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


[[Page 73781]]

Part VIII





Department of Health and Human Services





_______________________________________________________________________



Semiannual Regulatory Agenda

[[Page 73782]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)                          


  



_______________________________________________________________________

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

21 CFR Ch. I

42 CFR Chs. I-V

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

Unified Agenda of Federal Regulatory and Deregulatory Actions

AGENCY:  Office of the Secretary, HHS.

ACTION:  Semiannual regulatory agenda.

_______________________________________________________________________

SUMMARY:  The President's Executive Order 12866 and the Regulatory 
Flexibility Act of 1980 require semiannual publication of an agenda 
outlining all current, projected and recently completed rulemakings. 
The Unified Agenda of Federal Regulatory and Deregulatory Actions 
informs the public about regulatory actions under development within 
the Department, and it provides an opportunity for all concerned with 
the impact of the regulations to participate in their development at an 
early stage. The last such agenda was published on April 24, 2000.

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

SUPPLEMENTARY INFORMATION:  The regulatory actions described below 
continue to reflect the Department's efforts to embody in its 
rulemaking actions the Administration's continuing efforts to overhaul 
the Federal regulatory system so that it helps deliver important 
services to the American people while creating fewer burdens. These 
regulatory actions also are an indication of policy mandates for HHS, 
affecting such national priorities as: securing the confidentiality of 
Americans' health records; establishing improved access to health 
services for children; strengthening and modernizing the Medicare and 
Medicaid programs; assuring the safety of the American food supply; 
controlling the safety of clinical trials of emerging medical 
therapies; advances in health-insurance reform; and eliminating waste, 
fraud and abuse from the health care system. As backdrop to the 
Department's conduct of its regulatory responsibilities in all of the 
above-mentioned programmatic areas, there endures at HHS the focus and 
discipline that the principles of Executive Order 12866 have brought to 
the Department's regulatory functions.

     Public commentary is invited to assist the Department in 
continuing these efforts. Comments on entries in the agenda should 
be sent to the addresses listed below, depending on the specific 
agenda entry that is of interest. Comments may be sent to the 
Office of the Secretary if the responsible component of the 
Department is not apparent or if a comment covers subjects crossing 
agency lines.

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

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

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

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

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

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

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

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

    National Institutes of Health: Jerry Moore, 9000 Rockville 
Pike, Building 31, Room 1B25, Bethesda, Maryland 20205; Phone 301-
496-4606.

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

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

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

Dated: September 25, 2000.

 LaVarne Burton,

Executive Secretary to the Department.

                                  Office of the Secretary--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1096         Safe Harbor for Arrangements Involving Federally Qualified Health Centers..........     0991-AB06
1097         Revisions and Technical Corrections to 42 CFR Chapter V............................     0991-AB09
1098         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.........................................................................
----------------------------------------------------------------------------------------------------------------



[[Page 73783]]

                                    Office of the Secretary--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1099         Reproduction and Sale of Official Forms and Publications...........................     0991-AA83
1100         Shared Risk Exception to the Safe Harbor Provisions................................     0991-AA91
1101         Civil Money Penalty Safe Harbor To Protect Payment of Medicare and Medigap Premiums     0991-AB04
            for ESRD Beneficiaries..............................................................
1102         Safe Harbor for Ambulance Restocking...............................................     0991-AB05
1103         Standards for Privacy of Individually Indentifiable Health Information (Reg Plan        0991-AB08
            Seq. No. 30)........................................................................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.


                                   Office of the Secretary--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1104         Civil Money Penalties for Medicare+Choice Organizations and Medicaid Managed Care       0991-AB03
            Organizations.......................................................................
----------------------------------------------------------------------------------------------------------------


                                   Office of the Secretary--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1105         Revised OIG Civil Money Penalties Resulting From Public Law 104-191................     0991-AA90
1106         Privacy Act Exempt Record System From the Healthcare Integrity and Protection Data      0991-AA99
            Bank................................................................................
----------------------------------------------------------------------------------------------------------------


                   Substance Abuse and Mental Health Services Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1107         Final and Delegation of Authority To Implement SAMHSA's Accreditation Based System      0930-AA06
            for Opiod Treatment Program Monitoring (Reg Plan Seq. No. 31).......................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.


                  Substance Abuse and Mental Health Services Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1108         Substance Abuse Prevention and Treatment Block Grant Applications Due Date Change       0930-AA04
            from March 31 to October 1 for FY 2001 and Beyond...................................
----------------------------------------------------------------------------------------------------------------


                          Centers for Disease Control and Prevention--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1109         Packaging and Handling of Infectious Substances and Select Agents..................     0920-AA02
----------------------------------------------------------------------------------------------------------------



[[Page 73784]]

                          Centers for Disease Control and Prevention--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1110         Control of Communicable Diseases...................................................     0920-AA03
----------------------------------------------------------------------------------------------------------------


                                    Departmental Management--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1111         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
----------------------------------------------------------------------------------------------------------------
1112         Natural Rubber-Containing Drugs; User Labeling.....................................     0910-AB56
1113         Implementation of the Import Tolerance Provisions of the Animal Drug Availability       0910-AB71
            Act of 1996.........................................................................
1114         Substances Prohibited From Use in Animal Food or Feed..............................     0910-AB90
1115         Part 600-Biological Products: General (Section 610 Review).........................     0910-AC06
----------------------------------------------------------------------------------------------------------------


                                Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1116         Hearing Aids; Professional and Patient Labeling; Conditions for Sale (Reg Plan Seq.     0910-AA39
            No. 32).............................................................................
1117         Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution.     0910-AA49
1118         Investigational New Drugs: Export Requirements for Unapproved New Drug Products....     0910-AA61
1119         Safety Reporting and Recordkeeping Requirements for Marketed OTC Drugs.............     0910-AA86
1120         Labeling for Human Prescription Drugs; Revised Format (Reg Plan Seq. No. 33).......     0910-AA94
1121         Safety Reporting Requirements for Human Drug and Biological Products (Reg Plan Seq.     0910-AA97
            No. 34).............................................................................
1122         Radioactive Drugs for Basic Research...............................................     0910-AB00
1123         Administrative Practices and Procedures; Advisory Opinions and Guidelines..........     0910-AB14
1124         Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based       0910-AB28
            Products (Reg Plan Seq. No. 35).....................................................
1125         Applications for FDA Approval to Market a New Drug; Complete Response Letter;           0910-AB34
            Amendments to Unapproved Applications...............................................
1126         Expanded Access to Investigational Therapies.......................................     0910-AB37
1127         Electronic Submission of Adverse Drug Reaction Reports.............................     0910-AB42
1128         Distinguishing Marks for Drug Products Containing Insulin..........................     0910-AB43
1129         Pregnancy Labeling.................................................................     0910-AB44
1130         Pharmacy and Physician Compounding of Drug Products (Reg Plan Seq. No. 36).........     0910-AB58
1131         Drug Products That Present Demonstrable Difficulties for Compounding Because of         0910-AB59
            Reasons of Safety or Effectiveness..................................................
1132         Discontinuation of a Lifesaving Product............................................     0910-AB60
1133         Positron Emission Tomography Drugs; Current Good Manufacturing Practices (Reg Plan      0910-AB63
            Seq. No. 37)........................................................................
1134         Current Good Manufacturing Practice for Medicated Feeds............................     0910-AB70
1135         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) (Reg Plan Seq. No. 38)...............................................
1136         Fixed-Combination Prescription and Over-the-Counter Drugs for Human Use............     0910-AB79
1137         Stability Testing of Drugs.........................................................     0910-AB82
1138         Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary       0910-AB88
            Supplements (Reg Plan Seq. No. 39)..................................................
1139         Current Good Manufacturing Practice for Blood and Blood Components; Blood Labeling      0910-AB89
            Standards...........................................................................
1140         Submission in Electronic Format of Certain Labeling Information....................     0910-AB91
1141         Fees Relating to Drugs; Waiver and Reduction of Fees...............................     0910-AB92
1142         Periodic Testing for Certain Human Drug, Veterinary Drug, and Biological Product        0910-AB93
            Final Specifications................................................................

[[Page 73785]]

 
1143         Marking Requirements for and Prohibitions on the Reimportation of Imported Food         0910-AB95
            Products That Have Been Refused Admission into the United States....................
1144         Requirements Pertaining to Sampling Services and Private Laboratories Used in           0910-AB96
            Connection with Imported Food.......................................................
1145         Medical Devices, Medical Device Establishment Registration and Listing                  0910-AB99
            Requirements; Amendment.............................................................
1146         Availability for Public Disclosure and Submission to FDA for Public Disclosure of       0910-AC00
            Certain Data and Information Related to Gene Therapy or Xenotransplantation (Reg
            Plan Seq. No. 40)...................................................................
1147         Reporting Information Regarding Potential Fabrication or Falsification.............     0910-AC02
1148         Examination of Administrative Record and Other Advisory Committee Records..........     0910-AC03
1149         Status Reports for Quantity Marketed Information for Animal Drug Products Used in       0910-AC04
            Food-Producing Animals..............................................................
1150         Additional Safeguards for Children in Clinical Investigations......................     0910-AC07
1151         Addition to the List of Drug Products That Have Been Withdrawn or Removed From the      0910-AC08
            Market for Reasons of Safety or Effectiveness.......................................
1152         Labeling Dietary Supplements for Women Who Are or May Become Pregnant..............     0910-AC09
1153         Overwrap For Inhalation Products Packaged in Low Density Polyethylene (LDPE)            0910-AC10
            Containers..........................................................................
1154         Revocation of Conditions for Marketing Digoxin Products for Oral Use...............     0910-AC12
1155         Regulation of Carcinogenic Compounds Used in Food-Producing Animals; Definition of      0910-AC13
            ``No Residue''......................................................................
1156         Control of Salmonella Enteritidis in Shell Eggs During Production and Retail (Reg       0910-AC14
            Plan Seq. No. 41)...................................................................
1157         Premarket Notice Concerning Bioengineered Foods (Reg Plan Seq. No. 42).............     0910-AC15
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.


                                 Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1158         Over-the-Counter (OTC) Drug Review.................................................     0910-AA01
1159         New Animal Drug Approval Process; Implementation of Title I of the Generic Animal       0910-AA02
            Drug and Patent Term Restoration Act (GADPTRA)......................................
1160         Biological Products: Reporting of Biological Product Deviations in Manufacturing...     0910-AA12
1161         Fruit and Vegetable Juices: Development of HACCP and Label Warning Statements for       0910-AA43
            Juices (Reg Plan Seq. No. 43).......................................................
1162         Bioavailability and Bioequivalence Requirements....................................     0910-AA51
1163         Drugs Used for Treatment of Narcotic Addicts.......................................     0910-AA52
1164         Determination That Informed Consent Is Infeasible or Is Contrary to the Best            0910-AA89
            Interest of Recipients..............................................................
1165         Current Good Manufacturing Practice; Revision of Certain Labeling Controls.........     0910-AA98
1166         Use of Ozone-Depleting Substances..................................................     0910-AA99
1167         Establishment Registration and Listing of Human Cells and Tissue (Reg Plan Seq. No.     0910-AB05
            44).................................................................................
1168         Veterinary Feed Directives.........................................................     0910-AB09
1169         Exports; Notification and Recordkeeping Requirements...............................     0910-AB16
1170         Foreign Establishment Registration and Listing.....................................     0910-AB21
1171         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......................................................
1172         Blood Initiative...................................................................     0910-AB26
1173         Shell Eggs: Warning, Notice and Safe Handling Labeling Statements and Refrigeration     0910-AB30
            Requirements........................................................................
1174         Antibiotic Drug Approval and Exclusivity...........................................     0910-AB33
1175         Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs..     0910-AB39
1176         Supplements and Other Changes to Approved New Animal Drug Applications.............     0910-AB49
1177         Bulk Drug Substances for Use in Pharmacy Compounding...............................     0910-AB57
1178         Supplements and Other Changes to an Approved Application...........................     0910-AB61
1179         Food Labeling: Trans Fatty Acids in Nutrition Labeling and Nutrient Content Claims.     0910-AB66
1180         Presubmission Conferences..........................................................     0910-AB68
1181         Citizen Petitions; Actions That Can Be Requested by Petition; Denials, Withdrawals,     0910-AB73
            and Referrals for Other Administrative Action.......................................
1182         Surgeon's and Patient Examination Gloves; Reclassification.........................     0910-AB74
1183         180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications.............     0910-AB80
1184         Postmarketing Studies for Human Drugs and Licensed Biological Products: Status          0910-AB83
            Reports.............................................................................
1185         Food Additives: Food Contact Substances Notification System........................     0910-AB94
1186         State Certification of Mammography Facilities......................................     0910-AB98

[[Page 73786]]

 
1187         Addition to the List of Drug Products That Have Been Withdrawn From the Market for      0910-AC01
            Reasons of Safety or Effectiveness..................................................
1188         Efficacy Evidence Needed for Products To Be Used Against Toxic Substances When          0910-AC05
            Human Studies Are Unethical.........................................................
1189         Implementing Court Decisions, ANDA Approvals, and 180-Day Exclusivity..............     0910-AC11
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.


                                 Food and Drug Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1190         Infant Formula: Good Manufacturing Practice, Quality Control Procedures, Quality        0910-AA04
            Factors, Notification Requirements, and Records and Reports.........................
1191         Food Labeling Review...............................................................     0910-AA19
1192         Medical Foods......................................................................     0910-AA20
1193         Classification of Computer Software Programs That Are Medical Devices..............     0910-AA41
1194         Current Good Manufacturing Practice; Amendment of Certain Requirements for Finished     0910-AA45
            Pharmaceuticals.....................................................................
1195         Reinventing FDA Food Regulations...................................................     0910-AA58
1196         Direct-to-Consumer Promotion Regulations...........................................     0910-AA90
1197         Investigational Use New Animal Drug Regulations (Section 610 Review)...............     0910-AB02
1198         Suitability Determination for Donors of Human Cellular and Tissue-Based Products...     0910-AB27
1199         Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed..............     0910-AB50
1200         Revisions to the General Safety Requirements for Biological Products; Direct Final      0910-AB51
            Rule................................................................................
1201         Mandatory HACCP Regulations for Manufacturers of Rendered Products.................     0910-AB72
1202         Antibiotic Resistance Labeling.....................................................     0910-AB78
1203         Repackaging Approval Requirements..................................................     0910-AB81
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1204         Debarment Certification Regulations for Drug Applications..........................     0910-AA76
1205         Investigational New Drug Applications; Request for Information and Comments........     0910-AA83
1206         Investigational New Drug Applications; Clinical Holds for Drugs for Life-               0910-AA84
            Threatening Illnesses...............................................................
1207         Sterility Requirements for Aqueous-Based Drug Products for Oral Inhalation.........     0910-AA88
1208         Classification of Sheep as a Minor Species for All Data Collection Purposes........     0910-AB69
1209         Amendment of Various Device Regulations to Reflect Current American Society for         0910-AB84
            Testing and Materials Citations.....................................................
----------------------------------------------------------------------------------------------------------------


                        Health Resources and Services Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1210         Designation of Medically Underserved Populations and Health Professional Shortage       0906-AA44
            Areas...............................................................................
1211         Compliance Alternatives for Provision of Uncompensated Services....................     0906-AA52
1212         National Vaccine Injury Compensation Program: Revisions and Additions to the            0906-AA55
            Vaccine Injury Table................................................................
----------------------------------------------------------------------------------------------------------------



[[Page 73787]]

                         Health Resources and Services Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1213         Final Rule for the Health Professions, Nursing, Public Health, and Allied Health        0906-AA53
            Training Grant Programs Under 42 CFR Parts 57 and 58................................
----------------------------------------------------------------------------------------------------------------


                         Health Resources and Services Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1214         National Practitioner Data Bank for Adverse Information on Physicians and Other         0906-AA41
            Health Care Practitioners: Medical Malpractice Payments Reporting Requirements......
1215         Ricky Ray Hemophilia Relief Fund Program...........................................     0906-AA56
----------------------------------------------------------------------------------------------------------------


                                     Indian Health Service--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1216         Indian Child Protection and Family Violence Prevention Act Minimum Standards of         0917-AA02
            Character...........................................................................
1217         Contracts Under the Indian Self-Determination Act..................................     0917-AA04
----------------------------------------------------------------------------------------------------------------


                               National Institutes of Health--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1218         National Institutes of Health AIDS Research Loan Repayment Program.................     0925-AA02
1219         Undergraduate Scholarship Program Regarding Professions Needed by the NIH..........     0925-AA10
1220         National Cancer Institute Clinical Cancer Education Program........................     0925-AA17
1221         National Institutes of Health Loan Repayment Program for Research..................     0925-AA18
----------------------------------------------------------------------------------------------------------------


                                 National Institutes of Health--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1222         Traineeships.......................................................................     0925-AA11
1223         Additional DHHS Protections for Pregnant Women and Human Fetuses Involved as            0925-AA14
            Subjects in Research, and Pertaining to Human In Vitro Fertilization................
1224         National Research Service Awards...................................................     0925-AA16
1225         National Institute of Child Health and Human Development Contraception and              0925-AA19
            Infertility Research Loan Repayment Program.........................................
1226         Scientific Peer Review of Research Grant Applications and Research and Development      0925-AA20
            Contract Projects...................................................................
1227         Federal Policy (Common Rule) for the Protection of Human Subjects..................     0925-AA21
----------------------------------------------------------------------------------------------------------------


                                National Institutes of Health--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1228         NIH Privacy Act System of Records, 09-25-0213, ``Administration: Investigative          0925-AA23
            Records''...........................................................................
----------------------------------------------------------------------------------------------------------------



[[Page 73788]]

                            Office of Public Health and Science--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1229         Public Health Service Standards for the Protection of Research Misconduct               0940-AA01
            Whistleblowers......................................................................
----------------------------------------------------------------------------------------------------------------


                             Office of Public Health and Science--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1230         Standards of Compliance for Abortion-Related Services in Family Planning Service        0940-AA00
            Projects............................................................................
----------------------------------------------------------------------------------------------------------------


                            Health Care Financing Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1231         End Stage Renal Disease (ESRD) Conditions for Coverage (HCFA-3818-P) (Section 610       0938-AG82
            Review) (Reg Plan Seq. No. 45)......................................................
1232         Criteria for Medicare Coverage of Heart, Liver, and Lung Transplants (HCFA-3835-P)      0938-AH17
            (Reg Plan Seq. No. 46)..............................................................
1233         Requirements for Establishing and Maintaining Medicare Billing Privileges (HCFA-        0938-AH73
            6002-P).............................................................................
1234         Prospective Fee Schedule for Ambulance Services (HCFA-1002-P)......................     0938-AI72
1235         DME Surety Bonds (HCFA-6006-P).....................................................     0938-AJ64
1236         End Stage Renal Disease Bad Debt Payment (HCFA-1126-P).............................     0938-AK02
1237         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-P) (Reg Plan Seq. No. 47).......................................
1238         Payment for Clinical Psychology Training Programs and Physician Assistant Training      0938-AK15
            Programs (HCFA-1089-P) (Reg Plan Seq. No. 48).......................................
1239         Prospective Fee Schedule for Ambulance Services (HCFA-1002-P) (Reg Plan Seq. No.        0938-AK30
            49).................................................................................
1240         Elimination of Application of Federal Financial Participation Limits (HCFA-2086-P)      0938-AK32
            (Reg Plan Seq. No. 50)..............................................................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.


                             Health Care Financing Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1241         Payment for Nursing and Allied Health Science Education (HCFA-1685-F)..............     0938-AE79
1242         Home Health Agency (HHA) Conditions of Participation (HCFA-3819-F).................     0938-AG81
1243         Additional Supplier Standards (HCFA-6004-F)........................................     0938-AH19
1244         Requirements for Enrollment of Medicaid Recipients Under Cost Effective Employer-       0938-AH48
            Based Group Health Plans (HCFA-2047-F)..............................................
1245         Terms, Definitions, and Addresses: Technical Amendments (HCFA-9877-FC).............     0938-AH53
1246         Update of Ratesetting Methodology, Payment Rates and the List of Covered Surgical       0938-AH81
            Procedures for Ambulatory Surgical Centers Effective for Calendar Year 2000 (HCFA-
            1885-FC) (Reg Plan Seq. No. 51).....................................................
1247         Standard Unique Health Care Provider Identifier (HCFA-0045-F)......................     0938-AH99
1248         Medicare Program; Adjustments to Cost Limits for Skilled Nursing Facility Inpatient     0938-AI14
            Routine Service Costs (HCFA-1896-FN)................................................
1249         Medicare Program; Prospective Payment System for Hospital Outpatient Services (HCFA-    0938-AI56
            1005-F).............................................................................
1250         National Standard Employer Identifier (HCFA-0047-F)................................     0938-AI59
1251         Medicaid Program; Home and Community-Based Services (HCFA-2010-FC).................     0938-AI67
1252         Medicaid Managed Care; Regulatory Program To Implement Certain Medicaid Provisions      0938-AI70
            of the Balanced Budget Act of 1997 (HCFA-2001-F)....................................
1253         Expanded Coverage for Diabetes Outpatient Self-Management Training Services (HCFA-      0938-AI96
            3002-P) (Reg Plan Seq. No. 52)......................................................
1254         External Quality Review of Medicaid Managed Care Organizations (HCFA-2015-F).......     0938-AJ06
1255         Protection for Women Who Elect Reconstruction After a Mastectomy (HCFA-2040-IFC)        0938-AJ44
            (Reg Plan Seq. No. 53)..............................................................
1256         The Children's Health Insurance Program: Implementing the Balanced Budget Act of        0938-AJ75
            1997 (HCFA-2006-F) (Reg Plan Seq. No. 54)...........................................

[[Page 73789]]

 
1257         Application of Inherent Reasonableness to All Part B Services Other Than Physician      0938-AJ97
            Services (HCFA-1908-F) (Reg Plan Seq. No. 55).......................................
1258         Flexibility in Payment Methods for Services of Hospitals, Nursing Facilities, and       0938-AK04
            Intermediate Care Facilities for the Mentally Retarded (HCFA-2004-F)................
1259         Hospital Conditions of Participation; Anesthesia Services (HCFA-3049-F) (Reg Plan       0938-AK08
            Seq. No. 56)........................................................................
1260         Physicians' Referrals to Health Care Entities With Which They Have Financial            0938-AK31
            Relationships-Phase II (HCFA-1810-FC) (Reg Plan Seq. No. 57)........................
----------------------------------------------------------------------------------------------------------------
References in boldface appear in the Regulatory Plan in Part II of this issue of the Federal Register.


