONS FOR COVERAGE FOR END STAGE RENAL DISEASE 
FACILITIES. (HCFA-3048-N)

Priority: Substantive, Nonsignificant

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This rule would revise the existing condition for coverage at 
42 CFR section 405.2133, subpart U, to add a requirement for electronic 
data

[[Page 22828]]

reporting by all Medicare-certified ESRD facilities. It would also 
propose a new ESRD condition for coverage at section 405.2175 for all 
Medicare-certified ESRD facilities to develop and implement a quality 
assurance and performance improvement (QAPI) program. The new QAPI 
condition for coverage would propose minimum levels of performance by 
ESRD facilities in specific areas. In addition, it would propose a 
revision to section 405.2136 to require that the governing body of the 
ESRD facility be responsible for establishing and periodically 
monitoring the activity of the QAPI program proposed in section 
405.2175.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0938-AK05
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1188. OMNIBUS NURSING HOME REFORM REQUIREMENTS (HCFA-3488-F)

Priority: Other Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 431; 42 CFR 482; 42 CFR 483; 42 CFR 488

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       02/15/00

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Nancy Archer
Phone: 401 786-0596

RIN: 0938-AD81
_______________________________________________________________________




1189. ALTERNATIVE SANCTIONS FOR RENAL DIALYSIS FACILITIES (HCFA-3204-P)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 405; 42 CFR 488; 42 CFR 498

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       02/15/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Judith Kari
Phone: 410 786-6829

RIN: 0938-AG31
_______________________________________________________________________




1190. DESCRIPTION OF HCFA'S EVALUATION METHODOLOGY FOR THE PEER REVIEW 
ORGANIZATIONS FIFTH SCOPE OF WORK CONTRACTS (HCFA-3207-N)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 462

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/02/97                    62 FR 35824

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Heidi Gelzer
Phone: 410 786-9352

RIN: 0938-AG32
_______________________________________________________________________




1191. TELEPHONE REQUESTS FOR REVIEW OF PART B INITIAL CLAIM 
DETERMINATIONS (HCFA-4121-FC)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 405.802; 42 CFR 405.807

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/30/99                    64 FR 52665

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Rosalind Little
Phone: 410 786-6972

RIN: 0938-AG48
_______________________________________________________________________




1192. CLIA PROGRAM; CYTOLOGY PROFICIENCY TESTING (HCFA-2233-N)

Priority: Other Significant

CFR Citation: 42 CFR 493.855

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/17/00                    65 FR 14510

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Rhonda S. Whalen
Phone: 770 488-8155

RIN: 0938-AH35
_______________________________________________________________________




1193. MEDICARE SECONDARY PAYER CLARIFICATIONS AND AMENDMENTS (HCFA-1865-
P)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 411

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       05/18/98

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Herb Pollock
Phone: 410 786-4474

RIN: 0938-AH52
_______________________________________________________________________




1194. REVISION TO ACCRUAL BASIS OF ACCOUNTING POLICY (HCFA-1876-F)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 413.100

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/27/99                    64 FR 51908

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

[[Page 22829]]

Agency Contact: John Eppinger
Phone: 410 786-4518

RIN: 0938-AH61
_______________________________________________________________________




1195. UTILIZATION CONTROL AND DISCONTINUED REVIEW ACTIVITIES; MEDICAID 
(HCFA-2101-FC)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 400; 42 CFR 431; 42 CFR 456

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       02/15/00

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: State

Agency Contact: Pamela Butler
Phone: 410 786-6776

RIN: 0938-AH64
_______________________________________________________________________




1196. PROVIDER AND SUPPLIER BILLING WHEN MEDICARE IS SECONDARY PAYOR TO 
LIABILITY INSURANCE (HCFA-1848-P)

Priority: Other Significant

CFR Citation: 42 CFR 411; 42 CFR 489

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       01/28/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Anita Heygster
Phone: 410 786-4486

RIN: 0938-AH66
_______________________________________________________________________




1197. REVISION TO THE DEFINITION OF AN UNEMPLOYED PARENT (HCFA-2106-FC)

Priority: Substantive, Nonsignificant

CFR Citation: 45 CFR 233

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/07/98                    63 FR 42270

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Judith Rhoades
Phone: 410 786-4462

RIN: 0938-AH98
_______________________________________________________________________




1198. 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.

