[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]


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Part VIII


Department of Health and Human Services


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Semiannual Regulatory Agenda

[[Page 33040]]



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; Subtitle B, Chs. II, III, and XIII

Unified Agenda of Federal Regulatory and Deregulatory Actions

AGENCY: Office of the Secretary, HHS.

ACTION: Semiannual agenda.

_______________________________________________________________________

SUMMARY: The Regulatory Flexibility Act of 1980 and Executive Order 
12866 require the semiannual publication of an inventory of all 
rulemakings that will be under development or review during the ensuing 
12-month period. The purpose of this effort is to encourage more 
effective public participation in the regulatory process by publicly 
providing, at an early stage, information about regulatory actions that 
the Department is working on. All interested members of the public are 
thus invited to communicate to the Department their views on the 
rulemakings prospectively outlined below.

FOR FURTHER INFORMATION CONTACT: Ann Stallion, Department of Health and 
Human Services, Washington, DC 20201, (202) 690-7449, or the contact 
person for a specific component of the Department as listed below.

SUPPLEMENTARY INFORMATION: The regulatory actions capsulized below 
reflect an effort to present for public scrutiny a realistic forecast 
of the rulemaking activities that the Department will engage in over 
the next 12 months. Comments on the policy directions that these 
rulemakings will take should be sent to the agency representatives 
listed below, depending on the HHS component and the specific agenda 
entry that is of interest. Comments may be directed to the Office of 
the Secretary, if the responsible component of the Department is not 
apparent, or if a comment covers subjects crossing program lines.

    Administration on Aging: Harry Posman, Executive Secretariat, 
Room 4741, 330 Independence Avenue SW., Washington, DC 20201; Phone 
(202) 260-0669.

    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.

    Agency for Health Care Policy and Research: Phyllis Zucker, 
2101 East Jefferson Street, Suite 603, Rockville, MD; 20852; Phone 
(301) 594-1455.

    Centers for Disease Control and Prevention: Verla Neslund, 
Director, Executive Secretariat, 1600 Clifton Road, Building 16, 
Atlanta, GA 30333; Phone (404) 639-7120.

    Centers for Medicare & Medicaid Services: Michelle Shorrt, 
Director, Division of Regulations and Issuances, 7500 Security 
Boulevard, C4-26-05, Baltimore, MD 21244; Phone (410) 786-4675.

    Food and Drug Administration: Ed Dutra, Director, Regulatory 
Policy and Management Staff, 5600 Fishers Lane, Rockville, MD 
20857; Phone (301) 827-3480.

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

    Indian Health Service: Betty Gould, 12300 Twinbrook Parkway, 
Suite 450, Rockville, MD 20857; Phone (301) 443-1116.

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

    Office of the Secretary: Ann C. Agnew, Executive Secretary to 
the Department, Room 603H, Hubert H. Humphrey Building, 200 
Independence Avenue SW., Washington, DC 20201; Phone (202) 690-
7699.

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

     We have indicated as ``withdrawn'' numerous rulemakings 
mentioned in previous agendas because we do not plan any 
developmental work on them during the period covered by this 
agenda. Should work on these rulemakings begin again, appropriate 
new entries about them will appear in future agendas.

Dated: April 25, 2002.

 Ann C. Agnew,

Executive Secretary to the Department.

                                  Office of the Secretary--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
712        Safe Harbor for Arrangements Involving Federally Qualified Health Centers............     0991-AB06
713        Implementing the Bioterrorism Prevention and Response Act of 2001....................     0991-AB15
----------------------------------------------------------------------------------------------------------------


                                    Office of the Secretary--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
714        Shared Risk Exception to the Safe Harbor Provisions..................................     0991-AA91
715        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 33041]]


                                   Office of the Secretary--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
716        Revisions to 42 CFR Part 1003........................................................     0991-AB03
717        Civil Money Penalty Safe Harbor To Protect Payment of Medicare and Medigap Premiums       0991-AB04
            for ESRD Beneficiaries..............................................................
718        Governmentwide Debarment and Suspension (Nonprocurement) and Governmentwide               0991-AB12
            Requirements for Drug-Free Workplace (Grants).......................................
719        Modifications to Standards for Privacy of Individually Identifiable Health                0991-AB14
            Information.........................................................................
----------------------------------------------------------------------------------------------------------------


                                   Office of the Secretary--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
720        Safe Harbor for Ambulance Restocking.................................................     0991-AB05
721        Revisions and Technical Corrections to 42 CFR Chapter V..............................     0991-AB09
----------------------------------------------------------------------------------------------------------------


                  Substance Abuse and Mental Health Services Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
722        Seclusion and Restraint for Non-Medical Residential Facilities.......................     0930-AA10
----------------------------------------------------------------------------------------------------------------


                  Substance Abuse and Mental Health Services Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
723        Community Mental Health Services Block Grant.........................................     0930-AA08
724        Substance Abuse and Mental Health Services Administration Mental Health and Substance     0930-AA09
            Abuse Emergency Response Criteria...................................................
----------------------------------------------------------------------------------------------------------------


                         Centers for Disease Control and Prevention--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
725        Control of Communicable Diseases.....................................................     0920-AA03
726        Amendments to Quality Assurance and Administrative Provision for Approval of              0920-AA04
            Respiratory Protective Devices......................................................
----------------------------------------------------------------------------------------------------------------


                          Centers for Disease Control and Prevention--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
727        Methods for Estimating Radiation Dose and Guidelines for Assessing Probability of         0920-AA05
            Cancer for Energy Employees Occupational Illness Compensation Program...............
----------------------------------------------------------------------------------------------------------------


[[Page 33042]]


                          Centers for Disease Control and Prevention--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
728        DHHS Statement of Policy--Procedures for Designating Classes of Employees as Members      0920-AA07
            of the Special Exposure Cohort Under the Energy Employee Occupational Illness
            Compensation Act of 2000............................................................
----------------------------------------------------------------------------------------------------------------


                          Centers for Disease Control and Prevention--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
729        Packaging and Handling of Infectious Substances and Select Agents....................     0920-AA02
----------------------------------------------------------------------------------------------------------------


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


                                    Departmental Management--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
731        Administrative Wage Garnishment......................................................     0990-AA05
----------------------------------------------------------------------------------------------------------------


                                   Food and Drug Administration--Prerule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
732        Requirements for Submission of In Vivo Bioequivalence Data...........................     0910-AC23
----------------------------------------------------------------------------------------------------------------


                                Food and Drug Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
733        Over-the-Counter (OTC) Drug Review...................................................     0910-AA01
734        Establishment Registration and Product Listing for Drugs and Biologics...............     0910-AA49
735        Investigational New Drugs: Export Requirements for Unapproved New Drug Products......     0910-AA61
736        Safety Reporting Requirements for Human Drug and Biological Products.................     0910-AA97
737        Blood Initiative.....................................................................     0910-AB26
738        Applications for FDA Approval to Market a New Drug; Complete Response Letter;             0910-AB34
            Amendments to Unapproved Applications...............................................
739        Current Good Manufacturing Practice for Medicated Feeds..............................     0910-AB70
740        Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Dietary         0910-AB88
            Ingredients and Dietary Supplements.................................................
741        Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in     0910-AB91
            Electronic Format...................................................................
742        Requirements Pertaining to Sampling Services and Private Laboratories Used in             0910-AB96
            Connection With Imported Food.......................................................
743        Status Reports of Distribution and Use Information for Antimicrobial Animal Drug          0910-AC04
            Products Used in Food-Producing Animals.............................................
744        Control of Salmonella Enteritidis in Shell Eggs During Production and Retail.........     0910-AC14
745        Institutional Review Boards: Registration Requirements...............................     0910-AC17
746        Aluminum in Large- and Small-Volume Parenterals Used in Total Parenteral Nutrition...     0910-AC18
747        Use of Materials Derived From Bovine and Ovine Animals in FDA-Regulated Products.....     0910-AC19

[[Page 33043]]


748        Postmarketing Reports of Substandard or Ineffective Bulk Ingredients and Bulk             0910-AC20
            Ingredients From Unapproved Sources.................................................
749        Chronic Wasting Disease: Control of Food Products and Cosmetics Derived From Exposed      0910-AC21
            Animal Populations..................................................................
750        Exception From General Requirements for Informed Consent; Request for Comments and        0910-AC25
            Information.........................................................................
751        Bar Code Label Requirements for Human Drug Products..................................     0910-AC26
752        Medical Devices; Anesthesiology Devices; Proposed Reclassification of Pressure            0910-AC30
            Regulators for Use With Medical Oxygen..............................................
753        Medical Devices; Patient Examination and Surgeons' Gloves; Adulteration..............     0910-AC32
754        Amendments to the Performance Standard for Diagnostic X-Ray Systems and Their Major       0910-AC34
            Components..........................................................................
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
755        Determination That Informed Consent Is Infeasible or Is Contrary to the Best Interest     0910-AA89
            of Recipients.......................................................................
756        Labeling for Human Prescription Drugs; Revised Format................................     0910-AA94
757        Use of Ozone-Depleting Substances....................................................     0910-AA99
758        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......................................................
759        Revisions to the General Safety Requirements for Biological Products; Final Rule.....     0910-AB51
760        Supplements and Other Changes to an Approved Application.............................     0910-AB61
761        Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and      0910-AB66
            Health Claims.......................................................................
762        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)......................................................................
763        Antibiotic Resistance Labeling.......................................................     0910-AB78
764        Food Additives: Food Contact Substances Notification System..........................     0910-AB94
765        Marking Requirements for and Prohibitions on the Reimportation of Imported Food           0910-AB95
            Products That Have Been Refused Admission into the United States....................
766        Efficacy Evidence Needed for Products To Be Used Against Toxic Substances When Human      0910-AC05
            Studies Are Unethical...............................................................
767        Additional Safeguards for Children in Clinical Investigations of FDA Regulated            0910-AC07
            Products............................................................................
768        Revocation of Conditions for Marketing Digoxin Products for Oral Use.................     0910-AC12
769        Postmarket Surveillance..............................................................     0910-AC31
770        Redacting 510(k) Submissions.........................................................     0910-AC33
771        Section 17 Best Pharmaceuticals for Children Act.....................................     0910-AC35
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
772        Infant Formula: Requirements Pertaining to Good Manufacturing Practice, Quality           0910-AA04
            Control Procedures, Quality Factors, Notification Requirements, and Records and
            Reports.............................................................................
773        Investigational Use New Animal Drug Regulations (Section 610 Review).................     0910-AB02
774        Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-    0910-AB27
            Based Products (HCT/Ps).............................................................
775        Current Good Tissue Practice for Manufacturers of Human Cells, Tissues, and Cellular      0910-AB28
            and Tissue-Based Products (HCT/Ps)..................................................
776        Premarket Notice Concerning Bioengineered Foods......................................     0910-AC15
----------------------------------------------------------------------------------------------------------------