                             Health Care Financing Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1261         Changes to Peer Review Organization Regulations (HCFA-3135-F)......................     0938-AD38
1262         ''Without Fault'' and Beneficiary Waiver of Recovery As It Applies to Medicare          0938-AD95
            Overpayment Liability (HCFA-6007-F).................................................
1263         Protection of Income and Resources for Community Spouses of Institutionalized           0938-AE12
            Individuals (HCFA-2023-P)...........................................................
1264         Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) Services (HCFA-2028-    0938-AE72
            F)..................................................................................
1265         Coverage of Screening Pap Smears (HCFA-3705-F).....................................     0938-AE98
1266         Medicaid Payment for Covered Outpatient Drugs Under Rebate Agreements (HCFA-2046-       0938-AF42
            FC).................................................................................
1267         Referral to Child Support Enforcement Agencies of Medicaid Families (HCFA-2051-F)..     0938-AF68
1268         Disclosure of Confidential PRO and ESRD Network Organization Information for            0938-AG33
            Research Purposes (HCFA-3208-P).....................................................
1269         Effect of Change of Ownership on Provider and Supplier Penalties, Sanctions,            0938-AG59
            Underpayments and Overpayments (HCFA-2215-P)........................................
1270         Medicaid: Optional Coverage of TB-Related Services for Individuals Infected With        0938-AG72
            Tuberculosis (HCFA-2082-P)..........................................................
1271         Revision of Medicare/Medicaid Hospital Conditions of Participation (HCFA-3745-F)...     0938-AG79
1272         Physicians' Referrals to Health Care Entities With Which They Have Financial            0938-AG80
            Relationships-Expanded to Designated Health Services (HCFA-1809-FC).................
1273         Distinct Part Requirements for Nursing Homes and Prohibition on Financial Screening     0938-AG84
            of Applicants for Nursing Home Admission (HCFA-3815-P)..............................
1274         CLIA Program: Categorization of Waived Tests (HCFA-2225-FC)........................     0938-AG99
1275         Liability for Third Parties To Pay for Services (HCFA-2080-P)......................     0938-AH01
1276         State Plan Amendment (SPA) Reconsideration Process (HCFA-2096-P)...................     0938-AH24
1277         Hospice Care-Conditions of Participation (HCFA-3844-P).............................     0938-AH27
1278         Medicare Coverage of Services of Speech-Language Pathologists and Audiologists          0938-AH37
            (HCFA-1843-P).......................................................................
1279         Medicaid; Estate Recoveries (HCFA-2083-P)..........................................     0938-AH63
1280         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)...........................................
1281         Revisions to Conditions for Coverage for Ambulatory Surgical Centers (HCFA-3887-P).     0938-AH83
1282         Disclosure of Peer Review Organization Information in Response to Beneficiary           0938-AH85
            Complaints (HCFA-3241-P)............................................................
1283         National Standard for Identifiers of Health Plans (HCFA-4145-P)....................     0938-AH87
1284         Medicaid Program; Amendment to the Preadmission Screening and Annual Resident           0938-AH89
            Review Program (HCFA-2107-P)........................................................
1285         Medically Needy Determinations Under Welfare Reform (HCFA-2109-IFC)................     0938-AH92
1286         Medicaid Program; Coverage and Payment for Federally Qualified Health Center            0938-AH95
            Services (HCFA-2043-P)..............................................................
1287         Portability and Nondiscrimination in the Group Health Insurance Market (HCFA-2890-      0938-AI08
            F)..................................................................................
1288         Medicare Program; Improvements To the Appeals Process for Medicare Beneficiaries        0938-AI11
            Enrolled in HMOs, CMPs, and HCPPs (HCFA-4024-P).....................................
1289         Medicaid: Medical Child Support (HCFA-2081-P)......................................     0938-AI21
1290         Medicare/Medicaid Program; User Fees for Information, Products, and Services (HCFA-     0938-AI46
            6021-P).............................................................................
1291         Surety Bond Requirements for Comprehensive Outpatient Rehabilitation Facilities,        0938-AI48
            Rehabilitation Agencies, Community Mental Health Centers, and Independent Diagnostic
            Testing Facilities (HCFA-6005-P)....................................................
1292         Appeals of Carrier Determination That a Supplier Fails To Meet the Requirements for     0938-AI49
            Medicare Billing Privileges (HCFA-6003-P)...........................................
1293         Security Signature Standards (HCFA-0049-F).........................................     0938-AI57
1294         State Plan Requirements for Durable Medical Equipment Providers (HCFA-2007-P)......     0938-AI63

[[Page 73790]]

 
1295         Medicare Program; Advance Refunding of Debt and Methodology for Repayment of Loan       0938-AI75
            (HCFA-1777-P).......................................................................
1296         Revision of Procedures for Requesting Exceptions to Cost Limits for SNFs and            0938-AI80
            Elimination of Reclassifications (HCFA-1883-P)......................................
1297         Medicare Program; Medicare Coverage of and Payment for Bone Mass Measurements (HCFA-    0938-AI89
            3004-F).............................................................................
1298         Medicare Program; Coverage and Administrative Policies for Clinical Diagnostic          0938-AI92
            Laboratory Tests (HCFA-3250-F)......................................................
1299         Coverage of Religious Non-Medical Health Care Institutions (HCFA-1909-IFC).........     0938-AI93
1300         Reporting Outcome and Assessment Information Set (OASIS) Data as Part of the            0938-AJ10
            Conditions of Participation for Home Health Agencies (HCFA-3006-IFC)................
1301         Medicare Program; Criteria and Standards for Evaluating Intermediary and Carrier        0938-AJ15
            Performance: Millennium Compliance (HCFA-4002-GNC)..................................
1302         Rural Health Clinics: Amendments to Participation Requirements and Payment              0938-AJ17
            Provisions, and Establishment of a Quality Assessment and Improvement Program (HCFA-
            1910-P).............................................................................
1303         Hospital Conditions of Participation: Laboratory Services (HCFA-3 014-P)...........     0938-AJ29
1304         Medicare Hospice Care Amendments (HCFA-1022-P).....................................     0938-AJ36
1305         Emergency Medical Treatment and Labor Act (EMTALA) (HCFA-1063-P)...................     0938-AJ39
1306         Medicare/Medicaid and CLIA Programs: Clinical Laboratory Improvement Amendments of      0938-AJ47
            1988 Exemption of Laboratories in the State of California (HCFA-2245-N).............
1307         Medicare Program: Criteria for Making National Coverage Decision (HCFA-3432-P2)....     0938-AJ54
1308         Medicare Program: Prospective Payment System for Inpatient Rehabilitation Hospital      0938-AJ55
            Services (HCFA-1069-P)..............................................................
1309         Medicare Program; Sustainable Growth Rate for Fiscal Year 2000 (HCFA-1110-N).......     0938-AJ60
1310         Medicare and Medicaid Programs; Programs for All-Inclusive Care for the Elderly         0938-AJ63
            (PACE) (HCFA-1903-IFC)..............................................................
1311         State Health Insurance Assistance Program (SHIP) (HCFA-4005-IFC)...................     0938-AJ67
1312         Clinical Social Worker Services (HCFA-1088-P)......................................     0938-AJ71
1313         Medicaid Disproportionate Share Hospital Payments-Institutions for Mental Disease       0938-AJ74
            (HCFA-2062-N).......................................................................
1314         HHA Surety Bond (HCFA-6001-P)......................................................     0938-AJ81
1315         Medicare Program Update of Ambulatory Surgical Center Payment Rates Effective for       0938-AJ86
            Services On or After October 1, 1999 (HCFA-1085-N)..................................
1316         Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities-     0938-AJ93
            Update (HCFA-1112-P)................................................................
1317         Use of Restraint and Seclusion in Residential Treatment Facilities Providing            0938-AJ96
            Inpatient Psychiatric Services to Individuals Under Age 21 (HCFA-2065-IFC)..........
1318         Supplier Standards Related to Training Requirements for Oxygen, Orthotics and           0938-AJ98
            Prosthetics (HCFA-6010-NPRM)........................................................
1319         Conditions of Participation for Intermediate Care Facilities for the Mentally           0938-AJ99
            Retarded............................................................................
1320         Non-Federal Governmental Plans Exempt From HIPAA (HCFA-2033-IFC)...................     0938-AK00
1321         Changes to the Appeals Process for Beneficiaries Receiving Home Health Services in      0938-AK10
            the Fee For Service Program (HCFA-4006-IFC).........................................
1322         Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year        0938-AK11
            2001 (HCFA-1120-P)..................................................................
1323         Hospice Wage Index (HCFA-1135-N)...................................................     0938-AK13
1324         Practice Expense Data Collection (HCFA-1111-IFC)...................................     0938-AK14
1325         HIPPA Program; Bona Fide Wellness Programs (HCFA-2078-P)...........................     0938-AK19
1326         Providers of the Balanced Budget and Refinement Act; Hospital Inpatient Payments,       0938-AK20
            Rates and Costs of Graduate Medical Education (HCFA-1131-IFC).......................
1327         Application of Federal Financial Participation Limits (HCFA-2086-P)................     0938-AK22
1328         Conditions of Participation of Intermediate Care Facilities for Persons With Mental     0938-AK23
            Retardation (HCFA-3046-P)...........................................................
1329         Clinical Lab Requirements-Revisions to Regs Implementing CLIA (HCFA-2226-F)........     0938-AK24
1330         Prospective Payment System for Hospital Outpatient Services: Exception to the           0938-AK25
            Provider-Based Location Criteria for PPS-Exempt Facilities (HCFA-1143-P)............
1331         Criteria and Standards for Evaluating Intermediary and Carrier Performance During       0938-AK26
            FY 2001 (HCFA-4010-GNC).............................................................
1332         Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance       0938-AK27
            Amounts for Calendar Year 2001 (HCFA-8007-N)........................................
1333         Mandatory Transmission of Outcome and Assessment Info. Set for Non-Medicare/            0938-AK28
            Medicaid Patients in Home Health Agencies and Continued Delay of Requirements for
            Patients Receiving Personal Care Services...........................................
1334         Removal of the Requirements for the Cardiac Pacemaker Registry (HCFA-3045-F).......     0938-AK29
1335         Fire Safety Requirements for RNHCI, ASC, Hospices, PACE, Hospitals, and Long-Term       0938-AK35
            Care Facilities.....................................................................
1336         Conforming Regulations Changes and Statutory Revisions for Approval and Oversight       0938-AK36
            of Accreditation Organizations......................................................
----------------------------------------------------------------------------------------------------------------



[[Page 73791]]

                             Health Care Financing Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1337         Payment for Clinical Diagnostic Laboratory Tests (HCFA-1309-F).....................     0938-AB50
1338         Survey Requirements and Alternative Sanctions for Home Health Agencies (HCFA-2169-      0938-AE39
            F)..................................................................................
1339         Changes to the Long-Term Care Facility Survey Process (HCFA-3175-FC)...............     0938-AF02
1340         Requirements for Certain Health Insuring Organizations and OBRA `90 Technical           0938-AF15
            Amendments (HCFA-1018-F)............................................................
1341         Provider Reimbursement Determinations and Appeals (HCFA-1727-P)....................     0938-AF28
1342         Alternative Sanctions for Psychiatric Hospitals (HCFA-2191-P)......................     0938-AF32
1343         Medicaid: Outstationed Intake Locations for Certain Low-Income Pregnant Women,          0938-AF69
            Infants, and Children Under Age 19 (HCFA-2052-F)....................................
1344         Assessing Interest Against Medicare Secondary Payer (MSP) Debts (HCFA-6108-P)......     0938-AF87
1345         Revised Medicaid Management Information Systems (HCFA-2038-FN).....................     0938-AG10
1346         Medicare Program: Limitations on Medicare Coverage of Intermittent Positive             0938-AG44
            Pressure Breathing Machine Therapy (HCFA-3781-FN)...................................
1347         Definition of Skilled Nursing Facility (SNF) for Coverage of Durable Medical            0938-AH16
            Equipment (DME) and Home Health Services (HCFA-1834-P)..............................
1348         Payment Amount if Customary Charges Are Less Than Reasonable Costs (HCFA-1860-FC)..     0938-AH49
1349         Limitations on Liability (HCFA-4859-FC)............................................     0938-AH51
1350         Medicaid Hospice Care (HCFA-2016-P)................................................     0938-AH65
1351         Medicare Technical Conforming Amendments (HCFA-1858-FC)............................     0938-AH67
1352         Elimination of Certain Requirements for Peer Review Organizations in the                0938-AH68
            Utilization and Quality Review Process and a Change in the Length of Peer Review
            Organization Contracts (HCFA-3235-FC)...............................................
1353         Determination of Substandard Care in SNFs and NFs (HCFA-2240-P)....................     0938-AH69
1354         Waiver of Staffing Requirements for End Stage Renal Disease (ESRD) Facilities           0938-AH72
            Participating in an Experiment (HCFA-2236-GNC)......................................
1355         Medicare Program; Medicare Integrity Program (HCFA-7020-F).........................     0938-AI09
1356         State Child Health; Implementing Regulations for the State Children's Health            0938-AI28
            Insurance Program (HCFA-2006-F).....................................................
1357         Medicare Program; Medicare+Choice Program (HCFA-1030-FC)...........................     0938-AI29
1358         Health Insurance Reform: Standards for Electronic Transactions (HCFA-0149-F).......     0938-AI58
1359         State Child Health; State Children's Health Insurance Program Allotments and            0938-AI65
            Payments to States (HCFA-2114-F)....................................................
1360         Elimination of Application of Federal Financial Participation Limits (HCFA-2111-        0938-AI73
            IFC)................................................................................
1361         Medicaid Program; Changes to Eligibility of Non-U.S. Citizens (HCFA-2108-P)........     0938-AI74
1362         Health Insurance Reform Universal Health Care Identifier (HCFA-0048-NOI)...........     0938-AI91
1363         Peer Review Organization Contracts: Solicitation of Statements of Interest From In-     0938-AI99
            State Organizations (HCFA-3009-N)...................................................
1364         HHS' Recognition of NAIC Model Standards for Regulation of Medigap Policy (HCFA-        0938-AJ07
            2025-N).............................................................................
1365         Home Health Prospective Payment System (HCFA-1059-F)...............................     0938-AJ24
1366         Decision on the Funding for the AIDS Healthcare Foundation START Program, (HCFA-        0938-AJ43
            2041-N).............................................................................
1367         Federal Enforcement in Group and Individual Health Insurance Markets (HCFA-2019-FC)     0938-AJ48
1368         Schedules of Per Visit and Per Beneficiary Limitation on Home Health Agency Cost        0938-AJ57
            (HCFA-1060-NC)......................................................................
1369         Reapplication of the Community Health Accreditation Program, Incorporated (CHAP)        0938-AJ69
            for Continued Approval of Deeming Authority for Health Care Agencies (HHAs) (HCFA-
            2059-FN)............................................................................
1370         State Allotments for Payments of Medicare Part B Premiums for Qualified                 0938-AJ72
            Individuals: Federal Fiscal Year 2000 (HCFA-2063-N).................................
1371         Children's Health Insurance Program; Final Allotments to States, Commonwealths and      0938-AJ77
            Territories for Fiscal Years 1998 and 1999 (HCFA-2064-N)............................
1372         Announcement of Additional Applications From Hospitals Requesting Waivers for Organ     0938-AJ79
            Procurement Service Areas (HCFA-1055-N).............................................
1373         Monthly Actuary Rates and Monthly Supplementary Medical Insurance Premium Rates         0938-AJ80
            Beginning January 1, 2000 (HCFA-8006-N).............................................
1374         Payment for Upgraded Durable Medical Equipment (HCFA-1084-P).......................     0938-AJ82
1375         Inpatient Hospital Deductible and Extended Care Services for Coinsurance Amounts        0938-AJ83
            for FY 2000 (HCFA-8005-N)...........................................................
1376         Part A Premium for FY 2000 for the Uninsured, Aged and for Certain Disabled             0938-AJ84
            Individuals Who Have Exhausted Other Entitlements (HCFA-8004-N).....................
1377         Coverage of, and Payment of, Paramedic Intercept Ambulance Services (HCFA-1813-F)..     0938-AJ87
1378         Criteria and Standards for Evaluating Intermediary and Carrier Performance During       0938-AJ88
            FY 2000 (HCFA-4009-GNC).............................................................
1379         Medicare Graduate Medical Education Consortia (HCFA-1094-N)........................     0938-AJ89
1380         Sustainable Growth Rate for FY 2000 (HCFA-1110-N)..................................     0938-AJ90
1381         Medicare Program; Medicare Disproportionate Share (DSH) Adjustment Calculation:         0938-AJ92
            Change in the Treatment of Days in States With 1115 Expansion Waivers (HCFA-1124-
            IFC)................................................................................

[[Page 73792]]

 
1382         State Children's Health Insurance Program; Final Allotments to States,                  0938-AJ94
            Commonwealths, and Territories for Fiscal Year 2000 (HCFA-2067-N)...................
1383         Process for Requesting Recognition of New Technologies and Certain Drugs,               0938-AK01
            Biologicals and Medical Devices for Special Payment Under Hospital Outpatient PPS
            (HCFA-1128-N).......................................................................
1384         Schedules of Per Visit and Per Beneficiary Limitations on HHA Costs for Cost            0938-AK03
            Reporting Periods Beginning On or After October 1, 2000 (HCFA-1108-NC)..............
1385         Reporting Quality Assurance and Performance Improvement Data as Part of the             0938-AK05
            Conditions for Coverage for End Stage Renal Disease Facilities (HCFA-3048-N)........
1386         Medicare Program; Deductible Amount for Medigap High Deductible Options for             0938-AK06
            Calendar Year 2000 (HCFA-2893-N)....................................................
1387         Changes to the Hospital Inpatient Perspective Payment Systems and Fiscal Year 2001      0938-AK09
            Rates (HCFA-1118-F).................................................................
1388         Health Care and Employment Support Grants for People With Disabilities Beginning        0938-AK16
            Fiscal Year 2000 (HCFA-2076-N)......................................................
----------------------------------------------------------------------------------------------------------------


                          Administration for Children and Families--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1389         Child Support Enforcement for Indian Tribes........................................     0970-AB73
1390         Program Performance Standards for the Operation of Head Start Programs.............     0970-AB99
1391         Safeguarding Child Support and Expanded FPLS Information...........................     0970-AC01
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1392         Standards for Safe Transportation..................................................     0970-AB24
1393         Construction and Major Renovation of Head Start and Early Head Start Facilities....     0970-AB54
1394         Child Support Enforcement Program Omnibus Conforming Regulation....................     0970-AB81
1395         Incentive Payments and Audit Penalties to States and Political Subdivisions........     0970-AB85
1396         Family Child Care Program Option for Head Start Programs...........................     0970-AB90
1397         State Self-Assessments To Determine Compliance With Federal Regulations............     0970-AB96
1398         National Medical Support Notice....................................................     0970-AB97
1399         Technical Revision of Head Start Regulations To Make Them Conform To Recent             0970-AC00
            Statutory Revisions.................................................................
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1400         Methodology for Determining Whether an Increase in a State's Child Poverty Rate Is      0970-AB65
            the Result of the TANF Program......................................................
1401         Bonus To Reward High Performance States Under the Temporary Assistance for Needy        0970-AB66
            Families Block Grant................................................................
1402         Runaway and Homeless Youth Program.................................................     0970-AC04
----------------------------------------------------------------------------------------------------------------


                                  Administration on Aging--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
1403         Grants for State and Community Programs on Aging, Intrastate Funding Formulas;          0985-AA00
            Training, Research and Discretionary Programs; Vulnerable Elder Rights; and Grants
            to Indians and Native Hawaiians.....................................................
----------------------------------------------------------------------------------------------------------------


[[Page 73793]]

_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




1096. SAFE HARBOR FOR ARRANGEMENTS INVOLVING FEDERALLY QUALIFIED HEALTH 
CENTERS

Priority: Substantive, Nonsignificant

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

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

CFR Citation: 42 CFR 1001

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/01
NPRM Comment Period End         06/00/01

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-AB06
_______________________________________________________________________




1097. REVISIONS AND TECHNICAL CORRECTIONS TO 42 CFR CHAPTER V

Priority: Substantive, Nonsignificant

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

Legal Authority: 42 USC 1302; 42 USC 1320a-7; 42 USC 1320a-7a; 42 USC 
1320a-7b; 42 USC 1320a-7d(b); 42 USC 1395u

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

Legal Deadline: None

Abstract: This proposed rule sets forth several miscellaneous revisions 
and technical corrections to the OIG regulations codified in 42 CFR 
chapter V. Among other revisions, this rule revises or clarifies 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         12/00/00
Final Action                    12/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

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

RIN: 0991-AB09
_______________________________________________________________________




1098.  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                            10/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Federal

Agency Contact: Kathryn Ellis, Deputy Director, Office of Civil Rights, 
Department of Health and Human Services, Office of the Secretary, Room 
596-F, 200 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0403
Fax: 202 619-3818
Email: [email protected]

RIN: 0991-AB10
_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




1099. 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,

[[Page 73794]]

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              11/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0991-AA83
_______________________________________________________________________




1100. SHARED RISK EXCEPTION TO THE SAFE HARBOR PROVISIONS

Priority: Substantive, Nonsignificant

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

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

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                      03/00/01

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
_______________________________________________________________________




1101. CIVIL MONEY PENALTY SAFE HARBOR TO PROTECT PAYMENT OF MEDICARE AND 
MEDIGAP PREMIUMS FOR ESRD BENEFICIARIES

Priority: Substantive, Nonsignificant

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

Legal Authority: 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 and guidelines that, 
if met, would result in the particular arrangement being protected from 
civil sanctions under section 1128A(a)(5) of the Social Security Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/02/00                    65 FR 25460
NPRM Comment Period End         07/03/00
Final Action                    04/00/01

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
_______________________________________________________________________




1102. SAFE HARBOR FOR AMBULANCE RESTOCKING

Priority: Substantive, Nonsignificant

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

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

CFR Citation: 42 CFR 1001

Legal Deadline: None

Abstract: This rule will set forth 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                    03/00/01

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


_______________________________________________________________________



[[Page 73795]]

1103. STANDARDS FOR PRIVACY OF INDIVIDUALLY INDENTIFIABLE HEALTH 
INFORMATION

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

RIN: 0991-AB08
_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




1104. 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 
General (OCIG), 330 Independence Avenue SW., Washington, DC 20201
Phone: 202 619-0089

RIN: 0991-AB03
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Office of the Secretary (OS)



_______________________________________________________________________




1105. REVISED OIG CIVIL MONEY PENALTIES RESULTING FROM PUBLIC LAW 104-
191

Priority: Substantive, Nonsignificant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    04/26/00                    65 FR 24400

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0991-AA90
_______________________________________________________________________




1106. PRIVACY ACT EXEMPT RECORD SYSTEM FROM THE HEALTHCARE INTEGRITY AND 
PROTECTION DATA BANK

Priority: Substantive, Nonsignificant

CFR Citation: 45 CFR 56

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/01/00                    65 FR 34986

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0991-AA99
_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




1107.  FINAL AND DELEGATION OF AUTHORITY TO IMPLEMENT SAMHSA'S 
ACCREDITATION BASED SYSTEM FOR OPIOD TREATMENT PROGRAM MONITORING

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

RIN: 0930-AA06

[[Page 73796]]

_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




1108. SUBSTANCE ABUSE PREVENTION AND TREATMENT BLOCK GRANT APPLICATIONS 
DUE DATE CHANGE FROM MARCH 31 TO OCTOBER 1 FOR FY 2001 AND BEYOND

Priority: Routine and Frequent

Legal Authority: Not Yet Determined

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

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

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

RIN: 0930-AA04
_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




1109. PACKAGING AND HANDLING OF INFECTIOUS SUBSTANCES AND SELECT AGENTS

Priority: Other Significant

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

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/28/99                    64 FR 58022
Final Rule                      01/00/01

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
_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




1110. CONTROL OF COMMUNICABLE DISEASES

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

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

CFR Citation: 21 CFR 1240

Legal Deadline: None

Abstract: CDC proposes to recodify certain regulatory responsibilities 
of 21 CFR part 1240 that relate to interstate quarantine of persons, 
following transfer of these responsibilities from FDA to CDC. 
Department officials have agreed to transfer this authority.