CFR Citation: 42 CFR ch IV

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/31/97                    62 FR 59261

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Terrence Kay
Phone: 410 786-4497

RIN: 0938-AI16
_______________________________________________________________________




1199. MEDICARE PROGRAM: PHYSICIANS' REFERRALS; ISSUANCE OF ADVISORY 
OPINIONS (HCFA-1902-F)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 411.370 to 411.389

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/09/98                     63 FR 1646

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Joanne Sinsheimer
Phone: 410 786-4620

RIN: 0938-AI38
_______________________________________________________________________




1200. 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

CFR Citation: 42 CFR ch IV

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Notice                    04/20/99                    64 FR 19376

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0938-AI69
_______________________________________________________________________




1201. MEDICARE HOSPICE CARE (HCFA-1022-P)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Duplicate of 0938-AJ36          03/28/00

RIN: 0938-AI77
_______________________________________________________________________




1202. SOLVENCY STANDARDS FOR PROVIDER-SPONSORED ORGANIZATIONS (HCFA-
1011-F)

Priority: Other Significant

CFR Citation: 42 CFR 422

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/22/99                    64 FR 71673

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Greg Snyder
Phone: 410 786-0329

RIN: 0938-AI83
_______________________________________________________________________




1203. REPLACEMENT OF REASONABLE CHARGE METHODOLOGY BY FEE SCHEDULES 
(HCFA-1010-P)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 414

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/27/99                    64 FR 40534

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Joel Kaiser
Phone: 410 786-4499

RIN: 0938-AJ00
_______________________________________________________________________




1204. SUGGESTIONS PROGRAM ON METHODS TO IMPROVE MEDICARE EFFICIENCY 
(HCFA-4000-FC)

Priority: Other Significant

CFR Citation: 42 CFR 420.410

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/24/99                    64 FR 66396

Regulatory Flexibility Analysis Required: No

[[Page 22830]]

Government Levels Affected: None

Agency Contact: Sam Della Vecchia
Phone: 410 786-4481

RIN: 0938-AJ30
_______________________________________________________________________




1205. MEDICARE PROGRAM; PROCEDURES FOR MAKING MEDICAL SERVICES NATIONAL 
COVERAGE DECISIONS (HCFA-3432-P)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

General Notice                  04/27/99                    64 FR 22619

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Ron Milhourn
Phone: 410 786-5666
Email: [email protected]

RIN: 0938-AJ31
_______________________________________________________________________




1206. MEDICARE PROGRAM; SPECIAL PAYMENT LIMITS FOR CERTAIN DURABLE 
MEDICAL EQUIPMENT AND PROSTHETIC DEVICES (HCFA-1050-PN)

Priority: Substantive, Nonsignificant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Merged With 0938-AI37           02/02/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Joel Kaiser
Phone: 410 786-4499

RIN: 0938-AJ34
_______________________________________________________________________




1207. 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

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       03/17/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Geraldine Nicholson
Phone: 410 786-6967

RIN: 0938-AJ45
_______________________________________________________________________




1208. CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEM AND 
FISCAL YEAR 2000 RATES (HCFA-1053-F) (SECTION 610 REVIEW)

Priority: Economically Significant. Major under 5 USC 801.

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/30/99                    64 FR 41490

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Tzvi Hefter
Phone: 410 786-1304

RIN: 0938-AJ50
_______________________________________________________________________




1209.  APPEAL OF LOSS OF NURSE AIDE TRAINING PROGRAMS (HCFA-
2054-IFC)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: None

Legal Deadline: None

Abstract: This document corrects a technical error that appeared in the 
interim final rule with comment period published in the Federal 
Register on July 23, 1999, entitled ``Medicare and Medicaid Programs; 
Appeal of the Loss of Nurse Aide Training Programs.''