                                 Food and Drug Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
777        Exports; Notification and Recordkeeping Requirements.................................     0910-AB16

[[Page 33044]]


778        Foreign Establishment Registration and Listing.......................................     0910-AB21
779        Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs....     0910-AB39
780        State Certification of Mammography Facilities........................................     0910-AB98
781        Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as              0910-AC22
            Generally Recognized as Safe and Effective and Not Misbranded.......................
----------------------------------------------------------------------------------------------------------------


                                                   Food and Drug Administration--Discontinued Entries
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Regulation
Identification                                             Title                                             Date Withdrawn            Comments
    Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
0910-AA02       New Animal Drug Approval Process; Implementation of Title I of the Generic Animal Drug and      03/20/2002   Withdrawn - Publication is
                 Patent Term Restoration Act (GADPTRA)                                                                        not projected in the next
                                                                                                                              12 months
0910-AA19       Food Labeling Review                                                                            03/05/2002   Withdrawn
0910-AA20       Medical Foods                                                                                   03/05/2002   Withdrawn - Publication is
                                                                                                                              not projected in the next
                                                                                                                              12 months
0910-AA45       Current Good Manufacturing Practice; Amendment of Certain Requirements for Finished             03/06/2002   Withdrawn - Publication is
                 Pharmaceuticals                                                                                              not projected in the next
                                                                                                                              12 months
0910-AA51       Bioavailability and Bioequivalence Requirements                                                 03/06/2002   Withdrawn - Publication is
                                                                                                                              not projected in the next
                                                                                                                              12 months
0910-AA86       Safety Reporting and Recordkeeping Requirements for Marketed OTC Drugs                          03/06/2002   Withdrawn - Publication is
                                                                                                                              not projected in the next
                                                                                                                              12 months
0910-AA90       Direct-to-Consumer Promotion Regulations                                                        03/06/2002   Withdrawn - Publication is
                                                                                                                              not projected in the next
                                                                                                                              12 months
0910-AA98       Current Good Manufacturing Practice; Revision of Certain Labeling Controls                      03/06/2002   Withdrawn - Publication is
                                                                                                                              not projected in the next
                                                                                                                              12 months
0910-AB00       Radioactive Drugs for Basic Research                                                            03/06/2002   Withdrawn - Publication is
                                                                                                                              not projected in the next
                                                                                                                              12 months
0910-AB14       Administrative Practices and Procedures; Advisory Opinions and Guidelines                       03/06/2002   Withdrawn - Publication is
                                                                                                                              not projected in the next
                                                                                                                              12 months
0910-AB33       Antibiotic Drug Approval and Exclusivity                                                        03/06/2002   Withdrawn - Publication is
                                                                                                                              not projected in the next
                                                                                                                              12 months
0910-AB37       Expanded Access to Investigational Therapies                                                    03/06/2002   Withdrawn - Publication is
                                                                                                                              not projected in the next
                                                                                                                              12 months
0910-AB42       Electronic Submission of Postmarketing Safety Reports                                           03/06/2002   Withdrawn - Publication is
                                                                                                                              not projected in the next
                                                                                                                              12 months
0910-AB43       Distinguishing Marks for Drug Products Containing Insulin                                       03/06/2002   Withdrawn - Publication is
                                                                                                                              not projected in the next
                                                                                                                              12 months
0910-AB44       Pregnancy Labeling                                                                              03/06/2002   Withdrawn - Publication is
                                                                                                                              not projected in the next
                                                                                                                              12 months
0910-AB49       Supplements and Other Changes to Approved New Animal Drug Applications                          03/05/2002   Withdrawn
0910-AB50       Requirements for Liquid Medicated Feed and Free-Choice Medicated Feed                           03/05/2002   Withdrawn

[[Page 33045]]


0910-AB56       Natural Rubber-Containing Drugs; User Labeling                                                  03/06/2002   Withdrawn - Publication is
                                                                                                                              not projected in the next
                                                                                                                              12 months
0910-AB57       Bulk Drug Substances for Use in Pharmacy Compounding                                            03/06/2002   Withdrawn - Publication is
                                                                                                                              not projected in the next
                                                                                                                              12 months
0910-AB58       Pharmacy and Physician Compounding of Drug Products                                             03/06/2002   Withdrawn - Publication is
                                                                                                                              not projected in the next
                                                                                                                              12 months
0910-AB59       Drug Products That Present Demonstrable Difficulties for Compounding Because of Reasons of      03/06/2002   Withdrawn - Publication is
                 Safety or Effectiveness                                                                                      not projected in the next
                                                                                                                              12 months
0910-AB60       Discontinuation of a Lifesaving Product                                                         03/06/2002   Withdrawn - Publication is
                                                                                                                              not projected in the next
                                                                                                                              12 months
0910-AB63       Positron Emission Tomography Drugs; Current Good Manufacturing Practice                         03/06/2002   Withdrawn - Publication is
                                                                                                                              not projected in the next
                                                                                                                              12 months
0910-AB68       Presubmission Conferences                                                                       03/05/2002   Withdrawn
0910-AB71       Implementation of the Import Tolerance Provisions of the Animal Drug Availability Act of        03/05/2002   Withdrawn
                 1996
0910-AB72       Mandatory HACCP Regulations for Manufacturers of Rendered Products                              03/05/2002   Withdrawn
0910-AB73       Citizen Petitions; Actions That Can Be Requested by Petition; Denials, Withdrawals, and         03/05/2002   Withdrawn - Publication is
                 Referrals for Other Administrative Action                                                                    not projected in the next
                                                                                                                              12 months
0910-AB74       Surgeon's and Patient Examination Gloves; Reclassification                                      03/13/2002   Withdrawn - Publication is
                                                                                                                              not projected in the next
                                                                                                                              12 months
0910-AB79       Fixed-Combination Prescription and Over-the-Counter Drugs for Human Use                         03/06/2002   Withdrawn - Publication is
                                                                                                                              not projected in the next
                                                                                                                              12 months
0910-AB80       180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications                          03/06/2002   Withdrawn
0910-AB81       Repackaging Approval Requirements                                                               03/06/2002   Withdrawn - Publication is
                                                                                                                              not projected in the next
                                                                                                                              12 months
0910-AB82       Stability Testing of Drugs                                                                      03/06/2002   Withdrawn
0910-AB90       Substances Prohibited From Use in Animal Food or Feed                                           03/05/2002   Withdrawn
0910-AB92       Fees Relating to Drugs; Waiver and Reduction of Fees                                            03/06/2002   Withdrawn - Publication is
                                                                                                                              not projected in the next
                                                                                                                              12 months
0910-AB93       Periodic Testing for Certain Human Drug, Veterinary Drug, and Biological Product Final          03/06/2002   Withdrawn - Publication is
                 Specifications                                                                                               not projected in the next
                                                                                                                              12 months
0910-AB99       Medical Devices, Medical Device Establishment Registration and Listing Requirements;            03/13/2002   Withdrawn - Publication is
                 Amendment                                                                                                    not projected in the next
                                                                                                                              12 months
0910-AC00       Availability for Public Disclosure and Submission to FDA for Public Disclosure of Certain       03/05/2002   Withdrawn - Publication is
                 Data and Information Related to Gene Therapy or Xenotransplantation                                          not projected in the next
                                                                                                                              12 months
0910-AC01       Addition to the List of Drug Products That Have Been Withdrawn From the Market for Reasons      03/06/2002   Withdrawn - Publication is
                 of Safety or Effectiveness                                                                                   not projected in the next
                                                                                                                              12 months
0910-AC02       Reporting Information Regarding Falsification of Data                                           03/06/2002   Withdrawn - Publication is
                                                                                                                              not projected in the next
                                                                                                                              12 months
0910-AC03       Examination of Administrative Record and Other Advisory Committee Records                       03/06/2002   Withdrawn - Publication is
                                                                                                                              not projected in the next
                                                                                                                              12 months

[[Page 33046]]


0910-AC08       Addition to the List of Drug Products That Have Been Withdrawn or Removed From the Market       03/06/2002   Withdrawn - Publication is
                 for Reasons of Safety or Effectiveness                                                                       not projected in the next
                                                                                                                              12 months
0910-AC09       Labeling Dietary Supplements for Women Who Are or May Become Pregnant                           03/06/2002   Withdrawn - Publication is
                                                                                                                              not projected in the next
                                                                                                                              12 months
0910-AC10       Overwrap for Inhalation Products Packaged in Low Density Polyethylene (LDPE) Containers         03/06/2002   Withdrawn - Publication is
                                                                                                                              not projected in the next
                                                                                                                              12 months
0910-AC11       Implementing Court Decisions, ANDA Approvals, and 180-Day Exclusivity                           03/06/2002   Withdrawn - Publication is
                                                                                                                              not projected in the next
                                                                                                                              12 months
0910-AC13       Regulation of Carcinogenic Compounds Used in Food-Producing Animals; Definition of ``No         03/20/2002   Withdrawn - Publication is
                 Residue''                                                                                                    not projected in the next
                                                                                                                              12 months
0910-AC16       Rescission of Substantially Equivalent Decisions and Rescission Appeal Procedures               03/05/2002   Withdrawn - Publication is
                                                                                                                              not projected in the next
                                                                                                                              12 months
0910-AC24       Requirements for Medical Gas Containers and Closure Systems                                     03/06/2002   Withdrawn - Publication is
                                                                                                                              not projected in the next
                                                                                                                              12 months
0910-AC27       Promotion and Charging For Investigational Drugs                                                03/06/2002   Withdrawn - Publication is
                                                                                                                              not projected in the next
                                                                                                                              12 months
--------------------------------------------------------------------------------------------------------------------------------------------------------


                        Health Resources and Services Administration--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
782        National Practitioner Data Bank for Adverse Information on Physicians and Other           0906-AA41
            Health Care Practitioners: Medical Malpractice Payments Reporting Requirements......
783        Designation of Medically Underserved Populations and Health Professional Shortage         0906-AA44
            Areas...............................................................................
784        National Practitioner Data Bank for Adverse Information on Physicians and Other           0906-AA57
            Health Care Practitioners: Reporting Adverse and Negative Actions...................
----------------------------------------------------------------------------------------------------------------


                         Health Resources and Services Administration--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
785        National Vaccine Injury Compensation Program: Revisions and Additions to the Vaccine      0906-AA55
            Injury Table........................................................................
----------------------------------------------------------------------------------------------------------------


                         Health Resources and Services Administration--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
786        National Vaccine Injury Compensation Program: Revisions and Additions to the Vaccine      0906-AA58
            Injury Table........................................................................
787        Adoption of the Interim Final Rule as a Final Rule With Amendments for Ricky Ray          0906-AA59
            Hemophilia..........................................................................
----------------------------------------------------------------------------------------------------------------


[[Page 33047]]