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

[[Page 73797]]

_______________________________________________________________________


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


Departmental Management (HHSDM)



_______________________________________________________________________




1111. IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT IN AGENCY 
PROCEEDINGS

Priority: Substantive, Nonsignificant

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

CFR Citation: 45 CFR 13

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/19/87                    52 FR 23311
NPRM Comment Period End         08/17/87
Second NPRM                     11/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0990-AA02
_______________________________________________________________________


Department of Health and Human Services (HHS)             Prerule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________




1112. NATURAL RUBBER-CONTAINING DRUGS; USER LABELING

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321; 21 USC 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                           05/00/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0910-AB56
_______________________________________________________________________




1113. 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                           02/00/01
NPRM                            12/00/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0910-AB71
_______________________________________________________________________




1114. 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

[[Page 73798]]

further information regarding the presence of dioxins in mined clay 
products used in animal feeds or feed ingredients and the significance 
of these dioxins to the public health.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           06/00/01

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: State

Federalism:  Undetermined

Agency Contact: 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
_______________________________________________________________________




1115. PART 600-BIOLOGICAL PRODUCTS: GENERAL (SECTION 610 REVIEW)

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

Unfunded Mandates: Undetermined

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

CFR Citation: Not Yet Determined

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Begin Review of Current 
Regulation                      04/03/00
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)



_______________________________________________________________________




1116. HEARING AIDS; PROFESSIONAL AND PATIENT LABELING; CONDITIONS FOR 
SALE

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

RIN: 0910-AA39
_______________________________________________________________________




1117. REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN 
COMMERCIAL DISTRIBUTION

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

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

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

CFR Citation: 21 CFR 207

Legal Deadline: None

Abstract: The proposed rule would revise the regulations under part 207 
to clarify the requirements for registration and listing and to 
consolidate and reorganize the regulations. The proposal would also 
require the electronic submission of establishment registration and 
product listing information.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/01

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-AA49
_______________________________________________________________________




1118. 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

[[Page 73799]]

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                            03/00/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0910-AA61
_______________________________________________________________________




1119. 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                            09/00/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0910-AA86
_______________________________________________________________________




1120. LABELING FOR HUMAN PRESCRIPTION DRUGS; REVISED FORMAT

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

RIN: 0910-AA94
_______________________________________________________________________




1121. SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND BIOLOGICAL 
PRODUCTS

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

RIN: 0910-AA97
_______________________________________________________________________




1122. RADIOACTIVE DRUGS FOR BASIC RESEARCH

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

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

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

CFR Citation: 21 CFR 361

Legal Deadline: None

Abstract: The proposed rule would update FDA's regulations on the use 
of radioactive drugs for basic research to reflect technological 
changes in the field of radiopharmaceuticals. The proposed rule would 
also clarify and correct certain provisions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

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-AB00


_______________________________________________________________________



[[Page 73800]]

1123. 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                            04/00/01

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
_______________________________________________________________________




1124. CURRENT GOOD TISSUE PRACTICE FOR MANUFACTURERS OF HUMAN CELLULAR 
AND TISSUE-BASED PRODUCTS

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

RIN: 0910-AB28
_______________________________________________________________________




1125. 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
Reinventing Government: This rulemaking is part of the Reinventing 
Government effort. It will eliminate existing text in the CFR.

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

CFR Citation: 21 CFR 312; 21 CFR 314

Legal Deadline: None

Abstract: The proposed rule would amend the regulations on marketing 
approval of new drugs to discontinue the use of approvable and not 
approvable letters when taking action on a marketing application and 
instead use complete response letters. The proposed rule would also 
amend the regulations on extension of the review clock because of 
amendments to applications.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0910-AB34
_______________________________________________________________________




1126. EXPANDED ACCESS TO INVESTIGATIONAL THERAPIES

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 360bbb

CFR Citation: 21 CFR 312

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/01

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
_______________________________________________________________________




1127. ELECTRONIC SUBMISSION OF ADVERSE DRUG REACTION REPORTS

Priority: Substantive, Nonsignificant. 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                            05/00/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

[[Page 73801]]

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-AB42
_______________________________________________________________________




1128. 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                            04/00/01

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
_______________________________________________________________________




1129. PREGNANCY LABELING

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 revise the regulatory requirements 
for the pregnancy labeling subsection of the labeling requirements for 
human drugs and biologics.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/01

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

RIN: 0910-AB44
_______________________________________________________________________




1130. PHARMACY AND PHYSICIAN COMPOUNDING OF DRUG PRODUCTS

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

RIN: 0910-AB58
_______________________________________________________________________




1131. 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 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                            05/00/01

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-AB59
_______________________________________________________________________




1132. 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.

[[Page 73802]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/01

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
_______________________________________________________________________




1133. POSITRON EMISSION TOMOGRAPHY DRUGS; CURRENT GOOD MANUFACTURING 
PRACTICES

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

RIN: 0910-AB63
_______________________________________________________________________




1134. CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS

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

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

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

CFR Citation: 21 CFR 225

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/01

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
_______________________________________________________________________




1135. CGMPS FOR BLOOD AND BLOOD COMPONENTS: NOTIFICATION OF CONSIGNEES 
AND TRANSFUSION RECIPIENTS RECEIVING BLOOD AND BLOOD COMPONENTS AT 
INCREASED RISK OF TRANSMITTING HCV (LOOKBACK)

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

RIN: 0910-AB76
_______________________________________________________________________




1136. 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                            12/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0910-AB79
_______________________________________________________________________




1137. STABILITY TESTING OF DRUGS

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 specify required stability data that 
must be submitted with new drug applications.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/01

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


_______________________________________________________________________



[[Page 73803]]

1138. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR 
HOLDING DIETARY SUPPLEMENTS

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

RIN: 0910-AB88
_______________________________________________________________________




1139. CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD 
COMPONENTS; BLOOD LABELING STANDARDS

Priority: Other Significant

Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 360; 21 USC 
360j; 21 USC 371; 21 USC 374; 42 USC 216; 42 USC 262; 42 USC 263a; 42 
USC 264; 21 USC 331; 21 USC 355

CFR Citation: 21 CFR 606.121; 21 CFR 606.122

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0910-AB89
_______________________________________________________________________




1140. SUBMISSION IN ELECTRONIC FORMAT OF CERTAIN LABELING INFORMATION

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

Unfunded Mandates: Undetermined

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/01

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
_______________________________________________________________________




1141. 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                            12/00/00

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0910-AB92
_______________________________________________________________________




1142. PERIODIC TESTING FOR CERTAIN HUMAN DRUG, VETERINARY DRUG, AND 
BIOLOGICAL PRODUCT FINAL SPECIFICATIONS

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321; 21 USC 351; 21 USC 352; 21 USC 355; 21 USC 
360(b); 21 USC 371; 21 USC 374

CFR Citation: 21 CFR 211.165; 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.

[[Page 73804]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/01

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
_______________________________________________________________________




1143. 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                            12/00/00

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0910-AB95
_______________________________________________________________________




1144. 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                            02/00/01

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

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

RIN: 0910-AB96
_______________________________________________________________________




1145. MEDICAL DEVICES, MEDICAL DEVICE ESTABLISHMENT REGISTRATION AND 
LISTING REQUIREMENTS; AMENDMENT

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 360; 21 USC 
360c; 21 USC 360e; 21 USC 360i; 21 USC 360j; 21 USC 371; 21 USC 374

CFR Citation: Not Yet Determined

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/01

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
_______________________________________________________________________




1146. AVAILABILITY FOR PUBLIC DISCLOSURE AND SUBMISSION TO FDA FOR 
PUBLIC DISCLOSURE OF CERTAIN DATA AND INFORMATION RELATED TO GENE 
THERAPY OR XENOTRANSPLANTATION

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

RIN: 0910-AC00


_______________________________________________________________________



[[Page 73805]]

1147. REPORTING INFORMATION REGARDING POTENTIAL FABRICATION OR 
FALSIFICATION

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 355(i); 21 USC 360(j); 21 USC 349; 42 USC 262

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Leanne Cusumano, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, (HFD-7), Center for Drug Evaluation and Research, 5600 
Fishers Lane, Rockville, MD 20857
Phone: 301 594-2041
Fax: 301 827-0951
Email: [email protected]

RIN: 0910-AC02
_______________________________________________________________________




1148. 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                            01/00/01
Direct Final Rule               01/00/01

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
_______________________________________________________________________




1149. STATUS REPORTS FOR QUANTITY MARKETED INFORMATION FOR ANIMAL DRUG 
PRODUCTS USED IN FOOD-PRODUCING ANIMALS

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 360(b)

CFR Citation: 21 CFR 524

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/01

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

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




1150.  ADDITIONAL SAFEGUARDS FOR CHILDREN IN CLINICAL 
INVESTIGATIONS

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

Unfunded Mandates: Undetermined

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 355; 21 USC 360; 21 USC 360c-f; 
21 USC 360h-j; 21 USC 371; 21 USC 379e; 21 USC 381; 41 USC 216; 41 USC 
241; 41 USC 262; 41 USC 263b-n

CFR Citation: 21 CFR 50; 21 CFR 56

Legal Deadline: None

Abstract: The proposed rule would provide additional protection for 
children involved as subjects in clinical investigations of drug 
products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/01

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

[[Page 73806]]

Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AC07
_______________________________________________________________________




1151.  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                            01/00/01

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
_______________________________________________________________________




1152.  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(r)(6)

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 this process or qualify for a pregnancy claim. 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                            01/00/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Leanne Cusumano, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, (HFD-7), Center for Drug Evaluation and Research, 5600 
Fishers Lane, Rockville, MD 20857
Phone: 301 594-2041
Fax: 301 827-0951
Email: [email protected]

RIN: 0910-AC09
_______________________________________________________________________




1153.  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                            05/00/01

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
_______________________________________________________________________




1154.  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 proposed rule would revoke the regulation (21 CFR 
310.500) that established conditions for marketing digoxin products for 
oral use.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/00

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


_______________________________________________________________________



[[Page 73807]]

1155.  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 carcinogenic 
compounds must satisfy with respect to the sponsors' proposed 
regulatory methods.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/01

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
_______________________________________________________________________




1156.  CONTROL OF SALMONELLA ENTERITIDIS IN SHELL EGGS DURING 
PRODUCTION AND RETAIL

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

RIN: 0910-AC14
_______________________________________________________________________




1157.  PREMARKET NOTICE CONCERNING BIOENGINEERED FOODS

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

RIN: 0910-AC15
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




1158. OVER-THE-COUNTER (OTC) DRUG REVIEW

Priority: Routine and Frequent

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

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

[[Page 73808]]

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

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

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

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

Antidiarrheal Products  ANPRM 03/21/75 (40 FR 12924)  NPRM 04/30/86 (51 
FR 16138)  NPRM (Amendment)(Trav. Diar.) 04/00/01  Final Action 04/00/
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)

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 12/00/00

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

Antiperspirant Products  ANPRM 10/10/78 (43 FR 46694)  NPRM 08/20/82 
(47 FR 36492)  Final Action 04/00/01

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

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

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

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

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

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

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

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

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

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

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

Cough/Cold (Antitussive) Products  ANPRM 09/09/76 (41 FR 38312)  NPRM 
10/19/83 (48 FR 48576)  Final Action 08/12/87 (52 FR 30042)  NPRM 
(Amendment) (Warning) 07/06/89 (54 FR 28442)  NPRM (Amendment) 10/02/89 
(54 FR 40412)  Final Action (Amendment) (Warning) 07/06/90 (55 FR 
27806)  Final Action (Amendment) 10/03/90 (55 FR 40381)  NPRM 
(Amendment)(Warning) 06/19/92 (57 FR 27666)  NPRM 
(Amendment)(Ingredients) 12/09/92 (57 FR 58378)  Final Action 
(Amendment)(Warning) 10/20/93 (58 FR 54232)  Final Action 
(Amdt.)(Ingredients) 06/03/94 (59 FR 29172)  NPRM 
(Amendment)(Diphenhydramine) 08/29/97 (62 FR 45767)  NPRM 
(Amendment)(Flammability) 07/20/98 (63 FR 38762)  Final Action 
(Amendment)(Flammability) 08/01/00 (65 FR 46864)

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) 02/00/01

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) 02/00/01  Final Action 04/00/01

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

[[Page 73809]]

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

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

Cough/Cold (Nasal Decongestant) Products  ANPRM 09/09/76 (41 FR 
38312)  NPRM 01/15/85 (50 FR 2220)  NPRM (Amendment) 06/19/92 (57 FR 
27658)  Final Action 08/23/94 (59 FR 43386)  Final Action; Partial Stay 
03/08/96 (61 FR 9570)  NPRM (Phenylpropanolamine) 04/00/01

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 11/00/00

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

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

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

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

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

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

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

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

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

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

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

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

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

Internal Analgesic Products  ANPRM 07/08/77 (42 FR 35346)  NPRM 11/16/
88 (53 FR 46204)  NPRM (Amendment) (Overindulgence) 12/24/91 (56 FR 
66762)  NPRM (Amendment)(Sodium Bicarbonate) 02/02/94 (59 FR 
5068)  NPRM (Prof. Labeling)(Acute MI) 06/13/96 (61 FR 30002)  NPRM 
(Amendment)(Alcohol Warning) 11/14/97 (62 FR 61041)  Final Action 
(Alcohol Warning) 10/23/98 (63 FR 56789)  Final Action (Aspirin Prof. 
Label) 10/23/98 (63 FR 56802)  Final Action (Sodium Bicarbonate) 04/00/
01  Final Action (Amendment)(Overindulgence) 12/00/01

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

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

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 08/00/
01  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  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)

[[Page 73810]]

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

Ophthalmic Products  ANPRM 05/06/80 (45 FR 30002)  NPRM 06/28/83 (48 FR 
29788)  Final Action 03/04/88 (53 FR 7076)  Final Action (Anti-
infective) 12/18/92 (57 FR 60416)  NPRM (Amendment) (Warning) 02/23/98 
(63 FR 8888)  Final Action 06/21/00 (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)  ANPRM (Plaque/Gingivitis) 04/00/01  NPRM 04/00/01

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) 04/00/01

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)  NPRM (Amendment) 
12/00/01  Final Action 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) 04/00/01

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

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

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)

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

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

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

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

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

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

Vaginal Contraceptive Products  ANPRM 12/12/80 (45 FR 82014)  NPRM 02/
03/95 (60 FR 6892)  NPRM (Amendment) 04/00/01

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)

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) 04/00/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

Agency Contact: Rosemary Cook, Supervisor, Project Management Staff, 
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
_______________________________________________________________________




1159. NEW ANIMAL DRUG APPROVAL PROCESS; IMPLEMENTATION OF TITLE I OF THE 
GENERIC ANIMAL DRUG AND PATENT TERM RESTORATION ACT (GADPTRA)

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

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

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

CFR Citation: 21 CFR 514

[[Page 73811]]

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 12/00/00

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AA96.
For information concerning reporting requirements for marketed animal 
drugs, contact William C. Keller, Director, Division of Surveillance, 
Center for Veterinary Medicine, Food and Drug Administration, 7500 
Standish Place, Rockville, MD 20855, 301 827-6642.
For further information concerning generic animal drugs, contact Lonnie 
W. Luther, Chief, Quality Assurance Support Team, Center for Veterinary 
Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, 
MD 20855, 301 827-0209.
The federalism implications for the new animal drug approval process 
are undetermined.

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

RIN: 0910-AA02
_______________________________________________________________________




1160. BIOLOGICAL PRODUCTS: REPORTING OF BIOLOGICAL PRODUCT DEVIATIONS IN 
MANUFACTURING

Priority: Other Significant

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

CFR Citation: 21 CFR 600; 21 CFR 606

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AD67.

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

RIN: 0910-AA12


_______________________________________________________________________



[[Page 73812]]

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

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

RIN: 0910-AA43
_______________________________________________________________________




1162. BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

Priority: Substantive, Nonsignificant

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

Legal Authority: 21 USC 321; 21 USC 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                    03/00/01

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
_______________________________________________________________________




1163. DRUGS USED FOR TREATMENT OF NARCOTIC ADDICTS

Priority: Substantive, Nonsignificant

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

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

CFR Citation: 21 CFR 291; 42 CFR 8

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

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

Agency Contact: Elsworth Dory, Investigator, Division of Scientific 
Investigations, Department of Health and Human Services, Food and Drug 
Administration, (HFD-49), Center for Drug Evaluation and Research, 7520 
Standish Place, Rockville, MD 20855
Phone: 301 827-7264

RIN: 0910-AA52
_______________________________________________________________________




1164. 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                    06/00/01

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


_______________________________________________________________________



[[Page 73813]]

1165. 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                    06/00/01

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
_______________________________________________________________________




1166. 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                    03/00/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Leanne Cusumano, Regulatory Counsel, Regulatory Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, (HFD-7), Center for Drug Evaluation and Research, 5600 
Fishers Lane, Rockville, MD 20857
Phone: 301 594-2041
Fax: 301 827-0951
Email: [email protected]

RIN: 0910-AA99
_______________________________________________________________________




1167. ESTABLISHMENT REGISTRATION AND LISTING OF HUMAN CELLS AND TISSUE

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

RIN: 0910-AB05
_______________________________________________________________________




1168. VETERINARY FEED DIRECTIVES

Priority: Other Significant

Legal Authority: PL 104-250

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/02/99                    64 FR 35966
Final Action                    12/00/00

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0910-AB09
_______________________________________________________________________




1169. 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

[[Page 73814]]

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                    11/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0910-AB16
_______________________________________________________________________




1170. 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                    11/00/00

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0910-AB21
_______________________________________________________________________




1171. 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                    03/00/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0910-AB24
_______________________________________________________________________




1172. BLOOD INITIATIVE

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

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 600; 21 CFR 601; 21 CFR 606; 21 CFR 607; 21 CFR 
610; 21 CFR 640; 21 CFR 660; 21 CFR 680

Legal Deadline: None

Abstract: In multiple rulemakings, the Food and Drug Administration is 
amending the biologics regulations by removing, revising, or updating 
specific regulations applicable to blood, blood components, and blood 
derivative products to be more consistent with current practices and to 
remove unnecessary or outdated requirements. This action is based on a 
comprehensive review of the regulations that has been performed by FDA. 
It is also based on reports by the U.S. House of Representatives 
Committee on Government Reform and Oversight, Subcommittee on House 
Resources and Intergovernmental Relations; the General Accounting 
Office; the Institute of Medicine; as well as public comments. Some of 
the subjects intended to be addressed in the rulemakings include: 
``Lookback'' requirements for hepatitis C virus; notification of 
consignees and end

[[Page 73815]]

users of product safety information for plasma derivative products; 
notification of deferred donors; requirements for donor suitability and 
testing and infectious agent clearance. These actions are intended to 
help ensure the continued safety of the Nation's blood supply.

Timetable:
________________________________________________________________________

Albumin (Human), Plasma Protein Fraction (Human) and Immune Globulin 
(Human); Rev. of Reqs.  Direct Final Rule 05/14/99 (64 FR 26282)  NPRM 
05/14/99 (64 FR 26344)  DFR: Confirmation in Part and Tech. Amendment 
03/14/00 (65 FR 13678)  Final Action 08/28/00 (65 FR 52016)

Gen. Reqs. for Blood, Blood Compon., and Plasma Derivatives; 
Notification of Deferred Donors  NPRM 08/19/99 (64 FR 45355)  Final 
Action 03/00/01

Infectious Agent Clearance  NPRM 06/00/01

Plasma Derivatives and Other Blood-Derived Products; Reqs. for Tracking 
and Notification  ANPRM 08/19/99 (64 FR 45383)  NPRM 09/00/01

Reqs. for Testing Human Blood Donors for Evid. of Infection Due to 
Communicable Disease Agents  NPRM 08/19/99 (64 FR 45340)  Final Action 
03/00/01

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 03/00/01

Suitability Reqs. for Whole Blood and Source Plasma Donors  NPRM 09/00/
01

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Additional Information: See RIN 0910-AB76.