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/30/99                    64 FR 39934

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0938-AJ59
_______________________________________________________________________




1210.  PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR 
SKILLED NURSING FACILITIES-UPDATE (HCFA-1056-N)

Priority: Info./Admin./Other

Legal Authority: None

CFR Citation: None

Legal Deadline: None

Abstract: This notice sets forth the updates required in section 4432 
of the Balanced Budget Act of 1997 related to Medicare payments and 
consolidated billing for skilled nursing facilities.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          07/30/99                    64 FR 41684

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: John Davis, Health Insurance Specialist, Department of 
Health and Human Services, Health Care Financing Administration, 7500 
Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-0008
Email: [email protected]

RIN: 0938-AJ65
_______________________________________________________________________




1211.  REAPPLICATION OF THE AMERICAN OSTEOPATHIC ASSOCIATION 
(AOA) FOR CONTINUED APPROVAL OF DEEMING AUTHORITY FOR HOSPITALS (HCFA-
2057-FN)

Priority: Info./Admin./Other

Legal Authority: 42 USC 1395bb

CFR Citation: None

Legal Deadline: None

Abstract: This notice announces the approval of the American 
Osteopathic Association (ADA) for continued recognition as a national 
accreditation program for hospitals that wish to participate in the 
Medicare or Medicaid programs pursuant to section 1865(b) of the Social 
Security Act (the Act).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          02/22/00                     65 FR 8727

Regulatory Flexibility Analysis Required: No

[[Page 22831]]

Government Levels Affected: None

Agency Contact: Janice Adams-King, Program Evaluation Officer, 
Department of Health and Human Services, Health Care Financing 
Administration
Phone: 410 786-8354
Email: [email protected]

RIN: 0938-AJ66
_______________________________________________________________________




1212. REAPPLICATION OF THE JOINT COMMISSION FOR ACCREDITATION OF HEALTH 
CARE ORGANIZATIONS (JCAHO) FOR CONTINUED APPROVAL OF DEEMING AUTHORITY 
FOR HOME HEALTH AGENCIES (HHAS) (HCFA-2058-F)

Priority: Substantive, Nonsignificant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          02/22/00                     65 FR 8722

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0938-AJ68
_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




1213. 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                            06/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Tribal

Agency Contact: Ann Bowker, 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: 202 401-5308
Email: [email protected]

RIN: 0970-AB73
_______________________________________________________________________




1214. 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                            06/00/00

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
_______________________________________________________________________




1215. 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                            09/00/00

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
_______________________________________________________________________




1216. 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.

[[Page 22832]]

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                            09/00/00

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)



_______________________________________________________________________




1217. 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
_______________________________________________________________________




1218. 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/08/99                     64 FR 6013
NPRM Comment Period End         04/09/99
Final Action                    09/00/00

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
_______________________________________________________________________




1219. 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                    06/00/00

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
_______________________________________________________________________




1220. 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 Governors' Association and the American Public Human 
Services Association (formerly the American Public Welfare 
Association), will set forth 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                            12/06/99                    64 FR 68202

[[Page 22833]]

NPRM Comment Period End         02/04/00
Final Action                    08/00/00

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-AB66
_______________________________________________________________________




1221. 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, and its 
technical amendments, the Balanced Budget Act of 1997, the Adoption and 
Safe Families Act of 1997, and the Child Support Performance and 
Incentive Act of 1998.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              02/09/99                     64 FR 6237
Final Action                    06/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Anne M. Benson, Program Specialist, Department of 
Health and Human Services, Administration for Children and Families, MS 
OCSE, OCSE, 370 L'Enfant Promenade SW, DPP, Washington, DC 20447
Phone: 202 401-1467
Email: [email protected]

RIN: 0970-AB81
_______________________________________________________________________




1222. 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 implements 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 also implements 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
_______________________________________________________________________




1223. STATE SELF-ASSESSMENTS TO DETERMINE COMPLIANCE WITH FEDERAL 
REGULATIONS

Priority: Substantive, Nonsignificant

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

CFR Citation: 45 CFR 308

Legal Deadline: None

Abstract: The rule requires 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
_______________________________________________________________________




1224. 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 will mandate use of a national 
medical support notice and include 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                            11/15/99                    64 FR 62074
NPRM Comment Period End         01/14/00
Final Action                    11/00/00