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


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


                               National Institutes of Health--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
790        Undergraduate Scholarship Program Regarding Professions Needed by the NIH............     0925-AA10
791        National Institutes of Health Loan Repayment Program for Research....................     0925-AA18
792        NIH Center Grants....................................................................     0925-AA24
793        NIH Training Grants..................................................................     0925-AA28
----------------------------------------------------------------------------------------------------------------


                                 National Institutes of Health--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
794        Scientific Peer Review of Research Grant Applications and Research and Development        0925-AA20
            Contract Projects...................................................................
----------------------------------------------------------------------------------------------------------------


                                National Institutes of Health--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
795        Standards for a National Chimpanzee Sanctuary System.................................     0925-AA31
----------------------------------------------------------------------------------------------------------------


                                National Institutes of Health--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
796        National Institutes of Health AIDS Research Loan Repayment Program...................     0925-AA02
797        National Cancer Institute Clinical Cancer Education Program..........................     0925-AA17
798        National Institute of Child Health and Human Development Contraception and                0925-AA19
            Infertility Research Loan Repayment Program.........................................
799        National Institutes of Health Clinics Research Loan Repayment Program for Individuals     0925-AA25
            From Disadvantaged Backgrounds......................................................
800        NIH Loan Repayment Program for Minority Health Disparities Research..................     0925-AA26
801        Pediatric Research Loan Repayment Program............................................     0925-AA27
802        National Institutes of Health Loan Repayment Program for Clinical Researchers........     0925-AA30
----------------------------------------------------------------------------------------------------------------


[[Page 33048]]


                            Office of Public Health and Science--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
803        Public Health Services Policies on Research Misconduct...............................     0940-AA04
----------------------------------------------------------------------------------------------------------------


                              Office of Public Health and Science--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
804        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
----------------------------------------------------------------------------------------------------------------
805        Federal Policy (Common Rule) for the Protection of Human Subjects....................     0940-AA03
806        Protection of Human Research Subjects................................................     0940-AA05
----------------------------------------------------------------------------------------------------------------


                          Centers for Medicare & Medicaid Services--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
807        Requirements for Establishing and Maintaining Medicare Billing Privileges (CMS-6002-      0938-AH73
            P)..................................................................................
808        National Standard for Identifiers of Health Plans (CMS-1212-P).......................     0938-AH87
809        Medicare Hospice Care Amendments (CMS-1022-P)........................................     0938-AJ36
810        End-Stage Renal Disease Bad Debt Payment (CMS-1126-P)................................     0938-AK02
811        Conditions of Participation of Intermediate Care Facilities for Persons With Mental       0938-AK23
            Retardation (CMS-3046-P)............................................................
812        Review of National Coverage Determinations and Local Coverage Determinations (CMS-        0938-AK60
            3063-P).............................................................................
813        Revised Process for Making Medicare Coverage Determinations (NCDs) (CMS-3062-N)......     0938-AK61
814        Health Insurance Reform: Claims Attachments Standards (CMS-0050-P)...................     0938-AK62
815        Health Insurance Reform: Modifications to Standards for Electronic Transactions (CMS-     0938-AK64
            0003-P).............................................................................
816        Rate of Reimbursement of Photocopy Expenses for Prospective Payment System Providers      0938-AK68
            (CMS-3055-P)........................................................................
817        Modifications to Medicare Managed Care Rules (CMS-4041-P)............................     0938-AK71
818        Revisions to Transaction and Code Set Standards for Electronic Transactions (CMS-0005-    0938-AK76
            P)..................................................................................
819        Elimination of Statement of Intent Procedures for Filing Medicare Claims (CMS-1185-P)     0938-AK79
820        Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2003      0938-AL19
            Payment Rates (CMS-1206-P)..........................................................
821        Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities--      0938-AL20
            Update for FY 2003 (CMS-1202-P).....................................................
822        Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2003     0938-AL21
            (CMS-1204-P)........................................................................
823        Hospital Inpatient Rehabilitation Prospective Payment System for FY 2003 (CMS-1205-N)     0938-AL22
824        Hospital Inpatient Prospective Payment System for FY 2003 (CMS-1203-P)...............     0938-AL23
825        Payment for Respiratory Assist Devices with Bi-Level Capability and a Back-Up Rate        0938-AL27
            (CMS-1167-P)........................................................................
826        Self-Declaration of Citizenship (CMS-2085-P).........................................     0938-AL33
827        Hospice Wage Index for FY 2003 (CMS-1211-N)..........................................     0938-AL41
828        Electronic Submission of Cost Reports (CMS-1199-P)...................................     0938-AL51
829        Health Insurance Reform: National Standard for Identifiers of Health Plans (CMS-1212-     0938-AL52
            F)..................................................................................
830        Revised Civil Money Penalties, Assessments, Exclusions, and Related Appeals               0938-AL53
            Procedures (CMS-6146-P).............................................................
831        Effect of Change of Ownership on Provider and Supplier Penalties (CMS-2215-P)........     0938-AL72
832        Health Coverage Portability: Tolling Certain Time Periods and Interactions With           0938-AL88
            Family and Medical Leave Act (CMS-2158-P)...........................................
833        Changes to the Hospital Outpatient Prospective Payment System and Calendar Year 2004      0938-AL91
            Payment Rates (CMS-1471-P)..........................................................
----------------------------------------------------------------------------------------------------------------


[[Page 33049]]


                           Centers for Medicare & Medicaid Services--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
834        Security Standards (CMS-0049-F)......................................................     0938-AI57
835        National Standard Employer Identifier (CMS-0047-F)...................................     0938-AI59
836        External Quality Review of Medicaid Managed Care Organizations (CMS-2015-F)..........     0938-AJ06
837        Rural Health Clinics: Amendments to Participation Requirements and Payment                0938-AJ17
            Provisions, and Establishment of a Quality Assessment and Improvement Program (CMS-
            1910-F).............................................................................
838        Hospital Conditions of Participation: Laboratory Services (CMS-3014-F)...............     0938-AJ29
839        Non-Federal Governmental Plans Exempt From Health Insurance Portability Requirements      0938-AK00
            (CMS-2033-IFC)......................................................................
840        Fire Safety Requirements for RNHCI, ASC, Hospices, PACE, Hospitals, and Long-Term         0938-AK35
            Care Facilities and ICFs for the Mentally Retarded (CMS-3047-P).....................
841        Hospital Conditions of Participation: Quality Assessment and Performance Improvements     0938-AK40
            (CMS-3050-F)........................................................................
842        Supplementary Medical Insurance Premium Surcharge Agreements (CMS-4007-F)............     0938-AK42
843        Payment for Upgraded Durable Medical Equipment; Withdrawal of Proposed Rule (CMS-1084-    0938-AK50
            WN).................................................................................
844        Prospective Payment System for Long-Term Care Hospitals for FY 2003 (CMS-1177-P).....     0938-AK69
845        Medicare Inpatient Disproportionate Share Hospital (DSH) Adjustment Formula (CMS-1171-    0938-AK77
            IFC)................................................................................
846        State Allotments for Payment of Medicare Part B Premiums for Qualified Individuals;       0938-AK91
            Federal Fiscal Year 2001 (CMS-2087-PN)..............................................
847        Medicaid Managed Care; New Provisions (CMS-2104-F)...................................     0938-AK96
848        Modifications to the State Children's Health Insurance Program (CMS-2006-F)..........     0938-AL00
849        Home Health Prospective Payment System Rate Update for FY 2003 (CMS-1198-NC).........     0938-AL16
850        Medicare Program; Medicare-Endorsed Prescription Drug Discount Card Assistance            0938-AL28
            Initiative (CMS-4027-P).............................................................
851        Peer Review Organizations: Name and Other Changes--Technical Amendments (CMS-3088-FC)     0938-AL38
852        End-Stage Renal Disease--Rescission of Waiver of Conditions for Coverage Under a          0938-AL39
            State of Emergency in Houston, Texas Area (CMS-3074-F2).............................
853        Prospective Payment System for Inpatient Rehabilitation Hospital; Correcting              0938-AL40
            Amendment (CMS-1069-F2).............................................................
854        Physician Fee Schedule for CY 2002: Correction Notice (CMS-1169-CN)..................     0938-AL48
855        Notice of Modification of Beneficiary Assessment Requirements for Skilled Nursing         0938-AL55
            Facilities (CMS-1209-N).............................................................
856        Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance         0938-AL56
            Amounts for Calendar Year 2003 (CMS-8013-N).........................................
857        Revision of the Procedures for Requesting Exceptions to Cost Limits for Skilled           0938-AL61
            Nursing Facilities and Elimination of Reclassifications; Correction (CMS-1883-F3)...
858        Monthly Actuarial Rates and Monthly Supplementary Medical Insurance Premium Rate          0938-AL63
            Beginning January 1, 2003 (CMS-8014-N)..............................................
859        Request for Information on Benefit-Specific Waiting Periods (CMS-2150-N).............     0938-AL64
860        Part A Premiums for 2003 for the Uninsured Aged and for Certain Disabled Individuals      0938-AL69
            Who Have Exhausted Other Entitlement (CMS-8015-N)...................................
861        Medicaid Managed Care: Withdrawal (CMS-2001-F4)......................................     0938-AL83
862        FY 1999 SCHIP Reallocation Notice (CMS-2137-N).......................................     0938-AL86
----------------------------------------------------------------------------------------------------------------


                           Centers for Medicare & Medicaid Services--Long-Term Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
863        ''Without Fault'' and Beneficiary Waiver of Recovery As It Applies to Medicare            0938-AD95
            Overpayment Liability (CMS-6007-F)..................................................
864        Revision of Medicare/Medicaid Hospital Conditions of Participation (CMS-3745-F)......     0938-AG79
865        Home Health Agency (HHA) Conditions of Participation (CoPs) (CMS-3819-FC)............     0938-AG81
866        End Stage Renal Disease (ESRD) Conditions for Coverage (CMS-3818-P) (Section 610          0938-AG82
            Review).............................................................................
867        Criteria for Approval of Facilities to Perform Covered Heart, Liver, Lung, Pancreas,      0938-AH17
            and Intestinal Transplants (CMS-3835-P).............................................
868        Hospice Care--Conditions of Participation (CMS-3844-P)...............................     0938-AH27
869        Medicare and Medicaid Programs; Terms, Definitions, and Addresses: Technical              0938-AH53
            Amendments (CMS-9877-F).............................................................
870        Health Insurance Reform: Standard Unique Health Care Provider Identifier (CMS-0045-F)     0938-AH99
871        Medical Child Support and Health Insurance Coverage of Dependent Children (CMS-2081-      0938-AI21
            P)..................................................................................
872        Appeals of Carrier Determination That a Supplier Fails To Meet the Requirements for       0938-AI49
            Medicare Billing Privileges (CMS-6003-F)............................................
873        Coverage of Religious Non-Medical Health Care Institutions (CMS-1909-F)..............     0938-AI93

