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


[[Page 25387]]

Part VIII





Department of Health and Human Services





_______________________________________________________________________



Semiannual Regulatory Agenda

[[Page 25388]]



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 Regulatory Flexibility Act of 1980 and Executive Order 
12866 require the semiannual publication of an agenda outlining all 
current and projected rulemakings. The purpose of this exercise is to 
inform the public about regulatory actions under development within the 
Department, and to provide an opportunity for all concerned with the 
impact of these regulations to participate in their development at an 
early stage. The last such agenda was published on November 30, 2000.

FOR FURTHER INFORMATION CONTACT:  Ann Stallion, 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 capsulized below do 
not necessarily reflect the new policy perspectives of the Bush 
administration and HHS Secretary Thompson. The statutorily dictated 
timing of the regulatory agenda caused the Department to begin its 
efforts to put together information required for the agenda well before 
the new Administration came into place. The following agenda thus 
simply reflects ongoing efforts by HHS to comply with many longstanding 
statutory obligations, and/or to effect improvements at the program-
implementation level based on the Department's experience in 
administering existing programs. The timing of the October 2001 agenda 
will, obviously, provide the Department with an opportunity to set out 
a regulatory agenda that does reflect the policy directions that 
Secretary Thompson desires to take.

     Public commentary is invited. 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.

    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: Harry Posman, 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.

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

    Health Care Financing Administration: Anthony Mazzarella, 
Deputy Director, Operation Support Group, 7500 Security Boulevard, 
C4-26-05, Baltimore, Maryland 21244; Phone 410-786-7501.

    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 Gould, 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: Joe 
Faha, 5600 Fishers Lane, Room 12-A-17, Rockville, Maryland 20857; 
Phone 301-443-4640.

    Office of the Secretary: Ann C. Agnew, Executive Secretary to 
the Department, Room 603H, Hubert H. Humphrey Building, 200 
Independence Avenue SW., Washington, DC 20201.

Dated:  March 14, 2001.

 Ann C. Agnew,

Executive Secretary to the Department.

                                  Office of the Secretary--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
813         Governmentwide Debarment and Suspension (Nonprocurement) and Governmentwide              0991-AB12
            Requirements for Drug-Free Workplace (Grants).......................................
----------------------------------------------------------------------------------------------------------------


                                    Office of the Secretary--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
814         Reproduction and Sale of Official Forms and Publications............................     0991-AA83
815         Shared Risk Exception to the Safe Harbor Provisions.................................     0991-AA91
816         Civil Money Penalty Safe Harbor To Protect Payment of Medicare and Medigap Premiums      0991-AB04
            for ESRD Beneficiaries..............................................................
817         Safe Harbor for Ambulance Restocking................................................     0991-AB05

[[Page 25389]]

 
818         Revisions and Technical Corrections to 42 CFR Chapter V.............................     0991-AB09
819         Amending the Regulations Governing Nondiscrimination on the Basis of Race, Color,        0991-AB10
            National Origin, Handicap, Sex, and Age To Conform to the Civil Rights Restoration
            Act of 1987.........................................................................
----------------------------------------------------------------------------------------------------------------


                                   Office of the Secretary--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
820         Civil Money Penalties for Medicare+Choice Organizations and Medicaid Managed Care        0991-AB03
            Organizations.......................................................................
821         Safe Harbor for Arrangements Involving Federally Qualified Health Centers...........     0991-AB06
822         Definition of Terms; Substantially in Excess and Usual Charges and Clarification of      0991-AB13
            the Good Cause Exception............................................................
----------------------------------------------------------------------------------------------------------------


                                   Office of the Secretary--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
823         Standards for Privacy of Individually Indentifiable Health Information..............     0991-AB08
----------------------------------------------------------------------------------------------------------------


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


                  Substance Abuse and Mental Health Services Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
825         Final and Delegation of Authority To Implement SAMHSA's Accreditation Based System       0930-AA06
            for Opiod Treatment Program Monitoring..............................................
----------------------------------------------------------------------------------------------------------------


                         Centers for Disease Control and Prevention--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
826         Amendments to Quality Assurance and Administrative Provision for Approval of             0920-AA04
            Respiratory Protective Devices......................................................
827         Methods for Estimating Radiation Dose and Guidelines for Assessing Probability of        0920-AA05
            Cancer for Energy Employees Occupational Illness Compensation Program...............
----------------------------------------------------------------------------------------------------------------


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


[[Page 25390]]


                                  Departmental Management--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
830         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
----------------------------------------------------------------------------------------------------------------
831         Natural Rubber-Containing Drugs; User Labeling......................................     0910-AB56
832         Implementation of the Import Tolerance Provisions of the Animal Drug Availability        0910-AB71
            Act of 1996.........................................................................
833         Part 600-Biological Products: General (Section 610 Review)..........................     0910-AC06
----------------------------------------------------------------------------------------------------------------


                                Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
834         Over-the-Counter (OTC) Drug Review..................................................     0910-AA01
835         Hearing Aids; Professional and Patient Labeling; Conditions for Sale................     0910-AA39
836         Establishment Registration and Product Listing for Drugs and Biologics..............     0910-AA49
837         Investigational New Drugs: Export Requirements for Unapproved New Drug Products.....     0910-AA61
838         Safety Reporting and Recordkeeping Requirements for Marketed OTC Drugs..............     0910-AA86
839         Safety Reporting Requirements for Human Drug and Biological Products................     0910-AA97
840         Radioactive Drugs for Basic Research................................................     0910-AB00
841         Administrative Practices and Procedures; Advisory Opinions and Guidelines...........     0910-AB14
842         Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based        0910-AB28
            Products............................................................................
843         Applications for FDA Approval to Market a New Drug; Complete Response Letter;            0910-AB34
            Amendments to Unapproved Applications...............................................
844         Expanded Access to Investigational Therapies........................................     0910-AB37
845         Electronic Submission of Adverse Drug Reaction Reports..............................     0910-AB42
846         Distinguishing Marks for Drug Products Containing Insulin...........................     0910-AB43
847         Pregnancy Labeling..................................................................     0910-AB44
848         Positron Emission Tomography Drugs; Current Good Manufacturing Practices............     0910-AB63
849         Current Good Manufacturing Practice for Medicated Feeds.............................     0910-AB70
850         Fixed-Combination Prescription and Over-the-Counter Drugs for Human Use.............     0910-AB79
851         Repackaging Approval Requirements...................................................     0910-AB81
852         Stability Testing of Drugs..........................................................     0910-AB82
853         Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary        0910-AB88
            Supplements.........................................................................
854         Submission in Electronic Format of Certain Labeling Information.....................     0910-AB91
855         Fees Relating to Drugs; Waiver and Reduction of Fees................................     0910-AB92
856         Periodic Testing for Certain Human Drug, Veterinary Drug, and Biological Product         0910-AB93
            Final Specifications................................................................
857         Requirements Pertaining to Sampling Services and Private Laboratories Used in            0910-AB96
            Connection with Imported Food.......................................................
858         Medical Devices, Medical Device Establishment Registration and Listing Requirements;     0910-AB99
            Amendment...........................................................................
859         Availability for Public Disclosure and Submission to FDA for Public Disclosure of        0910-AC00
            Certain Data and Information Related to Gene Therapy or Xenotransplantation.........
860         Reporting Information Regarding Potential Fabrication or Falsification of Data......     0910-AC02
861         Status Reports for Quantity Marketed Information for Animal Drug Products Used in        0910-AC04
            Food-Producing Animals..............................................................
862         Labeling Dietary Supplements for Women Who Are or May Become Pregnant...............     0910-AC09
863         Overwrap for Inhalation Products Packaged in Low Density Polyethylene (LDPE)             0910-AC10
            Containers..........................................................................
864         Regulation of Carcinogenic Compounds Used in Food-Producing Animals; Definition of       0910-AC13
            ``No Residue''......................................................................
865         Control of Salmonella Enteritidis in Shell Eggs During Production and Retail........     0910-AC14
866         Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition...     0910-AC18
867         Use of Materials Derived from Ruminant Animals in FDA Regulated Products............     0910-AC19
868         Postmarketing Reports of Substandard or Ineffective Bulk Ingredients and Bulk            0910-AC20
            Ingredients from Unapproved Sources.................................................
----------------------------------------------------------------------------------------------------------------


[[Page 25391]]


                                 Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
869         New Animal Drug Approval Process; Implementation of Title I of the Generic Animal        0910-AA02
            Drug and Patent Term Restoration Act (GADPTRA)......................................
870         Current Good Manufacturing Practice; Amendment of Certain Requirements for Finished      0910-AA45
            Pharmaceuticals.....................................................................
871         Bioavailability and Bioequivalence Requirements.....................................     0910-AA51
872         Labeling for Human Prescription Drugs; Revised Format...............................     0910-AA94
873         Current Good Manufacturing Practice; Revision of Certain Labeling Controls..........     0910-AA98
874         Use of Ozone-Depleting Substances...................................................     0910-AA99
875         Exports; Notification and Recordkeeping Requirements................................     0910-AB16
876         Foreign Establishment Registration and Listing......................................     0910-AB21
877         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......................................................
878         Blood Initiative....................................................................     0910-AB26
879         Antibiotic Drug Approval and Exclusivity............................................     0910-AB33
880         Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs...     0910-AB39
881         Supplements and Other Changes to Approved New Animal Drug Applications..............     0910-AB49
882         Revisions to the General Safety Requirements for Biological Products; Direct Final       0910-AB51
            Rule................................................................................
883         Discontinuation of a Lifesaving Product.............................................     0910-AB60
884         Supplements and Other Changes to an Approved Application............................     0910-AB61
885         Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and     0910-AB66
            Health Claims.......................................................................
886         Presubmission Conferences...........................................................     0910-AB68
887         Surgeon's and Patient Examination Gloves; Reclassification..........................     0910-AB74
888         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 (Lookback)......................................................................
889         Antibiotic Resistance Labeling......................................................     0910-AB78
890         180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications..............     0910-AB80
891         Food Additives: Food Contact Substances Notification System.........................     0910-AB94
892         State Certification of Mammography Facilities.......................................     0910-AB98
893         Examination of Administrative Record and Other Advisory Committee Records...........     0910-AC03
894         Efficacy Evidence Needed for Products to be Used Against Toxic Substances When Human     0910-AC05
            Studies Are Unethical...............................................................
895         Additional Safeguards for Children in Clinical Investigations of FDA Regulated           0910-AC07
            Products............................................................................
896         Implementing Court Decisions, ANDA Approvals, and 180-Day Exclusivity...............     0910-AC11
897         Revocation of Conditions for Marketing Digoxin Products for Oral Use................     0910-AC12
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
898         Infant Formula: Good Manufacturing Practice, Quality Control Procedures, Quality         0910-AA04
            Factors, Notification Requirements, and Records and Reports.........................
899         Food Labeling Review................................................................     0910-AA19
900         Medical Foods.......................................................................     0910-AA20
901         Classification of Computer Software Programs That Are Medical Devices...............     0910-AA41
902         Reinventing FDA Food Regulations....................................................     0910-AA58
903         Determination That Informed Consent Is Infeasible or Is Contrary to the Best             0910-AA89
            Interest of Recipients..............................................................
904         Direct-to-Consumer Promotion Regulations............................................     0910-AA90
905         Investigational Use New Animal Drug Regulations (Section 610 Review)................     0910-AB02
906         Suitability Determination for Donors of Human Cellular and Tissue-Based Products....     0910-AB27
907         Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed...............     0910-AB50
908         Bulk Drug Substances for Use in Pharmacy Compounding................................     0910-AB57
909         Pharmacy and Physician Compounding of Drug Products.................................     0910-AB58
910         Drug Products That Present Demonstrable Difficulties for Compounding Because of          0910-AB59
            Reasons of Safety or Effectiveness..................................................
911         Mandatory HACCP Regulations for Manufacturers of Rendered Products..................     0910-AB72
912         Citizen Petitions; Actions That Can Be Requested by Petition; Denials, Withdrawals,      0910-AB73
            and Referrals for Other Administrative Action.......................................
913         Substances Prohibited From Use in Animal Food or Feed...............................     0910-AB90

[[Page 25392]]

 
914         Marking Requirements for and Prohibitions on the Reimportation of Imported Food          0910-AB95
            Products That Have Been Refused Admission into the United States....................
915         Addition to the List of Drug Products That Have Been Withdrawn From the Market for       0910-AC01
            Reasons of Safety or Effectiveness..................................................
916         Addition to the List of Drug Products That Have Been Withdrawn or Removed From the       0910-AC08
            Market for Reasons of Safety or Effectiveness.......................................
917         Premarket Notice Concerning Bioengineered Foods.....................................     0910-AC15
918         Rescission of Substantially Equivalent Decisions and Rescission Appeal Procedures...     0910-AC16
919         Institutional Review Boards: Registration Requirements..............................     0910-AC17
920         Chronic Wasting Disease: Control of Food Products and Cosmetics Derived from Exposed     0910-AC21
            Animal Populations..................................................................
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
921         Biological Products: Reporting of Biological Product Deviations in Manufacturing....     0910-AA12
922         Fruit and Vegetable Juices: Development of HACCP and Label Warning Statements for        0910-AA43
            Juices..............................................................................
923         Drugs Used for Treatment of Narcotic Addicts........................................     0910-AA52
924         Establishment Registration and Listing of Human Cells, Tissues, and Cellular and         0910-AB05
            Tissue-Based Products...............................................................
925         Veterinary Feed Directives..........................................................     0910-AB09
926         Shell Eggs: Warning, Notice and Safe Handling Labeling Statements and Refrigeration      0910-AB30
            Requirements........................................................................
927         Postmarketing Studies for Human Drugs and Licensed Biological Products: Status           0910-AB83
            Reports.............................................................................
928         Current Good Manufacturing Practice for Blood and Blood Components; Blood Labeling       0910-AB89
            Standards...........................................................................
----------------------------------------------------------------------------------------------------------------


                        Health Resources and Services Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
929         Designation of Medically Underserved Populations and Health Professional Shortage        0906-AA44
            Areas...............................................................................
930         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
----------------------------------------------------------------------------------------------------------------
931         National Practitioner Data Bank for Adverse Information on Physicians and Other          0906-AA41
            Health Care Practitioners: Medical Malpractice Payments Reporting Requirements......
932         Compliance Alternatives for Provision of Uncompensated Services.....................     0906-AA52
933         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--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
934         Ricky Ray Hemophilia Relief Fund Program............................................     0906-AA56
----------------------------------------------------------------------------------------------------------------


[[Page 25393]]


                                   Indian Health Service--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
935         Tribal Self-Governance Amendments...................................................     0917-AA05
----------------------------------------------------------------------------------------------------------------


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


                                    Indian Health Service--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
937         Contracts Under the Indian Self-Determination Act...................................     0917-AA04
----------------------------------------------------------------------------------------------------------------


                               National Institutes of Health--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
938         National Institutes of Health AIDS Research Loan Repayment Program..................     0925-AA02
939         Undergraduate Scholarship Program Regarding Professions Needed by the NIH...........     0925-AA10
940         National Cancer Institute Clinical Cancer Education Program.........................     0925-AA17
941         National Institutes of Health Loan Repayment Program for Research...................     0925-AA18
942         NIH Center Grants...................................................................     0925-AA24
943         National Institutes of Health Clinics Research Loan Repayment Program for                0925-AA25
            Individuals from Disadvantaged Backgrounds..........................................
944         NIH Loan Repayment Program for Minority Health Disparties Research..................     0925-AA26
945         Pediatric Research Loan Repayment Program...........................................     0925-AA27
946         NIH Training Grants.................................................................     0925-AA28
----------------------------------------------------------------------------------------------------------------


                                 National Institutes of Health--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
947         National Research Service Awards....................................................     0925-AA16
948         National Institute of Child Health and Human Development Contraception and               0925-AA19
            Infertility Research Loan Repayment Program.........................................
949         Scientific Peer Review of Research Grant Applications and Research and Development       0925-AA20
            Contract Projects...................................................................
----------------------------------------------------------------------------------------------------------------


                                National Institutes of Health--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
950         Traineeships........................................................................     0925-AA11
951         Additional Protections for Pregnant Women and Human Fetuses Involved in Research,        0925-AA14
            and Pertaining to Human In Vitro Fertilization......................................
952         Federal Policy (Common Rule) for the Protection of Human Subjects...................     0925-AA21
----------------------------------------------------------------------------------------------------------------


[[Page 25394]]


                              Office of Public Health and Science--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
953         Public Health Service Standards for the Protection of Research Misconduct                0940-AA01
            Whistleblowers......................................................................
954         Federal Policy (Common Rule) for the Protection of Human Subjects...................     0940-AA03
----------------------------------------------------------------------------------------------------------------


                             Office of Public Health and Science--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
955         Additional Protections for Pregnant Women and Human Fetuses Involved in Research,        0940-AA02
            and Pertaining to Human In Vitro Fertilization......................................
----------------------------------------------------------------------------------------------------------------


                            Health Care Financing Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
956         End Stage Renal Disease (ESRD) Conditions for Coverage (HCFA-3818-P) (Section 610        0938-AG82
            Review).............................................................................
957         Recognition of the American Osteopathic Association for Critical Access Hospitals        0938-AK84
            (HCFA-2099-PN)......................................................................
----------------------------------------------------------------------------------------------------------------


                             Health Care Financing Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
958         Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities-      0938-AK47
            Update (HCFA-1163-P)................................................................
----------------------------------------------------------------------------------------------------------------


                             Health Care Financing Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
959         ''Without Fault'' and Beneficiary Waiver of Recovery As It Applies to Medicare           0938-AD95
            Overpayment Liability (HCFA-6007-F).................................................
960         Medicaid Payment for Covered Outpatient Drugs Under Rebate Agreements (HCFA-2046-FC)     0938-AF42
961         Revision of Medicare/Medicaid Hospital Conditions of Participation (HCFA-3745-F)....     0938-AG79
962         Home Health Agency (HHA) Conditions of Participation (HCFA-3819-F)..................     0938-AG81
963         Liability for Third Parties To Pay for Services (HCFA-2080-P).......................     0938-AH01
964         Criteria for Approval of Facilities to Perform Covered Heart, Liver, Lung, Pancreas      0938-AH17
            and Intestinal Transplants (HCFA-3835-P)............................................
965         Hospice Care-Conditions of Participation (HCFA-3844-P)..............................     0938-AH27
966         Requirements for Enrollment of Medicaid Recipients Under Cost Effective Employer-        0938-AH48
            Based Group Health Plans (HCFA-2047-F)..............................................
967         Terms, Definitions, and Addresses: Technical Amendments (HCFA-9877-FC)..............     0938-AH53
968         Requirements for Establishing and Maintaining Medicare Billing Privileges (HCFA-6002-    0938-AH73
            P)..................................................................................
969         Update of Ratesetting Methodology, Payment Rates and the List of Covered Surgical        0938-AH81
            Procedures for Ambulatory Surgical Centers (HCFA-1885-FC)...........................
970         Revisions to Conditions for Coverage for Ambulatory Surgical Centers (HCFA-3887-P)..     0938-AH83
971         National Standard for Identifiers of Health Plans (HCFA-4145-P).....................     0938-AH87
972         Standard Unique Health Care Provider Identifier (HCFA-0045-F).......................     0938-AH99
973         Medicaid: Medical Child Support (HCFA-2081-P).......................................     0938-AI21
974         Surety Bond Requirements for Comprehensive Outpatient Rehabilitation Facilities,         0938-AI48
            Rehabilitation Agencies (HCFA-6005-P)...............................................
975         Appeals of Carrier Determination That a Physician or Other Supplier Fails To Meet        0938-AI49
            the Requirements for Medicare Billing Privileges (HCFA-6003-F)......................
976         Security Standards (HCFA-0049-F)....................................................     0938-AI57

[[Page 25395]]

 
977         National Standard Employer Identifier (HCFA-0047-F).................................     0938-AI59
978         Medicare Program; Advance Refunding of Debt and Methodology for Repayment of Loan        0938-AI75
            (HCFA-1777-P).......................................................................
979         Medicare Program; Medicare Coverage of and Payment for Bone Mass Measurements (HCFA-     0938-AI89
            3004-F).............................................................................
980         Medicare Program; Coverage and Administrative Policies for Clinical Diagnostic           0938-AI92
            Laboratory Tests (HCFA-3250-F)......................................................
981         Coverage of Religious Non-Medical Health Care Institutions (HCFA-1909-F)............     0938-AI93
982         External Quality Review of Medicaid Managed Care Organizations (HCFA-2015-F)........     0938-AJ06
983         Reporting Outcome and Assessment Information Set (OASIS) Data as Part of the             0938-AJ10
            Conditions of Participation for Home Health Agencies (HCFA-3006-F)..................
984         Rural Health Clinics: Amendments to Participation Requirements and Payment               0938-AJ17
            Provisions, and Establishment of a Quality Assessment and Improvement Program (HCFA-
            1910-F).............................................................................
985         Hospital Conditions of Participation: Laboratory Services (HCFA-3014-F).............     0938-AJ29
986         Medicare Hospice Care Amendments (HCFA-1022-P)......................................     0938-AJ36
987         Emergency Medical Treatment and Labor Act (EMTALA) (HCFA-1063-P)....................     0938-AJ39
988         Protection for Women Who Elect Reconstruction After a Mastectomy (HCFA-2040-IFC)....     0938-AJ44
989         Medicare Program: Prospective Payment System for Inpatient Rehabilitation Hospital       0938-AJ55
            Services (HCFA-1069-F)..............................................................
990         DME Surety Bonds (HCFA-6006-P)......................................................     0938-AJ64
991         State Health Insurance Assistance Program (SHIP) (HCFA-4005-F)......................     0938-AJ67
992         HHA Surety Bond (HCFA-6001-P).......................................................     0938-AJ81
993         Application of Inherent Reasonableness to All Part B Services Other Than Physician       0938-AJ97
            Services (HCFA-1908-F)..............................................................
994         Supplier Standards Related to Training Requirements for Oxygen, Therapeutic Shoes        0938-AJ98
            (HCFA-6010-NPRM)....................................................................
995         Non-Federal Governmental Plans Exempt From HIPAA (HCFA-2033-IFC)....................     0938-AK00
996         End Stage Renal Disease Bad Debt Payment (HCFA-1126-P)..............................     0938-AK02
997         Practice Expense Data Collection (HCFA-1111-IFC)....................................     0938-AK14
998         Payment for Clinical Psychology Training Programs (HCFA-1089-F).....................     0938-AK15
999         Provisions of the Balanced Budget and Refinement Act of 1999; Hospital Inpatient         0938-AK20
            Payments and Rates and Costs of Graduate Medical Education (HCFA-1131-IFC)..........
1000        Conditions of Participation of Intermediate Care Facilities for Persons With Mental      0938-AK23
            Retardation (HCFA-3046-P)...........................................................
1001        Clinical Lab Requirements-Revisions to Regulations Implementing CLIA (HCFA-2226-F)..     0938-AK24
1002        Prospective Fee Schedule for Ambulance Services (HCFA-1002-F).......................     0938-AK30
1003        Fire Safety Requirements for RNHCI, ASC, Hospices, PACE, Hospitals, and Long-Term        0938-AK35
            Care Facilities (HCFA-3047-P).......................................................
1004        Medicare Provider and Supplier Hearing Procedures (HCFA-2093-P).....................     0938-AK39
1005        Hospital Conditions of Participation: Quality Assessment and Performance                 0938-AK40
            Improvements (HCFA-3050-F)..........................................................
1006        Requirements for the Recredentialing of Medicare+Choice Organizations Providers          0938-AK41
            (HCFA-1160-F).......................................................................
1007        Supplementary Medical Insurance Premium Surcharge Agreements (HCFA-4007-P)..........     0938-AK42
1008        Medical Devices Coverage Decisions Related to Health Care Technology (HCFA-3059-P)..     0938-AK43
1009        Medicaid Management Information System Revised Definition of ``Mechanized Claims         0938-AK44
            Processing and Information Retrieval System'' (HCFA-2123-IFC).......................
1010        Medicare Program; Reporting and Repayment of Overpayments (HCFA-6011-P).............     0938-AK45
1011        Improvements to the Medicare+Choice Appeals and Grievance Procedures (HCFA-4024-F)..     0938-AK48
1012        Civil Money Penalties, Assessments, and Revised Sanction Authorities (HCFA-6145-FC).     0938-AK49
1013        Payment for Upgraded Durable Medical Equipment (HCFA-1084-F)........................     0938-AK50
1014        Update to the Prospective Payment System for Home Health Agencies for FY 2002 (HCFA-     0938-AK51
            1147-NC)............................................................................
1015        Recognition of the American Osteopathic Association for Ambulatory Surgical Center       0938-AK53
            Programs (HCFA-2079-FN).............................................................
1016        Prospective Payment System for Hospital Outpatient Services (HCFA-1159-P)...........     0938-AK54
1017        Medicare as Secondary Payer-Recovery of Conditional Payments (HCFA-6009-P)..........     0938-AK55
1018        Five Year Review of Work Relative Value Units Under the Physician Fee Schedule           0938-AK56
            Proposed Notice (HCFA-1170-PN)......................................................
1019        Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year         0938-AK57
            2002 (HCFA-1169-P)..................................................................
1020        Changes to National Coverage Determinations and Local Coverage Determinations (HCFA-     0938-AK58
            4019-FC)............................................................................
1021        Revisions to the Prospective Payment System for Hospital Outpatient Services             0938-AK59
            Mandated by BIPA (HCFA-1179-IFC)....................................................
1022        Challenges to National Coverage Determinations and Local Coverage Determinations         0938-AK60
            (HCFA-3063-P).......................................................................
1023        Revised Process for Making Medicare Coverage Decisions (HCFA-3062-N)................     0938-AK61
1024        Claims Attachment Standard (HCFA-0050-P)............................................     0938-AK62
1025        Standards for Electronic Signatures (HCFA-0051-F)...................................     0938-AK63
1026        Health Insurance Reform: Modifications to Standards for Electronic Transaction (HCFA-    0938-AK64
            0003-IFC)...........................................................................
1027        Replacement of Reasonable Charge Methodology by Fee Schedule (HCFA-1010-F)..........     0938-AK66