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

[[Page 22834]]

Email: [email protected]

RIN: 0970-AB97
_______________________________________________________________________




1225. TECHNICAL REVISION OF HEAD START REGULATIONS TO MAKE THEM CONFORM 
TO RECENT STATUTORY REVISIONS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 9801 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              10/00/00

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
_______________________________________________________________________




1226.  RUNAWAY AND HOMELESS YOUTH PROGRAM

Priority: Substantive, Nonsignificant

Legal Authority: PL 106-71, The Missing Exploited and Runaway Children 
Protection Act

CFR Citation: 45 CFR 1351

Legal Deadline: None

Abstract: This final rule would amend the Runaway and Homeless Program 
regulation provision requiring grant awards to recipients not to exceed 
a three year project period to a not to exceed a five year project 
period.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    09/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Tribal

Agency Contact: Stan Chappell, Senior Program Analyst, Department of 
Health and Human Services, Administration for Children and Families, 
DHHS/ACF/ACYF/Family Youth Services Bureau, 330 C Street SW, 
Washington, DC 20201
Phone: 202 205-8496
Fax: 202 260-9333
Email: [email protected]

RIN: 0970-AC04
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Administration for Children and Families (ACF)



_______________________________________________________________________




1227. TITLE IV-E FOSTER CARE ELIGIBILITY REVIEWS AND CHILD AND FAMILY 
SERVICES STATE PLAN REVIEWS, MEPA IMPLEMENTATION, AND ASFA 
IMPLEMENTATION

Priority: Other Significant

CFR Citation: 45 CFR 1355; 45 CFR 1356; 45 CFR 1357

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/25/00                     65 FR 4020

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Kathleen McHugh
Phone: 202 401-5789
Email: [email protected]

RIN: 0970-AA97
_______________________________________________________________________




1228. REQUIREMENTS FOR THE TRIBAL PROGRAMS

Priority: Other Significant

CFR Citation: 45 CFR 286 (New); 45 CFR 287 (New)

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    02/18/00                     65 FR 8477

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal, State, Tribal

Agency Contact: John Bushman
Phone: 202 401-2418
Email: [email protected]

RIN: 0970-AB78
_______________________________________________________________________




1229. REFUGEE RESETTLEMENT PROGRAM: REFUGEE CASH AND MEDICAL ASSISTANCE 
PROGRAMS

Priority: Other Significant

CFR Citation: 45 CFR 400

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      03/22/00                    65 FR 15409

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Gayle Smith
Phone: 202 401-9250

RIN: 0970-AB83
_______________________________________________________________________




1230. HEAD START APPEAL TIMELINES

Priority: Substantive, Nonsignificant

CFR Citation: 45 CFR 1303

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    02/01/00                     65 FR 4763

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Local, Tribal

Agency Contact: Douglas Klafehn
Phone: 202 205-8569

RIN: 0970-AB87
_______________________________________________________________________




1231. WELFARE-TO-WORK DATA COLLECTION

Priority: Other Significant

CFR Citation: 45 CFR 276

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       11/29/99

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Howard Rolston

[[Page 22835]]

Phone: 202 401-9220

RIN: 0970-AB92
_______________________________________________________________________




1232. PRIORITY FOR PREVIOUSLY SELECTED HEAD START AGENCIES

Priority: Other Significant

CFR Citation: 45 CFR 1302.12

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/15/99                    64 FR 69924

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Local, Tribal

Agency Contact: James Kolb
Phone: 202 205-8580

RIN: 0970-AB98
_______________________________________________________________________




1233. ASSETS FOR INDEPENDENCE RESERVE ACCOUNT

Priority: Substantive, Nonsignificant

CFR Citation: 45 CFR 1000

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              02/25/00                    65 FR 10027

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Richard Saul
Phone: 202 401-9341
Email: [email protected]

RIN: 0970-AC02
_______________________________________________________________________


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


Administration on Aging (AOA)



_______________________________________________________________________




1234. 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                            07/00/00

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Tribal

Federalism:  Undetermined

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. 00-6920 Filed 04-21-00; 8:45 am]
BILLING CODE 4150-04-F
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