Agency Contact: Steven F. Falter, Director, Regulations and Policy 
Staff, Department of Health and Human Services, Food and Drug 
Administration, Suite 200N (HFM-17), Center for Biologics Evaluation 
and Research, 1401 Rockville Pike, Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 594-1944
Email: [email protected]

RIN: 0910-AB26
_______________________________________________________________________




1173. SHELL EGGS: WARNING, NOTICE AND SAFE HANDLING LABELING STATEMENTS 
AND REFRIGERATION REQUIREMENTS

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

Legal Authority: 21 USC 321; 42 USC 264

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           05/19/98                    63 FR 27502
ANPRM Comment Period End        08/17/98
Economic Analysis for Refrigeration and Labeling of Shell Eggs  NPRM 
07/06/99 (64 FR 36492)  NPRM Comment Period End 09/20/99 (64 FR 
36492)  Final Action 11/00/00

Refrigeration and Labeling of Shell Eggs  NPRM 07/06/99 (64 FR 
36492)  NPRM Comment Period End 09/20/99 (64 FR 36492)  Final Action 
11/00/00

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal, State

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

Agency Contact: Geraldine A. June, Consumer Safety Officer, Department 
of Health and Human Services, Food and Drug Administration, (HFS-822), 
Center for Food Safety and Applied, Nutrition, 200 C Street SW, 
Washington, DC 20204
Phone: 202 205-4168
Email: [email protected]

RIN: 0910-AB30
_______________________________________________________________________




1174. ANTIBIOTIC DRUG APPROVAL AND EXCLUSIVITY

Priority: Substantive, Nonsignificant

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

Legal Authority: PL 105-115, sec 125

CFR Citation: 21 CFR 314

Legal Deadline: None

Abstract: The 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                    05/00/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Pauli C. Varki, Regulatory Counsel, Regulatory Policy

[[Page 73816]]

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: 301 827-5562
Email: [email protected]

RIN: 0910-AB33
_______________________________________________________________________




1175. 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 201, 250, 310, 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                    06/00/01

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
_______________________________________________________________________




1176. 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                      04/00/01

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
_______________________________________________________________________




1177. BULK DRUG SUBSTANCES FOR USE IN PHARMACY COMPOUNDING

Priority: Other Significant

Legal Authority: PL 105-115, sec 127

CFR Citation: 21 CFR 216

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

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
_______________________________________________________________________




1178. SUPPLEMENTS AND OTHER CHANGES TO AN APPROVED APPLICATION

Priority: Substantive, Nonsignificant

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

[[Page 73817]]

determined by the Secretary to have a substantial potential to 
adversely affect the identity, strength, quality, purity, and potency 
of the drug as they may relate to the safety and effectiveness of a 
drug, require prior approval of a supplemental application. A second 
category of changes may be made if FDA has not notified the company 
within 30 days after the submission of a supplement that prior approval 
is required. A third category of changes may be made upon submission of 
a supplement to the agency. The rule would also identify another 
category of changes that may be made without the submission of a 
supplement but which must be reported in an annual report.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/28/99                    64 FR 34608
Final Action                    04/00/01

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
_______________________________________________________________________




1179. FOOD LABELING: TRANS FATTY ACIDS IN NUTRITION LABELING AND 
NUTRIENT CONTENT CLAIMS

Priority: Economically Significant

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

CFR Citation: 21 CFR 101

Legal Deadline: None

Abstract: Section 403(q) of the Federal Food, Drug, and Cosmetic Act, 
which was added by the Nutrition Labeling and Education Act of 1990, 
requires that the label or labeling of food products bear nutrition 
information. Among other things, section 403(q) authorizes the Food and 
Drug Administration (FDA) to add or delete nutrients that are to be 
declared on the labels or labeling of food products by regulation if it 
finds such action necessary to assist consumers in maintaining healthy 
dietary practices. FDA issued final regulations implementing these 
provisions in 1993. FDA subsequently received a citizen petition 
requesting that FDA amend its regulations on food labeling to require 
that the amount of trans fatty acids be listed in the nutrition label 
and be limited wherever saturated fat limits are placed on nutrient 
content claims, health claims, or disqualifying levels and disclosure 
levels. In response to this petition and based on new evidence, FDA 
proposed the actions requested in the petition on November 17, 1999 (64 
FR 62746). In addition, FDA proposed to define the claim ``trans fat 
free.''

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/17/99                    64 FR 62746
Final Rule                      06/00/01

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
_______________________________________________________________________




1180. 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: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Gail Schmerfeld, Special Assistant, Department of 
Health and Human Services, Food and Drug Administration, HFV-100, 
Center for Veterinary Medicine, 7500 Standish Place, Rockville, MD 
20855
Phone: 301 594-1620

RIN: 0910-AB68
_______________________________________________________________________




1181. 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                    01/00/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health

[[Page 73818]]

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

RIN: 0910-AB73
_______________________________________________________________________




1182. 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 considering revising its present regulations governing 
the classification of surgeon's and patient examination gloves. The 
present rule classifies surgeon's and patient examination gloves as 
class I devices. FDA is considering reclassifying surgeon's and patient 
examination gloves as class II devices subject to special controls. FDA 
is also considering requiring additional labeling concerning powder and 
protein levels for these devices.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/30/99                    64 FR 41710
Final Action                    06/00/01

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
_______________________________________________________________________




1183. 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 a court decision in Mova 
Pharmaceutical v. Shalala, 140 F. 3d 1060 (D.C. Cir. 1998), 
invalidating an eligibility requirement for exclusivity.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/06/99                    64 FR 42873
NPRM Comment Period End         10/04/99
Final Action                    02/00/01

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
_______________________________________________________________________




1184. POSTMARKETING STUDIES FOR HUMAN DRUGS AND LICENSED BIOLOGICAL 
PRODUCTS: STATUS REPORTS

Priority: Substantive, Nonsignificant

Legal Authority: PL 105-115

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

Legal Deadline: Other, Statutory, October 1, 2001, Section 130(b) 
requires the FDA to report by October 1, 2001 to the House and Senate 
committees summarizing postmarketing study reports submitted by 
sponsors to FDA.

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Nathaniel Geary, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, Suite 200N 
(HFM-17), Center for Biologics Evaulation and Research, 1401 Rockville 
Pike, Rockville, MD 20852-1448
Phone: 301 827-6210
Email: [email protected]

RIN: 0910-AB83
_______________________________________________________________________




1185. FOOD ADDITIVES: FOOD CONTACT SUBSTANCES NOTIFICATION SYSTEM

Priority: Substantive, Nonsignificant

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

[[Page 73819]]

amended by EO 11991; 42 USC 300a to 300e; 42 USC 300aa-1; ...

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            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
_______________________________________________________________________




1186. STATE CERTIFICATION OF MAMMOGRAPHY FACILITIES

Priority: Other Significant

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/30/00                    65 FR 16847
NPRM Comment Period End         06/28/00
Final Rule                      05/00/01

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
_______________________________________________________________________




1187. ADDITION TO THE LIST OF DRUG PRODUCTS THAT HAVE BEEN WITHDRAWN 
FROM THE MARKET FOR REASONS OF SAFETY OR EFFECTIVENESS

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 353a

CFR Citation: 21 CFR 216.24

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/04/00                      65 FR 256
NPRM Comment Period End         03/20/00
Final Action                    12/00/00

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Regulatory 
Policy Staff, Department of Health and Human

[[Page 73820]]

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
_______________________________________________________________________




1188. 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, radiological, or nuclear substances when adequate and well-
controlled efficacy studies in humans cannot be ethically conducted 
because they would involve administering a potentially lethal or 
permanently disabling toxic substance or organism to healthy human 
volunteers without a proven treatment and field trials (assessment of 
use of the product after accidental or hostile exposure to the 
substance) are not feasible. FDA is taking this action because it 
recognized the importance of improving medical response capabilities to 
the use of lethal or permanently disabling chemical, biological, 
radiological, and nuclear substances in order to protect individuals 
exposed to these substances.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/05/99                    64 FR 53960
Final Action                    03/00/01

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
_______________________________________________________________________




1189.  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                      01/00/01

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
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




1190. INFANT FORMULA: GOOD MANUFACTURING PRACTICE, QUALITY CONTROL 
PROCEDURES, QUALITY FACTORS, NOTIFICATION REQUIREMENTS, AND RECORDS AND 
REPORTS

Priority: Other Significant

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

CFR Citation: 21 CFR 106; 21 CFR 107

Legal Deadline: None

Abstract: The agency published a proposed rule on July 9, 1996 that 
would establish current good manufacturing practice regulations, 
quality control procedures, quality factors, notification requirements, 
and records and reports for the production of infant formulas. This 
proposal was issued in response to the 1986 Amendments to the Infant 
Formula Act of 1980. Two final rules will be published: one, on Quality 
Factors and the second, on Good Manufacturing Practice, Quality Control 
Procedures Notification Requirements, and Records and Reports.

Timetable:
________________________________________________________________________

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

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

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

[[Page 73821]]

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AC46.

Agency Contact: Darla Danford, Supervisory Nutritionist, Department of 
Health and Human Services, Food and Drug Administration, (HFS-800), 
Center for Food Safety and Applied Nutrition, 200 C Street SW, 
Washington, DC 20204
Phone: 202 205-5365

RIN: 0910-AA04
_______________________________________________________________________




1191. FOOD LABELING REVIEW

Priority: Routine and Frequent

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

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

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

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

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

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

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

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

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

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

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

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

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

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

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
_______________________________________________________________________




1192. 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 73822]]

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Federalism:  Undetermined

Additional Information: Previously reported under RIN 0905-AD91.

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

RIN: 0910-AA20
_______________________________________________________________________




1193. CLASSIFICATION OF COMPUTER SOFTWARE PROGRAMS THAT ARE MEDICAL 
DEVICES

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

Unfunded Mandates: Undetermined

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

CFR Citation: Not Yet Determined

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE58.

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

RIN: 0910-AA41
_______________________________________________________________________




1194. 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 211.115; 21 CFR 
211.160; 21 CFR 211.166; 21 CFR 211.192; 21 CFR 211.220; 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 current agency 
policies or current industry practices. Among other things, the rule 
will create or clarify requirements for process and methods validation, 
appropriate laboratory testing procedures, and protection against 
contamination. The rule is designed to update the CGMP regulations in 
response to technological changes and the agency's experience with the 
regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/03/96                    61 FR 20104
NPRM Comment Period End         09/30/96
Final Action                    10/00/01

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
_______________________________________________________________________




1195. REINVENTING FDA FOOD REGULATIONS

Priority: Substantive, Nonsignificant

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

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

CFR Citation: 21 CFR 101; 21 CFR 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,

[[Page 73823]]

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)

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

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

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

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

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

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

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

RIN: 0910-AA58
_______________________________________________________________________




1196. 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
_______________________________________________________________________




1197. INVESTIGATIONAL USE NEW ANIMAL DRUG REGULATIONS (SECTION 610 
REVIEW)

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

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

Legal Authority: 5 USC 610; 21 USC 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 73824]]

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                   09/00/02

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
_______________________________________________________________________




1198. SUITABILITY DETERMINATION FOR DONORS OF HUMAN CELLULAR AND TISSUE-
BASED PRODUCTS

Priority: Other Significant

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

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/30/99                    64 FR 52696
NPRM Comment Period Reopened    04/18/00                    65 FR 20774
NPRM Comment Period End         07/17/00
Final Action                    10/00/01

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

RIN: 0910-AB27
_______________________________________________________________________




1199. REQUIREMENTS FOR LIQUID MEDICATED FEED AND FREE-CHOICE MEDICATED 
FEED

Priority: Substantive, Nonsignificant

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

CFR Citation: 21 CFR 558.5; 21 CFR 510.455

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             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


_______________________________________________________________________



[[Page 73825]]

1200. REVISIONS TO THE GENERAL SAFETY REQUIREMENTS FOR BIOLOGICAL 
PRODUCTS; DIRECT FINAL RULE

Priority: Substantive, Nonsignificant

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

Legal Authority: 42 USC 351

CFR Citation: 21 CFR 610.11(g)

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) issued a direct final 
rule and companion proposed rule to amend the biologics regulations by 
adding ``cellular therapy products'' to the list of products excepted 
from the general safety test (GST) and by adding an administrative 
procedure for obtaining an exemption from the GST requirements for 
other biological products. Because the agency received significant 
adverse comment on the administrative procedure portion of the direct 
final rule, FDA withdrew that portion of the rule and confirmed the 
remaining portion. FDA intends to finalize the companion proposed rule 
to respond to the significant adverse comment on the administrative 
procedure portion of the rule. FDA is taking this action because the 
GST may not be relevant or necessary for all biological products, 
including cellular therapy products, currently in various stages of 
development. This action is part of FDA's continuing effort to achieve 
the objectives of the President's ``Reinventing Government'' 
initiative, and is intended to reduce the burden of unnecessary 
regulations on biological products without diminishing the protection 
of the public health.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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




1201. 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
_______________________________________________________________________




1202. 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
_______________________________________________________________________




1203. 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

[[Page 73826]]

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: Christine Rogers, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Suite 3059 
(HFD-7), Center for Drug Evaluation and Research, 1451 Rockville Pike, 
Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AB81
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Food and Drug Administration (FDA)



_______________________________________________________________________




1204. DEBARMENT CERTIFICATION REGULATIONS FOR DRUG APPLICATIONS

Priority: Other Significant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       07/13/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Leanne Cusumano
Phone: 301 594-2041
Fax: 301 827-0951
Email: [email protected]

RIN: 0910-AA76
_______________________________________________________________________




1205. INVESTIGATIONAL NEW DRUG APPLICATIONS; REQUEST FOR INFORMATION AND 
COMMENTS

Priority: Other Significant

CFR Citation: 21 CFR 56; 21 CFR 312

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       07/28/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Joseph Griffin
Phone: 301 594-6758
Fax: 301 594-5298

RIN: 0910-AA83
_______________________________________________________________________




1206. INVESTIGATIONAL NEW DRUG APPLICATIONS; CLINICAL HOLDS FOR DRUGS 
FOR LIFE-THREATENING ILLNESSES

Priority: Substantive, Nonsignificant

CFR Citation: 21 CFR 312

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/01/00                    65 FR 34963

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Andrea C. Masciale
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA84
_______________________________________________________________________




1207. STERILITY REQUIREMENTS FOR AQUEOUS-BASED DRUG PRODUCTS FOR ORAL 
INHALATION

Priority: Substantive, Nonsignificant

CFR Citation: 21 CFR 200

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    05/26/00                    65 FR 34082

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Carol Drew
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AA88
_______________________________________________________________________




1208. CLASSIFICATION OF SHEEP AS A MINOR SPECIES FOR ALL DATA COLLECTION 
PURPOSES

Priority: Substantive, Nonsignificant

CFR Citation: 21 CFR 514.1

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/03/00                    65 FR 47668

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Margaret Oeller
Phone: 301 827-7581

RIN: 0910-AB69
_______________________________________________________________________




1209. AMENDMENT OF VARIOUS DEVICE REGULATIONS TO REFLECT CURRENT 
AMERICAN SOCIETY FOR TESTING AND MATERIALS CITATIONS

Priority: Routine and Frequent

CFR Citation: 21 CFR 801.410; 21 CFR 801.430

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      07/18/00                    65 FR 44435

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0910-AB84

[[Page 73827]]

_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1210. DESIGNATION OF MEDICALLY UNDERSERVED POPULATIONS AND HEALTH 
PROFESSIONAL SHORTAGE AREAS

Priority: Substantive, Nonsignificant

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

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

CFR Citation: 42 CFR 5; 42 CFR 51c

Legal Deadline: None

Abstract: This rule would consolidate the process for designating areas 
of health professional shortage and medical underservice that apply in 
several department programs, and would improve the criteria for 
designating medically underserved populations (MUPs) and Primary Care 
Health Professional Shortage Areas (HPSAs). This NPRM will address 
issues raised by comments received in 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                     01/00/01
NPRM Comment Period End         04/00/01

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
_______________________________________________________________________




1211. COMPLIANCE ALTERNATIVES FOR PROVISION OF UNCOMPENSATED SERVICES

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 124, subpart F

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/00
NPRM Comment Period End         12/00/00
Final Action                    06/00/01

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
_______________________________________________________________________




1212. NATIONAL VACCINE INJURY COMPENSATION PROGRAM: REVISIONS AND 
ADDITIONS TO THE VACCINE INJURY TABLE

Priority: Substantive, Nonsignificant

Legal Authority: PL 106-170

CFR Citation: 42 CFR 100

Legal Deadline: None

Abstract: This NPRM proposes several changes to the Vaccine Injury 
Table (Table) (42 CFR 100.3), which will have an effect upon petitions 
for compensation under the National Childhood Vaccine Injury 
Compensation Program including the following: (1) amending the Table by 
adding the injury of intussusception to the Table for vaccines 
containing live, oral, rhesus-based rotavirus, a category 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                            12/00/00

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Geoffrey Evans, Medical Director, Divison of Vaccine 
Injury Compensation, BHPR, 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

[[Page 73828]]

_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1213. FINAL RULE FOR THE HEALTH PROFESSIONS, NURSING, PUBLIC HEALTH, AND 
ALLIED HEALTH TRAINING GRANT PROGRAMS UNDER 42 CFR PARTS 57 AND 58

Priority: Substantive, Nonsignificant

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

Legal Authority: PL 105-392

CFR Citation: 42 CFR 57; 42 CFR 58

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/00/00

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Steve Tise, Acting Chief, Planning, Evaluation and 
Legislation Branch/ORP, BHPr, 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
_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




1214. NATIONAL PRACTITIONER DATA BANK FOR ADVERSE INFORMATION ON 
PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS: MEDICAL MALPRACTICE 
PAYMENTS REPORTING REQUIREMENTS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 11131

CFR Citation: 45 CFR 60.7

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0906-AA41
_______________________________________________________________________




1215.  RICKY RAY HEMOPHILIA RELIEF FUND PROGRAM

Priority: Substantive, Nonsignificant

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

Legal Authority: 42 USC 300c-22 note

CFR Citation: 42 CFR 130

Legal Deadline: None

Abstract: The Ricky Ray Hemophilia Relief Fund Act of 1998 established 
the Ricky Ray Hemophilia Relief Fund Program. It was designed to 
provide compassionate payments to certain individuals with blood-
clotting disorders, such as hemophilia, who contracted HIV through the 
use of antihemophilic factor administered between July 1, 1982 and 
December 31, 1987. The Act also provides for payments to certain 
individuals who contracted HIV from the foregoing persons. The final 
rule establishes procedures and requirements for documentation of 
eligibility and the mechanism for providing compassionate payments to 
qualified individuals under the statute.

[[Page 73829]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/02/00                    65 FR 47438


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Neil H. Sampson, Deputy Associate Administrator, Bureau 
of Health Professions, Department of Health and Human Services, Public 
Health Service, Room 8-05, Parklawn Building, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 443-5974

RIN: 0906-AA56
_______________________________________________________________________


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


Indian Health Service (IHS)



_______________________________________________________________________




1216. INDIAN CHILD PROTECTION AND FAMILY VIOLENCE PREVENTION ACT MINIMUM 
STANDARDS OF CHARACTER

Priority: Info./Admin./Other

Legal Authority: 25 USC 3201 et seq

CFR Citation: 42 CFR 36

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/25/99                    64 FR 14559
NPRM Comment Period End         07/26/99
Final Action                    01/00/01

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
_______________________________________________________________________




1217. CONTRACTS UNDER THE INDIAN SELF-DETERMINATION ACT

Priority: Info./Admin./Other

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

Legal Authority: 42 USC 2003; 25 USC 13

CFR Citation: 42 CFR 36.201-237

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/01/00                     65 FR 4797
NPRM Comment Period End         04/03/00
Final Rule                      11/00/00

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Tribal

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

RIN: 0917-AA04
_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




1218. NATIONAL INSTITUTES OF HEALTH AIDS RESEARCH LOAN REPAYMENT PROGRAM

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 68

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/01

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

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

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

RIN: 0925-AA02
_______________________________________________________________________




1219. UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING PROFESSIONS NEEDED BY 
THE NIH

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 68b

Legal Deadline: None

[[Page 73830]]

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                            02/00/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE57.

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

RIN: 0925-AA10
_______________________________________________________________________




1220. NATIONAL CANCER INSTITUTE CLINICAL CANCER EDUCATION PROGRAM

Priority: Info./Admin./Other

Legal Authority: 42 USC 216

CFR Citation: 42 CFR 52d

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/01

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
_______________________________________________________________________




1221. NATIONAL INSTITUTES OF HEALTH LOAN REPAYMENT PROGRAM FOR RESEARCH

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 288-3

CFR Citation: 42 CFR 68d

Legal Deadline: None

Abstract: Regulations will be issued to govern the awarding of 
educational loan repayments to qualified health professionals who agree 
to conduct research as employees of the National Institutes of Health.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/00/01

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
_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




1222. TRAINEESHIPS

Priority: Info./Admin./Other

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

CFR Citation: 42 CFR 63

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/30/98                    63 FR 58336
Final Rule                      11/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: Previously reported under RIN 0905-AE62.

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

RIN: 0925-AA11
_______________________________________________________________________




1223. ADDITIONAL DHHS PROTECTIONS FOR PREGNANT WOMEN AND HUMAN FETUSES 
INVOLVED AS SUBJECTS IN RESEARCH, AND PERTAINING TO HUMAN IN VITRO 
FERTILIZATION

Priority: Other Significant

Legal Authority: 5 USC 301; 42 USC 289

CFR Citation: 45 CFR 46, subpart B

Legal Deadline: None

Abstract: Current regulations which have been in effect for two decades 
will be revised to reflect provisions of Public Law 103-43 and recent 
changes in NIH and FDA policies on the involvement of women and human 
fetuses in research.

[[Page 73831]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/20/98                    63 FR 27794
Final Rule                      11/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Michele Russell-Einhorn J.D., Director of Regulatory 
Affairs, Department of Health and Human Services, National Institutes 
of Health, MSC 7507, Suite 3B01, Office for Protection from Research 
Risks, 6100 Executive Boulevard, Rockville, MD 20892-7507
Phone: 301 435-5649

RIN: 0925-AA14
_______________________________________________________________________




1224. 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                      12/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0925-AA16
_______________________________________________________________________




1225. 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                      02/00/01

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
_______________________________________________________________________




1226. SCIENTIFIC PEER REVIEW OF RESEARCH GRANT APPLICATIONS AND RESEARCH 
AND DEVELOPMENT CONTRACT PROJECTS

Priority: Substantive, Nonsignificant

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

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

CFR Citation: 42 CFR 52h

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/21/00                    65 FR 57132
Final Action                    03/00/01

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
_______________________________________________________________________




1227. FEDERAL POLICY (COMMON RULE) FOR THE PROTECTION OF HUMAN SUBJECTS

Priority: Other Significant

Legal Authority: 5 USC 301; 42 USC 289; 42 USC 300v-1(b)

CFR Citation: 45 CFR 46

Legal Deadline: 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.