[[Page 25396]]

 
1028        Physicians' Referrals to Health Care Entities With Which They Have Financial             0938-AK67
            Relationships-Phase II (HCFA-1810-FC)...............................................
1029        Increase in the Rate of Reimbursement of Photocopy Expenses for Prospective Payment      0938-AK68
            System Providers (HCFA-3055-P)......................................................
1030        Long Term Care Prospective Payment System for FY 2003 (HCFA-1177-P).................     0938-AK69
1031        Modifications to Managed Care Rules Based on Provisions of BIPA and Technical            0938-AK71
            Corrections (HCFA-1180-P)...........................................................
1032        Changes to the Hospital Inpatients Prospective Payment System for Fiscal Year 2002       0938-AK73
            Rates (HCFA-1158-P).................................................................
1033        Changes to Inpatient BIPA for Fiscal Year 2001 (HCFA-1178-IFC)......................     0938-AK74
1034        Medicare+Choice ESRD Rates (HCFA-1182-PN)...........................................     0938-AK75
1035        Revisions to Transaction and Code Set Standards for Electronic Transactions (HCFA-       0938-AK76
            0005-IFC)...........................................................................
1036        Medicare Inpatient Disproportionate Share Hospital Adjustment Calculation (HCFA-1171-    0938-AK77
            IFC)................................................................................
1037        Statement of Intent (HCFA-1185-P)...................................................     0938-AK79
1038        Procedures for Public Consultations for Coding and Payment Determinations for New        0938-AK80
            Laboratory Tests (HCFA-1186-N)......................................................
1039        Organ Procurement Organization Condition for Coverage (HCFA-3064-P).................     0938-AK81
1040        Qualification Requirements for Directors of Laboratories Performing High Complexity      0938-AK83
            Testing (HCFA-2094-NPRM)............................................................
1041        Protection and Promotion of Resident Rights (HCFA-3065-P)...........................     0938-AK85
1042        Standards for Electronic Transactions-Elimination of NDC Coding Standards (HCFA-0006-    0938-AK86
            P)..................................................................................
1043        Hospital Reference Laboratory and Medicare Secondary Payer (HCFA-1187-P)............     0938-AK87
1044        Portability in the Group Health Insurance Market (HCFA-2048-F)......................     0938-AK88
----------------------------------------------------------------------------------------------------------------


                             Health Care Financing Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1045        Changes to Peer Review Organization Regulations (HCFA-3135-F).......................     0938-AD38
1046        Protection of Income and Resources for Community Spouses of Institutionalized            0938-AE12
            Individuals (HCFA-2023-P)...........................................................
1047        Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Services (HCFA-2028-     0938-AE72
            F)..................................................................................
1048        Payment for Nursing and Allied Health Science Education (HCFA-1685-F)...............     0938-AE79
1049        Coverage of Screening Pap Smears (HCFA-3705-F)......................................     0938-AE98
1050        Referral to Child Support Enforcement Agencies of Medicaid Families (HCFA-2051-F)...     0938-AF68
1051        Disclosure of Confidential PRO and ESRD Network Organization Information for             0938-AG33
            Research Purposes (HCFA-3208-P).....................................................
1052        Effect of Change of Ownership on Provider and Supplier Penalties, Sanctions,             0938-AG59
            Underpayments and Overpayments (HCFA-2215-P)........................................
1053        Optional Coverage of Certain Tuberculosis to TB-Related Services, TB-Infected            0938-AG72
            Individuals (HCFA-2082-P)...........................................................
1054        Physicians' Referrals to Health Care Entities With Which They Have Financial             0938-AG80
            Relationships-Expanded to Designated Health Services (HCFA-1809-FC).................
1055        Distinct Part Requirements for Nursing Homes and Prohibition on Financial Screening      0938-AG84
            of Applicants for Nursing Home Admission (HCFA-3815-P)..............................
1056        CLIA Program: Categorization of Waived Tests (HCFA-2225-FC).........................     0938-AG99
1057        Additional Supplier Standards (HCFA-6004-FC)........................................     0938-AH19
1058        State Plan Amendment (SPA) Reconsideration Process (HCFA-2096-P)....................     0938-AH24
1059        Medicare Coverage of Services of Speech-Language Pathologists and Audiologists (HCFA-    0938-AH37
            1843-P).............................................................................
1060        Medicaid; Estate Recoveries (HCFA-2083-P)...........................................     0938-AH63
1061        Individual Market Health Insurance Reform: Portability From Group to Individual          0938-AH75
            Coverage; Federal Rules for Access in the Individual Market; State Alternative
            Mechanisms to Federal Rules (HCFA-2882-F)...........................................
1062        Disclosure of Peer Review Organization Information in Response to Beneficiary            0938-AH85
            Complaints (HCFA-3241-P)............................................................
1063        Medicaid Program; Amendment to the Preadmission Screening and Annual Resident Review     0938-AH89
            Program (HCFA-2107-P)...............................................................
1064        Medically Needy Determinations Under Welfare Reform (HCFA-2109-IFC).................     0938-AH92
1065        Medicaid Program; Coverage and Payment for Federally Qualified Health Center             0938-AH95
            Services (HCFA-2043-P)..............................................................
1066        Nondiscrimination in Health Coverage in the Group Market (HCFA-2022-F)..............     0938-AI08
1067        Medicare Program; Improvements to the Appeals Process for Medicare Beneficiaries         0938-AI11
            Enrolled in HMOs, CMPs, and HCPPs (HCFA-4024-P).....................................
1068        Medicare Program; Adjustments to Cost Limits for Skilled Nursing Facility Inpatient      0938-AI14
            Routine Service Costs (HCFA-1896-FN)................................................

[[Page 25397]]

 
1069        Medicare/Medicaid Program; User Fees for Information, Products, and Services (HCFA-      0938-AI46
            6021-P).............................................................................
1070        Prospective Payment System for Hospital Outpatient Services (HCFA-1005-F)...........     0938-AI56
1071        State Plan Requirements for Durable Medical Equipment Providers (HCFA-2007-P).......     0938-AI63
1072        Medicaid Program; Home and Community-Based Services (HCFA-2010-FC)..................     0938-AI67
1073        Medicaid Managed Care; Regulatory Program To Implement Certain Medicaid Provisions       0938-AI70
            of the Balanced Budget Act of 1997 (HCFA-2001-F)....................................
1074        Prospective Fee Schedule for Ambulance Services (HCFA-1002-P).......................     0938-AI72
1075        Revision of Procedures for Requesting Exceptions to Cost Limits for SNFs and             0938-AI80
            Elimination of Reclassifications (HCFA-1883-F)......................................
1076        Expanded Coverage for Diabetes Outpatient Self-Management Training Services (HCFA-       0938-AI96
            3002-F).............................................................................
1077        Medicare Program; Criteria and Standards for Evaluating Intermediary and Carrier         0938-AJ15
            Performance: Millennium Compliance (HCFA-4002-GNC)..................................
1078        Medicare/Medicaid and CLIA Programs: Clinical Laboratory Improvement Amendments of       0938-AJ47
            1988 Exemption of Laboratories in the State of California (HCFA-2245-N).............
1079        Medicare Program: Criteria for Making National Coverage Decision (HCFA-3432-P)......     0938-AJ54
1080        Medicare Program; Sustainable Growth Rate for Fiscal Year 2000 (HCFA-1110-N)........     0938-AJ60
1081        Medicare and Medicaid Programs; Programs for All-Inclusive Care for the Elderly          0938-AJ63
            (PACE) (HCFA-1903-P)................................................................
1082        Clinical Social Worker Services (HCFA-1088-F).......................................     0938-AJ71
1083        Medicaid Disproportionate Share Hospital Payments-Institutions for Mental Disease        0938-AJ74
            (HCFA-2062-N).......................................................................
1084        The Children's Health Insurance Program: Implementing the Balanced Budget Act of         0938-AJ75
            1997 (HCFA-2006-F)..................................................................
1085        Medicare Program Update of Ambulatory Surgical Center Payment Rates Effective for        0938-AJ86
            Services On or After October 1, 1999 (HCFA-1085-N)..................................
1086        Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities-      0938-AJ93
            Update (HCFA-1112-F)................................................................
1087        Use of Restraint and Seclusion in Residential Treatment Facilities Providing             0938-AJ96
            Inpatient Psychiatric Services to Individuals Under Age 21 (HCFA-2065-F)............
1088        Conditions of Participation for Intermediate Care Facilities for the Mentally            0938-AJ99
            Retarded............................................................................
1089        Flexibility in Payment Methods for Services of Hospitals, Nursing Facilities, and        0938-AK04
            Intermediate Care Facilities for the Mentally Retarded (HCFA-2004-F)................
1090        Hospital Conditions of Participation; Anesthesia Services (HCFA-3049-F).............     0938-AK08
1091        Changes to the Appeals Process for Beneficiaries Receiving Home Health Services in       0938-AK10
            the Fee For Service Program (HCFA-4006-P)...........................................
1092        Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year         0938-AK11
            2001 (HCFA-1120-F)..................................................................
1093        Revisions to Medicaid Upper Payment Limit Requirements for Hospital, Nursing             0938-AK12
            Facility, Intermediate Care Facility Services for the Mentally Retarded and Clinic
            Services (HCFA-2071-F)..............................................................
1094        Hospice Wage Index (HCFA-1135-N)....................................................     0938-AK13
1095        HIPAA Program; Bona Fide Wellness Programs (HCFA-2078-F)............................     0938-AK19
1096        Application of Federal Financial Participation Limits (HCFA-2086-F).................     0938-AK22
1097        Prospective Payment System for Hospital Outpatient Services: Exception to the            0938-AK25
            Provider-Based Location Criteria for PPS-Exempt Facilities (HCFA-1143-F)............
1098        Criteria and Standards for Evaluating Intermediary and Carrier Performance During FY     0938-AK26
            2001 (HCFA-4010-GNC)................................................................
1099        Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance        0938-AK27
            Amounts for Calendar Year 2001 (HCFA-8007-N)........................................
1100        Mandatory Transmission of OASIS for Non-Medicare/Medicaid Patients in Home Health        0938-AK28
            Agencies and Continued Delay of Requirements for Patients Receiving Personal Care
            Services (HCFA-2070-N)..............................................................
1101        Removal of the Requirements for the Cardiac Pacemaker Registry (HCFA-3045-F)........     0938-AK29
1102        Physicians' Referrals to Health Care Entities With Which They Have Financial             0938-AK31
            Relationships-Phase II (HCFA-1810-FC)...............................................
1103        Elimination of Application of Federal Financial Participation Limits (HCFA-2086-P)..     0938-AK32
1104        Conforming Regulations Changes and Statutory Revisions for Approval and Oversight of     0938-AK36
            Accreditation Organizations (HCFA-2088-P)...........................................
----------------------------------------------------------------------------------------------------------------


                          Administration for Children and Families--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1105        Program Performance Standards for the Operation of Head Start Programs..............     0970-AB99
1106        Safeguarding Child Support and Expanded FPLS Information............................     0970-AC01

[[Page 25398]]

 
1107        Developmental Disabilities and Bill of Rights Act...................................     0970-AC07
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1108        Construction and Major Renovation of Head Start and Early Head Start Facilities.....     0970-AB54
1109        Child Support Enforcement for Indian Tribes.........................................     0970-AB73
1110        Child Support Enforcement Program Omnibus Conforming Regulation.....................     0970-AB81
1111        Family Child Care Program Option for Head Start Programs............................     0970-AB90
1112        Technical Revision of Head Start Regulations To Make Them Conform to Recent              0970-AC00
            Statutory Revisions.................................................................
1113        High Performance Bonus Awards Under the TANF Program................................     0970-AC06
1114        Individual Development Accounts.....................................................     0970-AC08
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1115        Standards for Safe Transportation...................................................     0970-AB24
1116        Incentive Payments and Audit Penalties to States and Political Subdivisions.........     0970-AB85
1117        State Self-Assessments To Determine Compliance With Federal Regulations.............     0970-AB96
1118        National Medical Support Notice.....................................................     0970-AB97
----------------------------------------------------------------------------------------------------------------


                                  Administration on Aging--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1119        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.....................................................
1120        Grants for State and Community Programs on Aging, Family Caregivers, American            0985-AA01
            Indians, and Native Hawaiians (Section 610 Review)..................................
----------------------------------------------------------------------------------------------------------------

_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




813.  GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT) 
AND GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (GRANTS)

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

Legal Authority: 5 USC 301; 41 USC 701 et seq, sec 2455; PL 103-355; 31 
USC 6101 note; EO 12859

CFR Citation: 45 CFR 76; 45 CFR 82

Legal Deadline: None

Abstract: This proposed common rule is revised to simplify and 
streamline nonprocurement debarment and suspension requirements, as 
well as correspond to procurement regulations where possible. The 
revision will separate the debarment and suspension and Drug-Free 
Workplace regulations, and will be written in the plain language 
format.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/01

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Diane Osterhus, Federal Assistance Policy Specialist, 
Department of Health and Human Services, Office of the Secretary, Room 
517D, Office of Grants and Acquisition Management, 200 Independence 
Avenue SW., Washington, DC 20201
Phone: 202 690-6901
Fax: 202 690-5729

[[Page 25399]]

Email: [email protected]

RIN: 0991-AB12
_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




814. REPRODUCTION AND SALE OF OFFICIAL FORMS AND PUBLICATIONS

Priority: Info./Admin./Other

Legal Authority: 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. It amends existing prohibitions against ``misuse of 
symbols, emblems, or names in reference to Social Security or 
Medicare.'' Section 312 also 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              11/00/01

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
_______________________________________________________________________




815. SHARED RISK EXCEPTION TO THE SAFE HARBOR PROVISIONS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 1320a-7b; 42 USC 1395hh; PL 104-
191, sec 216(b)

CFR Citation: 42 CFR 1001

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

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 that 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                      08/00/01

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
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

Legal Authority: Social Security Act, sec 1128A(a)(5)

CFR Citation: 42 CFR 1003

Legal Deadline: None

Abstract: This final rule will 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 specifically establishes various standards that, if met, would 
result in the particular arrangement being protected from civil 
penalties under section 1128A(a)(5) of the Social Security Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/02/00                    65 FR 25460
NPRM Comment Period End         07/03/00
Final Action                    10/00/01

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
_______________________________________________________________________




817. SAFE HARBOR FOR AMBULANCE RESTOCKING

Priority: Substantive, Nonsignificant

Legal Authority: PL 100-93, sec 14(a)

[[Page 25400]]

CFR Citation: 42 CFR 1001

Legal Deadline: None

Abstract: This rule will set forth acceptable restocking arrangements 
between municipal and nonprofit ambulance companies and hospitals.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/22/00                    65 FR 32060
NPRM Comment Period End         07/21/00
Final Action                    10/00/01

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
_______________________________________________________________________




818. REVISIONS AND TECHNICAL CORRECTIONS TO 42 CFR CHAPTER V

Priority: Substantive, Nonsignificant

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 final rule sets forth several miscellaneous revisions 
and technical corrections to the OIG regulations codified in 42 CFR 
chapter V. Among other revisions, this rule makes 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                            10/20/00                    65 FR 63035
NPRM Comment Period End         12/20/00
Final Action                    09/00/01

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
_______________________________________________________________________




819. AMENDING THE REGULATIONS GOVERNING NONDISCRIMINATION ON THE BASIS 
OF RACE, COLOR, NATIONAL ORIGIN, HANDICAP, SEX, AND AGE TO CONFORM TO 
THE CIVIL RIGHTS RESTORATION ACT OF 1987

Priority: Other Significant

Legal Authority: PL 100-259, Civil Rights Restoration Act of 1987

CFR Citation: 45 CFR 80; 45 CFR 84; 45 CFR 86; 45 CFR 90; 45 CFR 91

Legal Deadline: None

Abstract: The Secretary proposes to amend the Department's regulations 
implementing title VI of the Civil Rights Act of 1964, as amended, 
section 504 of the Rehabilitation Act of 1973, as amended, title IX of 
the Education Amendments of 1972, and the Age Discrimination Act of 
1975, as amended. The principal proposed conforming change is to amend 
the regulations to add the definitions of ``program or activity'' or 
``program'' that correspond to the statutory definitions enacted under 
the Civil Rights Restoration Act of 1987.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/26/00                    65 FR 64194
NPRM Comment Period End         11/27/00
Final Action                    11/00/01
Final Action Effective          01/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Federal

Agency Contact: Roinsue Frohboese, Department of Health and Human 
Services, Office of the Secretary
Phone: 202 619-0403

RIN: 0991-AB10
_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




820. 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                             To Be                       Determined

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

[[Page 25401]]

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

RIN: 0991-AB03
_______________________________________________________________________




821. SAFE HARBOR FOR ARRANGEMENTS INVOLVING FEDERALLY QUALIFIED HEALTH 
CENTERS

Priority: Substantive, Nonsignificant

Legal Authority: PL 100-93, sec 14(a)

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: Next Action Undetermined

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
_______________________________________________________________________




822.  DEFINITION OF TERMS; SUBSTANTIALLY IN EXCESS AND USUAL 
CHARGES AND CLARIFICATION OF THE GOOD CAUSE EXCEPTION

Priority: Substantive, Nonsignificant

Legal Authority: Sec. 1128(b)(A) of the Social Security Act

CFR Citation: 42 CFR 1001

Legal Deadline: None

Abstract: This proposed rule would amend the OIG exclusion regulations 
at 42 CFR 1001.701, addressing excessive claims, by including 
definitions for the terms ``substantially in excess'' and ``usual 
charges'', and by clarifying the ``good cause'' exception set forth in 
this section.

Timetable: Next Action Undetermined

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-AB13
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Office of the Secretary (OS)



_______________________________________________________________________




823. STANDARDS FOR PRIVACY OF INDIVIDUALLY INDENTIFIABLE HEALTH 
INFORMATION

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 45 CFR 160; 45 CFR 164

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      12/28/00                    65 FR 82462
Delay of Effective Date To 04/
14/2001                         02/26/01                    66 FR 12434
Comment Period Extended         03/30/01                    66 FR 12738

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: State, Local, Tribal, Federal

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

Agency Contact: Roxanne Gibson
Phone: 202 260-5083

RIN: 0991-AB08
_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




824. 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.

[[Page 25402]]

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)         Completed Actions


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




825. FINAL AND DELEGATION OF AUTHORITY TO IMPLEMENT SAMHSA'S 
ACCREDITATION BASED SYSTEM FOR OPIOD TREATMENT PROGRAM MONITORING

Priority: Other Significant

CFR Citation: 42 CFR 8

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      01/17/01                     66 FR 4075
60-Day Delay of Effective Date 
To 05/18/2001                   03/19/01                    66 FR 15347

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

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

RIN: 0930-AA06
_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




826.  AMENDMENTS TO QUALITY ASSURANCE AND ADMINISTRATIVE 
PROVISION FOR APPROVAL OF RESPIRATORY PROTECTIVE DEVICES

Priority: Other Significant

Legal Authority: 29 USC 651 et seq; 30 USC 3; 30 USC 5; 30 USC 7; 30 
USC 811; 30 USC 842(h); 30 USC 844

CFR Citation: 42 CFR 84

Legal Deadline: None

Abstract: NIOSH plans to propose the Administrative/Quality Assurance 
sections of 42 CFR part 84, Approval of Respiratory Protective Devices. 
Areas for potential modification in this module are: 1) upgrade of 
Quality Assurance requirements; 2) ability to use private sector 
quality auditors and private sector testing laboratories in the 
approval program; 3) revised approval label requirements; 4) updated 
and restructured fee schedule; and 5) fee retention in the Respirator 
program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/01

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Larry Elliott, Acting Director, Office of Compensation 
Analysis and Support, Department of Health and Human Services, Centers 
for Disease Control and Prevention, NIOSH, R44, 5555 Ridge Avenue, 
Cincinnati, OH 45213
Phone: 513 841-4400

RIN: 0920-AA04
_______________________________________________________________________




827.  METHODS FOR ESTIMATING RADIATION DOSE AND GUIDELINES FOR 
ASSESSING PROBABILITY OF CANCER FOR ENERGY EMPLOYEES OCCUPATIONAL 
ILLNESS COMPENSATION PROGRAM

Priority: Other Significant

Legal Authority: PL 106-398, sec 3623

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: Pursant to Executive Order 13179, which implements section 
3623 of the Energy Employees Occupational Illness Compensation Program 
Act, Public Law 106-398, NIOSH plans to propose and finalize 
regulations, to establish:
1) Guidelines to assess the likelihood that an individual with cancer 
sustained that cancer in the performance of duty at a Department of 
Energy facility or an atomic weapons employer facility, as defined in 
that Act; and
2) Methods for arriving at and providing reasonable estimates of the 
radiation doses received by individuals applying for assistance under 
this program for whom there are inadequate records of radiation 
exposure.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/01

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Roland Berry Ann, Team Leader, Policy Development, 
Respirator Branch, Department of Health and Human Services, Centers for 
Disease Control and Prevention, NIOSH, P04, 1095 Willowdale Road, 
Morgantown, WV 26505
Phone: 304 285-5907

RIN: 0920-AA05

[[Page 25403]]

_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




828. PACKAGING AND HANDLING OF INFECTIOUS SUBSTANCES AND SELECT AGENTS

Priority: Other Significant

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
_______________________________________________________________________




829. 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: 42 CFR 70; 42 CFR 71

Legal Deadline: None

Abstract: CDC proposes to modify certain regulatory responsibilities of 
42 CFR 70 and 42 CFR 71 that relate to quarantine in order to bring the 
regulations up to date regarding modern communicable disease concerns.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule                       To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: State

Federalism:  Undetermined

Agency Contact: Chuck Gollmar, Deputy Director, 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
Email: [email protected]

RIN: 0920-AA03
_______________________________________________________________________


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


Departmental Management (HHSDM)



_______________________________________________________________________




830. 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                     08/00/01

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)



_______________________________________________________________________




831. NATURAL RUBBER-CONTAINING DRUGS; USER LABELING

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321; 21 USC 374; 21 USC 379; 42 USC 216; 42 USC 
241; 42 USC 262; 42 USC 264; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 371

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                           12/00/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

[[Page 25404]]

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
_______________________________________________________________________




832. IMPLEMENTATION OF THE IMPORT TOLERANCE PROVISIONS OF THE ANIMAL 
DRUG AVAILABILITY ACT OF 1996

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. This rule would implement the provisions in 
ADAA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           07/00/01
NPRM                            02/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: George A. (``Bert'') Mitchell, Associate Director for 
Policy and Regulations, Office of the Director, Department of Health 
and Human Services, Food and Drug Administration, HFV-1, Center for 
Veterinary Medicine, 7500 Standish Place, Rockville, MD 20855
Phone: 301 827-2957

RIN: 0910-AB71
_______________________________________________________________________




833. 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: 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                      04/03/00
End Review                      04/00/01

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)



_______________________________________________________________________




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

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351; 21 USC 352; 21 USC 353; 21 
USC 355; 21 USC 360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 360b; 
21 USC 361; 21 USC 371

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

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

[[Page 25405]]

Products'' and reproposed as ``Poison Treatment Products.'' NPRM for 
``Astringent (Wet Dressings) Products'' was included in the NPRM for 
``Skin Protectant Products.'' NPRM for ``Diaper Rash Products'' was 
included in NPRMs for ``Antifungal,'' ``Antimicrobial,'' ``External 
Analgesic'' and ``Skin Protectant Products.'' NPRM for ``Fever Blister/
Cold Sore Products (External)'' was included in NPRMs for ``External 
Analgesic'' and ``Skin Protectant Products.'' NPRM for ``Insect Bites 
and Stings (Relief) Products'' was included in NPRMs for ``External 
Analgesic'' and ``Skin Protectant Products.'' ``Poison Ivy/Oak/Sumac 
Prevention'' was included in NPRMs for ``External Analgesic'' and 
``Skin Protectant Products.'' NPRM for ``Mercurial (Topical) Products'' 
was included in revised NPRM for ``Antimicrobial Products.'' NPRM for 
``Alcohol (Topical) Products'' was included in revised NPRM for 
``Antimicrobial Products.'' The NPRM for ``Antimicrobial Products'' was 
updated and split into two sections: First Aid Products and Health Care 
Antiseptic Products.
SMALL ENTITIES AFFECTED: The effects, if any, vary depending on the 
individual rulemaking. However, the Agency anticipates that the rules 
would not have a significant economic impact on a substantial number of 
small entities as defined by the Regulatory Flexibility Act.