[[Page 33050]]


874        Reporting Outcome and Assessment Information Set (OASIS) Data as Part of the              0938-AJ10
            Conditions of Participation for Home Health Agencies (CMS-3006-F)...................
875        Use of Restraint and Seclusion in Residential Treatment Facilities Providing              0938-AJ96
            Inpatient Psychiatric Services to Individuals Under Age 21 (CMS-2065-F).............
876        Application of Inherent Reasonableness to All Medicare Part B Services (Other than        0938-AJ97
            Physician Services) (CMS-1908-F)....................................................
877        Supplier Standards for Home Oxygen, Therapeutic Shoes, Home Nutrition Therapy, and        0938-AJ98
            Consignment Closets (CMS-6010-P)....................................................
878        Clinical Lab Requirements--Revisions to Regulations Implementing CLIA (CMS-2226-F)...     0938-AK24
879        Improvements to the Medicare+Choice Appeals and Grievance Procedures (CMS-4024-F)....     0938-AK48
880        Physicians' Referrals to Health Care Entities With Which They Have Financial              0938-AK67
            Relationships--Phase II (CMS-1810-FC)...............................................
881        Organ Procurement Organization Condition for Coverage (CMS-3064-IFC).................     0938-AK81
882        Modifications to Managed Care Rules Based on Payment Provisions in BIPA and Technical     0938-AK90
            Corrections (CMS-4040-F)............................................................
883        Extending Medicare Entitlement When Disability Benefit Entitlement Ends Because of        0938-AK94
            Substantial Gainful Activity (CMS-4018-P)...........................................
884        Medicare Limits on the Valuation of a Depreciable Asset Recognized as an Allowance        0938-AL12
            for Depreciation and Interest on Capital Indebtedness After a Change of Ownership
            (CMS-1004-F)........................................................................
885        Update Interest Assessment on Medicare Overpayment and Underpayment (CMS-6014-P).....     0938-AL14
886        Requirements for Paid Feeding Assistants in Long-Term Care Facilities (CMS-2131-P)...     0938-AL18
887        Use of Restraint and Seclusion in Medicare and Medicaid Participating Facilities that     0938-AL26
            Provide Inpatient or Residential Care (CMS-2130-P)..................................
888        Medicare-Endorsed Prescription Drug Discount Card Assistance Initiative for State         0938-AL30
            Sponsors (CMS-4032-P)...............................................................
889        State Children's Health Insurance Program; Eligibility for Unborn Children (CMS-2127-     0938-AL37
            F)..................................................................................
890        Health Coverage Portability for Group Health Plans and Group Health Insurance Issuers     0938-AL43
            (CMS-2151-F)........................................................................
891        Interim Final Amendment for Mental Health Parity (CMS-2152-IFC)......................     0938-AL44
892        Permitting Premium Reductions as Additional Benefits Under Medicare+Choice Plans (CMS-    0938-AL49
            1208-P).............................................................................
893        Prospective Payment System for Psychiatric Hospitals (CMS-1213-P)....................     0938-AL50
894        Provider Reimbursement Determinations and Appeals (CMS-1727-P).......................     0938-AL54
895        Definition of Severe Medically Determinable Impairment (CMS-2143-P)..................     0938-AL57
896        Program for All-Inclusive Care for the Elderly (PACE): Program Revisions (CMS-1201-       0938-AL59
            IFC)................................................................................
897        SCHIP; Purchase of Family Coverage--Benefit Flexibility in Parent Coverage (CMS-2148-     0938-AL62
            P)..................................................................................
898        Revisions to Medicaid Cost-Sharing Regulations (CMS-2144-P)..........................     0938-AL66
899        Revisions to the Medicare Appeals Process (CMS-4004-P)...............................     0938-AL67
900        Notice of Intent to Conduct Negotiated Rulemaking for Special Payment Provisions and      0938-AL68
            Standards for Suppliers of Custom-Fabricated Orthotics and Prosthetics (CMS-6012-N).
901        DMERC Service Areas and Related Matters (CMS-1219-P).................................     0938-AL76
902        State Allotments for Payment of Medicare Part B Premiums for Qualifying Individuals;      0938-AL79
            Federal Fiscal Year 2002 (CMS-2136-PN)..............................................
903        Revisions to Conditions for Coverage for Ambulatory Surgical Centers (CMS-3887-P)....     0938-AL80
904        Flexibility in Payment Methods for Services of Hospitals, Nursing Facilities, and         0938-AL81
            Intermediate Care Facilities for the Mentally Retarded (CMS-2004-F).................
905        Continue to Allow States an Option Under the Medicaid Spousal Impoverishment              0938-AL84
            Provisions to Increase the Community Spouse's Income When Adjusting the Protected
            Resource Allowance (CMS-2128-F).....................................................
906        Medicaid Coverage Rules for Inmates of Public Institutions (CMS-2077-P)..............     0938-AL85
907        Targeted Case Management (CMS-2061-P)................................................     0938-AL87
908        Changes to the Hospital Inpatient Prospective Payment System and FY 2004 Rates (CMS-      0938-AL89
            1470-P).............................................................................
909        Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities--      0938-AL90
            Update for FY 2004 (CMS-1469-P).....................................................
910        Prospective Payment System for Long-Term Care Hospitals: FY 2004 (CMS-1472-P)........     0938-AL92
911        Prospective Payment System for Psychiatric Hospitals (CMS-1477-P)....................     0938-AL93
912        Home Health Prospective Payment System Rate Update for FY 2004 (CMS-1473-NC).........     0938-AL94
913        Prospective Payment System for Inpatient Rehabilitation Hospitals (CMS-1474-P).......     0938-AL95
914        Revisions to Payment Policies Under the Physician Fee Schedule for Calendar Year 2004     0938-AL96
            (CMS-1476-P)........................................................................
----------------------------------------------------------------------------------------------------------------


[[Page 33051]]


                           Centers for Medicare & Medicaid Services--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
915        Medicare Program; Coverage and Administrative Policies for Clinical Diagnostic            0938-AI92
            Laboratory Tests (CMS-3250-F).......................................................
916        Fee Schedule for Payment of Ambulance Services and Revisions to the Physician's           0938-AK30
            Certification Requirements for Coverage of Nonemergency Ambulance Services (CMS-1002-
            FC).................................................................................
917        Medicare Program; Reporting and Repayment of Overpayments (CMS-6011-P)...............     0938-AK45
918        Prospective Payment System for Hospital Outpatient Services: Criteria for                 0938-AK59
            Establishing New Pass-Through Categories for Medical Devices (CMS-1179-IFC).........
919        Qualification Requirements for Directors of Laboratories Performing High Complexity       0938-AK83
            Testing (CMS-2094-P)................................................................
920        Medicaid Upper Payment Limit for Non-State Government-Owned or -Operated Hospitals        0938-AL05
            (CMS-2134-F)........................................................................
921        Physicians' Referrals to Health Care Entities With Which They Have Financial              0938-AL29
            Relationships; Delay of Effective Date of the ``Set in Advance'' Provision (CMS-1809-
            IFC)................................................................................
922        Deductible Amount for Medigap High Deductible Options for Calendar Year 2002 (CMS-        0938-AL34
            2135-N).............................................................................
923        Prospective Payment System for Hospital Outpatient Services; Delay in Effective Date      0938-AL35
            of Calendar Year 2002 Payment Rates and the Pro Rata Reduction on Transitional Pass-
            Through Payment (CMS-1159-F3).......................................................
924        Disapproval of Alcon Laboratories Request for an Adjustment in Payment Amounts for        0938-AL36
            New Technology Intraocular Lenses Furnished by Ambulatory Surgical Centers (CMS-3061-
            FN).................................................................................
925        Correction of Certain Calendar Year 2003 Payment Rates Under the Hospital Outpatient      0938-AL42
            Prospective Payment System and the Pro Rata Reduction on Transitional Pass-Through
            Payment (CMS-1159-F4)...............................................................
926        Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities--      0938-AL47
            Correction Notice (CMS-1163-CN).....................................................
----------------------------------------------------------------------------------------------------------------


                                             Centers for Medicare & Medicaid Services--Discontinued Entries
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Regulation
Identification                                             Title                                             Date Withdrawn            Comments
    Number
--------------------------------------------------------------------------------------------------------------------------------------------------------
0938-AH81       Update of Ratesetting Methodology, Payment Rates and the List of Covered Surgical               03/03/2002   Withdrawn
                 Procedures for Ambulatory Surgical Centers (CMS-1885-FC)
0938-AI48       Surety Bond Requirements for Comprehensive Outpatient Rehabilitation Facilities,                03/06/2002   Withdrawn
                 Rehabilitation Agencies (CMS-6005-P)
0938-AI75       Advance Refunding of Debt and Methodology for Repayment of Loan (CMS-1777-P)                    03/20/2002   Withdrawn
0938-AI89       Medicare Coverage of, and Payment for, Bone Mass Measurements (CMS-3004-F)                      03/06/2002   Withdrawn
0938-AJ39       Emergency Medical Treatment and Labor Act (EMTALA) (CMS-1063-P)                                 03/03/2002   Withdrawn
0938-AJ44       Protection for Women Who Elect Reconstruction After a Mastectomy (CMS-2040-IFC)                 03/04/2002   Withdrawn
0938-AJ64       Surety Bonds Requirements for Suppliers of Durable Medical Equipment (CMS-6006-P)               03/14/2002   Withdrawn
0938-AJ81       Surety Bond Requirements for Home Health Agencies (HHAS) (CMS-6001-P)                           03/14/2002   Withdrawn
0938-AK15       Payment for Clinical Psychology Training Programs (CMS-1089-F)                                  03/03/2002   Withdrawn
0938-AK39       Medicare Provider and Supplier Hearing Procedures (CMS-2093-P)                                  03/06/2002   Withdrawn
0938-AK43       Medical Devices Coverage Decisions Related to Health Care Technology (CMS-3059-P)               03/20/2002   Withdrawn
0938-AK53       Recognition of the American Osteopathic Association for Ambulatory Surgical Center Programs     03/04/2002   Withdrawn
                 (CMS-2079-FN)
0938-AK63       Health Insurance Reform: Standards for Electronic Signatures (CMS-0051-F)                       03/03/2002   Withdrawn
0938-AK87       Hospital Reference Laboratory and Medicare Secondary Payer (CMS-1187-P)                         03/03/2002   Withdrawn
0938-AK88       Portability in the Group Health Insurance Market--Shared HHS Provisions (CMS-2048-F)            03/20/2002   Withdrawn
0938-AK92       Extended Medicaid for Certain Families Who Lose Medicaid Eligibility Because of Earned          03/04/2002   Withdrawn
                 Income and the Residency of Minor Parents and Pregnancy (CMS 2026-F)
0938-AK93       Home Health Prospective Payment System Refinements (CMS-1161-P)                                 03/20/2002   Withdrawn
0938-AK99       Relief From Medicare Part A Late Enrollment Penalty for Group Buy-In for State and Local        03/20/2002   Withdrawn
                 Retirees (CMS-4022-P)