[[Page 73832]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              10/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Michele Russell-Einhorn J.D., Director of Regulatory 
Affairs, Department of Health and Human Services, National Institutes 
of Health, MSC 7507, Suite 3B01, Office for Protection from Research 
Risks, 6100 Executive Boulevard, Rockville, MD 20892-7507
Phone: 301 435-5649

RIN: 0925-AA21
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


National Institutes of Health (NIH)



_______________________________________________________________________




1228. NIH PRIVACY ACT SYSTEM OF RECORDS, 09-25-0213, ``ADMINISTRATION: 
INVESTIGATIVE RECORDS''

Priority: Info./Admin./Other

CFR Citation: 45 CFR 5b

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      06/14/00                    65 FR 37288

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Timothy Wheeles
Phone: 301 402-5347
Fax: 301 402-0169

RIN: 0925-AA23
_______________________________________________________________________


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


Office of Public Health and Science (OPHS)



_______________________________________________________________________




1229. 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                            11/00/00
NPRM Comment Period End         01/00/01

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
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Office of Public Health and Science (OPHS)



_______________________________________________________________________




1230. STANDARDS OF COMPLIANCE FOR ABORTION-RELATED SERVICES IN FAMILY 
PLANNING SERVICE PROJECTS

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 59

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      07/03/00                    65 FR 41270

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Mireille Kanda
Phone: 301 594-4001

RIN: 0940-AA00

[[Page 73833]]

_______________________________________________________________________


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


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1231. END STAGE RENAL DISEASE (ESRD) CONDITIONS FOR COVERAGE (HCFA-3818-
P) (SECTION 610 REVIEW)

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

RIN: 0938-AG82
_______________________________________________________________________




1232. CRITERIA FOR MEDICARE COVERAGE OF HEART, LIVER, AND LUNG 
TRANSPLANTS (HCFA-3835-P)

 Regulatory Plan: This entry is Seq. No. 46 in Part II of this issue of 
the Federal Register.

RIN: 0938-AH17
_______________________________________________________________________




1233. REQUIREMENTS FOR ESTABLISHING AND MAINTAINING MEDICARE BILLING 
PRIVILEGES (HCFA-6002-P)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 424

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/00

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
_______________________________________________________________________




1234. PROSPECTIVE FEE SCHEDULE FOR AMBULANCE SERVICES (HCFA-1002-P)

Priority: Other Significant

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

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

CFR Citation: 42 CFR 410

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

Abstract: This proposed rule would establish a fee schedule for the 
payment of ambulance services under the Medicare program, implementing 
section 1834(l) of the Social Security Act. As required by that 
section, this proposed fee schedule for ambulance services was the 
product of a negotiated rulemaking process that was carried out 
consistent with the Federal Advisory Committee Act. The fee schedule 
described in this proposed rule would replace the current retrospective 
reasonable cost reimbursement system for providers and the reasonable 
charge system for suppliers of ambulance services. In addition, this 
proposed rule would require that payment for ambulance services would 
be made only on an assignment related basis; establish new codes to be 
reported on claims for ambulance services; establish increased payment 
for ambulance services furnished in rural areas based on the location 
of the beneficiary at the time the patient is placed on board the 
ambulance; and revise the physician certification requirements for 
coverage of non-emergency ambulance services.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice of Intent To Negotiate   01/22/99                     64 FR 3474
NPRM                            12/00/00

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: None

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

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

RIN: 0938-AI72
_______________________________________________________________________




1235. DME SURETY BONDS (HCFA-6006-P)

Priority: Economically Significant

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

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

CFR Citation: 42 CFR 424.57

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/00

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

Ralph Goldberg, Center for Health Plans and Providers, Department of 
Health and Human Services, Health Care Financing Administration, 7500

[[Page 73834]]

Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4870
Email: [email protected]

RIN: 0938-AJ64
_______________________________________________________________________




1236. END STAGE RENAL DISEASE BAD DEBT PAYMENT (HCFA-1126-P)

Priority: Other Significant

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

CFR Citation: 42 CFR 413.178

Legal Deadline: None

Abstract: This rule would remove the cap on end stage renal disease bad 
debts as stated in 42 CFR 413.178, which limits reimbursement of 
medicare bad debts to the end stage renal disease facility's uncovered 
costs. A final rule would be effective for cost reporting periods 
beginning on or after January 1, 2001.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/00
NPRM Comment Period End         02/00/01

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0938-AK02
_______________________________________________________________________




1237.  REVISIONS TO MEDICAID UPPER PAYMENT LIMIT REQUIREMENTS 
FOR HOSPITAL, NURSING FACILITY, INTERMEDIATE CARE FACILITY SERVICES FOR 
THE MENTALLY RETARDED AND CLINIC SERVICES (HCFA-2071-P)

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

RIN: 0938-AK12
_______________________________________________________________________




1238.  PAYMENT FOR CLINICAL PSYCHOLOGY TRAINING PROGRAMS AND 
PHYSICIAN ASSISTANT TRAINING PROGRAMS (HCFA-1089-P)

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

RIN: 0938-AK15
_______________________________________________________________________




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

 Regulatory Plan: This entry is Seq. No. 49 in Part II of this issue of 
the Federal Register.

RIN: 0938-AK30
_______________________________________________________________________




1240.  ELIMINATION OF APPLICATION OF FEDERAL FINANCIAL 
PARTICIPATION LIMITS (HCFA-2086-P)

 Regulatory Plan: This entry is Seq. No. 50 in Part II of this issue of 
the Federal Register.

RIN: 0938-AK32
_______________________________________________________________________


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


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1241. PAYMENT FOR NURSING AND ALLIED HEALTH SCIENCE EDUCATION (HCFA-
1685-F)

Priority: Other Significant

Legal Authority: PL 101-239, sec 6205; PL 101-508, sec 4004; PL 101-
508, sec 4159; 42 USC 1395x

CFR Citation: 42 CFR 413

Legal Deadline: None

Abstract: This rule will set forth our policy for the payment of the 
costs of approved nursing and allied health science programs, as 
directed by section 6205(b)(2) of OBRA `89. For the most part, the 
provisions set forth in this rule restate or clarify our current 
policies governing these costs, which were previously set forth in the 
provider reimbursement manual and other documents, but have never been 
included in the regulations. In addition, we are amending the list of 
approved programs and clarifying payment rules for certified registered 
nurse anesthetist programs. This rule will also address section 4004 of 
OBRA `90, which provides that, effective with cost reporting periods 
beginning on or after October 1, 1990, under certain conditions, costs 
incurred by a hospital or educational institution related to the 
hospital for clinical training are treated as pass-through costs and 
paid on the basis of reasonable cost even though the hospital does not 
operate the education programs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/22/92                    57 FR 43659
NPRM Comment Period End         11/23/92                    57 FR 43659
Final Rule                      12/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0938-AE79
_______________________________________________________________________




1242. HOME HEALTH AGENCY (HHA) CONDITIONS OF PARTICIPATION (HCFA-3819-F)

Priority: Other Significant

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

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

CFR Citation: 42 CFR 484

Legal Deadline: None

Abstract: This rule will revise home health agency conditions of 
participation to center on the patient, using outcome-oriented 
measures. Most of the current HHA conditions of participation have 
remained unchanged since home health services became a

[[Page 73835]]

Medicare benefit in 1966. Some limited modifications have been made 
over the years to comply with legislative changes. As a result, most of 
the conditions of participation continue to be structure- and process-
oriented.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/10/97                    62 FR 11005
NPRM Comment Period End         06/09/97
Final Rule                      12/00/00

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

Mary Vienna, Office of Clinical Standards and Quality, Department of 
Health and Human Services, Health Care Financing Administration, C4-05-
27, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-6940

RIN: 0938-AG81
_______________________________________________________________________




1243. ADDITIONAL SUPPLIER STANDARDS (HCFA-6004-F)

Priority: Other Significant

Legal Authority: PL 105-33, sec 4552(c)

CFR Citation: 42 CFR 424.57

Legal Deadline: None

Abstract: This rule would implement the provision of the Balanced 
Budget Act of 1997 (BBA `97) that requires the Secretary to establish 
service standards for persons seeking payment under part B of title 
XVIII of the Social Security Act for the providing of oxygen and oxygen 
equipment to beneficiaries within their homes. It would also establish 
additional standards for suppliers of diabetic footwear, home infusion 
equipment, and customized orthotics and prosthetics.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

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

Ralph Goldberg, Center for Health Plans and Providers, Department of 
Health and Human Services, Health Care Financing Administration, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4870
Email: [email protected]

RIN: 0938-AH19
_______________________________________________________________________




1244. 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                    59 FR 31569
Final Action                    12/00/00

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
_______________________________________________________________________




1245. TERMS, DEFINITIONS, AND ADDRESSES: TECHNICAL AMENDMENTS (HCFA-
9877-FC)

Priority: Substantive, Nonsignificant

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

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

CFR Citation: 42 CFR 400 to 440; 42 CFR 442 to 447; 42 CFR 455; 42 CFR 
456; 42 CFR 462 to 466; 42 CFR 473 to 476; 42 CFR 482 to 489; 42 CFR 
491 to 498

Legal Deadline: None

Abstract: This rule will initiate the rationalization of our system of 
definitions, correct outdated addresses and formulas, clarify which 
steps of the appeals process are binding and which are final, remove 
content that is duplicative or unnecessary, and make other clarifying 
editorial changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/00/00

Regulatory Flexibility Analysis Required: No

[[Page 73836]]

Government Levels Affected: None

Federalism:  Undetermined

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

RIN: 0938-AH53
_______________________________________________________________________




1246. UPDATE OF RATESETTING METHODOLOGY, PAYMENT RATES AND THE LIST OF 
COVERED SURGICAL PROCEDURES FOR AMBULATORY SURGICAL CENTERS EFFECTIVE 
FOR CALENDAR YEAR 2000 (HCFA-1885-FC)

 Regulatory Plan: This entry is Seq. No. 51 in Part II of this issue of 
the Federal Register.

RIN: 0938-AH81
_______________________________________________________________________




1247. STANDARD UNIQUE HEALTH CARE PROVIDER IDENTIFIER (HCFA-0045-F)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1320d-2

CFR Citation: 42 CFR 160; 42 CFR 162

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/07/98                    63 FR 25320
NPRM Comment Period End         07/06/98
Final Action                    12/00/00

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

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

Additional Information: None

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

RIN: 0938-AH99
_______________________________________________________________________




1248. MEDICARE PROGRAM; ADJUSTMENTS TO COST LIMITS FOR SKILLED NURSING 
FACILITY INPATIENT ROUTINE SERVICE COSTS (HCFA-1896-FN)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1320

CFR Citation: 42 CFR 1001

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

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

RIN: 0938-AI14
_______________________________________________________________________




1249. MEDICARE PROGRAM; PROSPECTIVE PAYMENT SYSTEM FOR HOSPITAL 
OUTPATIENT SERVICES (HCFA-1005-F)

Priority: Economically Significant. Major under 5 USC 801.

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

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

CFR Citation: 42 CFR 409.10; 42 CFR 413.124; 42 CFR 413.130; 42 CFR 
413; 42 CFR 489.20; 42 CFR 1003.105; 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 1003.101; 42 CFR 1003.102

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

Abstract: The Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33), 
enacted on August 5, 1997, provides for implementation of a Prospective 
Payment System (PPS) for hospital outpatient services (and for part B 
services furnished to inpatients who have no part A coverage) furnished 
on or after January 1, 1999. In the proposed rule published on 
September 8, 1998, HCFA indicated that implementation of the system 
would be delayed because of systems concerns. This system will also 
apply to partial hospitalization services furnished by community mental 
health centers. The BBA also requires a new method for calculating 
beneficiary copayments for the hospital outpatient services included 
under the PPS. The PPS will consist of about 340 groups of services, 
called ``Ambulatory Payment Classifications'' or APCs, that are related 
clinically and in terms of their resource use. We will assign a group 
weight to each group, based on the median cost (operating and capital) 
of the services included in the group. We will convert the weights for 
each group to payment rates using a national conversion factor, taking 
into account group weights and the projected volume of services for 
each group. In addition, this rule would establish the requirements for 
designating certain entities as provider-based or as a department of a 
hospital.

[[Page 73837]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/08/98                    63 FR 47551
Correction Notice               06/30/99                    64 FR 35258
NPRM Comment Period End         07/30/99
Final Action                    12/00/00

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

RIN: 0938-AI56
_______________________________________________________________________




1250. 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
Final Action                    12/00/00

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

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

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
_______________________________________________________________________




1251. MEDICAID PROGRAM; HOME AND COMMUNITY-BASED SERVICES (HCFA-2010-FC)

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 440; 42 CFR 441

Legal Deadline: None

Abstract: This rule expands State flexibility in providing 
prevocational, educational and supported employment services under the 
Medicaid home and community-based services waiver provisions of section 
1915(c) of the Social Security Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/00/00

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: State

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

RIN: 0938-AI67
_______________________________________________________________________




1252. MEDICAID MANAGED CARE; REGULATORY PROGRAM TO IMPLEMENT CERTAIN 
MEDICAID PROVISIONS OF THE BALANCED BUDGET ACT OF 1997 (HCFA-2001-F)

Priority: Other Significant. Major under 5 USC 801.

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

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/29/98                    63 FR 52021
NPRM Comment Period End         11/30/98
Final Action                    12/00/00

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses, Organizations, Governmental 
Jurisdictions

Government Levels Affected: Federal, Local, Tribal, State

Federalism:  Undetermined

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

RIN: 0938-AI70
_______________________________________________________________________




1253. EXPANDED COVERAGE FOR DIABETES OUTPATIENT SELF-MANAGEMENT TRAINING 
SERVICES (HCFA-3002-P)

 Regulatory Plan: This entry is Seq. No. 52 in Part II of this issue of 
the Federal Register.

RIN: 0938-AI96
_______________________________________________________________________




1254. EXTERNAL QUALITY REVIEW OF MEDICAID MANAGED CARE ORGANIZATIONS 
(HCFA-2015-F)

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

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 1302

CFR Citation: 42 CFR 438

Legal Deadline: None

Abstract: This rule amends the regulation to conform with the 
provisions of section 4705 of the Balanced Budget Act of 1997. It also 
requires State agencies that contract with managed care organizations 
to implement quality improvement strategies that address access and 
other aspects of care and services directly related to the quality of 
care provided

[[Page 73838]]

by these managed care organizations and performance through annual 
external, independent reviews conducted by accrediting organizations 
that are approved by HCFA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/01/99                    64 FR 67223
NPRM Comment Period Ended       01/31/00
Final Action                    04/00/01

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: State

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

Agency Contact: 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
_______________________________________________________________________




1255. PROTECTION FOR WOMEN WHO ELECT RECONSTRUCTION AFTER A MASTECTOMY 
(HCFA-2040-IFC)

 Regulatory Plan: This entry is Seq. No. 53 in Part II of this issue of 
the Federal Register.

RIN: 0938-AJ44
_______________________________________________________________________




1256. THE CHILDREN'S HEALTH INSURANCE PROGRAM: IMPLEMENTING THE BALANCED 
BUDGET ACT OF 1997 (HCFA-2006-F)

 Regulatory Plan: This entry is Seq. No. 54 in Part II of this issue of 
the Federal Register.

RIN: 0938-AJ75
_______________________________________________________________________




1257. APPLICATION OF INHERENT REASONABLENESS TO ALL PART B SERVICES 
OTHER THAN PHYSICIAN SERVICES (HCFA-1908-F)

 Regulatory Plan: This entry is Seq. No. 55 in Part II of this issue of 
the Federal Register.

RIN: 0938-AJ97
_______________________________________________________________________




1258. FLEXIBILITY IN PAYMENT METHODS FOR SERVICES OF HOSPITALS, NURSING 
FACILITIES, AND INTERMEDIATE CARE FACILITIES FOR THE MENTALLY RETARDED 
(HCFA-2004-F)

Priority: Other Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

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

CFR Citation: 42 CFR 447.205; 42 CFR 447.250 to 447.257; 42 CFR 
447.271; 42 CFR 447.272; 42 CFR 447.280

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/06/99                    64 FR 54263
Final Rule                      12/00/00

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: State

Federalism:  Undetermined

Agency Contact: Marge Lee, Health Insurance Specialist, Department of 
Health and Human Services, Health Care Financing Administration, S2-01-
16, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4361

RIN: 0938-AK04
_______________________________________________________________________




1259.  HOSPITAL CONDITIONS OF PARTICIPATION; ANESTHESIA SERVICES 
(HCFA-3049-F)

 Regulatory Plan: This entry is Seq. No. 56 in Part II of this issue of 
the Federal Register.

RIN: 0938-AK08
_______________________________________________________________________




1260.  PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH 
THEY HAVE FINANCIAL RELATIONSHIPS-PHASE II (HCFA-1810-FC)

 Regulatory Plan: This entry is Seq. No. 57 in Part II of this issue of 
the Federal Register.

RIN: 0938-AK31
_______________________________________________________________________


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


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1261. CHANGES TO PEER REVIEW ORGANIZATION REGULATIONS (HCFA-3135-F)

Priority: Substantive, Nonsignificant

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

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

CFR Citation: 42 CFR 400.200; 42 CFR 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

Legal Deadline: None

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

[[Page 73839]]

health maintenance organization contracts.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: William Roskey, Office of Clinical Standards and 
Quality, Department of Health and Human Services, Health Care Financing 
Administration, S1-09-18, 7500 Security Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-0433

RIN: 0938-AD38
_______________________________________________________________________




1262. ``WITHOUT FAULT'' AND BENEFICIARY WAIVER OF RECOVERY AS IT APPLIES 
TO MEDICARE OVERPAYMENT LIABILITY (HCFA-6007-F)

Priority: Substantive, Nonsignificant

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

Legal Authority: 42 USC 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: 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

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
_______________________________________________________________________




1263. PROTECTION OF INCOME AND RESOURCES FOR COMMUNITY SPOUSES OF 
INSTITUTIONALIZED INDIVIDUALS (HCFA-2023-P)

Priority: Other Significant

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Local, State

Federalism:  Undetermined

Agency Contact: Roy Trudel, Department of Health and Human Services, 
Health Care Financing Administration, C4-20-15, Center for Medicaid and 
State Operations, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-3417

RIN: 0938-AE12
_______________________________________________________________________




1264. EARLY AND PERIODIC SCREENING, DIAGNOSTIC, AND TREATMENT (EPSDT) 
SERVICES (HCFA-2028-F)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1396a(a)(43); 42 USC 1396d(r)

CFR Citation: 42 CFR 441.50; 42 CFR 440.40

Legal Deadline: None

Abstract: Section 1905(r) of the Social Security Act (the Act), added 
by section 6403 of OBRA `89, defines the following EPSDT services: 
screening services, vision services, dental services and hearing 
services. EPSDT services also are defined to include such other 
necessary health care, diagnostic services, treatment, and other 
measures described in section 1905(a) of the Act to correct or 
ameliorate defects, illnesses and conditions discovered by the 
screening services whether or not the services are covered under the 
State plan. Section 1902(a)(43) of the Act requires States to report to 
the Secretary certain information about EPSDT services provided under 
the plan during each fiscal year. This rule would set forth 
requirements to implement these statutory provisions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/01/93                    58 FR 51288
NPRM Comment Period End         11/30/93                    58 FR 51288


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Local, State

Federalism:  Undetermined

Agency Contact: Cindy Ruff, Center for Medicaid and State Operations, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-16-08, 7500 Security Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-5916

RIN: 0938-AE72


_______________________________________________________________________



[[Page 73840]]

1265. COVERAGE OF SCREENING PAP SMEARS (HCFA-3705-F)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

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

Legal Deadline: None

Abstract: This rule establishes regulations under section 6115 of OBRA 
'89 to govern Medicare part B coverage of screening pap smears 
(including a physician's interpretation of the test results) provided 
to a woman for the early detection of cervical cancer.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/26/93                    58 FR 62312
NPRM Comment Period End         01/24/94


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Joyce Eng, Office of Clinical Standards and Quality, 
Department of Health and Human Services, Health Care Financing 
Administration, C4-02-26, 7500 Security Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-4619

Sharon Lappalainen, Health Insurance Specialist, Department of Health 
and Human Services, Health Care Financing Administration, 7500 Security 
Boulevard, Baltimore, MD 2108
Phone: 410 786-9262

RIN: 0938-AE98
_______________________________________________________________________




1266. MEDICAID PAYMENT FOR COVERED OUTPATIENT DRUGS UNDER REBATE 
AGREEMENTS (HCFA-2046-FC)

Priority: Other Significant

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

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

CFR Citation: 42 CFR 447; 42 CFR 441

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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


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
_______________________________________________________________________




1267. REFERRAL TO CHILD SUPPORT ENFORCEMENT AGENCIES OF MEDICAID 
FAMILIES (HCFA-2051-F)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1396k; 42 USC 1302

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

Legal Deadline: None

Abstract: This rule will require State Medicaid agencies to refer 
Medicaid families with an absent parent to child support enforcement 
(CSE) agencies. Section 9142 of OBRA `87 required CSE agencies to 
provide all CSE services to such Medicaid families who have assigned to 
the State their rights to medical support. The purpose of these rules 
is to require States to make this referral to State CSE agencies to 
ensure that those recipients requiring CSE services receive them.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/22/93                    58 FR 49272
NPRM Comment Period End         11/22/93                    58 FR 49272


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Federalism:  Undetermined

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

RIN: 0938-AF68
_______________________________________________________________________




1268. DISCLOSURE OF CONFIDENTIAL PRO AND ESRD NETWORK ORGANIZATION 
INFORMATION FOR RESEARCH PURPOSES (HCFA-3208-P)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1320c-9; 42 USC 1302

CFR Citation: 42 CFR 405.2115; 42 CFR 476.144

Legal Deadline: None

Abstract: This rule would allow Peer Review Organizations (PROs) to 
disclose confidential information to researchers without the consent of 
the individuals who would be identified. The research must be directly 
related to the purposes of the PRO or ESRD program. Currently, PROs can 
only disclose to the public, nonconfidential aggregate data where no 
one is specifically identified. The statute, however, provides for 
limited disclosure and allows the Secretary to provide for disclosure 
in the regulations while assuring adequate

[[Page 73841]]

protection of the rights and interests of patients, health care 
practitioners, and providers. HCFA is now emphasizing the sharing of 
PRO data for educational and research purposes as evidenced by the 
implementation of the Uniform Clinical Data Set and the Health Care 
Quality Improvement Initiative. This regulatory revision would make 
confidential PRO information accessible to researchers while still 
protecting the identities of beneficiaries and practitioners from 
unwarranted disclosure.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0938-AG33
_______________________________________________________________________




1269. EFFECT OF CHANGE OF OWNERSHIP ON PROVIDER AND SUPPLIER PENALTIES, 
SANCTIONS, UNDERPAYMENTS AND OVERPAYMENTS (HCFA-2215-P)