Timetable:
________________________________________________________________________

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

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

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) (Overindulgence) 12/00/01  Final Action (Amendment)(Sodium 
B.) 06/00/02

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.) 12/00/01  Final Action 12/00/
01

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)  Final Action (Amendment) 
(Warning) 12/00/01

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 08/29/00 (65 FR 52302)  NPRM (Amendment) Clotrimazole 05/00/01

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 04/00/02

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

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)

[[Page 25406]]

Cough/Cold (Antihistamine) Products  ANPRM 09/09/76 (41 FR 38312)  NPRM 
01/15/85 (50 FR 2200)  NPRM (Amendment) 08/24/87 (52 FR 31892)  Final 
Action 12/09/92 (57 FR 58356)  Final Action (Amendment)(Warning) 01/28/
94 (59 FR 4216)  NPRM (Amendment)(Warning) 08/29/97 (62 FR 
45767)  Reopen Record (Common Cold) 08/25/00 (65 FR 51780)  Final 
Action (Amendment)(Warning) 12/00/01  Final Action 12/00/02

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)(Warning) 
08/29/97 (62 FR 45767)  NPRM (Amendment)(Flammability) 07/20/98 (63 FR 
38762)  Final Action (Amendment)(Flammability) 08/01/00 (65 FR 
46864)  Final Action (Amendment)(Warning) 12/00/01

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) 12/00/01

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) 12/00/01  Final Action 12/00/01

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)  Final Action (Amendment)(Levmetamfetamine) 07/
30/98 (63 FR 40647)  NPRM (Phenylpropanolamine) 06/00/01

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 06/00/01

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 
(Amendment)(Warning) 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 12/00/02

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)  Final Action 
12/00/01

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)  NPRM 12/00/01

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)

[[Page 25407]]

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 10/20/93 (58 FR 54224)  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)  NPRM 
(Amendment)(Ibuprofen) 10/00/01  Final Action 12/00/01  Final Action 
(Amendment)(Overindulgence) 12/00/01  Final Action (Sodium Bicarbonate) 
06/00/02

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) 07/00/01

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 01/00/
02  Final Action (Stim. Laxative) 12/00/03

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 (Merged with other rulemaking)  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 
(Amendment)(Warning) 12/00/01

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 06/21/00 (65 FR 38426)

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)  NPRM 04/00/01  ANPRM (Plaque/Gingivitis) 12/00/01

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 08/10/00 (65 FR 48902)

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) 12/00/01

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/
00/01  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) 12/00/01

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

[[Page 25408]]

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 (Astringent) 07/00/01  Final Action (Poison Ivy) 
07/00/01  Final Action 07/00/01

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)  Final Action 12/00/01

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)  ANPRM (and Insect Repellant) 08/00/01  NPRM (UVA/UVB) 
09/00/01

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 07/00/02

Vaginal Contraceptive Products  ANPRM 12/12/80 (45 FR 82014)  NPRM 02/
03/95 (60 FR 6892)  NPRM (Amendment) 12/00/01

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)  NPRM 01/00/02

Weight Control Products  ANPRM 02/26/82 (47 FR 8466)  NPRM 10/30/90 (55 
FR 45788)  Final Action 08/08/91 (56 FR 37792)  NPRM 
(Phenylpropanolamine) 06/00/01

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, HFD-560, Center for Drug 
Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2222

RIN: 0910-AA01
_______________________________________________________________________




835. 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.

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                            12/00/01

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: 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-AA39
_______________________________________________________________________




836. ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR DRUGS AND 
BIOLOGICS

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 
355; 21 USC 360; 21 USC 360b; 21 USC 371; 21 USC 374; 42 USC 262

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 regulations. The proposal would also 
require the electronic submission of establishment registration and 
product listing information.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/01

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-

[[Page 25409]]

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

RIN: 0910-AA49
_______________________________________________________________________




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

Priority: Routine and Frequent

Legal Authority: 21 USC 321; 21 USC 381; 21 USC 382; 21 USC 393; 42 USC 
241; 42 USC 243; 42 USC 262; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
353; 21 USC 355; 21 USC 371

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                            07/00/01

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 15-61 
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AA61
_______________________________________________________________________




838. SAFETY REPORTING AND RECORDKEEPING REQUIREMENTS FOR MARKETED OTC 
DRUGS

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

Unfunded Mandates: Undetermined

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

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                            12/00/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Audrey Thomas, Regulatory Policy Analyst, 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-AA86
_______________________________________________________________________




839. SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND BIOLOGICAL 
PRODUCTS

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

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 216; 42 USC 241; 42 USC 242a; 42 USC 262; 42 
USC 263; 42 USC 263a-n; 42 USC 264; 42 USC 300aa; 21 USC 321; 21 USC 
331; 21 USC 351 to 353; 21 USC 355; 21 USC 360; 21 USC 360b-j; 21 USC 
361a; 21 USC 371; 21 USC 374; 21 USC 375; 21 USC 379e; 21 USC 381

CFR Citation: 21 CFR 310; 21 CFR 312; 21 CFR 314; 21 CFR 600; 21 CFR 
320; 21 CFR 601; 21 CFR 606

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 safety reports received by FDA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

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

[[Page 25410]]

Fax: 301 827-5562

RIN: 0910-AA97
_______________________________________________________________________




840. RADIOACTIVE DRUGS FOR BASIC RESEARCH

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 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                            12/00/01

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
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AB00
_______________________________________________________________________




841. ADMINISTRATIVE PRACTICES AND PROCEDURES; ADVISORY OPINIONS AND 
GUIDELINES

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

Unfunded Mandates: Undetermined

Legal Authority: 15 USC 1451 to 1461; 42 USC 262; 42 USC 263b; 42 USC 
264; 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

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                            08/00/01

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
_______________________________________________________________________




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

Priority: Other Significant

Legal Authority: 42 USC 216; 42 USC 243; 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 
cells and tissue to follow current good tissue practice (GTP), which 
includes proper handling, processing, and storage of human cells and 
tissue, recordkeeping, and the maintenance of a quality program. FDA is 
also proposing to amend the current good manufacturing practice 
regulations that apply to medical device products and biological 
products containing human cells or tissues in order to incorporate the 
new GTP requirements into existing good manufacturing practice 
regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/08/01                     66 FR 1508
NPRM Comment Period End         05/08/01
Final Action                    01/00/03

Regulatory Flexibility Analysis Required: No

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

RIN: 0910-AB28
_______________________________________________________________________




843. APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG; COMPLETE 
RESPONSE LETTER; AMENDMENTS TO UNAPPROVED APPLICATIONS

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 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                            06/00/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Brian L. Pendleton, Regulatory Counsel, Regulatory 
Policy

[[Page 25411]]

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
Email: [email protected]

RIN: 0910-AB34
_______________________________________________________________________




844. EXPANDED ACCESS TO INVESTIGATIONAL THERAPIES

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 360bbb

CFR Citation: 21 CFR 312

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/01

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
_______________________________________________________________________




845. 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 355; 21 USC 371; 21 USC 374; 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

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                            11/00/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Audrey Thomas, Regulatory Policy Analyst, 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
_______________________________________________________________________




846. DISTINGUISHING MARKS FOR DRUG PRODUCTS CONTAINING INSULIN

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

Unfunded Mandates: Undetermined

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

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                            11/00/01

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
_______________________________________________________________________




847. PREGNANCY LABELING

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

Unfunded Mandates: Undetermined

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

CFR Citation: 21 CFR 201

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/01

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

[[Page 25412]]

Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AB44
_______________________________________________________________________




848. 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: Positron emission tomography (PET) is a medical imaging 
modality involving the use of a unique type of radiopharmaceutical 
drug. PET drugs are usually injected intravenously into patients for 
diagnostic purposes. Most PET drugs are produced using cyclotrons at 
locations that are in close proximity to the patients to whom the drugs 
are administered (e.g., in hospitals or academic institutions). Each 
PET drug is compounded under a physician's prescription and, due to the 
short half-lives of PET drugs, is administered to the patient within a 
few minutes or hours.
Under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act 
(the Act) (21 U.S.C. 351(a)(2)(B)), a drug is adulterated if the 
methods used in, or the facilities or controls used for, its 
manufacture, processing, packing, or holding do not conform to or are 
not operated or administered in conformity with current good 
manufacturing practice (CGMP) to assure that the drug meets the 
requirements of the Act as to safety and has the identity and strength, 
and meets the quality and purity characteristics, that it purports or 
is represented to possess. FDA's CGMP requirements for drug products 
are set forth in 21 CFR parts 210 and 211.
On November 21, 1997, the President signed into law the Food and Drug 
Administration Modernization Act (Modernization Act) (Pub. L. 105-115). 
Section 121 of the Modernization Act contains several provisions 
affecting the regulation of PET drugs. Section 121(c)(1)(A) of the 
Modernization Act directs FDA to establish, within two years after 
enactment, appropriate approval procedures and CGMP requirements for 
PET drugs. Section 121(c)(1)(B) requires FDA to consult with patient 
advocacy groups, professional associations, manufacturers, and other 
interested persons as the agency develops PET drug CGMP requirements 
and approval procedures. FDA's proposed rule on PET drug CGMP's will be 
designed to reflect the unique nature of PET drug products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/01

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
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AB63
_______________________________________________________________________




849. CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS

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

Unfunded Mandates: Undetermined

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                            12/00/01

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
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant. 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                            07/00/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

[[Page 25413]]

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
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AB79
_______________________________________________________________________




851. REPACKAGING APPROVAL REQUIREMENTS

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
353; 21 USC 355; 21 USC 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                            01/00/02

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
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AB81
_______________________________________________________________________




852. 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                            12/00/01

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
_______________________________________________________________________




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

Priority: Economically Significant. Major under 5 USC 801.

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

Legal Authority: 21 USC 321; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 
371; 21 USC 374; 21 USC 381; 21 USC 393; 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                            06/00/01

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

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: 202 205-4168
Fax: 202 205-5295
Email: [email protected]

RIN: 0910-AB88
_______________________________________________________________________




854. SUBMISSION IN ELECTRONIC FORMAT OF CERTAIN LABELING INFORMATION

Priority: Other Significant. 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; ...

[[Page 25414]]

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 certain labeing content described under sections 201.56 and 201.57 
be submitted to FDA in electronic format.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/01

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-AB91
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant. 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                            08/00/01

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
_______________________________________________________________________




856. PERIODIC TESTING FOR CERTAIN HUMAN DRUG, VETERINARY DRUG, AND 
BIOLOGICAL PRODUCT FINAL SPECIFICATIONS

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 
360(b); 21 USC 371; 21 USC 374

CFR Citation: 21 CFR 211.165; 21 CFR 314; 21 CFR 514; 21 CFR 601; 21 
CFR 610

Legal Deadline: None

Abstract: The proposed rule requests comments on when certain finished 
product laboratory tests to determine satisfactory conformance to final 
specifications for new human drug, animal drug, animal drugs and 
biological products may be performed on a periodic basis.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/01

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
_______________________________________________________________________




857. 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 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                            07/00/01

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 15-61 
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane, 
Rockville, MD 20857

[[Page 25415]]

Phone: 301 827-3380
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AB96
_______________________________________________________________________




858. 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; and (5) require notification of transfer of ownership 
for all premarket applications.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/01

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
_______________________________________________________________________




859. 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); 18 USC 1905; 21 USC 355(i); 
21 USC 371(a); 42 USC 264

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 for public disclosure of 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 would be able to be discussed in open session at scientific 
advisory committee meetings and at other suitable fora.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/18/01                     66 FR 4688
NPRM Comment Period End         04/18/01
Final Action                    02/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

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
_______________________________________________________________________




860. REPORTING INFORMATION REGARDING POTENTIAL FABRICATION OR 
FALSIFICATION OF DATA

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 349; 21 USC 
352; 21 USC 355i; 21 USC 360b; 21 USC 360c; 21 USC 360e; 21 USC 360i; 
21 USC 360j; 21 USC 360k; 21 USC 371; 21 USC 379e; 42 USC 262

CFR Citation: 21 CFR 70.3; 21 CFR 71.1; 21 CFR 170.3; 21 CFR 171.1; 21 
CFR 312.3; 21 CFR 312.56; 21 CFR 510.3; 21 CFR 511.1; 21 CFR 812.46

Legal Deadline: None

Abstract: The proposed rule would require sponsors to promptly report 
any information indicating that any person has or may have falsified 
data in the course of proposing, designing, performing, recording, 
supervising, or reviewing research, or in reporting research results.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

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-AC02
_______________________________________________________________________




861. 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 360b

CFR Citation: 21 CFR 524

Legal Deadline: None

Abstract: After approving a new animal drug application, the Food and 
Drug Administration (FDA) requires the

[[Page 25416]]

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                            02/00/02

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: William Keller, Division Director, Division of 
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
_______________________________________________________________________




862. LABELING DIETARY SUPPLEMENTS FOR WOMEN WHO ARE OR MAY BECOME 
PREGNANT

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321(n); 21 USC 342(f); 21 USC 343(a)(1); 21 USC 
343(r)(6); 21 USC 371(a)

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is proposing to 
require manufacturers to label their dietary supplements with a caution 
statement for women who are or may become pregnant unless there is 
evidence demonstrating that use in pregnancy is safe. FDA is including 
in this proposal a list of products that would not require this caution 
statement, as well as a petition process by which a product may be 
exempted from bearing the caution statement. FDA is also proposing to 
regulate manufacturers of dietary supplements that bear a claim about 
an effect on a condition associated with pregnancy to maintain and 
permit FDA inspection of certain records. FDA is proposing this rule 
because of the special safety concerns associated with use of any 
product during pregnancy.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/01

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
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AC09
_______________________________________________________________________




863. OVERWRAP FOR INHALATION PRODUCTS PACKAGED IN LOW DENSITY 
POLYETHYLENE (LDPE) CONTAINERS

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 358; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 375

CFR Citation: 21 CFR 200

Legal Deadline: None

Abstract: The proposed rule would require overwrap on all inhalation 
products packaged in low density polyethylene (LDPE) containers to 
prevent ingress of contaminates.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/01

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: None

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-AC10
_______________________________________________________________________




864. REGULATION OF CARCINOGENIC COMPOUNDS USED IN FOOD-PRODUCING 
ANIMALS; DEFINITION OF ``NO RESIDUE''

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 342; 21 USC 343; 21 USC 
348; 21 USC 351; 21 USC 352; 21 USC 353; 21 USC 360b; 21 USC 371

CFR Citation: 21 CFR 500.82; 21 CFR 500.84; 21 CFR 500.88

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is proposing to amend 
its regulations relating to the operational definition of the term ``no 
residue.'' The definition is used in determining whether any residue of 
carcinogenic compounds used in food-producing animals would ``be found 
in food produced from those animals under conditions of use reasonably 
certain to be followed in practice'' (21 CFR 500.80(a)). Under the 
current operational definition of no residue, it is possible for a 
residue detected by a method approved by FDA to be considered ``no 
residue.'' FDA is revising its regulations to make them consistent with 
a 1995 Department of Justice opinion regarding this definition. The 
proposed changes would revise the definition of ``no residue'' to mean 
that no residue is detected with an approved regulatory method. FDA 
would propose several conditions that sponsors of

[[Page 25417]]

carcinogenic compounds must satisfy with respect to the sponsors' 
proposed regulatory methods.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Steven Brynes, Regulatory Scientist, Department of 
Health and Human Services, Food and Drug Administration, HFV-151, 
Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD 
20855
Phone: 301 827-6975
Email: [email protected]

RIN: 0910-AC13
_______________________________________________________________________




865. CONTROL OF SALMONELLA ENTERITIDIS IN SHELL EGGS DURING PRODUCTION 
AND RETAIL

Priority: Economically Significant. Major under 5 USC 801.

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

Legal Authority: 21 USC 321; 21 USC 342; 21 USC 371; 21 USC 381; 21 USC 
393; 42 USC 264; 42 USC 343; 42 USC 264; 42 USC 271

CFR Citation: 21 CFR 116; 21 CFR 118

Legal Deadline: None

Abstract: The President's Council on Food Safety was established in 
August 1998 to improve the safety of the food supply through science-
based regulations and well-coordinated inspection, enforcement, 
research, and education programs. The Council has identified egg safety 
as one component of the public health issue of food safety that 
warrants immediate Federal, interagency action.
In July 1999, FDA and FSIS committed to developing an action plan to 
address the presence of salmonella enteritidis (SE) in shell eggs and 
egg products using a farm-to-table approach. FDA and FSIS held a public 
meeting on August 26, 1999, to obtain stakeholder input on the draft 
goals, as well as to further develop the objectives and action items 
for the action plan. The Egg Safety Action Plan was announced by the 
President on December 11, 1999. The goal of the Action Plan is to 
reduce egg-related SE illnesses by 50 percent by 2005 and eliminate 
egg-related SE illnesses by 2010.
The Egg Safety Action Plan consists of eight objectives covering all 
stages of the farm-to-table continuum as well as support functions. On 
March 30, 2000 (Columbus, OH), and April 6, 2000 (Sacramento, CA), 
joint public meetings were held by FDA and FSIS to solicit and discuss 
information related to the implementation of the objectives in the Egg 
Safety Action Plan.
In accordance with discussions at the public meetings, FDA intends to 
publish a proposed rule to require that shell eggs be produced under an 
SE risk reduction plan that is designed to prevent transovarian SE from 
contaminating eggs at the farm during production.
Because egg safety is a farm-to-table effort, FDA intends to include in 
its proposal certain provisions of the 1999 Food Code that are relevant 
to how eggs are handled, prepared, and served at retail establishments. 
In addition, the agency intends to propose specific requirements for 
retail establishments that serve populations most at-risk of egg-
related illness (i.e., the elderly, children, and the 
immunocompromised).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/01

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Rebecca Buckner, Consumer Safety Officer, 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: 202 205-4081
Fax: 202 205-4422
Email: [email protected]

Nancy Bufano, Consumer Safety Officer, 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: 202 401-2022
Fax: 202 205-4422
Email: [email protected]

RIN: 0910-AC14
_______________________________________________________________________




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

Priority: Other Significant

Legal Authority: 21 USC 352; 21 USC 321(n); 21 USC 371(a); 21 CFR 
201.51; 21 CFR 201.100; 21 CFR 314.125

CFR Citation: 21 CFR 201.323(c)

Legal Deadline: None

Abstract: The proposed rule would revise 21 CFR 323(c) to permit small 
volume parenterals and pharmacy bulk packages that contain less than 25 
ug/L of aluminum to state ``contains less than 25ug/L'' rather than the 
exact amount of aluminum.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/01

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: None

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-AC18
_______________________________________________________________________




867.  USE OF MATERIALS DERIVED FROM RUMINANT ANIMALS IN FDA 
REGULATED PRODUCTS

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

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: The U.S. Department of Agriculture's Animal and Plant Health 
Inspection Service maintains, by regulation in 9 CFR 94.18(a), a list 
of countries: (1) where bovine spongiform encephalopathy (BSE) exists; 
and (2) that present an undue risk of introducing BSE into the United 
States. This proposed rule would restrict, in FDA regulated products, 
the use of

[[Page 25418]]

most materials derived from ruminant animals born, raised, or 
slaughtered in a country listed in 9 CFR 94.18(a). In addition, there 
would be a waiver provision that could be used under appropriate 
criteria.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/01

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-AC19
_______________________________________________________________________




868.  POSTMARKETING REPORTS OF SUBSTANDARD OR INEFFECTIVE BULK 
INGREDIENTS AND BULK INGREDIENTS FROM UNAPPROVED SOURCES

Priority: Info./Admin./Other

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: Not Yet Determined

Legal Deadline: None

Abstract: The proposed rule would address reporting and other issues 
relating to the importation or receipt of bulk ingredients that are 
substandard, ineffective, or come from unapproved sources. The proposal 
is intended to enhance FDA's ability to help ensure that human drug 
products have the strength, quality, and purity appropriate for an 
approved human drug product.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Room 15-61 
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AC20
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




869. 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.

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 guidance 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

Records and Reports Concerning Experience with Approved New Animal 
Drugs  NPRM 12/17/91 (56 FR 65581)  Final Action 05/00/01

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: For information concerning reporting 
requirements for marketed animal drugs, contact William C. Keller, 
Director, Division of Surveillance, Center for Veterinary Medicine, 
Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 
301 827-6642.
For further information concerning generic animal drugs, contact Lonnie 
W. Luther, Chief, Quality Assurance

[[Page 25419]]

Support Team, Center for Veterinary Medicine, Food and Drug 
Administration, 7500 Standish Place, Rockville, MD 20855, 301 827-0209.

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

RIN: 0910-AA02
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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 211.113; 21 CFR 211.160; 21 CFR 
211.165; 21 CFR 211.166; 21 CFR 211.180; 21 CFR 211.192; 21 CFR 
211.220; 21 CFR 211.222; 21 CFR 211.240; 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; ...

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 certain current 
agency policies or current industry practices. In addition, among other 
things, the rule will create or clarify requirements for process and 
methods validation, appropriate laboratory testing procedures, and 
protection against contamination. The rule is designed to update the 
CGMP regulations in response to technological changes and the agency's 
experience with the regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/03/96                    61 FR 20104
NPRM Comment Period End         09/30/96
Final Action                    12/00/01

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
_______________________________________________________________________




871. BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

Priority: Substantive, Nonsignificant

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                    07/00/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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




872. LABELING FOR HUMAN PRESCRIPTION DRUGS; REVISED FORMAT

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321; 21 USC 360gg to 360ss; 21 USC 371; 21 USC 
374; 21 USC 379e; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 353; 21 
USC 355; 21 USC 358; 21 USC 360; 21 USC 360b; 42 USC 216; 42 USC 241; 
42 USC 262; 42 USC 264

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                            12/22/00                    65 FR 81082
Final Action                    02/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

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

Nancy M. Ostrove, Division of Drug Marketing, Advertising, and 
Communications, Department of Health and Human Services, Food and Drug 
Administration, (HFD-42), Center for Drug Evaluation and Research, 5600 
Fishers Lane, Rockville, MD 20857
Phone: 301 827-2828

RIN: 0910-AA94

[[Page 25420]]

_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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 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                    10/00/01

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-AA98
_______________________________________________________________________




874. USE OF OZONE-DEPLETING SUBSTANCES

Priority: Other Significant

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

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                    05/00/01

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

RIN: 0910-AA99
_______________________________________________________________________




875. EXPORTS; NOTIFICATION AND RECORDKEEPING REQUIREMENTS

Priority: Routine and Frequent

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

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                    06/00/01

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 15-61 
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AB16
_______________________________________________________________________




876. FOREIGN ESTABLISHMENT REGISTRATION AND LISTING

Priority: Routine and Frequent

Legal Authority: 21 USC 321; 21 USC 374; 42 USC 216; 42 USC 262; 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

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                    06/00/01

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

[[Page 25421]]

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Room 15-61 
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AB21
_______________________________________________________________________




877. 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 381; 21 USC 382; 21 USC 
393; 42 USC 216; 21 USC 321; 21 USC 343; 21 USC 352; 21 USC 355; 21 USC 
360b; 21 USC 362; 21 USC 371; 21 USC 374

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, 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                    09/00/01

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 15-61 
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AB24
_______________________________________________________________________




878. 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

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, Source 
Plasma 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: 1) labeling; 2) notification of consignees and end 
users of product safety information for plasma derivative products; 3) 
notification of deferred donors; 4) requirements for donor suitability 
and testing; and 5) 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)  DFR: Confirmation in Part and Tech. Amendment 
03/14/00 (65 FR 13678)  Final Action 08/28/00 (65 FR 52016)

Current Good Manufacturing Practice for Blood and Blood Components; 
Blood Labeling Standards  NPRM 12/00/01

Gen. Reqs. for Blood, Blood Compon., and Plasma Derivatives; 
Notification of Deferred Donors  NPRM 08/19/99 (64 FR 45355)  Final 
Action 05/00/01

Infectious Agent Clearance  NPRM 06/00/02

Plasma Derivatives and Other Blood-Derived Products; Reqs. for Tracking 
and Notification  ANPRM 08/19/99 (64 FR 45383)  NPRM 06/00/02

Reqs. for Testing Human Blood Donors for Evid. of Infection Due to 
Communicable Disease Agents  NPRM 08/19/99 (64 FR 45340)  Final Action 
05/00/01

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 05/00/01

Suitability Reqs. for Whole Blood and Source Plasma Donors  NPRM 12/00/
01

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: See RIN 0910-AB76. CGMP for Blood and Blood 
Components; Blood Labeling Standards formerly listed under 0910-AB89

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

[[Page 25422]]

Email: [email protected]

RIN: 0910-AB26
_______________________________________________________________________




879. ANTIBIOTIC DRUG APPROVAL AND EXCLUSIVITY

Priority: Substantive, Nonsignificant

Unfunded Mandates: Undetermined

Legal Authority: PL 105-115, sec 125

CFR Citation: 21 CFR 314

Legal Deadline: None

Abstract: The final 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                    10/00/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Paul C. Varki, 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
Email: [email protected]

RIN: 0910-AB33
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

Legal Authority: PL 105-115, sec 126

CFR Citation: 21 CFR 201; 21 CFR 250; 21 CFR 310; 21 CFR 329; 21 CFR 
361; 21 CFR 369; 21 CFR 290

Legal Deadline: None

Abstract: This final rule revises 21 CFR parts 10, 201, 250, 310, 329, 
361, 606, and 610 by removing the requirement that prescription drugs 
be labeled ``Caution: Federal law prohibits dispensing without 
prescription'' and substituting a requirement that prescription drugs 
be labeled ``Rx only.'' The rule also revises 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 also 
revises 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                            04/21/00                    65 FR 21378
Final Action                    08/00/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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




881. 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 U.S.C. 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                      12/00/01

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: William Marnane, Director, Division of Manufacturing 
Technologies, 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
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

[[Page 25423]]

stages of development. This action is part of FDA's continuing effort 
to achieve the objectives of the ``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 Withdrawn in 
Part                            08/05/98                    63 FR 41718
Final Action                    10/00/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Stephen M. Ripley, Team Leader, 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
_______________________________________________________________________




883. DISCONTINUATION OF A LIFESAVING PRODUCT

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 356(c)

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 U.S.C. 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                            11/07/00                    65 FR 66665
Final Action                    06/00/01

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
_______________________________________________________________________




884. 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 U.S.C. 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 will also identify another category of changes that may be made 
without the submission of a supplement but which must be reported in an 
annual report.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/28/99                    64 FR 34608
Final Action                    10/00/01

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
_______________________________________________________________________




885. FOOD LABELING: TRANS FATTY ACIDS IN NUTRITION LABELING, NUTRIENT 
CONTENT CLAIMS, AND HEALTH CLAIMS

Priority: Economically Significant. Major under 5 USC 801.