[[Page 33052]]


0938-AL06       Continue To Allow States an Option Under the Medicaid Spousal Impoverishment Provisions To      03/06/2002   Withdrawn
                 Increase the Community Spouse's Income When Adjusting the Protected Resource Allowance
                 (CMS-2128-P)
0938-AL45       Requirements for Long-term Care Facilities (CMS-3096-P)                                         03/06/2002   Withdrawn
--------------------------------------------------------------------------------------------------------------------------------------------------------


                          Administration for Children and Families--Proposed Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
927        Program Performance Standards for the Operation of Head Start Programs...............     0970-AB99
928        Safeguarding Child Support and Expanded FPLS Information.............................     0970-AC01
929        Developmental Disabilities and Bill of Rights Act....................................     0970-AC07
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Final Rule Stage
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
930        Construction and Major Renovation of Head Start and Early Head Start Facilities......     0970-AB54
931        Child Support Enforcement for Indian Tribes..........................................     0970-AB73
932        Child Support Enforcement Program Omnibus Conforming Regulation......................     0970-AB81
933        Family Child Care Program Option for Head Start Programs.............................     0970-AB90
934        Technical Revision of Head Start Regulations To Make Them Conform to Recent Statutory     0970-AC00
            Revisions...........................................................................
----------------------------------------------------------------------------------------------------------------


                           Administration for Children and Families--Completed Actions
----------------------------------------------------------------------------------------------------------------
                                                                                                    Regulation
 Sequence                                          Title                                          Identification
  Number                                                                                              Number
----------------------------------------------------------------------------------------------------------------
935        High Performance Bonus Awards Under the TANF Program.................................     0970-AC06
----------------------------------------------------------------------------------------------------------------


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

_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




712. SAFE HARBOR FOR ARRANGEMENTS INVOLVING FEDERALLY QUALIFIED HEALTH 
CENTERS

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 1001

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/02
NPRM Comment Period End         12/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

[[Page 33053]]

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

Related RIN: Related To 0991-AA91
RIN: 0991-AB06
_______________________________________________________________________




713. IMPLEMENTING THE BIOTERRORISM PREVENTION AND RESPONSE ACT OF 2001

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: None

Legal Deadline: None

Abstract: A variety of regulations will be required once the 
Bioterrorism Prevention and Response Act has been signed into law. 
These regulations would implement provisions that address, among other 
things, biological agents that have the potential to pose a national 
security threat, provisions relating to foods including recordkeeping 
regarding foods, food-shipment importation procedures and related 
matters.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State, Tribal, Federal

Agency Contact: Alex Azar, General Counsel, Department of Health and 
Human Services, Office of the Secretary
Phone: 202 690-7741

RIN: 0991-AB15
_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




714. SHARED RISK EXCEPTION TO THE SAFE HARBOR PROVISIONS

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 1001

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

Abstract: This final rule establishes a new statutory exception for 
risk-sharing arrangements under the Federal health care programs' anti-
kickback provisions. The rule sets forth an exception from liability 
for remuneration between an eligible organization and an individual or 
entity providing items or services in accordance with a written 
agreement between these parties. The rule allows remuneration between 
an organization and an individual or entity if a written agreement 
places the individual or entity at ``substantial financial risk'' for 
the cost or utilization of the items or services that the individual or 
entity is obligated to provide.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           05/23/97                    62 FR 28410
ANPRM Comment Period End        06/09/97
Interim Final Rule              11/19/99                    64 FR 63504
Final Rule                      10/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Additional Information: Interim final regulations were published on 
November 19, 1999 (64 FR 63504) and are currently in effect. See 42 CFR 
1001.952(t) and (u).

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

Related RIN: Related To 0991-AB06
RIN: 0991-AA91
_______________________________________________________________________




715. 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                            12/06/00                    65 FR 76460
NPRM Comment Period End         01/05/01
Final Action                    08/00/02
Final Action Effective          09/00/02

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Federal, Tribal

Agency Contact: Robinsue Frohboese, Acting Director, Office for Civil 
Rights, Department of Health and Human Services, Office of the 
Secretary
Phone: 202 619-0403

RIN: 0991-AB10

[[Page 33054]]

_______________________________________________________________________


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


Office of the Secretary (OS)



_______________________________________________________________________




716. REVISIONS TO 42 CFR PART 1003

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 revise part 1003, addressing the 
Office of Inspector General's authority to propose the imposition of 
civil money penalties and assessments, by reorganizing and simplifying 
existing regulatory text and eliminating obsolete references contained 
in the current regulations. Among the proposed revisions, this rule 
would establish separate subparts within part 1003 for various 
categories of violations; modify the current definition for the term 
``claim;'' update various references to managed care organization 
authorities; and clarify the application of section 1140 of the Social 
Security Act with respect to the misuse of certain Departmental 
symbols, emblems or names through Internet and e-mail communications.

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
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 1003

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule                       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-AB04
_______________________________________________________________________




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

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

Legal Authority: 5 USC 301; 41 USC 701 et seq, sec 2455; PL 103-355; 31 
USC 6101 note; EO 12689; EO 12549

CFR Citation: 45 CFR 76; 45 CFR 82

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/23/02                     67 FR 3315
NPRM Comment Period End         03/25/02


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0991-AB12
_______________________________________________________________________




719. MODIFICATIONS TO STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE 
HEALTH INFORMATION

Priority: Other Significant. Major under 5 USC 801.

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

Legal Authority: 42 USC 1320d-2; 42 USC 1320d-3; PL 104-191, sec 262; 
PL 104-191, sec 264

CFR Citation: 45 CFR 160; 45 CFR 164

Legal Deadline: None

Abstract: The Health Insurance Portability and Accountability Act of 
1996 (HIPAA) required the Department of Health and Human Services (the 
Department) to issue standards for health plans, health care 
clearinghouses, and certain health care providers to protect the 
privacy of individually identifiable health information. The Department 
published these standards, entitled ``Standards for Privacy of 
Individually Identifiable Health Information'' (the Privacy Rule), as a 
final rule on December 28, 2000. The final rule was effective on April 
14, 2001. The proposed rule would amend the Privacy Rule to, among 
other things, support the delivery of the highest quality of health 
care to patients and address concerns regarding the workability of the 
rule for entities subject to its requirements.

[[Page 33055]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/27/02                    67 FR 14775
NPRM Comment Period End         04/26/02


Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal, State, Local, Tribal

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

Agency Contact: Susan McAndrew, Senior Health Information, Policy 
Specialist, Department of Health and Human Services, Office of the 
Secretary, Office for Civil Rights, 200 Independence Avenue SW., 
Washington, DC 20201
Phone: 202 205-8725

RIN: 0991-AB14
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Office of the Secretary (OS)



_______________________________________________________________________




720. SAFE HARBOR FOR AMBULANCE RESTOCKING

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 1001

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/04/01                    66 FR 62679

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0991-AB05
_______________________________________________________________________




721. REVISIONS AND TECHNICAL CORRECTIONS TO 42 CFR CHAPTER V

Priority: Substantive, Nonsignificant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/18/02                    67 FR 11928

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal

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

RIN: 0991-AB09

_______________________________________________________________________


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


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




722. SECLUSION AND RESTRAINT FOR NON-MEDICAL RESIDENTIAL FACILITIES

Priority: Substantive, Nonsignificant

Legal Authority: PL 106-310

CFR Citation: Not Yet Determined

Legal Deadline: NPRM, Statutory, April 2001.

Abstract: The Secretary is required by statute to publish regulations 
governing States that license non-medical, community-based residential 
facilities for children and youth. The regulation requires States to 
develop licensing rules and monitoring requirements concerning behavior 
management practice that will ensure compliance; requires States to 
develop and implement such licensing rules and implementation 
requirements within one year; and ensures that States require such 
facilities to have adequate staff and that the States provide training 
for professional staff.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

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

Agency Contact: Joseph Denis Faha, Director, DLEA, SAMHSA, Department 
of Health and Human Services, Substance Abuse and Mental Health 
Services Administration, Room 12C-15, 5600 Fishers Lane, Rockville, MD 
20857
Phone: 301 443-7017
Fax: 301 443-1450
Email: [email protected]

RIN: 0930-AA10
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Substance Abuse and Mental Health Services Administration (SAMHSA)



_______________________________________________________________________




723. COMMUNITY MENTAL HEALTH SERVICES BLOCK GRANT

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 96

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       03/13/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Joseph Denis Faha
Phone: 301 443-7017
Fax: 301 443-1450
Email: [email protected]

RIN: 0930-AA08
_______________________________________________________________________




724. SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION MENTAL 
HEALTH AND SUBSTANCE ABUSE EMERGENCY RESPONSE CRITERIA

Priority: Other Significant

CFR Citation: 42 CFR 51d

[[Page 33056]]

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              10/11/01                    66 FR 51873

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Joseph Denis Faha
Phone: 301 443-7017
Fax: 301 443-1450
Email: [email protected]

RIN: 0930-AA09

_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




725. CONTROL OF COMMUNICABLE DISEASES

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

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

CFR Citation: 42 CFR 70; 42 CFR 71

Legal Deadline: None

Abstract: This proposal updates existing regulations related to 
prevention of the introduction, transmission, or spread of communicable 
diseases from foreign countries to the U.S. and from State to State. 
The regulation addresses the process by which persons infected with, or 
who have been exposed to, modern communicable diseases should be 
quarantined; surveillance of quarantined persons and requirements for 
carriers (e.g., airlines, etc.) to maintain passenger manifests for a 
determined period of time.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: State

Federalism:  Undetermined

Agency Contact: John Moore, Department of Health and Human Services, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., 
Atlanta, GA 30333
Phone: 404 639-7070

RIN: 0920-AA03
_______________________________________________________________________




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

Priority: Other Significant

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

CFR Citation: 42 CFR 84

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/02

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0920-AA04
_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




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

Priority: Other Significant

Legal Authority: 42 USC 73847; EO 13179

CFR Citation: 42 CFR 81; 42 CFR 82

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule                      04/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Undetermined

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

RIN: 0920-AA05

[[Page 33057]]

_______________________________________________________________________


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


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




728.  DHHS STATEMENT OF POLICY--PROCEDURES FOR DESIGNATING CLASSES 
OF EMPLOYEES AS MEMBERS OF THE SPECIAL EXPOSURE COHORT UNDER THE ENERGY 
EMPLOYEE OCCUPATIONAL ILLNESS COMPENSATION ACT OF 2000

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 7384g; EO 13129

CFR Citation: None

Legal Deadline: None

Abstract: Pursuant to the Energy Employees Occupational Illness 
Compensation Program Act, HHS plans to propose procedures to petition 
the Secretary to be added to the Special Exposure Cohort.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Statement of Proposed Procedures To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0920-AA07
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Centers for Disease Control and Prevention (CDC)