Priority: Substantive, Nonsignificant

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

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Mike Goldman, Division of Integrated Health Systems, 
Department of Health and Human Services, Health Care Financing 
Administration, S2-14-27, 7500 Security Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-6813

RIN: 0938-AG59
_______________________________________________________________________




1270. MEDICAID: OPTIONAL COVERAGE OF TB-RELATED SERVICES FOR INDIVIDUALS 
INFECTED WITH TUBERCULOSIS (HCFA-2082-P)

Priority: Economically Significant

Legal Authority: 42 USC 1396a(a)(10)(A)(ii); PL 103-66, sec 13603; 42 
USC 1396a(z)

CFR Citation: 42 CFR 435.219; 42 CFR 435.201; 42 CFR 440.250; 42 CFR 
436.201; 42 CFR 436.219; 42 CFR 440.164

Legal Deadline: None

Abstract: This rule would provide for optional Medicaid coverage of 
low-income individuals infected with tuberculosis (TB). These 
individuals would be eligible only for specified TB-related services. 
The rule would incorporate and interpret provisions of section 13603 of 
OBRA `93.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/10/99                    64 FR 49121


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Local

Federalism:  Undetermined

Agency Contact: Ingrid Osborne, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, S2-16-25, 7500 Security Boulevard, Baltimore, 
MD 21244-1850
Phone: 410 786-4461

RIN: 0938-AG72
_______________________________________________________________________




1271. REVISION OF MEDICARE/MEDICAID HOSPITAL CONDITIONS OF PARTICIPATION 
(HCFA-3745-F)

Priority: Other Significant

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

Legal Authority: 42 USC 1395x; 42 USC 1302; 42 USC 1395(cc); 42 USC 
1395(hh); 42 USC 1320(b)(8)

CFR Citation: 42 CFR 416; 42 CFR 482; 42 CFR 485; 42 CFR 489

Legal Deadline: None

Abstract: This rule will revise the requirements that hospitals must 
meet to participate in the Medicare and Medicaid programs. The revised 
requirements focus on patient care and the outcomes of that care, 
reflect a cross-functional view of patient treatment, encourage 
flexibility in meeting quality standards, and eliminate unnecessary 
procedural requirements. These changes are necessary to reflect 
advances in health care practices since the requirements were last 
revised in 1986.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Federalism:  Undetermined

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

RIN: 0938-AG79


_______________________________________________________________________



[[Page 73842]]

1272. PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY HAVE 
FINANCIAL RELATIONSHIPS-EXPANDED TO DESIGNATED HEALTH SERVICES (HCFA-
1809-FC)

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

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

CFR Citation: 42 CFR 411.1; 42 CFR 411.350 to 411.361; 42 CFR 424.22; 
42 CFR 435.1002; 42 CFR 435.1012; 42 CFR 455.100 to 455.103; 42 CFR 
455.108; 42 CFR 455.109

Legal Deadline: None

Abstract: This final rule with 90-day comment period (Phase I of this 
rulemaking) incorporates into regulations the provisions in paragraphs 
(a), (b), and (h) of section 1877 of the Social Security Act (the Act). 
Under section 1877, if a physician or a member of a physician's 
immediate family has a financial relationship with a health care 
entity, the physician may not make referrals to that entity for the 
furnishing of designated health services (DHS) under the Medicare 
program, unless an exception applies.
In addition, section 1877 of the Act provides that an entity may not 
present or cause to be presented a Medicare claim or bill to any 
individual, third party payer, or other entity for DHS furnished under 
a prohibited referral, nor may we make payment for a designated health 
service furnished under a prohibited referral.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/09/98                     63 FR 1659
NPRM Comment Period End         05/11/98


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

Federalism:  Undetermined

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

RIN: 0938-AG80
_______________________________________________________________________




1273. DISTINCT PART REQUIREMENTS FOR NURSING HOMES AND PROHIBITION ON 
FINANCIAL SCREENING OF APPLICANTS FOR NURSING HOME ADMISSION (HCFA-3815-
P)

Priority: Other Significant

Legal Authority: 42 USC 1395i-3; 42 USC 1396r(a); 42 USC 1302; 42 USC 
1395hh

CFR Citation: 42 CFR 409; 42 CFR 483

Legal Deadline: None

Abstract: This rule would define ``distinct part'' by specifying that a 
distinct part is a physically identifiable unit of an institution (that 
is, an entire ward, wing, floor, or building) including all beds in the 
unit. This rule would also prohibit nursing homes from financially 
screening private pay applicants for admission. Instead, nursing homes 
would be permitted to charge private pay applicants up to a two-month 
deposit before admission to ensure that sufficient funds are available 
to pay for care that the individual may receive before discharge.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Nancy Archer, Office of Clinical Standards 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-AG84
_______________________________________________________________________




1274. CLIA PROGRAM: CATEGORIZATION OF WAIVED TESTS (HCFA-2225-FC)

Priority: Other Significant. Major under 5 USC 801.

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

Legal Authority: 42 USC 263a

CFR Citation: 42 CFR 493.2; 42 CFR 493.39; 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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Judy Yost, Division of Outcomes and Improvements, 
Department of Health and Human Services, Health Care Financing 
Administration, S2-09-28, 7500 Security Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-3531

RIN: 0938-AG99
_______________________________________________________________________




1275. 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.

[[Page 73843]]

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal, State

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

RIN: 0938-AH01
_______________________________________________________________________




1276. STATE PLAN AMENDMENT (SPA) RECONSIDERATION PROCESS (HCFA-2096-P)

Priority: Substantive, Nonsignificant

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

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

CFR Citation: 42 CFR 430.18; 42 CFR 430.60

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0938-AH24
_______________________________________________________________________




1277. HOSPICE CARE-CONDITIONS OF PARTICIPATION (HCFA-3844-P)

Priority: Other Significant

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

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

CFR Citation: 42 CFR 418

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Federalism:  Undetermined

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

RIN: 0938-AH27
_______________________________________________________________________




1278. MEDICARE COVERAGE OF SERVICES OF SPEECH-LANGUAGE PATHOLOGISTS AND 
AUDIOLOGISTS (HCFA-1843-P)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 1395x; 42 USC 1395x(cc)(1); 42 USC 
1395x(ll)

CFR Citation: 42 CFR 484; 42 CFR 485

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Federalism:  Undetermined

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

RIN: 0938-AH37
_______________________________________________________________________




1279. MEDICAID; ESTATE RECOVERIES (HCFA-2083-P)

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

Unfunded Mandates: Undetermined

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

CFR Citation: 42 CFR 433

Legal Deadline: None

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

[[Page 73844]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: State

Federalism:  Undetermined

Agency Contact: Ingrid Osborne, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, S2-16-25, 7500 Security Boulevard, Baltimore, 
MD 21244-1850
Phone: 410 786-4461

RIN: 0938-AH63
_______________________________________________________________________




1280. 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.

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

Legal Authority: 42 USC 300gg-41 et seq

CFR Citation: 45 CFR 148

Legal Deadline: None

Abstract: This rule will address comments received on the interim final 
rule published on April 8, 1997, and further clarifies the departmental 
position on Public Health Service Act insurance reform requirements in 
the individual market.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: Federal, State, Local

Federalism:  Undetermined

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

RIN: 0938-AH75
_______________________________________________________________________




1281. REVISIONS TO CONDITIONS FOR COVERAGE FOR AMBULATORY SURGICAL 
CENTERS (HCFA-3887-P)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 416

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Judy Goldfarb, Office of Clinical Standards and 
Quality, Department of Health and Human Services, Health Care Financing 
Administration, S2-199.06, 7500 Security Boulevard, Baltimore, MD 
21244-1850
Phone: 410 786-6747

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

RIN: 0938-AH83
_______________________________________________________________________




1282. DISCLOSURE OF PEER REVIEW ORGANIZATION INFORMATION IN RESPONSE TO 
BENEFICIARY COMPLAINTS (HCFA-3241-P)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh; 42 USC 1320c-3(a)(14)

CFR Citation: 42 CFR 466.70(a); 42 CFR 476.101; 42 CFR 476.107; 42 CFR 
476.132; 42 CFR 476.133(b)(4)

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

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

RIN: 0938-AH85


_______________________________________________________________________



[[Page 73845]]

1283. NATIONAL STANDARD FOR IDENTIFIERS OF HEALTH PLANS (HCFA-4145-P)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1320d-1320-d-8

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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

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

Agency Contact: Faye Broseker, Center for Beneficiary Services, 
Department of Health and Human Services, Health Care Financing 
Administration, S1-07-06, 7500 Security Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-3342

RIN: 0938-AH87
_______________________________________________________________________




1284. MEDICAID PROGRAM; AMENDMENT TO THE PREADMISSION SCREENING AND 
ANNUAL RESIDENT REVIEW PROGRAM (HCFA-2107-P)

Priority: Substantive, Nonsignificant

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

Legal Authority: 42 USC 1396r(e); 42 USC 1302

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

Legal Deadline: None

Abstract: This rule would make changes to the preadmission screening 
and annual resident review program in accordance with the provisions of 
Public Law 104-315, which were included in the Reinventing Government 
effort. The rule would repeal the Medicaid program requirement for an 
annual review of nursing facility (NF) residents with mental illness or 
mental retardation. This rule would also add the requirement for NFs to 
notify the State when there is a significant change in the physical or 
mental condition of a resident, and add a statutory requirement that 
the State conduct a review promptly after notification of the 
resident's change in condition.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State

Federalism:  Undetermined

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

RIN: 0938-AH89
_______________________________________________________________________




1285. MEDICALLY NEEDY DETERMINATIONS UNDER WELFARE REFORM (HCFA-2109-
IFC)

Priority: Substantive, Nonsignificant

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

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

CFR Citation: 42 CFR 435; 42 CFR 436

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule               To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: State

Federalism:  Undetermined

Agency Contact: Jackie Wilder, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, S2-17-18, 7500 Security Boulevard, Baltimore, 
MD 21244-1850
Phone: 410 786-4579
Email: [email protected]

RIN: 0938-AH92
_______________________________________________________________________




1286. MEDICAID PROGRAM; COVERAGE AND PAYMENT FOR FEDERALLY QUALIFIED 
HEALTH CENTER SERVICES (HCFA-2043-P)

Priority: Substantive, Nonsignificant

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

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

Legal Deadline: None

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

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Tribal

[[Page 73846]]

Federalism:  Undetermined

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

RIN: 0938-AH95
_______________________________________________________________________




1287. PORTABILITY AND NONDISCRIMINATION IN THE GROUP HEALTH INSURANCE 
MARKET (HCFA-2890-F)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 300gg et seq

CFR Citation: 45 CFR 146

Legal Deadline: None

Abstract: This rule will address comments received on the interim final 
rule published April 8, 1997. It will also further clarify the 
Department's position on the minimum requirements applicable to group 
health plans and health insurance issuers offering group health 
insurance coverage. A group health plan or health insurance issuer 
offering group health coverage may provide greater rights to 
participants and beneficiaries than those currently provided. This rule 
will include the following: (1) limitations on preexisting condition 
exclusion periods; (2) certification and disclosure of previous 
coverage; (3) special enrollment periods for individuals (and 
dependents) losing other coverage; (4) use of affiliation period by 
HMOs as alternative to preexisting condition exclusion; (5) prohibited 
discrimination against individual participants and beneficiaries based 
on health status; (6) guaranteed availability in the small group 
market; and (7) guaranteed renewability in the large and small group 
markets.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: Federal

Federalism:  Undetermined

Additional Information: None

Agency Contact: Dave Holstein, Insurance Standards Team, Department of 
Health and Human Services, Health Care Financing Administration, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1564

RIN: 0938-AI08
_______________________________________________________________________




1288. MEDICARE PROGRAM; IMPROVEMENTS TO THE APPEALS PROCESS FOR MEDICARE 
BENEFICIARIES ENROLLED IN HMOS, CMPS, AND HCPPS (HCFA-4024-P)

Priority: Other Significant

Legal Authority: 42 USC 1395mm(c)(5)

CFR Citation: 42 CFR 417

Legal Deadline: None

Abstract: This rule would establish new administrative review 
requirements for Medicare beneficiaries enrolled in health maintenance 
organizations (HMOs), competitive medical plans (CMPs), and health care 
prepayment plans. This rule would implement section 1876(c)(5) of the 
Social Security Act, which specifies the appeal and grievance rights of 
Medicare enrollees in HMOs and CMPs. This rule would reduce timelines 
for nonurgent denials of care and make other improvements. We will also 
address related requirements of the Balanced Budget Act of 1997.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

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

RIN: 0938-AI11
_______________________________________________________________________




1289. MEDICAID: MEDICAL CHILD SUPPORT (HCFA-2081-P)

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 433; 42 CFR 433.135; 42 CFR 433.170

Legal Deadline: None

Abstract: This rule would require States to provide assurances 
satisfactory to the Secretary that the State has in effect laws 
relating to medical child support. This requirement would implement 
section 13623 of the Omnibus Budget Reconciliation Act of 1993 (Pub. L. 
103-66), commonly cited as OBRA 1993. The medical child support laws 
that the States must have in effect are set forth in 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
_______________________________________________________________________




1290. MEDICARE/MEDICAID PROGRAM; USER FEES FOR INFORMATION, PRODUCTS, 
AND SERVICES (HCFA-6021-P)

Priority: Substantive, Nonsignificant

Legal Authority: 31 USC 9701

CFR Citation: 42 CFR 401

Legal Deadline: None

Abstract: This rule would establish regulations relating to user fees 
for services we provide that confer benefits on specific individuals 
that are over and above those benefits received by the general public.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

[[Page 73847]]

Agency Contact: David Escobedo, Office of Financial Management, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5401

RIN: 0938-AI46
_______________________________________________________________________




1291. SURETY BOND REQUIREMENTS FOR COMPREHENSIVE OUTPATIENT 
REHABILITATION FACILITIES, REHABILITATION AGENCIES, COMMUNITY MENTAL 
HEALTH CENTERS, AND INDEPENDENT DIAGNOSTIC TESTING FACILITIES (HCFA-
6005-P)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395x(v); 42 USC 1395hh; 42 USC 
1395x(cc)(2); 42 USC 1395x(p)

CFR Citation: 42 CFR 413; 42 CFR 489

Legal Deadline: None

Abstract: The Balanced Budget Act of 1997 (BBA 1997) requires suppliers 
of durable medical equipment, home health agencies, comprehensive 
outpatient rehabilitation facilities, and rehabilitation agencies to 
furnish us with a surety bond in order to participate in the Medicare 
Program. The BBA 1997 also affords us the discretion to require other 
health care providers (other than physicians or other practitioners) to 
furnish us with a surety bond to participate in the Medicare program. 
This rule discusses the implementation of these provisions to require 
comprehensive outpatient rehabilitation facilities, rehabilitation 
agencies, and certain other providers and suppliers we have selected to 
furnish us with a surety bond on a continuing basis in order to 
participate in the Medicare program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Ralph Goldberg, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4870
Email: [email protected]

RIN: 0938-AI48
_______________________________________________________________________




1292. APPEALS OF CARRIER DETERMINATION THAT A SUPPLIER FAILS TO MEET THE 
REQUIREMENTS FOR MEDICARE BILLING PRIVILEGES (HCFA-6003-P)

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 405.874

Legal Deadline: None

Abstract: This rule would establish an administrative appeal process 
whereby suppliers can request an appeal for a determination that 
affects their Medicare part B billing number. The purpose of this rule 
is to update and clarify our policy and extend administrative appeal 
rights to all current and prospective suppliers who are denied 
enrollment in the Medicare program or whose Medicare billing privileges 
are revoked. This rule does not apply to those suppliers covered under 
the appeals provisions for our regulations at 42 CFR 498.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/25/99                    64 FR 57431
Final Action                     To Be                       Determined

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

RIN: 0938-AI49
_______________________________________________________________________




1293. SECURITY SIGNATURE STANDARDS (HCFA-0049-F)

Priority: Economically Significant. Major under 5 USC 801.

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

CFR Citation: 45 CFR 162

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/12/98                    63 FR 43242
Final Action                     To Be                       Determined

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
_______________________________________________________________________




1294. STATE PLAN REQUIREMENTS FOR DURABLE MEDICAL EQUIPMENT PROVIDERS 
(HCFA-2007-P)

Priority: Other Significant

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

Legal Authority: 42 USC 1396a(a)(65)(B)

CFR Citation: 42 CFR 441

Legal Deadline: None

Abstract: This rule would establish a requirement that durable medical 
equipment suppliers be required to furnish Medicaid State agencies with 
a surety bond in order to participate in the Medicaid program. This 
rule would implement section 4724(g) of the Balanced Budget Act of 
1997.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Governmental Jurisdictions, Businesses

Government Levels Affected: State, Local, Tribal

[[Page 73848]]

Agency Contact: Mary Linda Morgan, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, S2-26-12, 7500 Security Boulevard, Baltimore, 
MD 21244-1850
Phone: 410 786-2011
Email: [email protected]

RIN: 0938-AI63
_______________________________________________________________________




1295. 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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

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

RIN: 0938-AI75
_______________________________________________________________________




1296. REVISION OF PROCEDURES FOR REQUESTING EXCEPTIONS TO COST LIMITS 
FOR SNFS AND ELIMINATION OF RECLASSIFICATIONS (HCFA-1883-P)

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

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

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 413.30

Legal Deadline: None

Abstract: This rule would revise the procedures for granting exceptions 
to the cost limits for skilled nursing facilities and retain the 
current procedures for exceptions to the cost limits for home health 
agencies. It would remove the provision allowing reclassification for 
SNFs and HHAs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/11/98                    63 FR 42797


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0938-AI80
_______________________________________________________________________




1297. MEDICARE PROGRAM; MEDICARE COVERAGE OF AND PAYMENT FOR BONE MASS 
MEASUREMENTS (HCFA-3004-F)

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

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 1302; 42 USC 1395hh; 42 USC 1395rr(b)(1); 42 
USC 4106

CFR Citation: 42 CFR 410; 42 CFR 414

Legal Deadline: Other, Statutory, July 1, 1998, BBA Section 4106.

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              06/24/98                    63 FR 34320


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0938-AI89
_______________________________________________________________________




1298. 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).

[[Page 73849]]

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
_______________________________________________________________________




1299. COVERAGE OF RELIGIOUS NON-MEDICAL HEALTH CARE INSTITUTIONS (HCFA-
1909-IFC)

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 religious 
organization 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
Final Action                     To Be                       Determined

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
_______________________________________________________________________




1300. REPORTING OUTCOME AND ASSESSMENT INFORMATION SET (OASIS) DATA AS 
PART OF THE CONDITIONS OF PARTICIPATION FOR HOME HEALTH AGENCIES (HCFA-
3006-IFC)

Priority: Substantive, Nonsignificant

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

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

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

Legal Deadline: None

Abstract: This rule requires electronic reporting of data from the 
Outcome and Assessment Information Set (OASIS) as a condition of 
participation for 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: Tracey Mummert, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3398

RIN: 0938-AJ10
_______________________________________________________________________




1301. MEDICARE PROGRAM; CRITERIA AND STANDARDS FOR EVALUATING 
INTERMEDIARY AND CARRIER PERFORMANCE: MILLENNIUM COMPLIANCE (HCFA-4002-
GNC)

Priority: Info./Admin./Other

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

CFR Citation: 42 CFR ch IV

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          12/11/98                    63 FR 68464


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

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

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

RIN: 0938-AJ15


_______________________________________________________________________



[[Page 73850]]

1302. RURAL HEALTH CLINICS: AMENDMENTS TO PARTICIPATION REQUIREMENTS AND 
PAYMENT PROVISIONS, AND ESTABLISHMENT OF A QUALITY ASSESSMENT AND 
IMPROVEMENT PROGRAM (HCFA-1910-P)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 405

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Federal

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

RIN: 0938-AJ17
_______________________________________________________________________




1303. HOSPITAL CONDITIONS OF PARTICIPATION: LABORATORY SERVICES (HCFA-3 
014-P)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 482.27

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Organizations

Government Levels Affected: None

Federalism:  Undetermined

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

RIN: 0938-AJ29
_______________________________________________________________________




1304. MEDICARE HOSPICE CARE AMENDMENTS (HCFA-1022-P)

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

Unfunded Mandates: Undetermined

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

CFR Citation: 42 CFR 418

Legal Deadline: None

Abstract: This rule would implement sections 4441(a), 4442 to 4446, and 
4448 of the Balanced Budget Act of 1997. Specific changes include 
updating hospice payment rates, specifying payment according to the 
site of service, modifying the hospice benefit periods, clarifying the 
services covered under the benefit, allowing hospices to contract for 
physician services, allowing waivers of certain staffing requirements 
for hospice care provided in non-urbanized areas, and extending the 
period for physician certification of an individual's terminal illness. 
Additionally, the rule would clarify other current policies.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

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
_______________________________________________________________________




1305. EMERGENCY MEDICAL TREATMENT AND LABOR ACT (EMTALA) (HCFA-1063-P)

Priority: Other Significant

Unfunded Mandates: Undetermined

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

CFR Citation: 42 CFR 489.24

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: George Morey, CHPP, Department of Health and Human

[[Page 73851]]

Services, Health Care Financing Administration, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-4653

RIN: 0938-AJ39
_______________________________________________________________________




1306. MEDICARE/MEDICAID AND CLIA PROGRAMS: CLINICAL LABORATORY 
IMPROVEMENT AMENDMENTS OF 1988 EXEMPTION OF LABORATORIES IN THE STATE OF 
CALIFORNIA (HCFA-2245-N)

Priority: Other Significant

Legal Authority: 42 USC 263a

CFR Citation: 42 CFR 493

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal, State

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

RIN: 0938-AJ47
_______________________________________________________________________




1307. MEDICARE PROGRAM: CRITERIA FOR MAKING NATIONAL COVERAGE DECISION 
(HCFA-3432-P2)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: Not Yet Determined

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0938-AJ54
_______________________________________________________________________




1308. MEDICARE PROGRAM: PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT 
REHABILITATION HOSPITAL SERVICES (HCFA-1069-P)

Priority: Economically Significant. Major under 5 USC 801.