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

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 342; 21 USC 343; 21 USC 
348; 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

[[Page 25424]]

NPRM Comment Period Reopened    12/05/00                    65 FR 75887
Final Rule                      09/00/01

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
_______________________________________________________________________




886. 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                            08/25/00                    65 FR 51782
Final Rule                      09/00/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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: 301 594-1620

RIN: 0910-AB68
_______________________________________________________________________




887. 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 360l; 21 USC 371; 21 USC 374; 21 
USC 331; 21 USC 351 to 352; 21 USC 360; 21 USC 360c; 21 USC 360e; 21 
USC 360i; 21 USC 360j

CFR Citation: 21 CFR 801.437; 21 CFR 878.4460; 21 CFR 878.4461; 21 CFR 
880.6250; 21 CFR 880.6251; 21 CFR 801.440

Legal Deadline: None

Abstract: FDA is 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 reclassifying surgeon's and patient examination gloves 
as class II devices subject to special controls. FDA is also requiring 
additional labeling concerning powder and protein levels for these 
devices.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/30/99                    64 FR 41710
Final Action                    10/00/01

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
_______________________________________________________________________




888. CGMPS FOR BLOOD AND BLOOD COMPONENTS: NOTIFICATION OF CONSIGNEES 
AND TRANSFUSION RECIPIENTS RECEIVING BLOOD AND BLOOD COMPONENTS AT 
INCREASED RISK OF TRANSMITTING HCV (LOOKBACK)

Priority: Economically Significant. Major under 5 USC 801.

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

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                            11/16/00                    65 FR 69377
NPRM Comment Period End         02/14/01
Final Action                    03/00/02

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

[[Page 25425]]

_______________________________________________________________________




889. ANTIBIOTIC RESISTANCE LABELING

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321; 21 USC 371; 21 USC 374; 21 USC 379e; 42 
USC 216; 42 USC 241; 42 USC 262; 21 USC 331; 21 USC 351; 21 USC 352; 21 
USC 353; 21 USC 355; 21 USC 358; 21 USC 360; 21 USC 360b; ...

CFR Citation: 21 CFR 201.24

Legal Deadline: None

Abstract: The final 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                            09/19/00                     65 FR 5611
Final Rule                      11/00/01

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
_______________________________________________________________________




890. 180-DAY GENERIC DRUG EXCLUSIVITY FOR ABBREVIATED NEW DRUG 
APPLICATIONS

Priority: Substantive, Nonsignificant

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 recent court decisions, 
including 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                    11/00/01

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

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
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AB80
_______________________________________________________________________




891. FOOD ADDITIVES: FOOD CONTACT SUBSTANCES NOTIFICATION SYSTEM

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 321 et seq

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 1997, 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 published a proposed rule on the 
notification process for food contact substances on July 13, 2000. The 
comment period on the proposed rule ended on September 26, 2000.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/13/00                    65 FR 43269
Final Rule                      09/00/01

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

[[Page 25426]]

_______________________________________________________________________




892. STATE CERTIFICATION OF MAMMOGRAPHY FACILITIES

Priority: Other Significant

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

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 implement 
the MQSA quality standards, and to administer other related functions. 
FDA retains oversight responsibility for the activities of the States 
authorized to carry out certification requirements 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                      06/00/01

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
_______________________________________________________________________




893. 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                            01/08/01                     66 FR 1275
Direct Final Rule               01/08/01                     66 FR 1257
Direct Final Rule Withdrawn     05/00/01
Final Rule                      09/00/01

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
_______________________________________________________________________




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

Priority: Other Significant

Legal Authority: 15 USC 1451 to 1561; 21 USC 331; 21 USC 351 to 353; 21 
USC 355; 21 USC 360; 21 USC 360c to 360f; 21 USC 360h to 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; 21 USC 321; PL 105-115, sec 122, 111 stat 2322 
(21 USC 355 note)

CFR Citation: 21 CFR 601; 21 CFR 314

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, or radiological, substances when adequate and well-
controlled efficacy studies in humans cannot be conducted ethically. 
Efficacy studies in humans cannot be conducted ethically if: 1) the 
studies would involve administering a potentially lethal or permanently 
disabling toxic substance or organism to healthy human volunteers 
without a proven treatment; and 2) field trials (assessment of the 
product after natural accidental, or malicious exposure to the 
substance) are not feasible. FDA is taking this action because it 
recognizes the importance of improving medical responses 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                    08/00/01

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

RIN: 0910-AC05
_______________________________________________________________________




895. ADDITIONAL SAFEGUARDS FOR CHILDREN IN CLINICAL INVESTIGATIONS OF 
FDA REGULATED PRODUCTS

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321; 21 USC 343; 21 USC 346; 21 USC 346a; 21 
USC 348; 21 USC 350a; 21 USC 350b; 21 USC 351; 21 USC 352; 21 USC 353; 
21 USC 355; 21 USC 360; 21 USC 360c to 360f; 21 USC 360h to 360j; 21 
USC

[[Page 25427]]

371; 21 USC 379e; 21 USC 381; 41 USC 216; 41 USC 241; 41 USC 262; 41 
USC 263b to 263n

CFR Citation: 21 CFR 50; 21 CFR 56

Legal Deadline: Other, Statutory, April 17, 2001, The Children's Health 
Act of 2000 requires FDA to adopt existing HHS regulations within 6 
months of the date of its enactment on 10/17/2000. Thus FDA is required 
to adopt HHS Subpart D by 4/17/2001.

Abstract: The interim rule would provide additional protections for 
children involved as subjects in clinical investigations of FDA-
regulated products, as required by the Children's Health Act of 2000.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Rule                    04/00/01

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: None

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-AC07
_______________________________________________________________________




896. IMPLEMENTING COURT DECISIONS, ANDA APPROVALS, AND 180-DAY 
EXCLUSIVITY

Priority: Substantive, Nonsignificant

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

CFR Citation: 21 CFR 314.107(e)

Legal Deadline: None

Abstract: The interim rule will amend regulations governing 180-day 
generic drug exclusivity to redefine the term court decision. The 
definition of court decision will be changed to the decision of a 
District Court deciding the relevant patent litigation case. The 
regulations will then correctly define court decision in accordance 
with recent court holdings addressing the definition.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              07/13/00                    65 FR 43233
Final Rule                      11/00/01

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AC11
_______________________________________________________________________




897. REVOCATION OF CONDITIONS FOR MARKETING DIGOXIN PRODUCTS FOR ORAL 
USE

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
353; 21 USC 355; 21 USC 360b-f; 21 USC 360j; 21 USC 361a; 21 USC 371; 
21 USC 374; 21 USC 375; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 
242a; 42 USC 262; 42 USC 263b-n

CFR Citation: 21 CFR 310.500

Legal Deadline: None

Abstract: The final rule will revoke the regulation (21 CFR 310.500) 
that established conditions for marketing digoxin products for oral 
use.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/24/00                    65 FR 70538
Final Rule                      12/00/01

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Mary E. Catchings, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human Services, Food and Drug 
Administration, HFD-7, Center for Drug Evaluation and Research, 1451 
Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-0951

RIN: 0910-AC12
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




898. 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 formula. 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)

[[Page 25428]]

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

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
_______________________________________________________________________




899. 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: Federalism: Yes for Protein Hydrolysates; Broth 
in Tuna; and/or Labeling

Agency Contact: Christine L. Lewis, 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: 202 205-4561

RIN: 0910-AA19
_______________________________________________________________________




900. MEDICAL FOODS

Priority: Other Significant

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

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 U.S.C. 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

[[Page 25429]]

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Federalism:  Undetermined

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
_______________________________________________________________________




901. 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 would seek 
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

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
_______________________________________________________________________




902. REINVENTING FDA FOOD REGULATIONS

Priority: Substantive, Nonsignificant

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

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

Legal Deadline: None

Abstract: In response to President Clinton's memorandum to heads of 
departments and agencies entitled ``Regulatory Reinvention 
Initiative,'' FDA has initiated rulemaking to retain, revise, or revoke 
certain of its regulations for food. FDA published an advance notice of 
proposed rulemaking (ANPRM) on December 29, 1995, requesting 
information on the need to retain, revise, or revoke its food standards 
of identity regulations and its common or usual name regulations. In 
the same issue of the Federal Register, FDA proposed to improve the 
coordination of the food additive, GRAS, and color additive approval 
process with USDA for substances used in meat and poultry products. FDA 
proposed to revoke several lower fat milk standards on November 9, 
1995. On June 12, 1996, FDA published an ANPRM announcing its intention 
to review: 1) its human food labeling regulations pertaining to the 
exemption for soft drinks from requirements for the type size and 
placement of certain information on the information panel, requirements 
for listing ``statements of identity,'' and requirements for flavor 
labeling; 2) its infant formula regulations to ensure that they fully 
reflect the Federal Food, Drug, and Cosmetic Act; 3) its regulations 
pertaining to the discharge of waste aboard casino ships, passenger 
ships, and ferries; and 4) its food additive regulations to consolidate 
certain existing regulations. In the same June 12 issue of the Federal 
Register, FDA published a second ANPRM seeking public comment on 
possible ways to streamline various food additive regulations. FDA also 
proposed on June 12, 1996, to revoke certain food labeling regulations 
pertaining to labeling of food with number of servings and labeling 
Kosher and Kosher-style foods and to revoke the agency's voluntary 
filing of cosmetic product experiences. The latter was published August 
12, 1997.
On October 13, 1995, FDA proposed to revoke certain agency regulations 
that were obsolete or no longer necessary to achieve public health 
goals. The final rule (pertaining to food regulations only) was 
published on June 3, 1996. A confirmation of effective date 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 08/25/00 (65 FR 51758)

Notification Procedures for 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)

[[Page 25430]]

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 Effective 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
_______________________________________________________________________




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

Priority: Other Significant

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

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                    04/00/02

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
_______________________________________________________________________




904. 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 360k; 21 USC 361; 21 USC 362; 21 
USC 371; 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

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                            12/00/02

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-42), Center for Drug 
Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2828

RIN: 0910-AA90
_______________________________________________________________________




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

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

Unfunded Mandates: Undetermined

Legal Authority: 5 USC 610; 21 USC 351; 21 USC 353; 21 USC 360b; 21 USC 
371; 21 USC 321; 21 USC 352

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 of 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

[[Page 25431]]

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                    04/03/00
Proposed Rule                   02/00/03

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
_______________________________________________________________________




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

Priority: Other Significant

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 Reopened    04/18/00                    65 FR 20774
NPRM Comment Period End         07/17/00
Final Action                    01/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: State

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

Agency Contact: Astrid L. Szeto, Senior Regulatory Review 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-AB27
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

CFR Citation: 21 CFR 558.5; 21 CFR 510.455

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

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
_______________________________________________________________________




908. BULK DRUG SUBSTANCES FOR USE IN PHARMACY COMPOUNDING

Priority: Other Significant

Legal Authority: PL 105-115, sec 127; 21 USC 351; 21 USC 352; 21 USC 
353a; 21 USC 355; 21 USC 371

CFR Citation: 21 CFR 216

[[Page 25432]]

Legal Deadline: None

Abstract: Section 127 of the Food and Drug Administration Modernization 
Act of 1997 (Pub. L. 105-115) added section 503A to the Food, Drug, and 
Cosmetic Act (21 U.S.C. 353a). Section 503A governs the application of 
Federal law to the practice of pharmacy compounding. Under section 
503A(b)(1)(A), FDA may 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                     To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

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

RIN: 0910-AB57
_______________________________________________________________________




909. 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) they 
cannot compound regularly or in inordinate amounts of any drug products 
that are essentially copies of commercially available products; (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                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

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

RIN: 0910-AB58
_______________________________________________________________________




910. 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 U.S.C. 353a). Section 503A governs the application of 
Federal law

[[Page 25433]]

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                             To Be                       Determined

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
_______________________________________________________________________




911. 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                             To Be                       Determined

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
_______________________________________________________________________




912. 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; 21 USC 1034; 28 USC 2112; 42 USC 
201; 42 USC 262; 42 USC 263b to 263n; 42 USC 264; 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

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                     To Be                       Determined

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 15-61 
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AB73
_______________________________________________________________________




913. SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED

Priority: Substantive, Nonsignificant

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

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                            To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: State

Federalism:  Undetermined

[[Page 25434]]

Agency Contact: Randall A. Lovell, Veterinary Medical Officer, 
Department of Health and Human Services, Food and Drug Administration, 
HFV-222, Center for Veterinary Medicine, 7500 Standish Place, 
Rockville, MD 20855
Phone: 301 827-0176
Fax: 301 827-1484
Email: [email protected]

RIN: 0910-AB90
_______________________________________________________________________




914. 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                            01/22/01                     66 FR 6502
NPRM Comment Period End         04/09/01
Final Rule                       To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Room 15-61 
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AB95
_______________________________________________________________________




915. 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; 21 USC 351; 21 USC 352; 21 USC 355; 21 
USC 371

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 256
NPRM Comment Period End         03/20/00
Final Action                     To Be                       Determined

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

RIN: 0910-AC01
_______________________________________________________________________




916. ADDITION TO THE LIST OF DRUG PRODUCTS THAT HAVE BEEN WITHDRAWN OR 
REMOVED 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 NPRM proposes to amend 21 CFR 216.24 by adding three drug 
products, grepafloxacin, troglitazone, and cisapride 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                             To Be                       Determined

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

RIN: 0910-AC08
_______________________________________________________________________




917. PREMARKET NOTICE CONCERNING BIOENGINEERED FOODS

Priority: Other Significant

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

CFR Citation: 21 CFR 192; 21 CFR 592

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is requiring the 
submission to the agency of data and information regarding plant-
derived bioengineered foods that would be consumed by humans or 
animals. FDA is requiring that this submission be made at least 120 
days prior to the commercial distribution of such foods. FDA took this 
action to ensure that it has the appropriate amount of information 
about bioengineered foods to help to ensure that all market entry 
decisions by the industry are made consistently and in full compliance 
with the law. The action will permit the agency to assess on an ongoing 
basis whether plant-derived

[[Page 25435]]

bioengineered foods comply with the standards of the Federal Food, 
Drug, and Cosmetic Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/18/01                     66 FR 4706
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Linda Kahl, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, HFS-206, 
Center for Food Safety and Applied Nutrition, 200 C Street SW, 
Washington, DC 20204
Phone: 202 418-3101
Fax: 202 418-3131
Email: [email protected]

RIN: 0910-AC15
_______________________________________________________________________




918.  RESCISSION OF SUBSTANTIALLY EQUIVALENT DECISIONS AND 
RESCISSION APPEAL PROCEDURES

Priority: Substantive, Nonsignificant

Legal Authority: 15 USC 1451 to 1461; 21 USC 141 to 149; 21 USC 321 to 
394; 21 USC 467f; 21 USC 679; 21 USC 821; 21 USC 1034; 28 USC 2112; 42 
USC 201 to 262; 42 USC 263b; 42 USC 364; 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: 21 CFR 16; 21 CFR 807

Legal Deadline: None

Abstract: FDA may rescind a decision issued under the Federal Food, 
Drug, and Cosmetic Act (the Act) that a device is substantially 
equivalent to a legally marketed device, and therefore, may be 
marketed. In addition, under this rule a premarket notification 
(commonly known as a 510(k)) holder may request administrative review 
of a proposed rescission action. This rule would standardize the 
procedures for considering rescissions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   01/26/01                     66 FR 3526
Final Rule                       To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: None

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-AC16
_______________________________________________________________________




919.  INSTITUTIONAL REVIEW BOARDS: REGISTRATION REQUIREMENTS

Priority: Info./Admin./Other

Legal Authority: 21 USC 321; 21 USC 346; 21 USC 346a; 21 USC 348; 21 
USC 351; 21 USC 352; 21 USC 353; 21 USC 306c to 306f; 21 USC 360h to 
360j; 21 USC 371; 21 USC 379e; 21 USC 381; 42 USC 216; 42 USC 241; 42 
USC 262; 42 USC 263b to 263n; 42 USC 264

CFR Citation: 21 CFR 56.106

Legal Deadline: None

Abstract: The proposed rule would require institutional review boards 
(IRB) to register with FDA. The registration information would include 
the names, addresses, phone numbers, facsimile (fax) numbers, and 
electronic mail (e-mail) addresses of the responsible institutional 
official (if the IRB is affiliated with an institution) and IRB chair 
or contact, the range of active protocols (small, medium, or large) 
involving FDA-regulated products reviewed in the previous calendar 
year, and a description of the types of FDA-regulated products 
reviewed. The proposed rule would make it easier for FDA to inspect 
IRB's and to convey information to IRB's.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Room 15-61 
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-3380
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AC17
_______________________________________________________________________




920.  CHRONIC WASTING DISEASE: CONTROL OF FOOD PRODUCTS AND 
COSMETICS DERIVED FROM EXPOSED ANIMAL POPULATIONS

Priority: Other Significant

Legal Authority: 42 USC 264; 21 USC 301 et seq

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is proposing to 
prohibit the use for food, including dietary supplements, and cosmetics 
derived from any part of cervids, such as deer and elk, that have been 
exposed to chronic wasting disease (CWD). FDA is proposing this 
regulation because of potential risks to health.
CWD is a type of transmissible spongiform encephalopathy (TSE), a group 
of fatal, neurodegenerative diseases that include bovine spongiform 
encephalopathy (BSE) in cattle, scrapie in sheep, and Creutzfeldt-Jakob 
disease (CJD) in humans. CWD affects cervids in the United States and 
Canada.
CWD is endemic in cervid populations in certain areas of Colorado, 
Nebraska, and Wyoming. The disease has been identified in wild and 
farmed elk and wild deer populations. At least one published scientific 
article has reported that infectious CWD prion proteins in vitro can 
convert normal, non-infectious human prion proteins into abnormal, 
infectious forms. These data suggest that the agent of CWD could be 
transmitted to humans.
Currently, there are no analytical tests to identify animals in the 
pre-clinical phase of CWD, or any other TSE. CWD typically exhibits a 
long incubation period, during which time animals appear normal but are 
likely to be infectious. Therefore, FDA is proposing to require that 
food or cosmetic products derived from animals exposed to CWD not enter 
into commerce until scientific evidence indicates that these products 
do not represent a threat to public health.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

[[Page 25436]]

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Rebecca Buckner, Consumer Safety Officer, 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: 202 205-4081
Fax: 202 205-4422
Email: [email protected]

RIN: 0910-AC21
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Food and Drug Administration (FDA)



_______________________________________________________________________




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

Priority: Other Significant

CFR Citation: 21 CFR 600; 21 CFR 606

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/07/00                    65 FR 66621

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Paula S. McKeever
Phone: 301 827-6210

RIN: 0910-AA12
_______________________________________________________________________




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

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 21 CFR 120

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/19/01                     66 FR 6138

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: Federal

Agency Contact: Shellee Anderson
Phone: 202 205-5023
Email: [email protected]

RIN: 0910-AA43
_______________________________________________________________________




923. DRUGS USED FOR TREATMENT OF NARCOTIC ADDICTS

Priority: Substantive, Nonsignificant

CFR Citation: 21 CFR 291; 42 CFR 8

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/17/01                     66 FR 4076

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: State, Federal

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

Agency Contact: Elsworth Dory
Phone: 301 827-7264

RIN: 0910-AA52
_______________________________________________________________________




924. ESTABLISHMENT REGISTRATION AND LISTING OF HUMAN CELLS, TISSUES, AND 
CELLULAR AND TISSUE-BASED PRODUCTS

Priority: Other Significant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/19/01                     66 FR 5447

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Valerie Butler
Phone: 301 827-6210

RIN: 0910-AB05
_______________________________________________________________________




925. VETERINARY FEED DIRECTIVES

Priority: Other Significant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/08/00                    65 FR 76924

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: George Graber
Phone: 301 827-6651
Email: [email protected]

RIN: 0910-AB09
_______________________________________________________________________




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

Priority: Other Significant. Major under 5 USC 801.

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/05/00                    65 FR 76092

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: State, Federal

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

Agency Contact: Geraldine A. June
Phone: 202 205-4168
Email: [email protected]

RIN: 0910-AB30
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

CFR Citation: 21 CFR 314.81; 21 CFR 601.37; 21 CFR 601.70

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/30/00                    65 FR 64607
60-Day Delay of Effective Date  02/21/01                    66 FR 10815

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Nathaniel Geary
Phone: 301 827-6210

RIN: 0910-AB83

[[Page 25437]]

_______________________________________________________________________




928. CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS; 
BLOOD LABELING STANDARDS

Priority: Other Significant

CFR Citation: 21 CFR 606.121; 21 CFR 606.122

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn--See RIN 0910-AB26    02/22/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Sharon Carayiannis
Phone: 301 827-6210

RIN: 0910-AB89
_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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 a previous 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                     10/00/01
NPRM Comment Period End         12/00/01

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
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

Legal Authority: PL 106-170; 42 USC 300aa-14

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 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                            05/00/01

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, Department of Health and Human Services, 
Health Resources and Services Administration, Room 8A-46, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 443-4198
Fax: 301 443-8196
Email: [email protected]

RIN: 0906-AA55
_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




931. 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'' practitioners. It would also require malpractice payers,

[[Page 25438]]

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 and to provide the name of the 
corporate health care entity.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/24/98                    63 FR 71255
NPRM Comment Period End         02/22/99
Final Rule                      07/00/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: John M. Heyob, Acting Director, Division of Medicine, 
Bureau of Health Professions, Department of Health and Human Services, 
Public Health Service, Room 4C-25, Parklawn Building, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 443-6190

RIN: 0906-AA41
_______________________________________________________________________




932. 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 rules apply to facilities obligated under the Hospital 
Survey and Construction Act, commonly known as the Hill-Burton Act. The 
rules will 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 rules will also provide a compliance 
alternative for facilities with histories of uncompensated services 
deficits, to enable them to make up the deficits on a timely basis. 
These revisions will 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                            10/19/00                    65 FR 68975
NPRM Comment Period End         12/18/00
Final Action                    07/00/01

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Eulas Dortch, Director, Division of Facilities 
Compliance and Recovery, OSP, Department of Health and Human Services, 
Health Resources and Services Administration, Room 10C-16, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 443-8007
Fax: 301 443-0619
Email: [email protected]

RIN: 0906-AA52
_______________________________________________________________________




933. 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

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 that takes 
an interdisciplinary approach (and thus inhibits the achievement of the 
statute's clustered objectives), we are removing 19 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                    06/00/01

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, 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
Fax: 301 443-8003
Email: [email protected]

RIN: 0906-AA53

[[Page 25439]]

_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




934. RICKY RAY HEMOPHILIA RELIEF FUND PROGRAM

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 130

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      08/02/00                    65 FR 47438

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Neil H. Sampson
Phone: 301 443-5974

RIN: 0906-AA56
_______________________________________________________________________


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


Indian Health Service (IHS)



_______________________________________________________________________




935.  TRIBAL SELF-GOVERNANCE AMENDMENTS

Priority: Substantive, Nonsignificant

Legal Authority: PL 106-260, Sec 517(a)(2); 25 USC 450, Tribal Self-
Governance Amendments

CFR Citation: None

Legal Deadline: NPRM, Statutory, August 18, 2001.