_______________________________________________________________________




729. PACKAGING AND HANDLING OF INFECTIOUS SUBSTANCES AND SELECT AGENTS

Priority: Other Significant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       03/21/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Jonathan Y. Richmond
Phone: 404 639-2453

RIN: 0920-AA02

_______________________________________________________________________


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


Departmental Management (HHSDM)



_______________________________________________________________________




730. 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                     06/00/02

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)          Final Rule Stage


Departmental Management (HHSDM)



_______________________________________________________________________




731. ADMINISTRATIVE WAGE GARNISHMENT

Priority: Substantive, Nonsignificant

Legal Authority: 31 USC 3720D; 28 CFR 285.11

CFR Citation: 42 CFR 32

Legal Deadline: None

Abstract: The Department will add a new part 32 to title 42 of the Code 
of Federal Regulations (CFR) to implement the Administrative Wage 
Garnishment provisions of the Debt Collection Improvement Act of 1996 
(DCIA), Public Law 104-134, 110 Stat. 1321 to 1358, codified at 31 
U.S.C. 3720D, and implemented by the Department of Treasury at 31 
C.F.R. 285.11. The proposed rule will be another tool for the 
Department to collect its debts by allowing the Department to garnish 
the wages of non-Federal employees administratively (i.e., without the 
need for a court order). The wage withholding order will be required to 
withold amounts from an employee's wages and pay those amounts to the

[[Page 33058]]

Department in satisfaction of the indebtedness.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/13/02                    67 FR 11264
NPRM Comment Period End         05/13/02
Final Rule                      06/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: 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-AA05

_______________________________________________________________________


Department of Health and Human Services (HHS)             Prerule Stage


Food and Drug Administration (FDA)



_______________________________________________________________________




732. REQUIREMENTS FOR SUBMISSION OF IN VIVO BIOEQUIVALENCE DATA

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 
21 USC 355a; 21 USC 356; 21 USC 356a; 21 USC 356b; 21 USC 356c; 21 USC 
371; 21 USC 374; 21 USC 379

CFR Citation: 21 CFR 314.96(a)(1); 21 CFR 314.94(a)(7); 21 CFR 
320.21(b)(1)

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is proposing to amend 
its regulations on submission of bioequivalence (BE) data to require an 
abbreviated new drug application (ANDA) applicant to submit data from 
all BE studies the applicant conducts on a drug product formulation 
submitted for approval. In the past, ANDA applicants have submitted BE 
studies demonstrating that a generic product meets BE criteria for FDA 
to approve the ANDA but have not typically submitted additional BE 
studies conducted on the same drug product formulation. FDA is 
proposing to require ANDA applicants to submit information, in either a 
complete or summary report, from all additional passing and nonpassing 
BE studies conducted on the same drug product formulation submitted for 
approval.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           11/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Aida L. Sanchez, Special Assistant to the Director, 
Department of Health and Human Services, Food and Drug Administration, 
HFD-650, Center for Drug Evaluation and Research, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-5847

RIN: 0910-AC23
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




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

Priority: Routine and Frequent

Legal Authority: 21 USC 321p; 21 USC 351 to 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 to 345; 21 CFR 330; 21 CFR 333 to 
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.
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:
________________________________________________________________________

Antidiarrheal Products  NPRM (Amendment)(Trav. Diar.) 09/00/02  Final 
Action 09/00/02

Antiemetic Products  Final Action (Amendment) (Warning) 08/00/02

Antifungal (Topical) Products  Final Action Clotrimazole 02/08/02 (67 
FR 5942)

Antiperspirant Products  Final Action 04/00/03

Cough/Cold (Antihistamine) Products  Final Action (Amendment)(Warning) 
08/00/02

Cough/Cold (Antitussive) Products  Final Action (Amendment)(Warning) 
08/00/02

Cough/Cold (Combination) Products  Final Action 04/00/03

Cough/Cold (Nasal Decongestant) Products  NPRM (Phenylpropanolamine) 
10/00/02

Eligibility Criteria for Additional Conditions  Final Action 01/23/02 
(67 FR 3060)

External Analgesic Products  Final Action (Amendment)(Warning) 08/00/02

Ingrown Toenail Relief Products  NPRM 12/00/02

Internal Analgesic Products  NPRM (Amendment)(Ibuprofen) 09/00/02  NPRM 
(Amendment) (Pediatric) 04/00/03

Labeling of Drug Products for OTC Human Use  Final Action (Ca/Mg/K/Na) 
06/00/02  Final Action (Sodium Labeling) 06/00/02  NPRM (Sodium 
Labeling) 06/00/02  NPRM (Convenience Sizes) 12/00/02

Nighttime Sleep Aid Products  Final Action (Amendment)(Warning) 08/00/
02

Ophthalmic Products  NPRM (Emergency First Aid Eyewashes) 04/00/03

Oral Health Care Products  ANPRM (Plaque/Gingivitis) 04/00/03

Pediculicide Products  NPRM (Labeling Amendment) 06/00/02

Salicylate (Reye Syndrome)  Final Action (Warning) 09/00/02

[[Page 33059]]

Skin Protectant Products  Final Action 08/00/02  Final Action 
(Astringent) 11/00/02  NPRM (Astringent) 11/00/02

Status of Certain Category II and III Ingredients  Final Action 04/00/
02  Final Action 06/00/02

Sunscreen Products  Final Action (Names) 07/00/02  ANPRM (and Insect 
Repellent) 10/00/02  NPRM (UVA/UVB) 04/00/03

Vaginal Contraceptive Products  NPRM (Amendment) 12/00/02

Weight Control Products  NPRM (Phenylpropanolamine) 10/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Gerald M. Rachanow, Regulatory Counsel, Division of 
Over-the-Counter Drug Products, Department of Health and Human 
Services, Food and Drug Administration, HFD-560, Center for Drug 
Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

RIN: 0910-AA01
_______________________________________________________________________




734. ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR DRUGS AND 
BIOLOGICS

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

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
355; 21 USC 360; 21 USC 360b; 21 USC 371; 21 USC 374; 42 USC 262

CFR Citation: 21 CFR 201; 21 CFR 207; 21 CFR 314

Legal Deadline: None

Abstract: The proposed rule would amend FDA regulations on the 
registration of producers of drugs and the listing of drugs in 
commercial distribution. The proposed revisions would reorganize, 
consolidate, clarify, and modify current regulations concerning who 
must register establishments and list drug or biological products. The 
proposal describes when, how, and where to register and list, and what 
information must be submitted for registration and listing. The 
proposed regulations would also require the electronic submission of 
most registration and listing information.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/03

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Howard P. Muller, Office of Regulatory Policy, 
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
_______________________________________________________________________




735. 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 to 353; 21 USC 355; 
21 USC 371

CFR Citation: 21 CFR 312.110

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Room 15-61 
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AA61
_______________________________________________________________________




736. SAFETY REPORTING REQUIREMENTS FOR HUMAN DRUG AND BIOLOGICAL 
PRODUCTS

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

Unfunded Mandates: Undetermined

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

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

Legal Deadline: None

Abstract: This regulation is one component of the Secretary's 
initiative to reduce medical errors. The proposed

[[Page 33060]]

rule would amend the expedited and periodic safety reporting 
regulations for human drugs and biological products to revise certain 
definitions and reporting formats as recommended by the International 
Conference on Harmonisation and to define new terms; to possibly add to 
or revise current reporting requirements; to consider revising certain 
reporting time frames; and to suggest other revisions to these 
regulations to enhance the quality of safety reports received by FDA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Audrey Thomas, Regulatory Policy Analyst, Office of 
Regulatory Policy, 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-AA97
_______________________________________________________________________




737. BLOOD INITIATIVE

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

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 353; 21 USC 355; 
21 USC 360; 21 USC 371; 21 USC 374; 42 USC 216; 42 USC 262; 42 USC 263; 
42 USC 263a; 42 USC 264

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

Legal Deadline: None

Abstract: In multiple rulemakings, the Food and Drug Administration is 
amending the biologics regulations by removing, revising, or updating 
specific regulations applicable to blood, blood components, source 
plasma, and blood-derivative products to be more consistent with 
current practices and to remove unnecessary or outdated requirements. 
This action is based on a comprehensive review of the regulations that 
has been performed by FDA. It is also based on reports by the U.S. 
House of Representatives Committee on Government Reform and Oversight, 
Subcommittee on House Resources and Intergovernmental Relations; the 
General Accounting Office; the Institute of Medicine, as well as public 
comments. Some of the subjects intended to be addressed in the 
rulemakings include: 1) labeling; 2) notification of end users of 
plasma-derivative products of product safety information; and 3) 
requirements for donor suitability and testing. 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 06/11/01 (66 FR 31165)

Plasma Derivatives and Similar Recombinant-Based Products; Reqs. for 
Notification of Recalls and Withdrawals  ANPRM 08/19/99 (64 FR 
45383)  NPRM 04/00/03

Regulations for Human Blood and Blood Components Intended for 
Transfusion or For Further Manufacturing Use  NPRM 04/00/03

Reqs. for Testing Human Blood Donors for Evid. of Infection Due to 
Communicable Disease Agents  NPRM 08/19/99 (64 FR 45340)  Final Action 
06/11/01 (66 FR 31146)

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)  DFR: Confirmation in Part and Tech. Amendment 01/10/01 
(66 FR 1834)  Final Action 08/06/01 (66 FR 40886)

Revisions to Labeling and Storage Requirements for Blood and Blood 
Components, Including Source Plasma  NPRM 04/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Paula S. McKeever, Regulatory Policy Analyst, 
Department of Health and Human Services, Food and Drug Administration, 
Suite 200N (HFM-17), Center for Biologics Evaluation and Research, 1401 
Rockville Pike, Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 594-1944

Related RIN: Related To 0910-AB76
RIN: 0910-AB26
_______________________________________________________________________




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

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351 to 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                            01/00/03

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Brian L. Pendleton, Regulatory Counsel, Office of 
Regulatory Policy, Department of Health and Human Services, Food and 
Drug Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AB34

[[Page 33061]]

_______________________________________________________________________




739. CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS

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

Unfunded Mandates: Undetermined

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

CFR Citation: 21 CFR 225

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/03

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
_______________________________________________________________________




740. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR 
HOLDING DIETARY INGREDIENTS AND DIETARY SUPPLEMENTS

Priority: Economically Significant. Major under 5 USC 801.