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

CFR Citation: None

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

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

RIN: 0938-AJ55
_______________________________________________________________________




1309. MEDICARE PROGRAM; SUSTAINABLE GROWTH RATE FOR FISCAL YEAR 2000 
(HCFA-1110-N)

Priority: Substantive, Nonsignificant

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

CFR Citation: None

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    04/10/00                    65 FR 19000


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Marc Hartstein, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-4539

RIN: 0938-AJ60
_______________________________________________________________________




1310. MEDICARE AND MEDICAID PROGRAMS; PROGRAMS FOR ALL-INCLUSIVE CARE 
FOR THE ELDERLY (PACE) (HCFA-1903-IFC)

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

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              11/24/99                    64 FR 66233


Next Action Undetermined

[[Page 73852]]

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0938-AJ63
_______________________________________________________________________




1311. STATE HEALTH INSURANCE ASSISTANCE PROGRAM (SHIP) (HCFA-4005-IFC)

Priority: Info./Admin./Other

Legal Authority: 42 USC 1935w-7

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

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule               To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: State, Local

Federalism:  Undetermined

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

RIN: 0938-AJ67
_______________________________________________________________________




1312. CLINICAL SOCIAL WORKER SERVICES (HCFA-1088-P)

Priority: Substantive, Nonsignificant

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

Legal Authority: 42 USC 1395x

CFR Citation: 42 CFR 410

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

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

RIN: 0938-AJ71
_______________________________________________________________________




1313. MEDICAID DISPROPORTIONATE SHARE HOSPITAL PAYMENTS-INSTITUTIONS FOR 
MENTAL DISEASE (HCFA-2062-N)

Priority: Economically Significant. Major under 5 USC 801.

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

CFR Citation: None

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Federalism:  Undetermined

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

RIN: 0938-AJ74
_______________________________________________________________________




1314. HHA SURETY BOND (HCFA-6001-P)

Priority: Economically Significant

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

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

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

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

Abstract: This rule would amend our regulations to require an HHA 
surety bond of $50,000. We would remove the 15 percent provision based 
on concerns expressed by 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

[[Page 73853]]

for excessive interim payments attributable to the implementation of 
the interim payment systems made between October 1, 1997 and September 
30, 2000. Other suggestions recommended by GAO were to require a single 
$50,000 bond for both the Medicare and Medicaid programs and provide an 
exemption of those HHAs that demonstrate fiscal responsibility. 
However, these recommendations require congressional action. The final 
recommendation was to eliminate the HHA's option for substituting a 
Treasury note, U.S. bond, or other Federal public debt obligation for a 
surety bond. We generally agree with these recommendations except for 
the elimination of substituting a Treasury note, etc., for a surety 
bond.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Organizations

Government Levels Affected: None

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

Agency Contact: Ralph Goldberg, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4870
Email: [email protected]

RIN: 0938-AJ81
_______________________________________________________________________




1315. MEDICARE PROGRAM UPDATE OF AMBULATORY SURGICAL CENTER PAYMENT 
RATES EFFECTIVE FOR SERVICES ON OR AFTER OCTOBER 1, 1999 (HCFA-1085-N)

Priority: Other Significant

Legal Authority: Social Security Act, sec 1832(a)(2)(F); Social 
Security Act, sec 1833(i)(1); Social Security Act, sec 1833(i)(2)

CFR Citation: Not Yet Determined

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Bob Cereghino, Program Analyst, 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-AJ86
_______________________________________________________________________




1316. PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED 
NURSING FACILITIES-UPDATE (HCFA-1112-P)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 411; 42 CFR 489

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/10/00


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

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

RIN: 0938-AJ93
_______________________________________________________________________




1317. USE OF RESTRAINT AND SECLUSION IN RESIDENTIAL TREATMENT FACILITIES 
PROVIDING INPATIENT PSYCHIATRIC SERVICES TO INDIVIDUALS UNDER AGE 21 
(HCFA-2065-IFC)

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

Unfunded Mandates: Undetermined

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

CFR Citation: 42 CFR 441; 42 CFR 483

Legal Deadline: None

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

[[Page 73854]]

minimum safeguards to protect residents against the inappropriate use 
of restraint or seclusion.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule               To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0938-AJ96
_______________________________________________________________________




1318. SUPPLIER STANDARDS RELATED TO TRAINING REQUIREMENTS FOR OXYGEN, 
ORTHOTICS AND PROSTHETICS (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 oxygen providers. In addition, as recommended by the OIG, it 
proposes training standards for suppliers of customized orthotics and 
prosthetics, including diabetic footwear.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0938-AJ98
_______________________________________________________________________




1319. CONDITIONS OF PARTICIPATION FOR INTERMEDIATE CARE FACILITIES FOR 
THE MENTALLY RETARDED

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

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 1302

CFR Citation: Not Yet Determined

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Nancy Archer, Office of Clinical Standards 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-AJ99
_______________________________________________________________________




1320. NON-FEDERAL GOVERNMENTAL PLANS EXEMPT FROM HIPAA (HCFA-2033-IFC)

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

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: 45 CFR 146

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule               To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Agency Contact: Dave Holstein, Insurance Standards Team, Department of 
Health and Human Services, Health Care Financing Administration, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1564

RIN: 0938-AK00
_______________________________________________________________________




1321.  CHANGES TO THE APPEALS PROCESS FOR BENEFICIARIES 
RECEIVING HOME HEALTH SERVICES IN THE FEE FOR SERVICE PROGRAM (HCFA-
4006-IFC)

Priority: Other Significant

Legal Authority: Social Security Act, sec 1102; Social Security Act, 
sec 1155; Social Security Act, sec 1869(b); 42 USC 1302, subpart G; 42 
USC 1320C-4, subpart G; 42 USC 1395ff(6), subpart G; 42 USC 1395hh, 
subpart G; 42 USC 1395pp, subpart G; Social Security Act, sec 1102, 
subpart H; Social Security Act, sec 1842(b)(3)(C), subpart H; Social 
Security Act, sec 1869(b), subpart H; Social Security Act, sec 1871, 
subpart H; 42 USC 1302, subpart H; 42 USC 1395(b)(3)(C), subpart H; 42 
USC 1395ff(b), subpart H; 42 USC 1395hh, subpart H; ...

CFR Citation: 42 CFR 405

Legal Deadline: Other, Statutory, January 3, 2001, Section 4611 (BBA of 
1997).

Abstract: This regulation will clarify the home health appeals process 
and will also address problems created by the BBA provisions to split 
payment for home health services between Medicare part A and part B 
funds.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Rosalind Little, Center for Beneficiary Services, 
Department of Health and Human Services, Health Care Financing 
Administration, S1-05-18, 7500 Security Boulevard, Baltimore, MD 21244-
1850
Phone: 410 786-6972

RIN: 0938-AK10


_______________________________________________________________________



[[Page 73855]]

1322.  REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE 
SCHEDULE FOR CALENDAR YEAR 2001 (HCFA-1120-P)

Priority: Economically Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 1395w-4

CFR Citation: 42 CFR 414

Legal Deadline: None

Abstract: This rule proposes updates to physician payments by Medicare 
as required by section 1848 of the Social Security Act. In this 
proposal we set forth several policy changes involving resource-based 
practice expense and relative value units.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/17/00                    65 FR 44176


Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0938-AK11
_______________________________________________________________________




1323.  HOSPICE WAGE INDEX (HCFA-1135-N)

Priority: Routine and Frequent

Legal Authority: 42 USC 1395f(i)(1)

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This notice announces the annual update to the hospice wage 
index as required by statue. This update is effective October 1, 2000 
through September 30, 2001. The wage index is used to reflect local 
differences in wage levels. The hospice wage index methodology and 
values are based on recommendations of a negotiated rulemaking advisory 
committee and were originally published in the Federal Register on 
August 8, 1997.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: Undetermined

Agency Contact: Carol Blackford, Center for Health Plans and Providers, 
Department of Health and Human Services, Health Care Financing 
Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5909
Email: [email protected]

RIN: 0938-AK13
_______________________________________________________________________




1324.  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: 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, Room 1-H-5, 
Division of Medical Services Reimbursement, ELR, 6325 Security 
Boulevard, Baltimore, MD 21207
Phone: 301 594-1115

RIN: 0938-AK14
_______________________________________________________________________




1325.  HIPPA PROGRAM; BONA FIDE WELLNESS PROGRAMS (HCFA-2078-P)

Priority: Substantive, Nonsignificant

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

Legal Authority: PL 104-191

CFR Citation: 45 CFR 146

Legal Deadline: None

Abstract: This proposed rule would implement and clarify the term 
``bona fide wellness programs'' as it relates to regulations 
implementing the nondiscrimination provisions of the Internal Revenue 
Code, the Employee Retirement Income Security Act, and the Public 
Health Service Act, as added by the Health Insurance Portability and 
Accountability Act of 1996 (HIPAA).

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Ruth Bradford, Health Insurance Specialist, Department 
of Health and Human Services, Health Care Financing Administration
Phone: 410 786-2636

RIN: 0938-AK19
_______________________________________________________________________




1326.  PROVIDERS OF THE BALANCED BUDGET AND REFINEMENT ACT; 
HOSPITAL INPATIENT PAYMENTS, 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 
incorporates into regulations, certain statutory provisions relating to 
Medicare payments to hospitals for inpatient services that are 
contained in the Medicare, Medicaid, and 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

[[Page 73856]]

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

Government Levels Affected: None

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

RIN: 0938-AK20
_______________________________________________________________________




1327.  APPLICATION OF FEDERAL FINANCIAL PARTICIPATION LIMITS 
(HCFA-2086-P)

Priority: Other Significant

Legal Authority: 42 USC 1302

CFR Citation: 42 CFR 435

Legal Deadline: None

Abstract: This proposed rule would eliminate the current requirement 
that limits on Federal Financial Participation (FFP) must be applied to 
States that use less restrictive income methodologies than those used 
by related cash assistance programs in determining eligibility for 
Medicaid.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Roy Trudel, Department of Health and Human Services, 
Health Care Financing Administration, C4-20-15, Center for Medicaid and 
State Operations, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-3417

RIN: 0938-AK22
_______________________________________________________________________




1328.  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: Not Yet Determined

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
_______________________________________________________________________




1329.  CLINICAL LAB REQUIREMENTS-REVISIONS TO REGS 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:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                     To Be                       Determined

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
_______________________________________________________________________




1330.  PROSPECTIVE PAYMENT SYSTEM FOR HOSPITAL OUTPATIENT 
SERVICES: EXCEPTION TO THE PROVIDER-BASED LOCATION CRITERIA FOR PPS-
EXEMPT FACILITIES (HCFA-1143-P)

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

Legal Authority: sec 1102 of the Social Security Act; 42 USC 1302; 42 
USC 1395(b); 42 USC 1395(g); 42 USC 1395(l); 42 USC 1395(o); 42 USC 
1395(i); 42 USC 1395(i); 42 USC 1395(n); 42 USC 1395x(v); 42 USC 
1395hh; 42 USC 1395rr; 42 USC 1395tt; 42 USC 1385ww; ...

CFR Citation: 42 CFR 413

Legal Deadline: None

Abstract: This rule would revise the criteria related to provider-based 
status requirements for hospitals excluded from the hospital inpatient 
prospective payment system (PPS) under section 4417 of the Balanced 
Budget Act of

[[Page 73857]]

1997 (BBA). We are proposing to require that satellites of a hospital 
that qualifies for a PPS exclusion under section 4417 of BBA must be 
located within the same Metropolitan Statistical Area as the hospital, 
instead of requiring that these satellites meet the existing 
requirement of location within the immediate vicinity of the hospital. 
The satellites of these excluded hospitals would still be required to 
comply with the other provider-based status criteria.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Michael Lefkowitz, Health Insurance Specialist, 
Department of Health and Human Services, Health Care Financing 
Administration
Phone: 410 786-5316

RIN: 0938-AK25
_______________________________________________________________________




1331.  CRITERIA AND STANDARDS FOR EVALUATING INTERMEDIARY AND 
CARRIER PERFORMANCE DURING FY 2001 (HCFA-4010-GNC)

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

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 421.122

Legal Deadline: None

Abstract: This notice describes the criteria and standards to be used 
for evaluating the performance of fiscal intermediaries and carriers in 
the administration of the Medicare program beginning October 1, 2000.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Kristy McCarthy, Health Insurance Specialist, 
Department of Health and Human Services, Health Care Financing 
Administration, S1-01-26, 7500 Security Blvd, Baltimore, MD 21207
Phone: 410 786-7139

RIN: 0938-AK26
_______________________________________________________________________




1332.  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.

Legal Authority: 42 USC 1395e-2(b)(2)

CFR Citation: Not Yet Determined

Legal Deadline: Final, Statutory, September 30, 2000.

Abstract: This notice announces the inpatient hospital deductible and 
the hospital and extended care services coinsurance amounts for 
services furnished in calendar year 2001 under Medicare's hospital 
insurance program (Medicare part A). The Medicare statute specifies the 
formulae used to determine these amounts.
The inpatient hospital deductible will be $792. The daily coinsurance 
amounts will be: (a) $198 for the 61st through 90th day of 
hospitalization in a benefit period; (b) $396 for lifetime reserve 
days; and (c) $99 for the 21st through 100th day of extended care 
services in a skilled nursing facility in a benefit period.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0938-AK27
_______________________________________________________________________




1333.  MANDATORY TRANSMISSION OF OUTCOME AND ASSESSMENT INFO. 
SET FOR NON-MEDICARE/MEDICAID PATIENTS IN HOME HEALTH AGENCIES AND 
CONTINUED DELAY OF REQUIREMENTS FOR PATIENTS RECEIVING PERSONAL CARE 
SERVICES

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

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This notice announces to home health agencies (HHAs), State 
survey agencies, Medicare and Medicaid beneficiaries, software vendors, 
and the general public, changes to and effective dates for, the 
mandatory encoding, masking, and transmission of Outcome and Assessment 
Information Set (OASIS) data for Non-Medicare and Non-Medicaid patients 
receiving skilled care. In addition, changes to the Health Care 
Financing Administration (HCFA) OASIS State-based system will be made 
to accommodate masking and to ensure that private vendor software 
complies with current HCFA-defined data submission specifications. We 
are continuing to delay the requirements regarding OASIS use, 
collection, encoding, and transmission for at least two more years for 
patients receiving only personal care services regardless of payer 
source.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Mary Weakland, Center for Medicaid and State 
Operations, Department of Health and Human Services, Health Care 
Financing Administration, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6835

RIN: 0938-AK28
_______________________________________________________________________




1334.  REMOVAL OF THE REQUIREMENTS FOR THE CARDIAC PACEMAKER 
REGISTRY (HCFA-3045-F)

Priority: Substantive, Nonsignificant

Legal Authority: Social Security Act, sec 1102; Social Security Act, 
sec 1819; Social Security Act, sec 1861; Social Security Act, sec 1864; 
Social Security Act, sec 1866; Social Security Act, sec 1871; ...

CFR Citation: 42 CFR 409; 42 CFR 410; 42 CFR 489; 42 CFR 498

Legal Deadline: None

Abstract: The Federal Drug Administration has eliminated the Cardiac 
Pacemaker Registry. This rule

[[Page 73858]]

removes all references to the registry from 42 CFR.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal

Agency Contact: Shana Olshan, Bureau of Policy Development, Department 
of Health and Human Services, Health Care Financing Administration, C4-
10-07, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-5246

RIN: 0938-AK29
_______________________________________________________________________




1335.  FIRE SAFETY REQUIREMENTS FOR RNHCI, ASC, HOSPICES, PACE, 
HOSPITALS, AND LONG-TERM CARE FACILITIES

Priority: Substantive, Nonsignificant

Legal Authority: sec 1101 of the Social Security Act; sec 1871 of the 
Social Security Act

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 
the 2000 edition of the life safety code, published by the National 
Fire Protection Association.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

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
_______________________________________________________________________




1336.  CONFORMING REGULATIONS CHANGES AND STATUTORY REVISIONS 
FOR APPROVAL AND OVERSIGHT OF ACCREDITATION ORGANIZATIONS

Priority: Other Significant

Unfunded Mandates: Undetermined

Legal Authority: PL 104-134, sec 516(b); sec 1865(b) of the Social 
Security Act

CFR Citation: 42 CFR 488.1; 42 CFR 488.5; 42 CFR 488.6; 42 CFR 488.8

Legal Deadline: None

Abstract: This proposed rule would implement, or conform to 
regulations, certain statutory provisions relating to hospital 
oversight, and other policy updates for approval and oversight of 
accreditation. It would incorporate statutory timeframes and procedures 
for processing national accreditation organizations' applications for 
approval, under section 1865(b) of the Social Security Act.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Undetermined

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

RIN: 0938-AK36
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Health Care Financing Administration (HCFA)



_______________________________________________________________________




1337. PAYMENT FOR CLINICAL DIAGNOSTIC LABORATORY TESTS (HCFA-1309-F)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 405; 42 CFR 413; 42 CFR 414; 42 CFR 424; 42 CFR 
431; 42 CFR 447

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/09/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Cathy Black
Phone: 410 786-4544

RIN: 0938-AB50
_______________________________________________________________________




1338. SURVEY REQUIREMENTS AND ALTERNATIVE SANCTIONS FOR HOME HEALTH 
AGENCIES (HCFA-2169-F)

Priority: Other Significant

CFR Citation: 42 CFR 488; 42 CFR 489; 42 CFR 498

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/10/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Local, State, Federal

Agency Contact: Patricia Miller
Phone: 410 786-6780

RIN: 0938-AE39
_______________________________________________________________________




1339. CHANGES TO THE LONG-TERM CARE FACILITY SURVEY PROCESS (HCFA-3175-
FC)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 442; 42 CFR 488

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/09/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Helene Fredeking
Phone: 410 786-7304

RIN: 0938-AF02


_______________________________________________________________________



[[Page 73859]]

1340. REQUIREMENTS FOR CERTAIN HEALTH INSURING ORGANIZATIONS AND OBRA 
`90 TECHNICAL AMENDMENTS (HCFA-1018-F)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 434.20 to 72; 42 CFR 435.212; 42 CFR 435.326

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/09/00

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Betty Stanton
Phone: 410 786-3247

RIN: 0938-AF15
_______________________________________________________________________




1341. PROVIDER REIMBURSEMENT DETERMINATIONS AND APPEALS (HCFA-1727-P)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 405.1801 to 405.1889; 42 CFR 413.30 to 413.64; 42 
CFR 417.576; 42 CFR 417.810

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/09/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Morton Marcus
Phone: 410 786-4477

RIN: 0938-AF28
_______________________________________________________________________




1342. ALTERNATIVE SANCTIONS FOR PSYCHIATRIC HOSPITALS (HCFA-2191-P)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 488

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/09/00

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: State, Federal

Agency Contact: Shirley Eldridge
Phone: 410 786-6836

RIN: 0938-AF32
_______________________________________________________________________




1343. MEDICAID: OUTSTATIONED INTAKE LOCATIONS FOR CERTAIN LOW-INCOME 
PREGNANT WOMEN, INFANTS, AND CHILDREN UNDER AGE 19 (HCFA-2052-F)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 435.901; 42 CFR 435.902; 42 CFR 435.903; 42 CFR 
435.904; 42 CFR 435.907; 42 CFR 436.2; 42 CFR 436.3; 42 CFR 435.3

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/15/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Robert Tomlinson
Phone: 410 786-4463

RIN: 0938-AF69
_______________________________________________________________________




1344. ASSESSING INTEREST AGAINST MEDICARE SECONDARY PAYER (MSP) DEBTS 
(HCFA-6108-P)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 405.378; 42 CFR 411.24(m); 42 CFR 411.39

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/09/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: John W. Albert
Phone: 410 786-7457

RIN: 0938-AF87
_______________________________________________________________________




1345. REVISED MEDICAID MANAGEMENT INFORMATION SYSTEMS (HCFA-2038-FN)

Priority: Substantive, Nonsignificant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       10/26/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Richard H. Friedman
Phone: 410 786-4451

RIN: 0938-AG10
_______________________________________________________________________




1346. MEDICARE PROGRAM: LIMITATIONS ON MEDICARE COVERAGE OF INTERMITTENT 
POSITIVE PRESSURE BREATHING MACHINE THERAPY (HCFA-3781-FN)

Priority: Substantive, Nonsignificant

CFR Citation: 45 CFR 500

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       10/26/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Francine Spencer
Phone: 410 786-4614

RIN: 0938-AG44
_______________________________________________________________________




1347. DEFINITION OF SKILLED NURSING FACILITY (SNF) FOR COVERAGE OF 
DURABLE MEDICAL EQUIPMENT (DME) AND HOME HEALTH SERVICES (HCFA-1834-P)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 409; 42 CFR 410

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/09/00

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

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

RIN: 0938-AH16
_______________________________________________________________________




1348. PAYMENT AMOUNT IF CUSTOMARY CHARGES ARE LESS THAN REASONABLE COSTS 
(HCFA-1860-FC)

Priority: Other Significant

CFR Citation: 42 CFR 413.13

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    02/22/00                     65 FR 8660

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Ward Pleines
Phone: 410 786-4528

RIN: 0938-AH49


_______________________________________________________________________



[[Page 73860]]

1349. LIMITATIONS ON LIABILITY (HCFA-4859-FC)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 411.404

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/09/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Denis M. Garrison
Phone: 410 786-5643

RIN: 0938-AH51
_______________________________________________________________________




1350. MEDICAID HOSPICE CARE (HCFA-2016-P)

Priority: Substantive, Nonsignificant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/16/00

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: State, Local

Agency Contact: Tom Shenk
Phone: 410 786-3295

RIN: 0938-AH65
_______________________________________________________________________




1351. MEDICARE TECHNICAL CONFORMING AMENDMENTS (HCFA-1858-FC)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 409.50; 42 CFR 409.61; 42 CFR 410.152

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/09/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Martha Kuespert
Phone: 410 786-4605

RIN: 0938-AH67
_______________________________________________________________________




1352. ELIMINATION OF CERTAIN REQUIREMENTS FOR PEER REVIEW ORGANIZATIONS 
IN THE UTILIZATION AND QUALITY REVIEW PROCESS AND A CHANGE IN THE LENGTH 
OF PEER REVIEW ORGANIZATION CONTRACTS (HCFA-3235-FC)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 462.107; 42 CFR 466.71; 42 CFR 466.73

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/09/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: William Roskey
Phone: 410 786-0433

RIN: 0938-AH68
_______________________________________________________________________




1353. DETERMINATION OF SUBSTANDARD CARE IN SNFS AND NFS (HCFA-2240-P)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 488.301

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/09/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal, State, Local

Agency Contact: Patricia Miller
Phone: 410 786-6780

RIN: 0938-AH69
_______________________________________________________________________




1354. WAIVER OF STAFFING REQUIREMENTS FOR END STAGE RENAL DISEASE (ESRD) 
FACILITIES PARTICIPATING IN AN EXPERIMENT (HCFA-2236-GNC)

Priority: Other Significant

CFR Citation: 42 CFR 405.2136; 42 CFR 405.2161; 42 CFR 405.2162; 42 CFR 
405.2163

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/09/00

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: William Roskey
Phone: 410 786-0433

RIN: 0938-AH72
_______________________________________________________________________




1355. MEDICARE PROGRAM; MEDICARE INTEGRITY PROGRAM (HCFA-7020-F)

Priority: Other Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 400; 42 CFR 421

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/17/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Brenda Thew
Phone: 410 786-4889

RIN: 0938-AI09
_______________________________________________________________________




1356. STATE CHILD HEALTH; IMPLEMENTING REGULATIONS FOR THE STATE 
CHILDREN'S HEALTH INSURANCE PROGRAM (HCFA-2006-F)

Priority: Economically Significant

CFR Citation: 42 CFR 457

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Duplicate of RIN 0938-AJ75      08/10/00

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: Federal, State, Local

Agency Contact: Cheryl Austein-Casnoff
Phone: 410 786-4196

Cynthia Shirk
Phone: 410 786-6614

RIN: 0938-AI28
_______________________________________________________________________




1357. MEDICARE PROGRAM; MEDICARE+CHOICE PROGRAM (HCFA-1030-FC)

Priority: Other Significant

CFR Citation: 42 CFR 417; 42 CFR 422

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/29/00                    65 FR 40170

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Tony Culotta
Phone: 410 786-4661

RIN: 0938-AI29


_______________________________________________________________________



[[Page 73861]]

1358. HEALTH INSURANCE REFORM: STANDARDS FOR ELECTRONIC TRANSACTIONS 
(HCFA-0149-F)

Priority: Other Significant. Major under 5 USC 801.