Abstract: Section 517(a)(2) requires that proposed regulations be 
published in the Federal Register no later than one year after the date 
of enactment

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Paula K. Williams, Director of Tribal Self-Governance, 
Department of Health and Human Services, Indian Health Service, Room 
54-55, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 443-7821

RIN: 0917-AA05
_______________________________________________________________________


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


Indian Health Service (IHS)



_______________________________________________________________________




936. 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                    10/00/01

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, Suite 
605, 12302 Twinbrook Parkway, Rockville, MD 20857
Phone: 301 443-1589

RIN: 0917-AA02
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Indian Health Service (IHS)



_______________________________________________________________________




937. CONTRACTS UNDER THE INDIAN SELF-DETERMINATION ACT

Priority: Info./Admin./Other

CFR Citation: 42 CFR 36.201-237

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      10/03/00                    65 FR 58918

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Tribal

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

RIN: 0917-AA04

[[Page 25440]]

_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




938. 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                            08/00/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Additional Information: 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
_______________________________________________________________________




939. 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 10 consecutive 
weeks of service (employment) at the NIH during which the individual is 
attending the educational institution and receiving the NIH 
scholarship. The proposed new regulations will cover this program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/01

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-AA10
_______________________________________________________________________




940. 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                            06/00/01

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
_______________________________________________________________________




941. 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                            08/00/01

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
_______________________________________________________________________




942.  NIH CENTER GRANTS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; PL 106-310; PL 106-525; PL 106-505

CFR Citation: 42 CFR 52a

Legal Deadline: None

Abstract: NIH proposes to amend the current center grants regulations 
to reflect new authorities set forth in sections 409C, 452E, 485F and 
445I of the PHS Act. Section 409C concerns centers of excellence 
regarding research on autism; section 452E concerns centers regarding 
research on ``fragile x;'' section 452F concerns centers of excellence 
for research education and training for individuals who are members of 
minority health disparity populations, and section 445I concerns 
centers of excellence in Alzheimer's disease research and treatment.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/01

Regulatory Flexibility Analysis Required: No

[[Page 25441]]

Small Entities Affected: Governmental Jurisdictions

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-AA24
_______________________________________________________________________




943.  NATIONAL INSTITUTES OF HEALTH CLINICS RESEARCH LOAN 
REPAYMENT PROGRAM FOR INDIVIDUALS FROM DISADVANTAGED BACKGROUNDS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; PL 105-392; PL 106-554

CFR Citation: 42 CFR 68a

Legal Deadline: None

Abstract: NIH proposes to amend the current regulations by revising 
sections 68a.8(a) to reflect the increase in the maximum annual loan 
repayment from $20,000 to $35,000, and other sections to reflect 
expansion of the program to include extramural investigators from 
disadvantaged backgrounds. This action is necessary because of the 
enactment of the Health Professions Education Partnership Act of 1998, 
Public Law 105-392, and enactment of the Consolidated Appropriations 
Act of 2001, Public Law 106-554. Section 410 of Public Law 105-392 
amends section 487E(a) of the PHS Act to increase the maximum annual 
amount.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/01

Regulatory Flexibility Analysis Required: No

Small Entities Affected: 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-AA25
_______________________________________________________________________




944.  NIH LOAN REPAYMENT PROGRAM FOR MINORITY HEALTH DISPARTIES 
RESEARCH

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; PL 106-525

CFR Citation: 42 CFR 68f

Legal Deadline: None

Abstract: NIH propses to establish regulations to implement the program 
authorized under section 485G of the PHS Act. Section 103 of the 
Minority Health and Health Disparities Research and Education Act of 
2000 amends the PHS Act by adding a new section 485G which authorizes 
the program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/01

Regulatory Flexibility Analysis Required: No

Small Entities Affected: 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-AA26
_______________________________________________________________________




945.  PEDIATRIC RESEARCH LOAN REPAYMENT PROGRAM

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; PL 106-310

CFR Citation: 42 CFR 68f

Legal Deadline: None

Abstract: NIH proposes to establish regulations to implement the 
Pediatric Research Loan Repayment Program authorized under section 487F 
of the PHS Act. Section 1002 of Public Law 106-310 amends the PHS Act 
by adding a new section 487F which authorizes the program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/01

Regulatory Flexibility Analysis Required: No

Small Entities Affected: 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-AA27
_______________________________________________________________________




946.  NIH TRAINING GRANTS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; PL 106-310

CFR Citation: 42 CFR 63a

Legal Deadline: None

Abstract: NIH proposes to amend the training grants regulations to 
implement the new authority under section 452G of the PHS Act. This 
action is necessitated by enactment of the Children's Act of 2000. 
Section 1002 of this act adds a new section 452G that authorizes the 
Director of NICHD in consultation with the Administrator of HRSA, to 
support activities to provide for an increase in the number and size of 
institutional training grants to institutions supporting pediatric 
training.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/01

Regulatory Flexibility Analysis Required: No

Small Entities Affected: 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-AA28

[[Page 25442]]

_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




947. 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 12 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 12 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                      06/00/01

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
_______________________________________________________________________




948. 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                      05/00/01

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
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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                            09/21/00                    65 FR 57132
Final Action                    06/00/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0925-AA20
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


National Institutes of Health (NIH)



_______________________________________________________________________




950. TRAINEESHIPS

Priority: Info./Admin./Other

CFR Citation: 42 CFR 63

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      11/06/00                    65 FR 66511

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0925-AA11
_______________________________________________________________________




951. ADDITIONAL PROTECTIONS FOR PREGNANT WOMEN AND HUMAN FETUSES 
INVOLVED IN RESEARCH, AND PERTAINING TO HUMAN IN VITRO FERTILIZATION

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Transferred to RIN 0940-AA02    03/12/01

RIN: 0925-AA14
_______________________________________________________________________




952. FEDERAL POLICY (COMMON RULE) FOR THE PROTECTION OF HUMAN SUBJECTS

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Transferred to RIN 0940-AA03    03/12/01

RIN: 0925-AA21

[[Page 25443]]

_______________________________________________________________________


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


Office of Public Health and Science (OPHS)



_______________________________________________________________________




953. 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                            11/28/00                    65 FR 70830
NPRM Comment Period End         01/29/01
Final Rule                      06/00/01

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
_______________________________________________________________________




954. FEDERAL POLICY (COMMON RULE) FOR THE PROTECTION OF HUMAN SUBJECTS

Priority: Other Significant

Legal Authority: 5 USC 301; 42 USC 289

CFR Citation: 45 CFR 46

Legal Deadline: None

Abstract: In compliance with the President's Memorandum of March 27, 
1997, this interim final rule would amend the Federal Policy (common 
rule) for the Protection of Human Subjects to add a new section that 
applies only to classified research involving human subjects. The new 
section would modify the Federal Policy by: 1) prohibiting any 
executive branch agency from engaging in classified research involving 
human subjects unless the agency has adopted the Federal Policy and the 
interim final rule; 2) eliminating the availability of waiver of 
informed consent and expedited review for classified research involving 
human subjects; 3) enhancing the informed consent requirements and 
allowing for disclosure of classified information if necessary; and 4) 
changing the composition of the institutional review board (IRB) and 
establishing a process for individual IRB approvals of classified 
research.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              12/00/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Dr. Clifford Scharke, Department of Health and Human 
Services, Office of Public Health and Science, Suite 3B01, 6100 
Executive Boulevard, Rockville, MD 20852
Phone: 301 435-5647

RIN: 0940-AA03
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Office of Public Health and Science (OPHS)



_______________________________________________________________________




955. ADDITIONAL PROTECTIONS FOR PREGNANT WOMEN AND HUMAN FETUSES 
INVOLVED IN RESEARCH, AND PERTAINING TO HUMAN IN VITRO FERTILIZATION

Priority: Other Significant

CFR Citation: 45 CFR 46, subpart B

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      01/17/01                     66 FR 3878
60-Day Delay of Effective Date 
To 05/18/2001                   03/19/01                    66 FR 15352

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Melody Lin
Phone: 301 435-5647

RIN: 0940-AA02
_______________________________________________________________________


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


Health Care Financing Administration (HCFA)



_______________________________________________________________________




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

Priority: Other Significant

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 494

Legal Deadline: None

Abstract: This proposed rule would revise the current conditions for 
coverage for end stage renal disease (ESRD) facilities approved to 
provide ESRD service under Medicare. It would update the conditions to 
reflect developments in technology and equipment, emphasize the total 
patient experience and develop performance expectations for the 
facility that result in quality, comprehensive care for the dialysis 
patient.

[[Page 25444]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/01

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Governmental Jurisdictions, Businesses, 
Organizations

Government Levels Affected: None

Agency Contact: Robert Miller, Department of Health and Human Services, 
Health Care Financing Administration, S3-02-01, Office of Clinical 
Standards and Quality, 7500 Security Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-6797
Email: [email protected]

RIN: 0938-AG82
_______________________________________________________________________




957.  RECOGNITION OF THE AMERICAN OSTEOPATHIC ASSOCIATION FOR 
CRITICAL ACCESS HOSPITALS (HCFA-2099-PN)

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

Legal Authority: Social Security Act, sec 1865(b)

CFR Citation: 42 CFR 488.4

Legal Deadline: Final, Statutory, September 14, 2001.

Abstract: This notice announces the application of the AOA for deeming 
authority to survey critical access hospitals (CHAs) for Medicare 
participation in lieu of survey by a State survey agency.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Notice                 04/16/01                    66 FR 19509
Final Action                    09/00/01

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: State

Agency Contact: Irene Dustin, Health Program Evaluation Officer, 
Department of Health and Human Services, Health Care Financing 
Administration, S3-13-21, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0495
Email: [email protected]

RIN: 0938-AK84
_______________________________________________________________________


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


Health Care Financing Administration (HCFA)



_______________________________________________________________________




958.  PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR 
SKILLED NURSING FACILITIES-UPDATE (HCFA-1163-P)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: Social Security Act, sec 1888(e); 42 USC 1395yy(e)

CFR Citation: 42 CFR 411.15; 42 CFR 489.20

Legal Deadline: None

Abstract: This rule sets forth updates to the payment rates used under 
the prospective payment system (PPS) for skilled nursing facilities 
(SNFs), for fiscal year 2002.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/00/01

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: William Ullman, Department of Health and Human 
Services, Health Care Financing Administration, C4-13-15, 7500 Security 
Boulevard, Baltimore, MD 21244-1850
Phone: 401 786-5667

RIN: 0938-AK47
_______________________________________________________________________


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


Health Care Financing Administration (HCFA)



_______________________________________________________________________




959. ``WITHOUT FAULT'' AND BENEFICIARY WAIVER OF RECOVERY AS IT APPLIES 
TO MEDICARE OVERPAYMENT LIABILITY (HCFA-6007-F)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1395gg

CFR Citation: 42 CFR 401; 42 CFR 466.86; 42 CFR 466.94; 42 CFR 473.14; 
42 CFR 493.1834; 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

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: Barbara Wright, Health Insurance Specialist, Department 
of Health and Human Services, Health Care Financing Administration, C3-
14-00, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4292

RIN: 0938-AD95
_______________________________________________________________________




960. MEDICAID PAYMENT FOR COVERED OUTPATIENT DRUGS UNDER REBATE 
AGREEMENTS (HCFA-2046-FC)

Priority: Other Significant

Legal Authority: 42 USC 1396a(a); 42 USC 1396r-8; 42 USC 1396b(a); 42 
USC 1302

[[Page 25445]]

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: Larry Reed, Chief, Medicaid Noninstitutional Payment 
Policy Branch, Department of Health and Human Services, Health Care 
Financing Administration, S2-01-16, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-3325

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

RIN: 0938-AF42
_______________________________________________________________________




961. REVISION OF MEDICARE/MEDICAID HOSPITAL CONDITIONS OF PARTICIPATION 
(HCFA-3745-F)

Priority: Other Significant

Legal Authority: 42 USC 1395x; 42 USC 1302; 42 USC 1395(cc); 42 USC 
1395hh; 42 USC 13206-8

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: Stephanie Dyson, Health Insurance Specialist, 
Department of Health and Human Services, Health Care Financing 
Administration, S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-9226

RIN: 0938-AG79
_______________________________________________________________________




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

Priority: Other Significant

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, 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


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: 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

Rachael Weinstein, Health Insurance Specialist, Department of Health 
and Human Services, Health Care Financing Administration, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6775

RIN: 0938-AG81
_______________________________________________________________________




963. 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

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

[[Page 25446]]

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

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
_______________________________________________________________________




964. CRITERIA FOR APPROVAL OF FACILITIES TO PERFORM COVERED HEART, 
LIVER, LUNG, PANCREAS AND INTESTINAL TRANSPLANTS (HCFA-3835-P)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 482

Legal Deadline: None

Abstract: The rule establishes conditions of participation for 
facilities to perform Medicare-covered transplants.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Federalism:  Undetermined

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

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

Eva Fung, Health Insurance Specialist, Department of Health and Human 
Services, Health Care Financing Administration, S3-06-6, 7500 Security 
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-7539

RIN: 0938-AH17
_______________________________________________________________________




965. HOSPICE CARE-CONDITIONS OF PARTICIPATION (HCFA-3844-P)

Priority: Other Significant

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

Rachael Weinstein, Health Insurance Specialist, Department of Health 
and Human Services, Health Care Financing Administration, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6775

RIN: 0938-AH27
_______________________________________________________________________




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

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


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Additional Information: 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
_______________________________________________________________________




967. TERMS, DEFINITIONS, AND ADDRESSES: TECHNICAL AMENDMENTS (HCFA-9877-
FC)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 1395x(v)(1)(A); 42 USC 1395hh

CFR Citation: 42 CFR 400 to 440; 42 CFR 442 to 447; 42 CFR 455; 42 CFR

[[Page 25447]]

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: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Margie Teeters, Department of Health and Human 
Services, Health Care Financing Administration, Division of Regulation 
and Issuances
Phone: 410 786-4678

RIN: 0938-AH53
_______________________________________________________________________




968. 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: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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
_______________________________________________________________________




969. UPDATE OF RATESETTING METHODOLOGY, PAYMENT RATES AND THE LIST OF 
COVERED SURGICAL PROCEDURES FOR AMBULATORY SURGICAL CENTERS (HCFA-1885-
FC)

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: The final rule will update the criteria for determining which 
surgical procedures can be appropriately and safely performed in an 
Ambulatory Surgical Center (ASC); make additions to and deletions from 
the current list of Medicare covered ASC procedures based on the 
revised criteria; rebase the ASC payment rates using charge and 
utilization data collected by a 1994 survey of ASCs; refine the 
ratesetting methodology that was implemented by a final notice 
published on February 8, 1990 in the Federal Register; require that ASC 
payment, coverage and wage index updates be implemented annually on 
January 1, rather than having these updates occur randomly throughout 
the year; establish a payment rate for Extracorporeal Shock Wave 
Lithotripsy; reduce regulatory burden; and make several technical 
policy changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/12/98                    63 FR 32290


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Bob Cereghino, Program Analyst, Department of Health 
and Human Services, Health Care Financing Administration, C4-03-06, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4645

RIN: 0938-AH81
_______________________________________________________________________




970. 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: Marcia Newton, Office of Clinical Standards and 
Quality, Department of Health and Human Services, Health Care Financing 
Administration, S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-5265

Joan Brooks, Health Insurance Specialist, Department of Health and 
Human Services, Health Care Financing Administration, 7500 Security 
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-5526

RIN: 0938-AH83

[[Page 25448]]

_______________________________________________________________________




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

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1320d-2(b)(1)

CFR Citation: 45 CFR 162

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

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

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: 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
_______________________________________________________________________




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

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1320d-2(h)(1)

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


Next Action Undetermined

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
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 1396a(a)(60); 42 USC 1396(a)(25), 
(45) and (60); 42 USC 1396(a)(60); 42 USC 139b(o)(2); 42 USC 1396g-1

CFR Citation: 42 CFR 433; 42 CFR 433.135; 42 CFR 433.137; 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 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
_______________________________________________________________________




974. SURETY BOND REQUIREMENTS FOR COMPREHENSIVE OUTPATIENT 
REHABILITATION FACILITIES, REHABILITATION AGENCIES (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 405; 42 CFR 413; 42 CFR 489

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

Abstract: This rule would require comprehensive outpatient 
rehabilitation facilities and rehabilitation agencies to furnish us 
with a surety bond on a continuing basis in order to participate in the 
Medicare program, in accordance with provisions of the Balanced Budget 
Act of 1997 (105-33).

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Ralph Goldberg, Division of Provider and Supplier 
Enrollment, 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
_______________________________________________________________________




975. APPEALS OF CARRIER DETERMINATION THAT A PHYSICIAN OR OTHER SUPPLIER 
FAILS TO MEET THE REQUIREMENTS FOR MEDICARE BILLING PRIVILEGES (HCFA-
6003-F)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 1395u(b)(3)(C); 42 USC 1395ff(b)

[[Page 25449]]

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


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

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

Yvonne West, Health Insurance Specialist, Department of Health and 
Human Services, Health Care Financing Administration, 7500 Security 
Blvd., Baltimore, MD 21244
Phone: 410 786-6479

RIN: 0938-AI49
_______________________________________________________________________




976. SECURITY STANDARDS (HCFA-0049-F)

Priority: Economically Significant. Major under 5 USC 801.

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

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
NPRM Comment Period End         10/13/98


Next Action Undetermined

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
_______________________________________________________________________




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

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: PL 104-191; 42 USC 1320d to 1320-d-8

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. Use of one standard in the 
health care industry will reduce the cost of identifying employers in 
electronic health care transactions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/16/98                    63 FR 32784
NPRM Comment Period End         08/17/98


Next Action Undetermined

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
_______________________________________________________________________




978. 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 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: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Ann Pash, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4516
Email: [email protected]

RIN: 0938-AI75

[[Page 25450]]

_______________________________________________________________________




979. 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 and 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
_______________________________________________________________________




980. MEDICARE PROGRAM; COVERAGE AND ADMINISTRATIVE POLICIES FOR CLINICAL 
DIAGNOSTIC LABORATORY TESTS (HCFA-3250-F)

Priority: Other Significant

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

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

CFR Citation: 42 CFR ch 410

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

Abstract: This 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 and 
Quality, Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4635

RIN: 0938-AI92
_______________________________________________________________________




981. COVERAGE OF RELIGIOUS NON-MEDICAL HEALTH CARE INSTITUTIONS (HCFA-
1909-F)

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 403; 42 CFR 440.170; 42 CFR 488.2; 42 CFR 488.6; 
42 CFR 489.102; 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

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 nonmedical health care 
institutions in their place. This change permits any qualified 
religious, nonmedical, health care institution to apply for payment for 
furnishing nonmedical services under Medicare. Section 4454 also 
authorizes payment for such services as an option benefit under State 
Medicaid plans. The rule sets forth minimum requirements and conditions 
of participation to qualify as a religious nonmedical health care 
institution for purposes of receiving payment for services furnished 
under Medicare and Medicaid.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              11/30/99                    64 FR 67028


Next Action Undetermined

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
_______________________________________________________________________




982. 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 implements section 1932(c) of the Social Security 
Act, added by section 4705 of the Balanced Budget Act of 1997. It 
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

[[Page 25451]]

NPRM Comment Period End         01/31/00


Next Action Undetermined

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
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

Legal Authority: 42 USC 1302; 42 USC 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 Home Health Agencies (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: 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-AJ10
_______________________________________________________________________




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

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 405; 42 CFR 491

Legal Deadline: None

Abstract: This rule would amend the requirements for certification and 
payment 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 the use of RHC space or 
equipment, and other RHC resources by another Medicare entity. The rule 
also requires establishment of a quality assessment and performance 
improvement program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/28/00                    65 FR 10450


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: David Worgo, Center for Health Plans and Providers, 
Division of Integrated Services, Department of Health and Human 
Services, Health Care Financing Administration, C4-15-18, 7500 Security 
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-5919

RIN: 0938-AJ17
_______________________________________________________________________




985. HOSPITAL CONDITIONS OF PARTICIPATION: LABORATORY SERVICES (HCFA-
3014-F)

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                            11/16/00                    65 FR 69416


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

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
_______________________________________________________________________




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

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

Unfunded Mandates: Undetermined

[[Page 25452]]

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: Next Action Undetermined

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
_______________________________________________________________________




987. 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 applicability of the 
Emergency Medical Treatment and Labor Act (EMTALA).

Timetable: Next Action Undetermined

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
_______________________________________________________________________




988. 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; 42 USC 300gg-52

CFR Citation: 45 CFR 146; 45 CFR 148

Legal Deadline: None

Abstract: The final rule would implement the requirements of the 
Women's Health and Cancer Rights Act of 1998 (WHCRA) (Pub. L. 105-277). 
The rules will provide protection to patients who are receiving 
benefits in connection with a mastectomy and who elect breast 
reconstruction. WHCRA provides coverage for all stages of 
reconstruction of the breast on which the mastectomy has been 
performed; surgery and reconstruction of the other breast to produce a 
symmetrical appearance; and coverage for prostheses and treatment of 
physical complications of a mastectomy, including lymphedema. Group 
health plans and health insurance issuers that offer medical and 
surgical benefits for mastectomies are subject to WHCRA's coverage 
requirements.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Kathryn McCann, Health Insurance Specialist, Department 
of Health and Human Services, Health Care Financing Administration, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7623

RIN: 0938-AJ44
_______________________________________________________________________




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

Priority: Economically Significant. Major under 5 USC 801.

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

CFR Citation: None

Legal Deadline: None

Abstract: This rule would implement the new prospective payment system 
for rehabilitation facilities, pursuant to section 1886(j) of the 
Social Security Act, as added by section 4421 of the Balanced Budget 
Act, and as amended by section 125 of the Balanced Budget Refinement 
Act of 1999.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   11/03/00                    65 FR 66304


Next Action Undetermined

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, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-4603

RIN: 0938-AJ55
_______________________________________________________________________




990. 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 proposed 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.

[[Page 25453]]

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Ralph Goldberg, Division of Provider and Supplier 
Enrollment, 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-AJ64
_______________________________________________________________________




991. STATE HEALTH INSURANCE ASSISTANCE PROGRAM (SHIP) (HCFA-4005-F)

Priority: Info./Admin./Other

Legal Authority: 42 USC 13956-4; 42 USC 1395w-21(d); 42 USC 1395w-27(e)

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              06/01/00                    65 FR 34983


Next Action Undetermined

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
_______________________________________________________________________




992. 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 4312(b); PL 105-33, sec 4724(b); PL 
105-33, sec 1861(o)(7); PL 105-33, sec 1861(v)(1); PL 105-33, sec 
1891(b); PL 105-33, sec 1903(i)(18); PL 105-33, sec 1128F

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 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.

Timetable: Next Action Undetermined

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, Division of Provider and Supplier 
Enrollment, 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
_______________________________________________________________________




993. 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: PL 105-33, sec 4316

CFR Citation: 42 CFR 405

Legal Deadline: None

Abstract: This rule implements sections 1842(b)(8) and (9) of the 
Social Security Act, as revised by section 4316 of the Balanced Budget 
Act of 1997. It sets forth the process for establishing realistic and 
equitable payment amounts for all Medicare part B items and services 
(other than physician services) when the existing payment amounts are 
inherently unreasonable because they are either grossly excessive or 
grossly deficient. This rule describes the factors HCFA (or its 
carriers) will consider and the procedures that will be followed in 
establishing realistic and equitable payment amounts.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0938-AJ97
_______________________________________________________________________




994. SUPPLIER STANDARDS RELATED TO TRAINING REQUIREMENTS FOR OXYGEN, 
THERAPEUTIC SHOES (HCFA-6010-NPRM)

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 the suppliers of home oxygen therapy and suppliers of therapeutic 
shoes.

[[Page 25454]]

Timetable: Next Action Undetermined

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

Frank Whelan, Health Insurance Sepicalist, Department of Health and 
Human Services, Health Care Financing Administration, C3-02-16, 7500 
Security Blvd., Baltimore, MD 21244
Phone: 410 786-1302

RIN: 0938-AJ98
_______________________________________________________________________




995. 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 correction to 45 
CFR 146.150, Guaranteed Availability of Coverage for Employers in the 
Small Group Market.