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

Legal Authority: 21 USC 321; 21 USC 342; 21 USC 343; 21 USC 348; 21 USC 
371; 21 USC 374; 21 USC 381; 21 USC 393; 42 USC 264

CFR Citation: 21 CFR 111

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Karen Strauss, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, (HFS-820), 200 
C Street SW., Washington, DC 20204
Phone: 202 205-4168
Fax: 202 205-5295
Email: [email protected]

RIN: 0910-AB88
_______________________________________________________________________




741. REQUIREMENTS FOR SUBMISSION OF LABELING FOR HUMAN PRESCRIPTION 
DRUGS AND BIOLOGICS IN ELECTRONIC FORMAT

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 353; 21 USC 
355; 21 USC 360; 21 USC 371; 21 USC 374; 21 USC 379e; ...

CFR Citation: 21 CFR 314; 21 CFR 601

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is proposing to amend 
its regulations governing the format in which certain labeling in new 
drug applications, abbreviated new drug applications, certain 
biological license applications, supplements, and annual reports is 
required to be submitted. The proposal would require that certain 
labeing content described under section 201.160(d)(3) be submitted to 
FDA in electronic format.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/02

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Virginia G. Beakes, Regulatory Counsel, Office of 
Regulatory Policy, 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-AB91
_______________________________________________________________________




742. 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

[[Page 33062]]

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                            10/00/02

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Room 15-61 
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AB96
_______________________________________________________________________




743. STATUS REPORTS OF DISTRIBUTION AND USE INFORMATION FOR 
ANTIMICROBIAL ANIMAL DRUG PRODUCTS USED IN FOOD-PRODUCING ANIMALS

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 360b(e); 21 USC 371(a)

CFR Citation: 21 CFR 510.300

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. 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 assist in 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 to 
help assess the correlation between resistance in human pathogens and 
the use of antimicrobial drugs in food-producing animals.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/00/03

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
_______________________________________________________________________




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

Priority: Economically Significant. Major under 5 USC 801.

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

Legal Authority: 21 USC 321; 21 USC 342; 21 USC 371; 21 USC 381; 21 USC 
393; 42 USC 243; 42 USC 264; 42 USC 271; ...

CFR Citation: 21 CFR 16; 21 CFR 116; 21 CFR 118

Legal Deadline: None

Abstract: The President's Council on Food Safety was established in 
August 1998 to improve the safety of the food supply through science-
based regulations and well-coordinated inspection, enforcement, 
research, and education programs. The Council has identified egg safety 
as one component of the public health issue of food safety that 
warrants immediate Federal, interagency action.
In July 1999, the Food and Drug Administration (FDA) and the Food 
Safety Inspection Service (FSIS) committed to developing an action plan 
to address the presence of salmonella enteritidis (SE) in shell eggs 
and egg products using a farm-to-table approach. FDA and FSIS held a 
public meeting on August 26, 1999, to obtain stakeholder input on the 
draft goals, as well as to further develop the objectives and action 
items for the action plan. The Egg Safety Action Plan was announced on 
December 11, 1999. The goal of the Action Plan is to reduce egg-related 
SE illnesses by 50 percent by 2005 and eliminate egg-related SE 
illnesses by 2010.
The Egg Safety Action Plan consists of eight objectives covering all 
stages of the farm-to-table continuum as well as support functions. On 
March 30, 2000 (Columbus, OH), April 6, 2000 (Sacramento, CA), and July 
31, 2000 (Washington, DC), joint public meetings were held by FDA and 
FSIS to solicit and discuss information related to the implementation 
of the objectives in the Egg Safety Action Plan.
In accordance with discussions at the public meetings, FDA intends to 
publish a proposed rule to require that shell eggs be produced under an 
SE risk reduction plan that is designed to prevent transovarian SE from 
contaminating eggs at the farm during production.
Because egg safety is a farm-to-table effort, FDA intends to include in 
its proposal certain provisions of the 1999 Food Code that are relevant 
to how eggs are handled, prepared, and served at certain retail 
establishments. In addition, the agency plans to propose specific 
requirements for certain retail establishments that serve populations

[[Page 33063]]

most at-risk of egg-related illness (i.e., the elderly, children, and 
the immunocompromised).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Rebecca Buckner, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, 3B-033/HFS-
306, Office of Plant and Dairy Foods and Beverages, Center for Food 
Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, 
MD 20740
Phone: 301 436-1486
Fax: 301 436-2632
Email: [email protected]

Nancy Bufano, Consumer Safety Officer, Department of Health and Human 
Services, Food and Drug Administration, HFS-306, Center for Food Safety 
and Applied Nutrition, 200 C Street SW., Washington, DC 20204
Phone: 202 401-2022
Fax: 202 205-4422
Email: [email protected]

RIN: 0910-AC14
_______________________________________________________________________




745. INSTITUTIONAL REVIEW BOARDS: REGISTRATION REQUIREMENTS

Priority: Info./Admin./Other

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

CFR Citation: 21 CFR 56.106

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Room 15-61 
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AC17
_______________________________________________________________________




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

Priority: Other Significant

Legal Authority: 21 USC 321(n); 21 USC 352; 21 USC 355; 21 USC 371(a); 
21 CFR 201.51; 21 CFR 201.100; 21 CFR 314.125

CFR Citation: 21 CFR 201.323(c)

Legal Deadline: None

Abstract: The proposed rule would revise 21 CFR 323(c) to permit small-
volume parenterals and pharmacy bulk packages that contain no more than 
25 ug/L of aluminum to state ``contains no more than 25ug/L'' rather 
than the exact amount of aluminum.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/02

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0910-AC18
_______________________________________________________________________




747. USE OF MATERIALS DERIVED FROM BOVINE AND OVINE ANIMALS IN FDA-
REGULATED PRODUCTS

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

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: The U.S. Department of Agriculture's Animal and Plant Health 
Inspection Service maintains, by regulation in 9 CFR 94.18(a), a list 
of countries: 1) where bovine spongiform encephalopathy (BSE) exists; 
and 2) that present an undue risk of introducing BSE into the United 
States. This proposed rule would restrict, in FDA-regulated products, 
the use of most materials derived from bovine and ovine animals born, 
raised, or slaughtered in a country listed in 9 CFR 94.18(a). In 
addition, there would be a waiver provision that could be used under 
appropriate criteria.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/03

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Rebecca Buckner, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, 3B-033/HFS-
306, Office of Plant and Dairy Foods and Beverages, Center for Food 
Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, 
MD 20740
Phone: 301 436-1486
Fax: 301 436-2632
Email: [email protected]

RIN: 0910-AC19
_______________________________________________________________________




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

Priority: Info./Admin./Other

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

[[Page 33064]]

CFR Citation: Not Yet Determined

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Room 15-61 
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AC20
_______________________________________________________________________




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

Priority: Other Significant

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

CFR Citation: Not Yet Determined

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/00/03

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Rebecca Buckner, Consumer Safety Officer, Department of 
Health and Human Services, Food and Drug Administration, 3B-033/HFS-
306, Office of Plant and Dairy Foods and Beverages, Center for Food 
Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, 
MD 20740
Phone: 301 436-1486
Fax: 301 436-2632
Email: [email protected]

RIN: 0910-AC21
_______________________________________________________________________




750. EXCEPTION FROM GENERAL REQUIREMENTS FOR INFORMED CONSENT; REQUEST 
FOR COMMENTS AND INFORMATION

Priority: Other Significant

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

CFR Citation: 21 CFR 50.23

Legal Deadline: None

Abstract: FDA is proposing to clarify its regulations about the 
exception from the general requirement for informed consent in life-
threatening situations necessitating the use of a test article. This 
clarification will explain how the regulations would apply during 
emergencies, including a response to chemical or biological terrorism, 
requiring the use of investigational products regulated by FDA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Bonnie M. Lee, Associate Director for Human Subject 
Protection Policy, Department of Health and Human Services, Food and 
Drug Administration, Room 9C24 (HF-34), Office of Good Clinical 
Practice, Office of Science Coordination & Communication, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 827-1259
Fax: 301 827-1169
Email: [email protected]

RIN: 0910-AC25
_______________________________________________________________________




751. BAR CODE LABEL REQUIREMENTS FOR HUMAN DRUG PRODUCTS

Priority: Other Significant. Major under 5 USC 801.

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

CFR Citation: 21 CFR 201.25; 21 CFR 601.67

Legal Deadline: None

Abstract: This regulation is one component of the Secretary's 
initiative to reduce medical errors. The proposal would require human 
drug products and biological products and possibly other products to 
have a bar code. The bar code would contain certain information about 
the product and,

[[Page 33065]]

when used in conjunction with bar code scanners and computer equipment, 
would help reduce the number of medication errors.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Room 15-61 
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AC26
_______________________________________________________________________




752.  MEDICAL DEVICES; ANESTHESIOLOGY DEVICES; PROPOSED 
RECLASSIFICATION OF PRESSURE REGULATORS FOR USE WITH MEDICAL OXYGEN

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 351; 21 USC 360c(e)(1); 21 USC 371

CFR Citation: 21 CFR 868.2700; 21 CFR 868.5905

Legal Deadline: None

Abstract: The Food and Drug Administration is proposing to reclassify 
pressure regulators for use with medical oxygen from class I to class 
II and to establish a special control for oxygen pressure regulators to 
address problems of fire and explosion associated with use of these 
devices. The special control will be a guidance document that includes 
standardized testing, performance, and labeling guidance for industry. 
Devices that meet the special control will be exempt from the premarket 
notification requirements of the act. The agency believes it is taking 
a least burdensome approach for industry. This rule will enable all 
manufacturers to most easily comply by implementing a phase-in 
compliance approach that will minimize the cost. FDA seeks to 
reclassify these devices under section 513(e)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360c(e)(1)).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Federalism:  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
Fax: 301 594-4795
Email: [email protected]

RIN: 0910-AC30
_______________________________________________________________________




753.  MEDICAL DEVICES; PATIENT EXAMINATION AND SURGEONS' GLOVES; 
ADULTERATION

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 351; 21 USC 352; 21 USC 
371; 21 USC 374

CFR Citation: 21 CFR 800.20

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is proposing to amend 
the sampling plans, test method, and acceptable quality levels in 21 
CFR 800.20. As prescribed by this regulation, FDA samples patient 
examination and surgeons' gloves and examines them for visual defects 
and water leaks. Glove lots are considered adulterated if they do not 
meet specified quality levels. This proposal would clarify sampling 
plans and the scoring of defects, lower acceptance rates for leaking 
gloves, raise rejection rates for leaking gloves, and add tightened 
inspection schemes for reexamined glove lots. The rule is intended to 
facilitate industry compliance and enhance the safety and effectiveness 
of gloves.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Undetermined

Federalism:  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
Fax: 301 594-4795
Email: [email protected]

RIN: 0910-AC32
_______________________________________________________________________




754.  AMENDMENTS TO THE PERFORMANCE STANDARD FOR DIAGNOSTIC X-RAY 
SYSTEMS AND THEIR MAJOR COMPONENTS

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 301 et seq; 21 USC 360kk et seq