CFR Citation: 45 CFR 160; 45 CFR 162

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/17/00                    65 FR 50312

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: State

Agency Contact: Joy Glass
Phone: 410 786-6125

RIN: 0938-AI58
_______________________________________________________________________




1359. STATE CHILD HEALTH; STATE CHILDREN'S HEALTH INSURANCE PROGRAM 
ALLOTMENTS AND PAYMENTS TO STATES (HCFA-2114-F)

Priority: Other Significant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      05/24/00                    65 FR 33616

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal, State

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

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

RIN: 0938-AI65
_______________________________________________________________________




1360. ELIMINATION OF APPLICATION OF FEDERAL FINANCIAL PARTICIPATION 
LIMITS (HCFA-2111-IFC)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 435

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/10/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

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

RIN: 0938-AI73
_______________________________________________________________________




1361. MEDICAID PROGRAM; CHANGES TO ELIGIBILITY OF NON-U.S. CITIZENS 
(HCFA-2108-P)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 435; 42 CFR 440

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/16/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Robert Tomlinson
Phone: 410 786-4463

RIN: 0938-AI74
_______________________________________________________________________




1362. HEALTH INSURANCE REFORM UNIVERSAL HEALTH CARE IDENTIFIER (HCFA-
0048-NOI)

Priority: Other Significant

CFR Citation: 42 CFR ch IV

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/09/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Mary Emerson
Phone: 410 786-7065
Email: [email protected]

RIN: 0938-AI91
_______________________________________________________________________




1363. PEER REVIEW ORGANIZATION CONTRACTS: SOLICITATION OF STATEMENTS OF 
INTEREST FROM IN-STATE ORGANIZATIONS (HCFA-3009-N)

Priority: Other Significant

CFR Citation: 42 CFR ch IV

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          07/29/98                    63 FR 40534

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Udo Nwachukwu
Phone: 410 786-7234

RIN: 0938-AI99
_______________________________________________________________________




1364. HHS' RECOGNITION OF NAIC MODEL STANDARDS FOR REGULATION OF MEDIGAP 
POLICY (HCFA-2025-N)

Priority: Other Significant

CFR Citation: 42 CFR ch IV

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/04/98                    63 FR 67078

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Larry Cutler
Phone: 410 786-5903

RIN: 0938-AJ07
_______________________________________________________________________




1365. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM (HCFA-1059-F)

Priority: Other Significant. Major under 5 USC 801.

CFR Citation: 42 CFR ch IV

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    07/03/00                    65 FR 41128

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Robert Wardwell
Phone: 410 786-3254

RIN: 0938-AJ24
_______________________________________________________________________




1366. DECISION ON THE FUNDING FOR THE AIDS HEALTHCARE FOUNDATION START 
PROGRAM, (HCFA-2041-N)

Priority: Info./Admin./Other

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          03/04/99                    64 FR 10479

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Wayne Smith
Phone: 410 786-6762

RIN: 0938-AJ43


_______________________________________________________________________



[[Page 73862]]

1367. FEDERAL ENFORCEMENT IN GROUP AND INDIVIDUAL HEALTH INSURANCE 
MARKETS (HCFA-2019-FC)

Priority: Substantive, Nonsignificant

CFR Citation: 45 CFR 150

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/20/99                    64 FR 45785

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Rochelle Shevitz
Phone: 410 786-1570

RIN: 0938-AJ48
_______________________________________________________________________




1368. SCHEDULES OF PER VISIT AND PER BENEFICIARY LIMITATION ON HOME 
HEALTH AGENCY COST (HCFA-1060-NC)

Priority: Other Significant

CFR Citation: 42 CFR 413.30

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          08/05/99                    64 FR 42766

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Michael Bussacca
Phone: 410 786-4602

RIN: 0938-AJ57
_______________________________________________________________________




1369. REAPPLICATION OF THE COMMUNITY HEALTH ACCREDITATION PROGRAM, 
INCORPORATED (CHAP) FOR CONTINUED APPROVAL OF DEEMING AUTHORITY FOR 
HEALTH CARE AGENCIES (HHAS) (HCFA-2059-FN)

Priority: Substantive, Nonsignificant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    02/22/00                     65 FR 8725

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0938-AJ69
_______________________________________________________________________




1370. STATE ALLOTMENTS FOR PAYMENTS OF MEDICARE PART B PREMIUMS FOR 
QUALIFIED INDIVIDUALS: FEDERAL FISCAL YEAR 2000 (HCFA-2063-N)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          05/30/00                    65 FR 34478

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

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

RIN: 0938-AJ72
_______________________________________________________________________




1371. CHILDREN'S HEALTH INSURANCE PROGRAM; FINAL ALLOTMENTS TO STATES, 
COMMONWEALTHS AND TERRITORIES FOR FISCAL YEARS 1998 AND 1999 (HCFA-2064-
N)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          05/24/00                    65 FR 33634

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Local

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

RIN: 0938-AJ77
_______________________________________________________________________




1372. ANNOUNCEMENT OF ADDITIONAL APPLICATIONS FROM HOSPITALS REQUESTING 
WAIVERS FOR ORGAN PROCUREMENT SERVICE AREAS (HCFA-1055-N)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/17/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Mark Horney
Phone: 410 786-4554

RIN: 0938-AJ79
_______________________________________________________________________




1373. MONTHLY ACTUARY RATES AND MONTHLY SUPPLEMENTARY MEDICAL INSURANCE 
PREMIUM RATES BEGINNING JANUARY 1, 2000 (HCFA-8006-N)

Priority: Routine and Frequent

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          10/22/99                    64 FR 57105

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Carter S. Warfield
Phone: 410 786-6396

RIN: 0938-AJ80
_______________________________________________________________________




1374. PAYMENT FOR UPGRADED DURABLE MEDICAL EQUIPMENT (HCFA-1084-P)

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 414.225 (New)

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       08/09/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: William J. Long
Phone: 410 786-5655
Email: [email protected]

RIN: 0938-AJ82
_______________________________________________________________________




1375. INPATIENT HOSPITAL DEDUCTIBLE AND EXTENDED CARE SERVICES FOR 
COINSURANCE AMOUNTS FOR FY 2000 (HCFA-8005-N)

Priority: Economically Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          10/22/99                    64 FR 56199

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Local, Tribal

Agency Contact: Clare McFarland
Phone: 410 786-6390

RIN: 0938-AJ83


_______________________________________________________________________



[[Page 73863]]

1376. PART A PREMIUM FOR FY 2000 FOR THE UNINSURED, AGED AND FOR CERTAIN 
DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER ENTITLEMENTS (HCFA-8004-N)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          10/22/99                    64 FR 57101

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: State

Agency Contact: Clare McFarland
Phone: 410 786-6390

RIN: 0938-AJ84
_______________________________________________________________________




1377. COVERAGE OF, AND PAYMENT OF, PARAMEDIC INTERCEPT AMBULANCE 
SERVICES (HCFA-1813-F)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/15/00                    65 FR 13911

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Local

Agency Contact: Robert Niemann
Phone: 301 966-4569

RIN: 0938-AJ87
_______________________________________________________________________




1378. CRITERIA AND STANDARDS FOR EVALUATING INTERMEDIARY AND CARRIER 
PERFORMANCE DURING FY 2000 (HCFA-4009-GNC)

Priority: Routine and Frequent

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          12/03/99                    64 FR 67920

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Sue Lathroum
Phone: 410 786-7409

RIN: 0938-AJ88
_______________________________________________________________________




1379. MEDICARE GRADUATE MEDICAL EDUCATION CONSORTIA (HCFA-1094-N)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          01/05/00                      65 FR 494

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Sid Mazumdar
Phone: 410 786-6673

RIN: 0938-AJ89
_______________________________________________________________________




1380. SUSTAINABLE GROWTH RATE FOR FY 2000 (HCFA-1110-N)

Priority: Economically Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       09/01/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Marc Hartstein
Phone: 410 786-4539

RIN: 0938-AJ90
_______________________________________________________________________




1381. MEDICARE PROGRAM; MEDICARE DISPROPORTIONATE SHARE (DSH) ADJUSTMENT 
CALCULATION: CHANGE IN THE TREATMENT OF DAYS IN STATES WITH 1115 
EXPANSION WAIVERS (HCFA-1124-IFC)

Priority: Other Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 412

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Merged With RIN 0938-AK09       08/01/00

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

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

Agency Contact: Stephen Phillips
Phone: 410 786-4548

RIN: 0938-AJ92
_______________________________________________________________________




1382. STATE CHILDREN'S HEALTH INSURANCE PROGRAM; FINAL ALLOTMENTS TO 
STATES, COMMONWEALTHS, AND TERRITORIES FOR FISCAL YEAR 2000 (HCFA-2067-
N)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          05/24/00                    65 FR 33638

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Sharon Brown
Phone: 410 786-0673
Email: [email protected]

RIN: 0938-AJ94
_______________________________________________________________________




1383. PROCESS FOR REQUESTING RECOGNITION OF NEW TECHNOLOGIES AND CERTAIN 
DRUGS, BIOLOGICALS AND MEDICAL DEVICES FOR SPECIAL PAYMENT UNDER 
HOSPITAL OUTPATIENT PPS (HCFA-1128-N)

Priority: Other Significant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Notice                          04/07/00                    65 FR 18341

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Diane Milstead
Phone: 410 786-3355

RIN: 0938-AK01
_______________________________________________________________________




1384. SCHEDULES OF PER VISIT AND PER BENEFICIARY LIMITATIONS ON HHA 
COSTS FOR COST REPORTING PERIODS BEGINNING ON OR AFTER OCTOBER 1, 2000 
(HCFA-1108-NC)

Priority: Other Significant

CFR Citation: 42 CFR 413.30

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       10/10/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Michael Bussacca
Phone: 410 786-4602

RIN: 0938-AK03


_______________________________________________________________________



[[Page 73864]]

1385. REPORTING QUALITY ASSURANCE AND PERFORMANCE IMPROVEMENT DATA AS 
PART OF THE CONDITIONS FOR COVERAGE FOR END STAGE RENAL DISEASE 
FACILITIES (HCFA-3048-N)

Priority: Substantive, Nonsignificant

CFR Citation: None

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Merged With RIN 0938-AG82       08/11/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Robert Miller
Phone: 410 786-6797
Email: [email protected]

RIN: 0938-AK05
_______________________________________________________________________




1386.  MEDICARE PROGRAM; DEDUCTIBLE AMOUNT FOR MEDIGAP HIGH 
DEDUCTIBLE OPTIONS FOR CALENDAR YEAR 2000 (HCFA-2893-N)

Priority: Routine and Frequent

Legal Authority: sec 1882 of the Social Security Act

CFR Citation: None

Legal Deadline: None

Abstract: This notice announced the calendar year 2000 deductible 
amount for Medigap high deductible options ($1,530.00).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          04/10/00                    65 FR 18999

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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-AK06
_______________________________________________________________________




1387.  CHANGES TO THE HOSPITAL INPATIENT PERSPECTIVE PAYMENT 
SYSTEMS AND FISCAL YEAR 2001 RATES (HCFA-1118-F)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 410; 42 CFR 412; 42 CFR 413; 42 CFR 485

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

Abstract: We are revising the Medicare hospital inpatient prospective 
payment system for operating costs to: (1) implement applicable 
statutory requirements, including a number of provisions of the 
Medicare, Medicaid, and State Children's Health Insurance Program 
Balanced Budget Refinement Act of 1999 (Public Law 106-113); and (2) 
implement changes arising from our continuing experience with the 
system. In addition, in the Addendum to this final rule, we describe 
changes to the amounts and factors used to determine the rates for 
Medicare hospital inpatient services for operating costs and capital-
related costs. These changes apply to discharges occurring on or after 
October 1, 2000. We also set forth rate-of-increase limits and make 
changes to our policy for hospitals and hospital units excluded from 
the prospective payment systems.
We are making changes to the policies governing payments to hospitals 
for the direct costs of graduate medical education, sole community 
hospitals and critical access hospitals.
We are adding a new condition of participation on organ, tissue, and 
eye procurement for critical access hospitals that parallels the 
condition of participation that we previously published for all other 
Medicare-participating hospitals.
Lastly, we are finalizing a January 20, 2000 interim final rule with 
comment period (65 FR 3136) that sets forth the criteria to be used in 
calculating the Medicare disproportionate share adjustment in reference 
to Medicaid expansion waiver patient days under section 1115 of the 
Social Security Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Proposed Rule                   05/05/00                    65 FR 26281
Comment Period End              07/05/00
Final Rule                      08/01/00                    65 FR 47054
Final Rule Effective            10/01/00

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0938-AK09
_______________________________________________________________________




1388.  HEALTH CARE AND EMPLOYMENT SUPPORT GRANTS FOR PEOPLE WITH 
DISABILITIES BEGINNING FISCAL YEAR 2000 (HCFA-2076-N)

Priority: Info./Admin./Other

Legal Authority: None

CFR Citation: None

Legal Deadline: None

Abstract: This notice announces the availability of HCFA funding, 
through grants, for eligible States under the Ticket to Work and Work 
Incentives Act of 1999 (TWWIIA). The grant program is designed to 
assist States in developing infrastructures to support the competitive 
employment of people with disabilities by extending necessary Medicaid 
coverage to these individuals. This notice contains information about 
the grants, application requirements, review procedures, and other 
relevant information.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          05/31/00                    65 FR 34715

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State, Federal

Agency Contact: Aaron Blight, Health Insurance Specialist, Department 
of Health and Human Services, Health Care Financing Administration, S2-
14-26, 7500 Security Blvd, Baltimore, MD
Phone: 410 786-9560

RIN: 0938-AK16

[[Page 73865]]

_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




1389. CHILD SUPPORT ENFORCEMENT FOR INDIAN TRIBES

Priority: Other Significant

Legal Authority: 42 USC 655(f)

CFR Citation: 45 CFR 309

Legal Deadline: None

Abstract: This NPRM proposes to specify how tribes can obtain direct 
payments from the Department of Health and Human Services for provision 
of child support enforcement services if they submit a plan meeting the 
objectives of title IV-D, including establishment of paternity, 
modification and enforcement of support orders, and location of absent 
parents.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/21/00                    65 FR 50800
NPRM Comment Period End         12/19/00
Final Action                    08/00/01

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
_______________________________________________________________________




1390. 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                            01/00/01

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
_______________________________________________________________________




1391. 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                            01/00/01

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
_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




1392. STANDARDS FOR SAFE TRANSPORTATION

Priority: Other Significant

Legal Authority: 42 USC 9801 et seq

CFR Citation: 45 CFR 1310

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/15/95                    60 FR 31612
NPRM Comment Period End         08/14/95
Final Action                    11/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Local, Tribal

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start, Department of Health and Human Services, Administration for 
Children and Families, 330 C Street SW., Washington, DC 20447
Phone: 202 205-8569

[[Page 73866]]

Email: [email protected]

RIN: 0970-AB24
_______________________________________________________________________




1393. 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                    01/00/01

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
_______________________________________________________________________




1394. CHILD SUPPORT ENFORCEMENT PROGRAM OMNIBUS CONFORMING REGULATION

Priority: Substantive, Nonsignificant

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

Legal Authority: 42 USC 1302

CFR Citation: 45 CFR 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                    01/00/01

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

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

RIN: 0970-AB81
_______________________________________________________________________




1395. INCENTIVE PAYMENTS AND AUDIT PENALTIES TO STATES AND POLITICAL 
SUBDIVISIONS

Priority: Substantive, Nonsignificant

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

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

Legal Deadline: NPRM, Statutory, April 1999.

Abstract: This regulation implements the requirements in 42 U.S.C. 
609(a)(8), which provide for a penalty of 1 percent to 5 percent of a 
State's Temporary Assistance for Needy Families (TANF) funds if the 
Secretary of HHS determines that the State failed to meet the paternity 
establishment percentages or other performance measures established by 
the Secretary. It also implements a new incentive system, enacted under 
Public Law 105-200. Based on 42 U.S.C. 658A, States will receive 
incentives according to their performance on key statutory indicators 
and performance standards from a capped pool of funds beginning in FY 
2000. These funds must be reinvested in the title IV-D Program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/08/99                    64 FR 55074
Final Action                    10/00/00

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Joyce Pitts, Department of Health and Human Services, 
Administration for Children and Families, MS OCSE, DPP, Division of 
Policy and Planning, 370 L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 401-5374
Email: [email protected]

RIN: 0970-AB85
_______________________________________________________________________




1396. 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                    08/00/01

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
_______________________________________________________________________




1397. STATE SELF-ASSESSMENTS TO DETERMINE COMPLIANCE WITH FEDERAL 
REGULATIONS

Priority: Substantive, Nonsignificant

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

CFR Citation: 45 CFR 308

Legal Deadline: None

Abstract: The rule requires States to conduct annual reviews on certain 
aspects of the State title IV-D programs and provide a report to the 
Secretary.

[[Page 73867]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/08/99                    64 FR 55102
Final Action                    11/00/00

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Jan Rothstein, Program Specialist, Department of Health 
and Human Services, Administration for Children and Families, DHHS, 
Office of Child Support Enforcement, 370 L'Enfant Promenade SW., 
Washington, DC 20447
Phone: 202 401-5073
Email: [email protected]

RIN: 0970-AB96
_______________________________________________________________________




1398. NATIONAL MEDICAL SUPPORT NOTICE

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 652(f); 42 USC 666(a)(19)

CFR Citation: 45 CFR 303.32

Legal Deadline: Final, Statutory, November 15, 2000.

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/15/99                    64 FR 62074
NPRM Comment Period End         01/14/00
Final Action                    11/00/00

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal, State, Local, Tribal

Agency Contact: Elizabeth Matheson, Director, Policy and Planning 
Division, 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
Email: [email protected]

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

RIN: 0970-AB97
_______________________________________________________________________




1399. 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              01/00/01

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: None

Agency Contact: Douglas Klafehn, Deputy Associate Commissioner, Head 
Start, Department of Health and Human Services, Administration for 
Children and Families, 330 C Street SW., Washington, DC 20447
Phone: 202 205-8569
Email: [email protected]

RIN: 0970-AC00
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Administration for Children and Families (ACF)



_______________________________________________________________________




1400. METHODOLOGY FOR DETERMINING WHETHER AN INCREASE IN A STATE'S CHILD 
POVERTY RATE IS THE RESULT OF THE TANF PROGRAM

Priority: Other Significant

CFR Citation: 45 CFR 284 (New)

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    06/23/00                    65 FR 39233

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Howard Rolston
Phone: 202 401-9220
Email: [email protected]

RIN: 0970-AB65
_______________________________________________________________________




1401. BONUS TO REWARD HIGH PERFORMANCE STATES UNDER THE TEMPORARY 
ASSISTANCE FOR NEEDY FAMILIES BLOCK GRANT

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 45 CFR 270 (New)

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/30/00                    65 FR 52814

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Howard Rolston
Phone: 202 401-9220
Email: [email protected]

RIN: 0970-AB66
_______________________________________________________________________




1402. RUNAWAY AND HOMELESS YOUTH PROGRAM

Priority: Substantive, Nonsignificant

CFR Citation: 45 CFR 1351

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    08/17/00                    65 FR 50139

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Tribal

Agency Contact: Stan Chappell
Phone: 202 205-8496
Fax: 202 260-9333
Email: [email protected]

RIN: 0970-AC04

[[Page 73868]]

_______________________________________________________________________


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


Administration on Aging (AOA)



_______________________________________________________________________




1403. GRANTS FOR STATE AND COMMUNITY PROGRAMS ON AGING, INTRASTATE 
FUNDING FORMULAS; TRAINING, RESEARCH AND DISCRETIONARY PROGRAMS; 
VULNERABLE ELDER RIGHTS; AND GRANTS TO INDIANS AND NATIVE HAWAIIANS

Priority: Substantive, Nonsignificant

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

Legal Authority: 42 USC 3001 et seq

CFR Citation: 45 CFR 1321; 45 CFR 1326 to 1328

Legal Deadline: None

Abstract: The Administration on Aging (AoA) in consultation with the 
Office of Management and Budget, has determined that it is no longer 
necessary to pursue final action on rules proposed earlier to implement 
the 1992 amendments to the Older Americans Act. The provisions of the 
Act remain in force and need no further regulations to implement them. 
AoA anticipates promulgating rules in the latter part of 2000 to 
implement the provisions to the next reauthorization of the Older 
Americans Act, if necessary.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/00

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Tribal

Federalism:  Undetermined

Agency Contact: Edwin Walker, Director, Office of Program Operations 
and Development, Department of Health and Human Services, 
Administration on Aging, Room 4733, 330 Independence Avenue SW., Cohen 
Building, Washington, DC 20201
Phone: 202 619-0011

RIN: 0985-AA00
[FR Doc. 00-25800 Filed 11-29-00]
BILLING CODE 4150-24-S