Timetable: Next Action Undetermined

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
_______________________________________________________________________




996. 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 
unrecovered costs. With respect to hospital-based providers, this 
regulation permits clearer distinctions to be made between various 
types of services, and ensures that these services will be paid for in 
an appropriate manner.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Katie Walker, 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
_______________________________________________________________________




997. PRACTICE EXPENSE DATA COLLECTION (HCFA-1111-IFC)

Priority: Substantive, Nonsignificant

Legal Authority: Sec 212 of BBRA of 1999; 42 USC 1395w-4

CFR Citation: 42 CFR 414

Legal Deadline: None

Abstract: This interim final rule establishes criteria for physician 
and non-physician specialty groups for submitting supplemental practice 
expense survey data for use in determining payments under the physician 
fee schedule. This interim final rule solicits public comments on the 
criteria for supplemental surveys.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              05/03/00                    65 FR 25664
Final Rule                      11/01/00                    65 FR 65376


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Kenneth Marsalek, Program Analyst, Department of Health 
and Human Services, Health Care Financing Administration, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 301 786-1115

RIN: 0938-AK14
_______________________________________________________________________




998. PAYMENT FOR CLINICAL PSYCHOLOGY TRAINING PROGRAMS (HCFA-1089-F)

Priority: Other Significant

Legal Authority: Social Security Act, sec 1861(v); Social Security Act, 
sec 1886(a)(4); PL 105-33

CFR Citation: 42 CFR 413.85

Legal Deadline: None

Abstract: This final rule revises our policy on Medicare payment for 
approved nursing and allied health education programs to permit payment 
for the costs incurred by a provider for the clinical training of 
students enrolled in a clinical psychology training program or a 
physician assistant training program. Consistent with the Conference 
Agreement language in the Conference Report accompanying the Balanced 
Budget Act of 1997 (Public Law 105-33), these clinical training costs 
would be paid separately on a reasonable cost basis pursuant to 
sections 1861(v) and 1886(a)(4) of the Social Security Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/12/01                     66 FR 3377


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Tzvi Hefter, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-07-07, 7500 Security Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-1304

RIN: 0938-AK15

[[Page 25455]]

_______________________________________________________________________




999. PROVISIONS OF THE BALANCED BUDGET AND REFINEMENT ACT OF 1999; 
HOSPITAL INPATIENT PAYMENTS AND RATES AND COSTS OF GRADUATE MEDICAL 
EDUCATION (HCFA-1131-IFC)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1302; 12 USC 1395hh; PL 106-113

CFR Citation: 42 CFR 410.152; 42 CFR 412.90; 42 CFR 412.102; 42 CFR 
412.103; 42 CFR 412.105; 42 CFR 412.108; 42 CFR 413.40; 42 CFR 413.70; 
42 CFR 413.86; ...

Legal Deadline: None

Abstract: This interim final rule with comment period implements, or 
regulations to, certain statutory provisions conforms the relating to 
Medicare payments to hospitals for inpatient services that are 
contained in the Medicare, Medicaid, and (SCHIP) State Children's 
Health Insurance Program Balanced Budget Refinement Act of 1999 (Pub. 
L. 106-113). These provisions relate to reclassification of hospitals 
from urban to rural status, reclassification of certain hospitals for 
purposes of payment during Federal fiscal year 2000, critical access 
hospitals, payments to hospitals excluded under the hospital inpatient 
prospective payment system, and payments for indirect and direct 
graduate medical education costs.
Many of the provisions of Public Law 106-113 modify changes to the 
Social Security Act made by the Balanced Budget Act of 1997 (Pub. L. 
105-33). These provisions are already in effect in accordance with 
Public Law 106-113.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              08/01/00                    65 FR 47026
Interim Final Rule Effective    08/01/00
Interim Final Rule Comment 
Period End                      08/31/00


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Stephen Phillips, Center for Health Plans and 
Providers, Department of Health and Human Services, Health Care 
Financing Administration, C4-05-27, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4548

RIN: 0938-AK20
_______________________________________________________________________




1000. CONDITIONS OF PARTICIPATION OF INTERMEDIATE CARE FACILITIES FOR 
PERSONS WITH MENTAL RETARDATION (HCFA-3046-P)

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

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 1302; 42 USC 1396d

CFR Citation: 42 CFR 400; 42 CFR 435; 42 CFR 440; 42 CFR 441; 42 CFR 
483

Legal Deadline: None

Abstract: This rule would revise the Conditions of Participation for 
Intermediate Care Facilities for Persons with Mental Retardation (ICFs/
MR). It would set forth new requirements that an ICF/MR must meet to 
participate in the Medicaid program, as well as adhere to current 
trends in the field of developmental disabilities. It would also 
increase our focus on client-directed choices, while maintaining 
essential client protections that reinforce our mandate to protect the 
health, safety, and welfare of the clients we serve.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Nancy Archer, Office of Clinical Standards and 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-AK23
_______________________________________________________________________




1001. CLINICAL LAB REQUIREMENTS-REVISIONS TO REGULATIONS IMPLEMENTING 
CLIA (HCFA-2226-F)

Priority: Other Significant

Legal Authority: PL 100-578

CFR Citation: 42 CFR 493

Legal Deadline: None

Abstract: This rule revises regulations applicable to clinical 
laboratories under the Clinical Laboratory Improvement Amendments of 
1988 (CLIA), Public Law 100-578. The regulations apply to laboratories 
that examine human specimens for the diagnosis, prevention or treatment 
of any disease or impairment of, or the assessment of the health of, 
human beings. This rule concludes the phase-in for certain quality 
control and personnel requirements, and addresses comments received on 
previously promulgated CLIA rules. In addition, this rule consolidates 
and reorganizes the requirements for patient test management, quality 
control and quality assurance in a manner that parallels the path of a 
specimen through the testing process. While this regulation pertains to 
complex technical requirements, plain language is used whenever 
possible, as mandated by the Regulatory Reform Initiative.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Cecelia Hinkel, Health Insurance Specialist, Department 
of Health and Human Services, Health Care Financing Administration
Phone: 410 786-3347

RIN: 0938-AK24
_______________________________________________________________________




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

Priority: Other 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 4531(b)

CFR Citation: 42 CFR 410

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

Abstract: The Balanced Budget Act (BBA) 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.

[[Page 25456]]

However, other statutory obligations and the scope of systems changes 
required to implement the ambulance fee schedule were so numerous as to 
make it impossible for us to accomplish this concurrent with the 
critical work that we and our contractors had to perform to assure that 
our respective systems were compliant with the year 2000 requirements. 
Therefore, since we were unable to implement the ambulance fee schedule 
on January 1, 2000, we have delayed implementation of the fee schedule 
for ambulance services until January 1, 2001. This action is in keeping 
with our objective to have the ambulance fee schedule become effective 
as soon as possible after the January 1, 2000 statutory date, given our 
year 2000 activities and our other statutory obligations to implement 
various revised payment systems in calendar year 2000. In addition to 
setting the payment rates, the Secretary is to ensure that the 
aggregate amount of payment made for ambulance services in 2001 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. 
Negotiations were conducted by a committee chartered under the Federal 
Advisory Committee Act (FACA) (5 U.S.C. App. 2). We used the services 
of an impartial conveyer to help identify interests that would be 
significantly affected by the proposed rule (including residents of 
rural areas) and the names of persons who were willing and qualified to 
represent those interests. The Negotiated Rulemaking Committee on the 
Medicare Ambulance Services Fee Schedule consisted of national 
representatives of interests that were likely to be significantly 
affected by the fee schedule. To the extent that this proposed rule 
accurately reflected the Committee Statement as signed on February 14, 
2000, each member to the Committee agreed not to comment on those 
issues on which consensus was reached.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/12/00                    65 FR 55076
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Glenn McGuire, Department of Health and Human Services, 
Health Care Financing Administration, S3-05-27, Office of Clinical 
Standards and Quality, 7500 Security Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-0596

RIN: 0938-AK30
_______________________________________________________________________




1003. FIRE SAFETY REQUIREMENTS FOR RNHCI, ASC, HOSPICES, PACE, 
HOSPITALS, AND LONG-TERM CARE FACILITIES (HCFA-3047-P)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 403; 42 CFR 416; 42 CFR 418; 42 CFR 460; 42 CFR 
482; 42 CFR 483

Legal Deadline: None

Abstract: This rule would update current fire safety requirements to 
generally conform to the 2000 edition of the Life Safety Code, 
published by the National Fire Protection Association.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Tamara Syrek, Health Insurance Specialist, Department 
of Health and Human Services, Health Care Financing Administration
Phone: 410 786-3529

RIN: 0938-AK35
_______________________________________________________________________




1004.  MEDICARE PROVIDER AND SUPPLIER HEARING PROCEDURES (HCFA-
2093-P)

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

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 498.40; 42 CFR 498.70; 42 CFR 498.83; 42 CFR 
498.88

Legal Deadline: None

Abstract: This rule would revise current hearing regulations applicable 
to enforcement actions taken by HCFA against Medicare providers and 
suppliers (and, in some cases, certain Medicaid providers) based on a 
lack of compliance with Federal certification requirements. 
Specifically, this rule would revise existing requirements governing 
the level of specificity that petitioners must include when seeking 
review of agency actions governed by these hearing regulations. 
Additionally, this rule would clarify the meaning of ``good cause'' as 
that term is used in the hearing regulations to judge whether 
petitioners may file requests for review after filing deadlines have 
passed. The rule would also require dismissal of petitions for review 
when a petitioner has failed to file a sufficiently detailed hearing 
request within the time allotted by the regulations.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Organizations

Government Levels Affected: None

Agency Contact: Sandy Haydock, Health Insurance Specialist, Department 
of Health and Human Services, Health Care Financing Administration, 
7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-3822

RIN: 0938-AK39
_______________________________________________________________________




1005.  HOSPITAL CONDITIONS OF PARTICIPATION: QUALITY ASSESSMENT 
AND PERFORMANCE IMPROVEMENTS (HCFA-3050-F)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 482.21

Legal Deadline: None

Abstract: This rule requires hospitals to develop and maintain a 
quality assessment and performance improvement (QAPI) program. The QAPI 
focuses the providers' efforts on the actual care delivered to 
patients, the performance of the hospital as an organization, and the 
impact of treatment furnished by the hospital on the health status of 
its patients. In addition, QAPI entails all activities required for 
measuring quality of care and maintaining it at acceptable levels. 
Performance improvement activities aim to improve overall performance 
assuming that there is no permanent threshold for good performance. 
Under performance improvement framework,

[[Page 25457]]

hospitals will continuously study and improve the processes of 
healthcare and delivery of service.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/19/97                    62 FR 66725
NPRM Comment Period End         02/17/98


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

Agency Contact: Stephanie Dyson, Health Insurance Specialist, 
Department of Health and Human Services, Health Care Financing 
Administration, S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-9226

RIN: 0938-AK40
_______________________________________________________________________




1006.  REQUIREMENTS FOR THE RECREDENTIALING OF MEDICARE+CHOICE 
ORGANIZATIONS PROVIDERS (HCFA-1160-F)

Priority: Substantive, Nonsignificant

Legal Authority: Social Security Act, sec 1102; Social Security Act, 
sec 1871

CFR Citation: 42 CFR 422.204

Legal Deadline: None

Abstract: This rule would change the requirements of recredentialing 
providers for Medicare+Choice Organizations from at least every 2 years 
to at least every 3 years.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/27/00                    65 FR 81813


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Siera Gollan, Health Insurance Specialist, Department 
of Health and Human Services, Health Care Financing Administration, 
7500 Security Blvd., Baltimore, MD 21244
Phone: 410 786-6664

RIN: 0938-AK41
_______________________________________________________________________




1007.  SUPPLEMENTARY MEDICAL INSURANCE PREMIUM SURCHARGE 
AGREEMENTS (HCFA-4007-P)

Priority: Substantive, Nonsignificant

Legal Authority: Social Security Act, sec 1839(e)

CFR Citation: 42 CFR 408.200; 42 CFR 408.201; 42 CFR 408.202; 42 CFR 
408.205; 42 CFR 408.207; 42 CFR 408.210; ...

Legal Deadline: None

Abstract: This rule would implement section 1839(e) of the SSA, as 
amended by section 144 of the SAA Amendments of 1994 and the Balanced 
Budget Act of 1997 to allow State and local government agencies to pay 
a lump sum for the Supplementary Medical Insurance (SMI) late 
enrollment fee due for a designated group of eligible individuals.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State, Local

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

Sandy Clarke, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Blvd, Baltimore, MD 21244
Phone: 410 786-7451

RIN: 0938-AK42
_______________________________________________________________________




1008.  MEDICAL DEVICES COVERAGE DECISIONS RELATED TO HEALTH CARE 
TECHNOLOGY (HCFA-3059-P)

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

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 1302; 42 USC 1395y; 42 USC 1395hh; 42 USC 410; 
42 USC 411

CFR Citation: 42 CFR 405.207

Legal Deadline: None

Abstract: This rule exemption would permit coverage for, and payment, 
of routine patient care costs associated with certain approved clinical 
trials of delays subject to the investigational devices. This would 
also include costs due to medical complications associated with 
participating in approved clinical trials.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

Sharon Hippler, Office of Clinical Standards and Quality, Department of 
Health and Human Services, Health Care Financing Administration, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4633

RIN: 0938-AK43
_______________________________________________________________________




1009.  MEDICAID MANAGEMENT INFORMATION SYSTEM REVISED DEFINITION 
OF ``MECHANIZED CLAIMS PROCESSING AND INFORMATION RETRIEVAL SYSTEM'' 
(HCFA-2123-IFC)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 433.111; 42 CFR 433.112; 42 CFR 433.119

Legal Deadline: None

Abstract: This rule revises the definition of mechanized claims 
processing and information retrieval systems to include the eligibility 
determination function. This change allows States to request enhanced 
FFP at the 90 and 75 percent levels to perform the function by either 
the Medicaid Management Information Systems or the integrated 
eligibility determination systems.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: State, Federal

[[Page 25458]]

Agency Contact: Harvey Heyman, Health Insurance Specialist, Department 
of Health and Human Services, Health Care Financing Administration, 
7500 Security Blvd., Baltimore, MD 21044
Phone: 410 786-0712

RIN: 0938-AK44
_______________________________________________________________________




1010.  MEDICARE PROGRAM; REPORTING AND REPAYMENT OF OVERPAYMENTS 
(HCFA-6011-P)

Priority: Other Significant

Legal Authority: Social Security Act, sec 1102; Social Security Act, 
sec 1871

CFR Citation: 42 CFR 401.310

Legal Deadline: None

Abstract: This proposed rule would modify a notice of proposed 
rulemaking published on March 25, 1998. That notice proposed to amend 
regulations governing liability for overpayments to providers, 
suppliers, and individuals.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Barbara Wright, Health Insurance Specialist, Department 
of Health and Human Services, Health Care Financing Administration, C3-
14-00, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4292

RIN: 0938-AK45
_______________________________________________________________________




1011.  IMPROVEMENTS TO THE MEDICARE+CHOICE APPEALS AND GRIEVANCE 
PROCEDURES (HCFA-4024-F)

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

Unfunded Mandates: Undetermined

Legal Authority: BBA, sec 4001; PL 105-33; Social Security Act, sec 
1851 to 1859

CFR Citation: 42 CFR 422; 42 CFR 489

Legal Deadline: NPRM, Judicial, January 19, 2001.

Abstract: This rule sets forth several improvements to the 
Medicare+Choice (M+C) appeal and grievance procedures. Most notably, 
this rule will: 1) ensure that M+C enrollees receive written notice, 
including information about appeal rights, at least 4 days before the 
proposed termination date of provider services; and 2) establishes a 
new fast-track independent review process for appealing decisions to 
terminate services.
This rule also clarifies hospitals' responsibility for issuing 
discharge notices, amends the Medicare provider agreement regulations 
with regard to beneficiary notification requirements, and sets forth 
beneficiary grievance procedures.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/24/01                     66 FR 7593
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Organizations

Government Levels Affected: None

Additional Information: The Settlement Agreement in Grijalua v. Shalala 
contemplates that a final rule will be published by the end of 2002.

Agency Contact: Tony Culotta, Department of Health and Human Services, 
Health Care Financing Administration, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-4661

RIN: 0938-AK48
_______________________________________________________________________




1012.  CIVIL MONEY PENALTIES, ASSESSMENTS, AND REVISED SANCTION 
AUTHORITIES (HCFA-6145-FC)

Priority: Info./Admin./Other

Legal Authority: PL 105-33, sec 4541(a)(2); PL 105-33, sec 4311(b); PL 
105-33, sec 4317; PL 105-33, sec 4031(a)(2); PL 105-33, sec 4531(b)(2); 
PL 104-191, sec 231(c); ...

CFR Citation: 42 CFR 402.1; 42 CFR 402.105; 42 CFR 402.107; 42 CFR 
405.520

Legal Deadline: None

Abstract: This rule with comment period is a technical rule that amends 
our civil money penalty (CMP) authorities. It adds CMP authorities that 
were enacted as part of the Balanced Budget Act of 1997 (BBA) and 
delegated to us. The rule delineates our authority to assess penalties 
for: failure to bill outpatient therapy services or comprehensive 
outpatient rehabilitation services (CORS) on an assignment-related 
basis, failure to bill ambulance services on an assignment-related 
basis, failure to provide an itemized statement for Medicare items and 
services to a Medicare beneficiary upon his/her request, and failure of 
physicians or nonphysician practitioners to provide diagnostic codes 
for items or services they furnish or failure to provide this 
information to the entity furnishing the item or service ordered by the 
practitioner. As a result of the BBA's redesignation of a statutory 
paragraph, the rule also includes a technical change to an existing 
delegated authority. Additionally, the rule includes a technical change 
that corrects the amount of the CMP in section 405.520(c) and also 
serves as a cross-reference to the requirements in other sections of 
the regulations.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Joel Cohen, Office of Financial Management, Department 
of Health and Human Services, Health Care Financing Administration, C3-
04-06, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-3349

RIN: 0938-AK49
_______________________________________________________________________




1013.  PAYMENT FOR UPGRADED DURABLE MEDICAL EQUIPMENT (HCFA-
1084-F)

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 414

Legal Deadline: None

Abstract: This rule amends the Medicare regulations to permit Medicare 
suppliers to furnish certain upgraded durable medical on an assignment 
basis. Medicare payment will be made to suppliers as if the DME were 
without the upgraded features.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

[[Page 25459]]

Government Levels Affected: None

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

RIN: 0938-AK50
_______________________________________________________________________




1014.  UPDATE TO THE PROSPECTIVE PAYMENT SYSTEM FOR HOME HEALTH 
AGENCIES FOR FY 2002 (HCFA-1147-NC)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh; Social Security Act, sec 
1102; Social Security Act, sec 1871

CFR Citation: Not Yet Determined

Legal Deadline: Other, Statutory, October 1, 2001, Rate updates 
required by BBA of 97.
Rates for instructing Medicare contractors about system changes must be 
published in the Federal Register by 07/01/01.

Abstract: This notice with comment sets forth an update to the 60-day 
national home health episode rates and the national per visits amounts 
used in the calculation of the low utilization payment adjustment 
(LUPA) under the Medicare prospective payment system for home health 
agencies. These rates replace the 60-day episode rates and the national 
per visits amounts used in calculation of the LUPA (published in the 
July 3, 200 FR (65 FR 41128).

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Susan Levy, Health Insurance Specialist, Department of 
Health and Human Services, Health Care Financing Administration, C4-05-
27, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-9364

RIN: 0938-AK51
_______________________________________________________________________




1015.  RECOGNITION OF THE AMERICAN OSTEOPATHIC ASSOCIATION FOR 
AMBULATORY SURGICAL CENTER PROGRAMS (HCFA-2079-FN)

Priority: Routine and Frequent

Legal Authority: Social Security Act, sec 1865(b)(l); Social Security 
Act, sec 1832(a)(F)(i)

CFR Citation: Not Yet Determined

Legal Deadline: NPRM, Statutory, January 12, 2001, Must be published 60 
days after receipt of the November 14, 2000 application.

Abstract: In this notice we announce the receipt of an application from 
the American Osteopathic Association (AOA), for recognition as a 
national accreditation program for ambulatory surgical centers 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, describing the 
nature of the request, and providing a 30-day public comment period.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Notice                 03/14/01                    66 FR 14906


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Joan Benny, Health Insurance Specialist, Department of 
Health and Human Services, Health Care Financing Administration, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7233

RIN: 0938-AK53
_______________________________________________________________________




1016.  PROSPECTIVE PAYMENT SYSTEM FOR HOSPITAL OUTPATIENT 
SERVICES (HCFA-1159-P)

Priority: Other Significant

Legal Authority: 42 USC 1395; BBA `97; BBRA `99; BIPA `00

CFR Citation: 42 CFR 419

Legal Deadline: Final, Statutory, November 1, 2001.

Abstract: This rule would include the payment system recalibration, 
implementation of relevant provisions of the Benefits Improvement and 
Protection Act (BIPA) of 2000, and other related policies.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              11/13/00                    65 FR 67798


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Chuck Braver, Department of Health and Human Services, 
Health Care Financing Administration, Center for Health Plans and 
Providers, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6719

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-AK54
_______________________________________________________________________




1017.  MEDICARE AS SECONDARY PAYER-RECOVERY OF CONDITIONAL 
PAYMENTS (HCFA-6009-P)

Priority: Other Significant

Legal Authority: None

CFR Citation: 42 CFR 411.20; 42 CFR 411.24

Legal Deadline: None

Abstract: This rule clarifies provider and supplier responsibilities in 
recovery of conditional payments.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: William Zavoina, Department of Health and Human 
Services, Health Care Financing Administration, Bureau of Program 
Operations, 1445 Meadows East Building, Baltimore, MD 21207
Phone: 410 966-7461

RIN: 0938-AK55

[[Page 25460]]

_______________________________________________________________________




1018.  FIVE YEAR REVIEW OF WORK RELATIVE VALUE UNITS UNDER THE 
PHYSICIAN FEE SCHEDULE PROPOSED NOTICE (HCFA-1170-PN)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1395w-4(c)

CFR Citation: Not Yet Determined

Legal Deadline: NPRM, Statutory, May 1, 2001.

Abstract: This notice discusses changes to work relative value units 
(RVUs) affecting payment for physician services.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal

Agency Contact: Terrence Kay, Center for Health Plans and Providers, 
Division of Practitioner and Ambulatory C, Department of Health and 
Human Services, Health Care Financing Administration, 7500 Security 
Boulevard, C4-10-26, Baltimore, MD 21244
Phone: 410 786-4497

James Menas, Department of Health and Human Services, Health Care 
Financing Administration, C4-05-04, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4507

RIN: 0938-AK56
_______________________________________________________________________




1019.  REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE 
SCHEDULE FOR CALENDAR YEAR 2002 (HCFA-1169-P)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 CFR 1395w-4

CFR Citation: Not Yet Determined

Legal Deadline: Final, Statutory, November 1, 2001.

Abstract: This rule with comment period makes several changes affecting 
Medicare part B payments, and implements several provisions of the 
BIPA.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: Federal

Agency Contact: Diane Milstead, Department of Health and Human 
Services, Health Care Financing Administration, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-3355

Terrence Kay, Center for Health Plans and Providers, Division of 
Practitioner and Ambulatory C, Department of Health and Human Services, 
Health Care Financing Administration, 7500 Security Boulevard, C4-10-
26, Baltimore, MD 21244
Phone: 410 786-4497

RIN: 0938-AK57
_______________________________________________________________________




1020.  CHANGES TO NATIONAL COVERAGE DETERMINATIONS AND LOCAL 
COVERAGE DETERMINATIONS (HCFA-4019-FC)

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 405

Legal Deadline: None

Abstract: This regulation would clarify when and under what 
circumstances Medicare coverage policy could be challenged.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: James Bossenmeyer, Health Insurance Specialist, 
Department of Health and Human Services, Health Care Financing 
Administration, C5-16-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-9317
Email: [email protected]

RIN: 0938-AK58
_______________________________________________________________________




1021.  REVISIONS TO THE PROSPECTIVE PAYMENT SYSTEM FOR HOSPITAL 
OUTPATIENT SERVICES MANDATED BY BIPA (HCFA-1179-IFC)

Priority: Other Significant

Legal Authority: 42 USC 1395l; BBA 1997; BBRA 1999; BIPA 2000

CFR Citation: 42 CFR 419

Legal Deadline: None

Abstract: This rule implements the requirement of the BIPA to establish 
criteria for new categories of medical devices for transitional pass-
through payment under the outpatient prospective payment system. The 
criteria would become effective on July 1, 2001.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Federal

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-AK59
_______________________________________________________________________




1022.  CHALLENGES TO NATIONAL COVERAGE DETERMINATIONS AND LOCAL 
COVERAGE DETERMINATIONS (HCFA-3063-P)

Priority: Other Significant

Legal Authority: Sec 522 of the BIPA 2000

CFR Citation: 42 CFR 405

Legal Deadline: NPRM, Statutory, October 1, 2001.
The effective date for regulation changes is 10/01/01.

Abstract: This rule proposes changes to the appeals process for 
national and local coverage determinations.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: James Bossenmeyer, Health Insurance Specialist, 
Department of Health and Human Services, Health Care Financing 
Administration, C5-16-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-9317
Email: [email protected]

RIN: 0938-AK60

[[Page 25461]]

_______________________________________________________________________




1023.  REVISED PROCESS FOR MAKING MEDICARE COVERAGE DECISIONS 
(HCFA-3062-N)

Priority: Other Significant

Legal Authority: Sec 522 of the BIPA 2000

CFR Citation: Not Yet Determined

Legal Deadline: Other, Statutory, October 1, 2001, Revision notice.

Abstract: This notice revises the process for making Medicare coverage 
decisions.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Vadim Lubarsky, Health Insurance Specialist, Department 
of Health and Human Services, Health Care Financing Administration, C5-
16-03, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0840

RIN: 0938-AK61
_______________________________________________________________________




1024.  CLAIMS ATTACHMENT STANDARD (HCFA-0050-P)

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

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

Legal Authority: 42 USC 1320d-2(a)(2)(B)

CFR Citation: 45 CFR 162

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

Abstract: This rule proposes an electronic standard transmissions for 
claims attachments. The standard is required by HIPAA. It would be used 
to transmit clinical data, beyond those data contained in the claims 
standard, to help establish medical necessity or coverage.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: State, Local, Federal, Tribal

Federalism:  Undetermined

Procurement: This is a procurement-related action for which there is a 
statutory requirement. There is a paperwork burden associated with this 
action.

Agency Contact: James Krall, Health Insurance Specialist, Department of 
Health and Human Services, Health Care Financing Administration, 7500 
Securtiy Blvd., Baltimore, MD 21244
Phone: 410 786-6999

RIN: 0938-AK62
_______________________________________________________________________




1025.  STANDARDS FOR ELECTRONIC SIGNATURES (HCFA-0051-F)

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

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

Legal Authority: PL 104-91; SSA, Sec. 1171 to 1179

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This final rule is being jointly developed by HCFA and the 
Department of Commerce. The final rule implements administrative 
simplification initiatives that have a national scope beyond the 
Medicare and Medicaid programs. This rule establishes standards for 
electronic signature for health care claims processing.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/12/98                    63 FR 43242
NPRM Comment Period End         10/13/98


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: State, Local, Federal

Federalism:  Undetermined

Additional Information: Previously reported under 0938-AI57.

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-AK63
_______________________________________________________________________




1026.  HEALTH INSURANCE REFORM: MODIFICATIONS TO STANDARDS FOR 
ELECTRONIC TRANSACTION (HCFA-0003-IFC)

Priority: Other Significant

Unfunded Mandates: Undetermined

Legal Authority: Social Security Act, sec 1871

CFR Citation: 45 CFR 162

Legal Deadline: None

Abstract: This rule adopts a revised national council for prescription 
drug programs (NCPDP) standards for batched retail pharmacy 
transactions under 45 CFR 162.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Marilyn Abramovitz, Health Insurance Specialist, 
Department of Health and Human Services, Health Care Financing 
Administration, N2-14-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5939

RIN: 0938-AK64
_______________________________________________________________________




1027.  REPLACEMENT OF REASONABLE CHARGE METHODOLOGY BY FEE 
SCHEDULE (HCFA-1010-F)

Priority: Other Significant

Unfunded Mandates: Undetermined

Legal Authority: Social Security Act, sec 1833; Social Security Act, 
sec 1842

CFR Citation: 42 CFR 414

Legal Deadline: None

Abstract: This final rule implements fee schedules for payment of items 
and services, excluding ambulance services, still subject to the 
reasonable charge payment methodology. The authority for establishing 
these fee schedules is provided by the Balanced Budget Act of 1997, 
which amended the Social Security Act. A fee schedule for ambulance 
services is mandated by a different statutory provision. The Social 
Security Act specifies that statewide or other areawide fee schedules 
may be implemented for the following items and services: medical 
supplies; home dialysis supplies and equipment; therapeutic shoes; 
parenteral and

[[Page 25462]]

enteral nutrients, equipment, and supplies; electromyogram devices; 
salivation devices; blood products; and transfusion medicine. This 
final rule describes changes made to the proposed fee schedule payment 
methodology for these items and services and provides that the fee 
schedules are effective for all specified covered items and services 
furnished on or after January 1, 2002. Fee schedules will not be 
implemented for electromyogram devices and salivation devices at this 
time since these items are not covered by Medicare.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Organizations

Government Levels Affected: None

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

RIN: 0938-AK66
_______________________________________________________________________




1028.  PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH 
THEY HAVE FINANCIAL RELATIONSHIPS-PHASE II (HCFA-1810-FC)

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

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 1302; 42 USC 1395hh; 42 USC 1395nn

CFR Citation: 42 CFR 411

Legal Deadline: None

Abstract: On January 4, 2001, we issued a final rule with comment 
period (phase I) to incorporate into regulations paragraphs (a), (b), 
and (h) of section 1877 of the Social Security Act. This final rule 
with comment period (phase II) will address comments from the January 
9, 1998 proposed rule concerning the remainder of section 1877, 
including the ownership and investment exceptions and the compensation 
exceptions. In addition, this final rule will address comments from the 
January 4, 2001 final rule with comment period.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: State, Local

Federalism:  Undetermined

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

RIN: 0938-AK67
_______________________________________________________________________




1029.  INCREASE IN THE RATE OF REIMBURSEMENT OF PHOTOCOPY 
EXPENSES FOR PROSPECTIVE PAYMENT SYSTEM PROVIDERS (HCFA-3055-P)

Priority: Economically Significant

Legal Authority: Social Security Act, sec 1102; Social Security Act, 
sec 1154; Social Security Act, sec 1159; Social Security Act, sec 1866; 
Social Security Act, sec 1871

CFR Citation: 42 CFR 476.78

Legal Deadline: None

Abstract: This rule would increase the rate of reimbursement for 
photocopy expenses of Medicare Prospective Payment System (PPS) 
providers of medical records requested by Utilization and Quality 
Control Peer Review Organizations. We would increase the rate from 7 
cents to 11 cents per page, which includes labor and supply costs, to 
reflect inflationary adjustments for these two cost components only.
This rule is necessary due to increases in the inflation factor, and 
increases in salaries and cost of living. We would specify a provision 
for periodic review and adjustment of the per-page reimbursement cost 
to account for inflation and changes in technology. The methodology for 
calculating the per-page reimbursement rate would remain unchanged.
We also propose to expand the scope of the regulation to encompass 
other providers subject to the Medicare PPS (for example, skilled 
nursing facilities and home health agencies), as well as hospitals.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Agency Contact: Valerie Mattison-Brown, Department of Health and Human 
Services, Health Care Financing Administration, Office of Clinical 
Standards, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5958

RIN: 0938-AK68
_______________________________________________________________________




1030.  LONG TERM CARE PROSPECTIVE PAYMENT SYSTEM FOR FY 2003 
(HCFA-1177-P)

Priority: Other Significant

Unfunded Mandates: Undetermined

Legal Authority: BBA, sec 4422(a)(1); BBRA, sec 123; BIPA, sec 307

CFR Citation: 42 CFR 412

Legal Deadline: NPRM, Statutory, November 1, 2001, 60 Days before the 
final rule.

Abstract: This regulation will implement a prospective payment system 
for long-term care hospitals.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, Federal

Federalism:  Undetermined

Agency Contact: Judith H. Richter, Department of Health and Human 
Services, Health Care Financing Administration, C4-07-07, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-2590

RIN: 0938-AK69
_______________________________________________________________________




1031.  MODIFICATIONS TO MANAGED CARE RULES BASED ON PROVISIONS 
OF BIPA AND TECHNICAL CORRECTIONS (HCFA-1180-P)

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

Legal Authority: BIPA, sec 601 to 608; BIPA, sec 611 to 621; BIPA, sec 
623; BIPA, sec 634

CFR Citation: Not Yet Determined

[[Page 25463]]

Legal Deadline: None

Abstract: Implements certain technical and minor provisions of sections 
601 to 634 of the Medical Payment Provisions of the Medicare, Medicaid 
and SCHIP Benefit and Improvement Act of 2000.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: A. G. D'Alberto, Office of Managed Care, Department of 
Health and Human Services, Health Care Financing Administration, S3-02-
01, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-1100

RIN: 0938-AK71
_______________________________________________________________________




1032.  CHANGES TO THE HOSPITAL INPATIENTS PROSPECTIVE PAYMENT 
SYSTEM FOR FISCAL YEAR 2002 RATES (HCFA-1158-P)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: Social Security Act, sec 1886(d)

CFR Citation: 42 CFR 412; 42 CFR 413; 42 CFR 485; 42 CFR 486

Legal Deadline: Final, Statutory, August 1, 2001.

Abstract: We are revising the Medicare hospital inpatient prospective 
payment for operating costs to implement changes arising from our 
continuing experience with the system. In addition, in the Addendum to 
this final rule, we described changes to the amounts and factors used 
to determine the rates for Medicare hospital inpatient services for 
operating costs and capita-related costs. These changes apply to 
discharges occurring on or after October 1, 2001. We also set forth 
rate-of-increase limits and made changes to our policy for hospitals 
and hospital units excluded from the prospective payment systems.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Stephen Phillips, Center for Health Plans and 
Providers, Department of Health and Human Services, Health Care 
Financing Administration, C4-05-27, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4548

RIN: 0938-AK73
_______________________________________________________________________




1033.  CHANGES TO INPATIENT BIPA FOR FISCAL YEAR 2001 (HCFA-
1178-IFC)

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

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

Legal Authority: PL 106-554

CFR Citation: Not Yet Determined

Legal Deadline: Other, Statutory, April 1, 2001, Enacted by the BIPA 
2000 on December 21, 2000.

Abstract: The BIPA 2000, enacted on December 21, 2000, contained 
numerous provisions affecting inpatient hospital payment policies. 
These provisions have varying effective dates. In accordance with the 
statute, the changes in this regulation are effective either 
retroactively to October 1, 2000, upon enactment of BIPA 2000 (Dec. 21, 
2000), or will be effective on April 1, 2001.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Stephen Phillips, Center for Health Plans and 
Providers, Department of Health and Human Services, Health Care 
Financing Administration, C4-05-27, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4548

RIN: 0938-AK74
_______________________________________________________________________




1034.  MEDICARE+CHOICE ESRD RATES (HCFA-1182-PN)

Priority: Other Significant

Legal Authority: BIPA 2000, sec 605

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This notice announces HCFA's new payment methodology for 
beneficiaries with ESRD who are enrolled in Medicare+Choice plans.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: Anne Hornsby, Health Insurance Specialist, Department 
of Health and Human Services, Health Care Financing Administration, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1181

RIN: 0938-AK75
_______________________________________________________________________




1035.  REVISIONS TO TRANSACTION AND CODE SET STANDARDS FOR 
ELECTRONIC TRANSACTIONS (HCFA-0005-IFC)

Priority: Other Significant

Legal Authority: Social Security Act, sec 1871

CFR Citation: 45 CFR 162

Legal Deadline: None

Abstract: This rule adopts revisions to the standards for electronic 
health care transactions adopted by the Secretary in regulations 
published August 2000. These revisions enable covered entities to 
comply with the standards.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Tribal, Federal

Agency Contact: Stanley B. Nachimson, Senior Technical Advisor, 
Department of Health and Human Services, Health Care Financing 
Administration, N2-16-03, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6153

RIN: 0938-AK76
_______________________________________________________________________




1036.  MEDICARE INPATIENT DISPROPORTIONATE SHARE HOSPITAL 
ADJUSTMENT CALCULATION (HCFA-1171-IFC)

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 412106

Legal Deadline: None

[[Page 25464]]

Abstract: This rule defines ``Medicaid patient days'' in the Medicare 
DSH adjustment calculations.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Stephen Phillips, Center for Health Plans and 
Providers, Department of Health and Human Services, Health Care 
Financing Administration, C4-05-27, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-4548

RIN: 0938-AK77
_______________________________________________________________________




1037.  STATEMENT OF INTENT (HCFA-1185-P)

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

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 424

Legal Deadline: NPRM, Statutory, November 1, 2001.

Abstract: This regulation is a review of Medicare statement of intent 
provisions.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: David Walczak, Center for Health Plans and Providers, 
Plan and 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-AK79
_______________________________________________________________________




1038.  PROCEDURES FOR PUBLIC CONSULTATIONS FOR CODING AND 
PAYMENT DETERMINATIONS FOR NEW LABORATORY TESTS (HCFA-1186-N)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1395(h)

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: The Benefits Improvement and Protection Act (BIPA) of 2000, 
section 531 has a statutory deadline of December 20, 2001 to establish 
procedures for coding and payment determinations for new clinical 
laboratory tests in a manner consistent with procedures of 
International Classification of Diseases 9-CM. The procedures will 
require a minimum of one public meeting per year to allow laboratory 
and durable medical equipment industries to participate in coding and 
payment decisions.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, Federal

Agency Contact: Tzvi Hefter, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-07-07, 7500 Security Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-1304

RIN: 0938-AK80
_______________________________________________________________________




1039.  ORGAN PROCUREMENT ORGANIZATION CONDITION FOR COVERAGE 
(HCFA-3064-P)

Priority: Other Significant

Legal Authority: 42 USC 1320b-8(b)(1)(A)(i); 42 USC 273(b)(2)

CFR Citation: 42 CFR 486.301

Legal Deadline: Final, Statutory, January 1, 2002, Requires 
promulgation of new conditions.

Abstract: This rule will establish conditions for coverage for organ 
procurement organizations (OPOs) to be certified by the Secretary to 
receive payment from Medicare and Medicaid for organ procurement costs 
and to be designated by the Secretary for a specific geographic service 
area.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Jacqueline Morgan, Health Insurance Specialist, 
Department of Health and Human Services, Health Care Financing 
Administration, S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4282

RIN: 0938-AK81
_______________________________________________________________________




1040.  QUALIFICATION REQUIREMENTS FOR DIRECTORS OF LABORATORIES 
PERFORMING HIGH COMPLEXITY TESTING (HCFA-2094-NPRM)

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

Unfunded Mandates: Undetermined

Legal Authority: USPHSA, sec 353

CFR Citation: 42 CFR 493.1443

Legal Deadline: None

Abstract: This rule revises the qualification requirements by which an 
individual with a doctoral degree may qualify to serve as a director of 
a laboratory that performs high complexity testing.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Cecelia Hinkel, Health Insurance Specialist, Department 
of Health and Human Services, Health Care Financing Administration
Phone: 410 786-3347

RIN: 0938-AK83
_______________________________________________________________________




1041.  PROTECTION AND PROMOTION OF RESIDENT RIGHTS (HCFA-3065-P)

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

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 290aa, Public Health Service Act

CFR Citation: Not Yet Determined

Legal Deadline: NPRM, Statutory, October 7, 2001, Rule must be 
promulgated per part H, sec 593, title V of the Public Health Service 
Act.

Abstract: This rule will impose regulations to ensure protection and 
promotion of residents' rights to be free from physical or mental 
abuse, corporal punishment, and any restraints or

[[Page 25465]]

involuntary seclusion imposed for purpose of discipline or convenience.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: State, Local

Federalism:  Undetermined

Agency Contact: Julie Moyers, Health Insurance Specialist, Health 
Standards and Quality Bureau, Department of Health and Human Services, 
Health Care Financing Administration, S1-09-07, 7500 Security 
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-6772

RIN: 0938-AK85
_______________________________________________________________________




1042.  STANDARDS FOR ELECTRONIC TRANSACTIONS-ELIMINATION OF NDC 
CODING STANDARDS (HCFA-0006-P)

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

Unfunded Mandates: Undetermined

Legal Authority: Social Security Act, sec 1171-79

CFR Citation: 42 CFR 162.1002

Legal Deadline: None

Abstract: This regulation will change the standard codes for drugs and 
biologics. It withdraws the designation of the NDC code set as the 
standard for institutional and professional providers.

Timetable: Next Action Undetermined

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: Stanley B. Nachimson, Senior Technical Advisor, 
Department of Health and Human Services, Health Care Financing 
Administration, N2-16-03, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6153

RIN: 0938-AK86
_______________________________________________________________________




1043.  HOSPITAL REFERENCE LABORATORY AND MEDICARE SECONDARY 
PAYER (HCFA-1187-P)

Priority: Info./Admin./Other

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This regulation will address current procedures with respect 
to independent laboratories' administrative requirements in gathering 
and verifying Medicare Secondary Payer information in reference lab 
situations involving ``nonpatient'' claims.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: Paul Olenick, Director, Division of Beneficiary and 
Insurance Issues, Department of Health and Human Services, Health Care 
Financing Administration, C4-07-07, 7500 Security Boulevard, Baltimore, 
MD 21244-1850
Phone: 410 786-4472

RIN: 0938-AK87
_______________________________________________________________________




1044.  PORTABILITY IN THE GROUP HEALTH INSURANCE MARKET (HCFA-
2048-F)

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

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 300gg

CFR Citation: 42 CFR 144.103; 42 CFR 146.101; 42 CFR 143.111; 42 CFR 
146.113; 42 CFR 146.115; 42 CFR 146.117; 42 CFR 146.119; ...

Legal Deadline: None

Abstract: This regulation will specify the limitations on only 
preexisting conditions exclusion periods imposed by group health 
insurance issues and non-Federal government plans, and the requirements 
on such issues and plans to offer special enrollment to certain 
individuals who lose eligibility for other coverage when a new 
dependent becomes eligible through marriage, birth or adoption.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/08/97                    62 FR 16893
Interim Final Rule Comment 
Period End                      07/07/97
Interim Final Rule Effective    07/07/97


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Local

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

Agency Contact: Tim Hrynick, Health Insurance Specialist, Department of 
Health and Human Services, Health Care Financing Administration, S3-16-
26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4478

RIN: 0938-AK88

[[Page 25466]]

_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1045. CHANGES TO PEER REVIEW ORGANIZATION REGULATIONS (HCFA-3135-F)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 400.200; 42 CFR 466.1; 42 CFR 466.71; 42 CFR 
466.76; 42 CFR 466.78; 42 CFR 466.83; 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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       02/13/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: William Roskey
Phone: 410 786-0433

RIN: 0938-AD38
_______________________________________________________________________




1046. PROTECTION OF INCOME AND RESOURCES FOR COMMUNITY SPOUSES OF 
INSTITUTIONALIZED INDIVIDUALS (HCFA-2023-P)

Priority: Other Significant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn-Under review          02/22/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: State, Local

Federalism:  Undetermined

Agency Contact: Roy Trudel
Phone: 410 786-3417

RIN: 0938-AE12
_______________________________________________________________________




1047. EARLY AND PERIODIC SCREENING, DIAGNOSTIC, AND TREATMENT (EPSDT) 
SERVICES (HCFA-2028-F)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 441.50; 42 CFR 440.40

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       04/23/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: State, Local

Agency Contact: Cindy Ruff
Phone: 410 786-5916

RIN: 0938-AE72
_______________________________________________________________________




1048. PAYMENT FOR NURSING AND ALLIED HEALTH SCIENCE EDUCATION (HCFA-
1685-F)

Priority: Other Significant

CFR Citation: 42 CFR 413

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      01/12/01                     66 FR 3358
Final Rule Effective            01/12/01
60-Day Delay of Effective Date  03/12/01                    66 FR 14342

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Rebecca Hirshorn
Phone: 410 786-3411

RIN: 0938-AE79
_______________________________________________________________________




1049. COVERAGE OF SCREENING PAP SMEARS (HCFA-3705-F)

Priority: Other Significant

CFR Citation: 42 CFR 410.10; 42 CFR 410.32; 42 CFR 410.56; 42 CFR 
411.15

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       02/06/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Joyce Eng
Phone: 410 786-4619

Sharon Lappalainen
Phone: 410 786-9262

RIN: 0938-AE98
_______________________________________________________________________




1050. REFERRAL TO CHILD SUPPORT ENFORCEMENT AGENCIES OF MEDICAID 
FAMILIES (HCFA-2051-F)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 433.135; 42 CFR 433.137; 42 CFR 433.151; 42 CFR 
433.160

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn-Under review          02/22/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Federalism:  Undetermined

Agency Contact: Robert Nakielny
Phone: 410 786-4466

RIN: 0938-AF68
_______________________________________________________________________




1051. DISCLOSURE OF CONFIDENTIAL PRO AND ESRD NETWORK ORGANIZATION 
INFORMATION FOR RESEARCH PURPOSES (HCFA-3208-P)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 405.2115; 42 CFR 476.144

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       02/13/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Alfreda Staton
Phone: 410 786-6940

RIN: 0938-AG33
_______________________________________________________________________




1052. EFFECT OF CHANGE OF OWNERSHIP ON PROVIDER AND SUPPLIER PENALTIES, 
SANCTIONS, UNDERPAYMENTS AND OVERPAYMENTS (HCFA-2215-P)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 405.1801; 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 
489.13; 42 CFR 489.18

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn-Under review          02/22/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Mike Goldman
Phone: 410 786-6813

RIN: 0938-AG59
_______________________________________________________________________




1053. OPTIONAL COVERAGE OF CERTAIN TUBERCULOSIS TO TB-RELATED SERVICES, 
TB-INFECTED INDIVIDUALS (HCFA-2082-P)

Priority: Economically Significant

CFR Citation: 42 CFR 435.219; 42 CFR 435.201; 42 CFR 440.250; 42 CFR

[[Page 25467]]

436.201; 42 CFR 436.219; 42 CFR 440.164

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn-Under review          02/22/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Local

Federalism:  Undetermined

Agency Contact: Ingrid Osborne
Phone: 410 786-4461

RIN: 0938-AG72
_______________________________________________________________________




1054. PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY HAVE 
FINANCIAL RELATIONSHIPS-EXPANDED TO DESIGNATED HEALTH SERVICES (HCFA-
1809-FC)

Priority: Other Significant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      01/04/01                      66 FR 856
60-Day Delay of Effective Date 
To 04/06/2001                   02/02/01                     66 FR 8771
60-Day Extension of Comment 
Period                          04/04/01                    66 FR 17813

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: State

Agency Contact: Joanne Sinsheimer
Phone: 410 786-4620

RIN: 0938-AG80
_______________________________________________________________________




1055. DISTINCT PART REQUIREMENTS FOR NURSING HOMES AND PROHIBITION ON 
FINANCIAL SCREENING OF APPLICANTS FOR NURSING HOME ADMISSION (HCFA-3815-
P)

Priority: Other Significant

CFR Citation: 42 CFR 409; 42 CFR 483

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       02/13/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Nancy Archer
Phone: 401 786-0596

RIN: 0938-AG84
_______________________________________________________________________




1056. CLIA PROGRAM: CATEGORIZATION OF WAIVED TESTS (HCFA-2225-FC)

Priority: Other Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 493.2; 42 CFR 493.39; 42 CFR 493.45; 42 CFR 
493.47; 42 CFR 493.49; 42 CFR 493.53; 42 CFR 493.1775; 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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn-Under review          02/22/01

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Judy Yost
Phone: 410 786-3531

RIN: 0938-AG99
_______________________________________________________________________




1057. ADDITIONAL SUPPLIER STANDARDS (HCFA-6004-FC)

Priority: Other Significant

CFR Citation: 42 CFR 424.57

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/11/00                    65 FR 60366

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Charles Waldhauser
Phone: 410 786-6140

Ralph Goldberg
Phone: 410 786-4870
Email: [email protected]

RIN: 0938-AH19
_______________________________________________________________________




1058. STATE PLAN AMENDMENT (SPA) RECONSIDERATION PROCESS (HCFA-2096-P)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 430.18; 42 CFR 430.60

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       04/23/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Robert Tomlinson
Phone: 410 786-4463

RIN: 0938-AH24
_______________________________________________________________________




1059. MEDICARE COVERAGE OF SERVICES OF SPEECH-LANGUAGE PATHOLOGISTS AND 
AUDIOLOGISTS (HCFA-1843-P)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 484; 42 CFR 485

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn-Under review          03/06/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Jacqueline Gordon
Phone: 410 786-4517

RIN: 0938-AH37
_______________________________________________________________________




1060. MEDICAID; ESTATE RECOVERIES (HCFA-2083-P)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 433

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn-Under review          02/22/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: State

Federalism:  Undetermined

Agency Contact: Ingrid Osborne
Phone: 410 786-4461

RIN: 0938-AH63

[[Page 25468]]

_______________________________________________________________________




1061. INDIVIDUAL MARKET HEALTH INSURANCE REFORM: PORTABILITY FROM GROUP 
TO INDIVIDUAL COVERAGE; FEDERAL RULES FOR ACCESS IN THE INDIVIDUAL 
MARKET; STATE ALTERNATIVE MECHANISMS TO FEDERAL RULES (HCFA-2882-F)

Priority: Other Significant. Major under 5 USC 801.

CFR Citation: 45 CFR 148

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn-Under review          02/22/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: State, Local, Federal

Federalism:  Undetermined

Agency Contact: Gertrude Saunders
Phone: 410 786-5888
Email: [email protected]

RIN: 0938-AH75
_______________________________________________________________________




1062. DISCLOSURE OF PEER REVIEW ORGANIZATION INFORMATION IN RESPONSE TO 
BENEFICIARY COMPLAINTS (HCFA-3241-P)

Priority: Other Significant

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)

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       02/13/01

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Alfreda Staton
Phone: 410 786-1910

RIN: 0938-AH85
_______________________________________________________________________




1063. MEDICAID PROGRAM; AMENDMENT TO THE PREADMISSION SCREENING AND 
ANNUAL RESIDENT REVIEW PROGRAM (HCFA-2107-P)

Priority: Substantive, Nonsignificant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn-Under review          02/22/01

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: State

Federalism:  Undetermined

Agency Contact: Jan Earle
Phone: 410 786-9004

RIN: 0938-AH89
_______________________________________________________________________




1064. MEDICALLY NEEDY DETERMINATIONS UNDER WELFARE REFORM (HCFA-2109-
IFC)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 435; 42 CFR 436

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn-Under review          02/22/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: State

Federalism:  Undetermined

Agency Contact: Jackie Wilder
Phone: 410 786-4579
Email: [email protected]

RIN: 0938-AH92
_______________________________________________________________________




1065. MEDICAID PROGRAM; COVERAGE AND PAYMENT FOR FEDERALLY QUALIFIED 
HEALTH CENTER SERVICES (HCFA-2043-P)

Priority: Substantive, Nonsignificant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn-Under review          02/22/01

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: State, Tribal

Federalism:  Undetermined

Agency Contact: David Worgo
Phone: 410 786-5919

RIN: 0938-AH95
_______________________________________________________________________




1066. NONDISCRIMINATION IN HEALTH COVERAGE IN THE GROUP MARKET (HCFA-
2022-F)

Priority: Other Significant. Major under 5 USC 801.

CFR Citation: 45 CFR 146

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/08/01                     66 FR 1378
Interim Final Rule Effective    03/09/01
60-Day Delay of Effective Date 
To 05/08/2001                   03/09/01                    66 FR 14076
Withdrawn-Under review          05/02/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal

Agency Contact: Dave Holstein
Phone: 410 786-1564

RIN: 0938-AI08
_______________________________________________________________________




1067. MEDICARE PROGRAM; IMPROVEMENTS TO THE APPEALS PROCESS FOR MEDICARE 
BENEFICIARIES ENROLLED IN HMOS, CMPS, AND HCPPS (HCFA-4024-P)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Duplicate of RIN 0938-AK48      01/18/01

RIN: 0938-AI11
_______________________________________________________________________




1068. MEDICARE PROGRAM; ADJUSTMENTS TO COST LIMITS FOR SKILLED NURSING 
FACILITY INPATIENT ROUTINE SERVICE COSTS (HCFA-1896-FN)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 1001

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       02/08/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Richard Strauss
Phone: 410 786-2019
Email: [email protected]

RIN: 0938-AI14
_______________________________________________________________________




1069. MEDICARE/MEDICAID PROGRAM; USER FEES FOR INFORMATION, PRODUCTS, 
AND SERVICES (HCFA-6021-P)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 401

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       11/02/99

[[Page 25469]]

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: David Escobedo
Phone: 410 786-5401

RIN: 0938-AI46
_______________________________________________________________________




1070. PROSPECTIVE PAYMENT SYSTEM FOR HOSPITAL OUTPATIENT SERVICES (HCFA-
1005-F)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 409.10; 42 CFR 413; 42 CFR 413.124; 42 CFR 
413.130; 42 CFR 489.20; 42 CFR 103.105; 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 103.101; 42 CFR 103.102

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    04/07/00                    65 FR 18434

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Chuck Braver
Phone: 410 786-6719

RIN: 0938-AI56
_______________________________________________________________________




1071. STATE PLAN REQUIREMENTS FOR DURABLE MEDICAL EQUIPMENT PROVIDERS 
(HCFA-2007-P)

Priority: Other Significant

CFR Citation: 42 CFR 441

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn-Under review          02/22/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: State, Local, Tribal

Agency Contact: Mary Linda Morgan
Phone: 410 786-2011
Email: [email protected]

RIN: 0938-AI63
_______________________________________________________________________




1072. MEDICAID PROGRAM; HOME AND COMMUNITY-BASED SERVICES (HCFA-2010-FC)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 440; 42 CFR 441

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/10/00                    65 FR 60105

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Bill Coons
Phone: 410 786-5921

RIN: 0938-AI67
_______________________________________________________________________




1073. 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.

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/19/01                     66 FR 6227
Final Action Effective          04/19/01
60-Day Delay of Effective Date 
To 06/18/2001                   02/26/01                    66 FR 11546

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Local, Tribal, Federal

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

Agency Contact: Michael Fiore
Phone: 410 786-0623

RIN: 0938-AI70
_______________________________________________________________________




1074. PROSPECTIVE FEE SCHEDULE FOR AMBULANCE SERVICES (HCFA-1002-P)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Duplicate of RIN 0938-AK30      02/01/01

RIN: 0938-AI72
_______________________________________________________________________




1075. REVISION OF PROCEDURES FOR REQUESTING EXCEPTIONS TO COST LIMITS 
FOR SNFS AND ELIMINATION OF RECLASSIFICATIONS (HCFA-1883-F)

Priority: Other Significant

CFR Citation: 42 CFR 413.30

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/10/00                    65 FR 60104

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Steve Raitzyk
Phone: 410 786-4599

RIN: 0938-AI80
_______________________________________________________________________




1076. EXPANDED COVERAGE FOR DIABETES OUTPATIENT SELF-MANAGEMENT TRAINING 
SERVICES (HCFA-3002-F)

Priority: Economically Significant

CFR Citation: 42 CFR 410; 42 CFR 414; 42 CFR 424; 42 CFR 476; 42 CFR 
498

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/29/00                    65 FR 83130

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Mary Stojak
Phone: 410 786-6939

RIN: 0938-AI96
_______________________________________________________________________




1077. MEDICARE PROGRAM; CRITERIA AND STANDARDS FOR EVALUATING 
INTERMEDIARY AND CARRIER PERFORMANCE: MILLENNIUM COMPLIANCE (HCFA-4002-
GNC)

Priority: Info./Admin./Other

CFR Citation: 42 CFR ch IV

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          12/11/98                    63 FR 68464

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Sue Lathroum
Phone: 410 786-7409

RIN: 0938-AJ15
_______________________________________________________________________




1078. 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

CFR Citation: 42 CFR 493

[[Page 25470]]

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn-Under review          02/22/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Federal

Agency Contact: Jim Cometa
Phone: 410 786-6720

RIN: 0938-AJ47
_______________________________________________________________________




1079. MEDICARE PROGRAM: CRITERIA FOR MAKING NATIONAL COVERAGE DECISION 
(HCFA-3432-P)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn-Under review          03/06/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Patricia Brocato-Simons
Phone: 410 786-0261

RIN: 0938-AJ54
_______________________________________________________________________




1080. MEDICARE PROGRAM; SUSTAINABLE GROWTH RATE FOR FISCAL YEAR 2000 
(HCFA-1110-N)

Priority: Substantive, Nonsignificant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    04/10/00                    65 FR 19000

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Marc Hartstein
Phone: 410 786-4539

RIN: 0938-AJ60
_______________________________________________________________________




1081. MEDICARE AND MEDICAID PROGRAMS; PROGRAMS FOR ALL-INCLUSIVE CARE 
FOR THE ELDERLY (PACE) (HCFA-1903-P)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn-Under review          03/06/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Janet Samen
Phone: 410 786-9161

RIN: 0938-AJ63
_______________________________________________________________________




1082. CLINICAL SOCIAL WORKER SERVICES (HCFA-1088-F)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 410

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/19/00                    65 FR 62681
Merged With RIN 0938-AK57       02/13/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Paul Kim
Phone: 410 786-7410

RIN: 0938-AJ71
_______________________________________________________________________




1083. MEDICAID DISPROPORTIONATE SHARE HOSPITAL PAYMENTS-INSTITUTIONS FOR 
MENTAL DISEASE (HCFA-2062-N)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       05/01/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Christine Hinds
Phone: 410 786-4578

RIN: 0938-AJ74
_______________________________________________________________________




1084. THE CHILDREN'S HEALTH INSURANCE PROGRAM: IMPLEMENTING THE BALANCED 
BUDGET ACT OF 1997 (HCFA-2006-F)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 457

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/11/01                     66 FR 2490

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Local

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

Agency Contact: Cheryl Austein-Casnoff
Phone: 410 786-4196

Cynthia Shirk
Phone: 410 786-6614

RIN: 0938-AJ75
_______________________________________________________________________




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

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          02/09/00                     65 FR 6380

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Bob Cereghino
Phone: 410 786-4645

RIN: 0938-AJ86
_______________________________________________________________________




1086. PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED 
NURSING FACILITIES-UPDATE (HCFA-1112-F)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 411; 42 CFR 489

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/31/00                    65 FR 46770

Regulatory Flexibility Analysis Required: No

[[Page 25471]]

Government Levels Affected: None

Agency Contact: Susan Burris
Phone: 410 786-6655
Email: [email protected]

RIN: 0938-AJ93
_______________________________________________________________________




1087. USE OF RESTRAINT AND SECLUSION IN RESIDENTIAL TREATMENT FACILITIES 
PROVIDING INPATIENT PSYCHIATRIC SERVICES TO INDIVIDUALS UNDER AGE 21 
(HCFA-2065-F)

Priority: Economically Significant

CFR Citation: 42 CFR 441; 42 CFR 483

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      01/11/01                     66 FR 2316
Final Rule Effective            03/12/01
60-Day Delay of Effective Date 
To 05/11/2001                   03/12/01                    66 FR 14343

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Mary Kay Mullen
Phone: 410 786-5480

RIN: 0938-AJ96
_______________________________________________________________________




1088. CONDITIONS OF PARTICIPATION FOR INTERMEDIATE CARE FACILITIES FOR 
THE MENTALLY RETARDED

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Duplicate of RIN 0938-AK23      02/01/01

RIN: 0938-AJ99
_______________________________________________________________________




1089. 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.

CFR Citation: 42 CFR 447.205; 42 CFR 447.250 to 447.257; 42 CFR 
447.271; 42 CFR 447.272; 42 CFR 447.280

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn-Under review          02/22/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: State

Federalism:  Undetermined

Agency Contact: Marge Lee
Phone: 410 786-4361

RIN: 0938-AK04
_______________________________________________________________________




1090. HOSPITAL CONDITIONS OF PARTICIPATION; ANESTHESIA SERVICES (HCFA-
3049-F)

Priority: Other Significant

CFR Citation: 42 CFR 416.42; 42 CFR 482.52; 42 CFR 485.639

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      01/18/01                     66 FR 4674
Final Rule Effective            01/18/01
60-Day Delay of Effective Date  03/19/01                    66 FR 15352

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

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

Agency Contact: Debbie Hattery
Phone: 410 786-1855

RIN: 0938-AK08
_______________________________________________________________________




1091. CHANGES TO THE APPEALS PROCESS FOR BENEFICIARIES RECEIVING HOME 
HEALTH SERVICES IN THE FEE FOR SERVICE PROGRAM (HCFA-4006-P)

Priority: Other Significant

CFR Citation: 42 CFR 405

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       02/13/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Rosalind Little
Phone: 410 786-6972

RIN: 0938-AK10
_______________________________________________________________________




1092. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR 
CALENDAR YEAR 2001 (HCFA-1120-F)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 414

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/02/00                    65 FR 65376

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Diane Milstead
Phone: 410 786-3355

RIN: 0938-AK11
_______________________________________________________________________




1093. REVISIONS TO MEDICAID UPPER PAYMENT LIMIT REQUIREMENTS FOR 
HOSPITAL, NURSING FACILITY, INTERMEDIATE CARE FACILITY SERVICES FOR THE 
MENTALLY RETARDED AND CLINIC SERVICES (HCFA-2071-F)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 447

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/10/00                    65 FR 60151
Final Action                    01/12/01                     66 FR 3148

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Local

Agency Contact: Robert Weaver
Phone: 410 786-5914

RIN: 0938-AK12
_______________________________________________________________________




1094. HOSPICE WAGE INDEX (HCFA-1135-N)

Priority: Routine and Frequent

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          10/06/00                    65 FR 60071

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Carol Blackford
Phone: 410 786-5909
Email: [email protected]

RIN: 0938-AK13
_______________________________________________________________________




1095. HIPAA PROGRAM; BONA FIDE WELLNESS PROGRAMS (HCFA-2078-F)

Priority: Substantive, Nonsignificant

CFR Citation: 45 CFR 146

[[Page 25472]]

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/08/01                     66 FR 1420
Withdrawn-Under review          02/22/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Ruth Bradford
Phone: 410 786-2636

RIN: 0938-AK19
_______________________________________________________________________




1096. APPLICATION OF FEDERAL FINANCIAL PARTICIPATION LIMITS (HCFA-2086-
F)

Priority: Other Significant

CFR Citation: 42 CFR 435

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/31/00                    65 FR 64919
Final Action                    01/11/01                     66 FR 2316

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Roy Trudel
Phone: 410 786-3417

RIN: 0938-AK22
_______________________________________________________________________




1097. PROSPECTIVE PAYMENT SYSTEM FOR HOSPITAL OUTPATIENT SERVICES: 
EXCEPTION TO THE PROVIDER-BASED LOCATION CRITERIA FOR PPS-EXEMPT 
FACILITIES (HCFA-1143-F)

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

CFR Citation: 42 CFR 413

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       12/12/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Michael Lefkowitz
Phone: 410 786-5316

RIN: 0938-AK25
_______________________________________________________________________




1098. CRITERIA AND STANDARDS FOR EVALUATING INTERMEDIARY AND CARRIER 
PERFORMANCE DURING FY 2001 (HCFA-4010-GNC)

Priority: Other Significant

CFR Citation: 42 CFR 421.122

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          10/31/00                    65 FR 47706

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Kristy McCarthy
Phone: 410 786-7139

RIN: 0938-AK26
_______________________________________________________________________




1099. INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED CARE 
SERVICES COINSURANCE AMOUNTS FOR CALENDAR YEAR 2001 (HCFA-8007-N)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/19/00                    65 FR 62725

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Clare McFarland
Phone: 410 786-6390

RIN: 0938-AK27
_______________________________________________________________________




1100. MANDATORY TRANSMISSION OF OASIS FOR NON-MEDICARE/MEDICAID PATIENTS 
IN HOME HEALTH AGENCIES AND CONTINUED DELAY OF REQUIREMENTS FOR PATIENTS 
RECEIVING PERSONAL CARE SERVICES (HCFA-2070-N)

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

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn-Under review          04/27/01

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Mary Weakland
Phone: 410 786-6835

RIN: 0938-AK28
_______________________________________________________________________




1101. REMOVAL OF THE REQUIREMENTS FOR THE CARDIAC PACEMAKER REGISTRY 
(HCFA-3045-F)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 409; 42 CFR 410; 42 CFR 489; 42 CFR 498

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    10/19/00                    65 FR 62645

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal

Agency Contact: Shana Olshan
Phone: 410 786-5246

RIN: 0938-AK29
_______________________________________________________________________




1102. PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY HAVE 
FINANCIAL RELATIONSHIPS-PHASE II (HCFA-1810-FC)

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

CFR Citation: 42 CFR 411

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       12/27/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: State, Local

Federalism:  Undetermined

Agency Contact: Joanne Sinsheimer
Phone: 410 786-4620

RIN: 0938-AK31
_______________________________________________________________________




1103. ELIMINATION OF APPLICATION OF FEDERAL FINANCIAL PARTICIPATION 
LIMITS (HCFA-2086-P)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Duplicate of RIN 0938-AK22      02/13/01

RIN: 0938-AK32

[[Page 25473]]

_______________________________________________________________________




1104. CONFORMING REGULATIONS CHANGES AND STATUTORY REVISIONS FOR 
APPROVAL AND OVERSIGHT OF ACCREDITATION ORGANIZATIONS (HCFA-2088-P)

Priority: Other Significant

CFR Citation: 42 CFR 488.1; 42 CFR 488.5; 42 CFR 488.6; 42 CFR 488.8

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn-Under review          02/22/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

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

RIN: 0938-AK36
_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




1105. PROGRAM PERFORMANCE STANDARDS FOR THE OPERATION OF HEAD START 
PROGRAMS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 9801 et seq

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                            10/00/01

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
Email: [email protected]

RIN: 0970-AB99
_______________________________________________________________________




1106. SAFEGUARDING CHILD SUPPORT AND EXPANDED FPLS INFORMATION

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 652 to 654; 42 USC 663; 42 USC 653A; 42 USC 
654A

CFR Citation: 45 CFR 303.21

Legal Deadline: None

Abstract: The Personal Responsibility and Work Opportunity 
Reconciliation Act of 1996 made far-reaching amendments to title IV-D 
of the Social Security Act, which governs the child support enforcement 
program. The Balanced Budget Act of 1997, the Adoption and Safe 
Families Act of 1997 and the Child Support Performance and Incentive 
Act of 1998 further amended title IV-D. A significant result of this 
legislation is an expansion in the scope of information available to 
State IV-D child support enforcement agencies. The legislation has 
rendered obsolete or inconsistent several regulations at 45 CFR chapter 
III, Office of Child Support Enforcement, including the regulations on 
the Federal Parent Locator Service, the State Parent Locator Services, 
offset of Federal payments for purposes of collecting child support, 
and safeguarding of information. This regulation would update various 
sections in 45 CFR chapter III to reflect the statutory changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Local

Agency Contact: Eileen C. Brooks, Program Specialist, 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
_______________________________________________________________________




1107.  DEVELOPMENTAL DISABILITIES AND BILL OF RIGHTS ACT

Priority: Substantive, Nonsignificant

Legal Authority: PL 106-402

CFR Citation: Not Yet Determined

Legal Deadline: NPRM, Statutory, October 30, 2001, Not later than one 
year from enactment of the Developmental Disabilities and Bill of 
Rights Act of 2000.

Abstract: A notice of proposed rulemaking will be published in the 
Federal Register by October 30, 2001, to amend current regulations and 
to implement changes made by the Developmental Disabilities Assistance 
and Bill of Rights Act of 2000.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Agency Contact: Elsbeth Wyatt, Program Specialist, Department of Health 
and Human Services, Administration for Children and Families, ADD HHH-
300F, 370 L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 690-5841

RIN: 0970-AC07

[[Page 25474]]

_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




1108. CONSTRUCTION AND MAJOR RENOVATION OF HEAD START AND EARLY 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 and 
Early Head Start agencies in requesting to use Head Start grant funds 
to construct or perform major renovation on a Head Start or Early Head 
Start Facility.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/08/99                     64 FR 6013
NPRM Comment Period End         04/09/99
Final Action                    06/00/01

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
Email: [email protected]

RIN: 0970-AB54
_______________________________________________________________________




1109. 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 rule specifies 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                            08/21/00                    65 FR 50800
NPRM Comment Period End         12/19/00
Final Action                    12/00/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Tribal

Agency Contact: Paige Biava, Division of Policy and Planning, 
Department of Health and Human Services, Administration for Children 
and Families, Office of Child Support Enforcement, 370 L'Enfant 
Promenade SW., Washington, DC 20447
Phone: 202 401-9386

RIN: 0970-AB73
_______________________________________________________________________




1110. CHILD SUPPORT ENFORCEMENT PROGRAM OMNIBUS CONFORMING REGULATION

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302

CFR Citation: 45 CFR 301 to 305

Legal Deadline: None

Abstract: This rule eliminates child support enforcement program 
regulations rendered obsolete or inconsistent with the Personal 
Responsibility and Work Opportunity Reconciliation Act of 1996, 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                    09/00/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Eileen C. Brooks, Program Specialist, 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-AB81
_______________________________________________________________________




1111. 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                            08/29/00                    65 FR 52394
Final Action                    11/00/01

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
Email: [email protected]

RIN: 0970-AB90
_______________________________________________________________________




1112. 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 to 1303; 45 CFR 1308

Legal Deadline: None

Abstract: This rule will correct several Head Start regulations which 
define Head Start programs as ``nonprofit'' agencies. Recent statutory 
changes now allow ``for-profit'' agencies to receive Head Start grant 
funds.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              09/00/01

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: None

[[Page 25475]]

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
Email: [email protected]

RIN: 0970-AC00
_______________________________________________________________________




1113.  HIGH PERFORMANCE BONUS AWARDS UNDER THE TANF PROGRAM

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 401 et seq

CFR Citation: 45 CFR 270

Legal Deadline: None

Abstract: This interim final regulation specifies how we will compute 
scores and rank States on the affordability and quality components of 
the child care measure for awarding high performance bonuses to States 
in FY 2002 and FY 2003 under the Temporary Assistance for Needy 
Families (TANF) program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/00/01

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Stephanie Fanjul, Deputy Associate Commissioner for 
Child Care, Department of Health and Human Services, Administration for 
Children and Families, Room 2046, 330 C Street SW., Washington, DC 
20201
Phone: 202 690-6782
Email: [email protected]

RIN: 0970-AC06
_______________________________________________________________________




1114.  INDIVIDUAL DEVELOPMENT ACCOUNTS

Priority: Substantive, Nonsignificant

Legal Authority: PL 105-285

CFR Citation: 45 CFR 1000

Legal Deadline: None

Abstract: This final rule implements a statutory requirement in the 
Assets for Independence Act under title IV of the Community 
Opportunities, Accountability, and Training and Educational Services 
Act of 1998, requiring the Secretary of HHS to prescribe regulation 
that grantees must follow in accounting for amounts grantees deposit in 
reserve funds established under the Assets for Independence Program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              02/25/00                    65 FR 10027
Final Action                    04/00/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Sheldon Shalit, Office of Community Services, 
Department of Health and Human Services, Administration for Children 
and Families, OCS, 5th Floor West, 370 L'Enfant Promenade SW., 
Washington, DC 20447
Phone: 202 401-4807

RIN: 0970-AC08
_______________________________________________________________________


DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)         Completed Actions


Administration for Children and Families (ACF)



_______________________________________________________________________




1115. STANDARDS FOR SAFE TRANSPORTATION

Priority: Other Significant

CFR Citation: 45 CFR 1310

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/18/01                     66 FR 5295

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Local, Tribal

Agency Contact: Douglas Klafehn
Phone: 202 205-8569
Email: [email protected]

RIN: 0970-AB24
_______________________________________________________________________




1116. INCENTIVE PAYMENTS AND AUDIT PENALTIES TO STATES AND POLITICAL 
SUBDIVISIONS

Priority: Substantive, Nonsignificant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/27/00                    65 FR 82177

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Joyce Pitts
Phone: 202 401-5374
Email: [email protected]

RIN: 0970-AB85
_______________________________________________________________________




1117. STATE SELF-ASSESSMENTS TO DETERMINE COMPLIANCE WITH FEDERAL 
REGULATIONS

Priority: Substantive, Nonsignificant

CFR Citation: 45 CFR 308

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/12/00                    65 FR 77742

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Jan Rothstein
Phone: 202 401-5073
Email: [email protected]

RIN: 0970-AB96
_______________________________________________________________________




1118. NATIONAL MEDICAL SUPPORT NOTICE

Priority: Substantive, Nonsignificant

CFR Citation: 45 CFR 303.32

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/27/00                    65 FR 82154
60-Day Delay of Effective Date 
To 03/27/2001                   01/26/01                     66 FR 8073

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Local, Tribal, Federal

Agency Contact: Elizabeth Matheson
Phone: 202 401-9386
Email: [email protected]

John Seneta
Phone: 202 401-5154

[[Page 25476]]

Email: [email protected]

RIN: 0970-AB97
_______________________________________________________________________


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


Administration on Aging (AOA)



_______________________________________________________________________




1119. 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

Legal Authority: 42 USC 3001 et seq

CFR Citation: 45 CFR 1321; 45 CFR 1326 to 1328

Legal Deadline: None

Abstract: In response to the recent reauthorization of the Older 
Americans Act, Public Law 106-501, the Administration on Aging (AoA) 
proposes to promulgate rules implementing the 2000 amendments by the 
latter part of 2001.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/01

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
_______________________________________________________________________




1120.  GRANTS FOR STATE AND COMMUNITY PROGRAMS ON AGING, FAMILY 
CAREGIVERS, AMERICAN INDIANS, AND NATIVE HAWAIIANS (SECTION 610 REVIEW)

Priority: Substantive, Nonsignificant

Legal Authority: PL 106-501

CFR Citation: 42 CFR 1321; 42 CFR 1322; 42 CFR 1326; 42 CFR 1328

Legal Deadline: NPRM, Statutory, December 31, 2001.

Abstract: In response to the recent reauthorization of the Older 
Americans Act (Pub. L. 106-501), the Assistant Secretary shall consult 
and coordinate with State agencies, area agencies on aging, and 
recipients of grants under title VI in the development of Federal 
regulations under this Act. Those provisions of the Act that were not 
changed may need no further regulations after consultation with 
affected parties, and the extent of regulation development required for 
the new family caregivers program will, in major part, depend on the 
Assistant Secretary's consultation with those parties funded to carry 
out the new prrogram.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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-AA01
[FR Doc. 01-6922 Filed 05-11-01; 8:45 am]
BILLING CODE 4150-24-S