CFR Citation: 21 CFR 1020.30; 21 CFR 1020.31; 21 CFR 1020.32

Legal Deadline: None

Abstract: This rule amends the performance standard for diagnostic x-
ray systems and their components in 21 CFR 1020.30, 1020.31, and 
1020.32 to address the changes in technology and practice and to fully 
utilize the currently accepted metric system.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department 
of Health and Human Services, Food and Drug Administration, HFZ-215, 
Center for Devices and Radiological Health, 1350 Piccard Drive, 
Rockville, MD 20850
Phone: 301 827-2974
Fax: 301 594-4795
Email: [email protected]

RIN: 0910-AC34

[[Page 33066]]

_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




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

Priority: Other Significant

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

CFR Citation: 21 CFR 50; 21 CFR 312

Legal Deadline: None

Abstract: The final rule would establish 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. Under Federal law, 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, contrary to the 
best interests of recipients, or contrary to national security 
interests.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              10/05/99                    64 FR 54180
Final Action                    07/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: Federal

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Room 15-61 
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AA89
_______________________________________________________________________




756. LABELING FOR HUMAN PRESCRIPTION DRUGS; REVISED FORMAT

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

Unfunded Mandates: Undetermined

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

CFR Citation: 21 CFR 201

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/22/00                    65 FR 81082
NPRM Comment Period End         03/22/01
NPRM Comment Period Reopened    03/30/01
NPRM Comment Period Reopening 
End                             06/22/01
Final Action                    09/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0910-AA94
_______________________________________________________________________




757. USE OF OZONE-DEPLETING SUBSTANCES

Priority: Other Significant

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

CFR Citation: 21 CFR 2

Legal Deadline: None

Abstract: FDA is amending the regulation that permits the use of ozone-
depleting substances in particular circumstances to set the standard 
FDA will use to determine when the use of ozone-depleting substances 
(ODS) is no longer essential under the Clean Air Act (CAA) and set a 
new standard to determine when a new essential-use designation should 
be granted after the effective date of the rule. FDA is also amending 
the regulations to better conform to other statutes and regulations 
relating to ozone-depleting substances to eliminate potential confusion 
and conflicts. FDA is eliminating out-of-date transitional provisions 
and making other nonsubstantive housekeeping changes to its regulations 
on ozone-depleting substances. The intended effect of the rule is to 
protect the health and safety of medical product users while complying 
with the CAA and the Montreal Protocol.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

ANPRM                           03/06/97                    62 FR 10242
ANPRM Comment Period End        05/05/97
NPRM                            09/01/99                    64 FR 47719
NPRM Comment Period End         11/30/99
Final Action                    10/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Office of 
Regulatory Policy, Department of Health and Human Services, Food and 
Drug Administration, Suite 3037 (HFD-7), Center for Drug Evaluation and 
Research, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562
Email: [email protected]

RIN: 0910-AA99

[[Page 33067]]

_______________________________________________________________________




758. FDA EXPORT REFORM AND ENHANCEMENT ACT OF 1996; REPORTING AND 
RECORDKEEPING REQUIREMENTS FOR UNAPPROVED OR VIOLATIVE PRODUCTS IMPORTED 
FOR FURTHER PROCESSING OR INCORPORATION AND LATER EXPORT

Priority: Substantive, Nonsignificant

Legal Authority: 15 USC 1453 to 1455; 21 USC 321; 21 USC 343; 21 USC 
352; 21 USC 355; 21 USC 360b; 21 USC 362; 21 USC 371; 21 USC 374; 21 
USC 381; 21 USC 382; 21 USC 393; 42 USC 216

CFR Citation: 21 CFR 1.84

Legal Deadline: None

Abstract: The final rule would establish reporting and recordkeeping 
requirements to implement sections 801(d)(3) and 801(d)(4) of the 
Federal Food, Drug, and Cosmetic Act (the Act) as amended by the Food 
and Drug Administration (FDA) Export Reform and Enhancement Act of 
1996. Section 801(d)(3) of the Act provides that, under prescribed 
conditions, drug and device components, food and color additives, 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                    11/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Room 15-61 
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AB24
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 351

CFR Citation: 21 CFR 610.11(g)

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Direct Final Rule               04/20/98                    63 FR 19399
Proposed Rule - Companion 
Document to Direct Final Rule   04/20/98                    63 FR 19431
Direct Final Rule Confirmation 
in Part                         08/05/98                    63 FR 41718
Direct Final Rule Withdrawn in 
Part                            08/05/98                    63 FR 41718
Final Action                    03/00/03

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
_______________________________________________________________________




760. SUPPLEMENTS AND OTHER CHANGES TO AN APPROVED APPLICATION

Priority: Other Significant

Legal Authority: 21 USC 356a

CFR Citation: 21 CFR 314

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/28/99                    64 FR 34608
Final Action                    01/00/03

Regulatory Flexibility Analysis Required: No

[[Page 33068]]

Government Levels Affected: None

Agency Contact: Howard P. Muller, Office of Regulatory Policy, 
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
_______________________________________________________________________




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

Priority: Economically Significant. Major under 5 USC 801.

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

Legal Authority: 21 USC 321; 21 USC 331; 21 USC 342; 21 USC 343; 21 USC 
348; 21 USC 371; ...

CFR Citation: 21 CFR 101

Legal Deadline: None

Abstract: Section 403(q) of the Federal Food, Drug, and Cosmetic Act, 
which was added by the Nutrition Labeling and Education Act of 1990 
(NLEA), requires that the label or labeling of food products bear 
nutrition information. Among other things, section 403(q) of the Act 
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 NLEA 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
NPRM Comment Period Reopened    12/05/00                    65 FR 75887
NPRM Comment Period End         01/19/01
Final Rule                      09/00/02

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
Fax: 202 205-5532
Email: [email protected]

RIN: 0910-AB66
_______________________________________________________________________




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

Priority: Economically Significant. Major under 5 USC 801.

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

CFR Citation: 21 CFR 606; 21 CFR 610

Legal Deadline: None

Abstract: This rulemaking is one of a number of actions being taken to 
amend the biologics regulations to remove, revise, or update the 
regulations applicable to blood, blood components, and blood 
derivatives. These actions are based on a comprehensive review of the 
regulations performed by FDA, and are also based on reports by the U.S. 
House of Representatives Committee on Government Reform and Oversight, 
Subcommittee on House Resources and Intergovernmental Relations, the 
General Accounting Office, and the Institute of Medicine, as well as 
public comments. In this rulemaking, FDA will amend the biologics 
regulations to require that blood establishments prepare and follow 
written procedures for appropriate action when it is determined that 
blood and blood components pose an increased risk for transmitting 
hepatitis C virus (HCV) infection because they have been collected from 
a donor who, at a later date, tested reactive for evidence of HCV. The 
HIV lookback regulations will be amended for consistency.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/16/00                    65 FR 69377
NPRM Comment Period End         02/14/01
Final Action                    09/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Paula S. McKeever, Regulatory Policy Analyst, 
Department of Health and Human Services, Food and Drug Administration, 
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

Related RIN: Related To 0910-AB26
RIN: 0910-AB76
_______________________________________________________________________




763. ANTIBIOTIC RESISTANCE LABELING

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

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

CFR Citation: 21 CFR 201.24

Legal Deadline: None

Abstract: The final rule would require the inclusion of certain 
statements about the use of antibiotics in the prescription drug 
labeling of these products. These statements will emphasize the proper 
use of these products in an effort to reduce the development of drug-
resistant bacterial strains.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/19/00                    65 FR 56511
Final Rule                      12/00/02

Regulatory Flexibility Analysis Required: No

[[Page 33069]]

Government Levels Affected: None

Agency Contact: Christine F. 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
_______________________________________________________________________




764. FOOD ADDITIVES: FOOD CONTACT SUBSTANCES NOTIFICATION SYSTEM

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 321 et seq

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

Legal Deadline: None

Abstract: In November 1997, Congress amended the Federal Food, Drug, 
and Cosmetic Act (FFD&C) to establish a notification process whereby 
manufacturers and suppliers of components of food contact materials may 
notify FDA 120 days prior to marketing a new food contact substance. If 
FDA does not object to the notification within 120 days, the substance 
may be marketed with the same status as a regulated food additive. FDA 
is authorized to publish regulations outlining the information required 
to be submitted in premarket notifications for food-contact substances 
submitted to the agency. FDA is also authorized to publish regulations 
that identify when a food additive petition is required in lieu of a 
premarket notification. FDA is not required to accept a premarket 
notification in any fiscal year for which an appropriation is not 
specifically made for this program. FDA expects that the majority of 
food-contact substances that are currently the subject of food additive 
petitions will be the subject of premarket notifications. FDA also 
expects that substances currently reviewed under the agency's threshold 
of regulation process will be reviewed as premarket notifications under 
the new process. Unlike food additive regulations, premarket 
notifications will be specific to the notifier. The proposed use of a 
similar or identical substance produced by another manufacturer will 
require a separate premarket notification submission. Also, unlike food 
additive petitions, the existence of the notification and any otherwise 
releasable data within the notification is not publicly available until 
the 120-day period has expired. FDA maintains a publicly available list 
of effective premarket notifications to assist manufacturers, 
distributors, and users of food packaging and other food-contact 
materials. FDA published a proposed rule on the notification process 
for food contact substances on July 13, 2000. The comment period on the 
proposed rule ended on September 26, 2000. Three comments were received 
on the proposed rule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/13/00                    65 FR 43269
Final Rule                      05/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Mitchell Alan Cheeseman, Consumer Safety Officer, 
Department of Health and Human Services, Food and Drug Administration, 
HFS-205, Center for Food Safety and Applied Nutrition, 5100 Paint 
Branch Parkway, College Park, MD 20704
Phone: 202 418-3083
Fax: 202 418-3131
Email: [email protected]

RIN: 0910-AB94
_______________________________________________________________________




765. MARKING REQUIREMENTS FOR AND PROHIBITIONS ON THE REIMPORTATION OF 
IMPORTED FOOD PRODUCTS THAT HAVE BEEN REFUSED ADMISSION INTO THE UNITED 
STATES

Priority: Other Significant

Legal Authority: 15 USC 145; 15 USC 1454; 15 USC 1455; 21 USC 321; 21 
USC 343; 21 USC 352; 21 USC 355; 21 USC 360b; 21 USC 362; 21 USC 371; 
21 USC 374; 21 USC 381; 21 USC 382; 21 USC 393; 42 USC 216; 42 USC 241; 
42 USC 243; 42 USC 262; 42 USC 264

CFR Citation: 21 CFR 1.98

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/22/01                     66 FR 6502
NPRM Comment Period End         04/09/01
Final Rule                      06/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Philip L. Chao, Senior Policy Analyst, Department of 
Health and Human Services, Food and Drug Administration, Room 15-61 
(HF-23), Office of Policy, Planning and Legislation, 5600 Fishers Lane, 
Rockville, MD 20857
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AB95
_______________________________________________________________________




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

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

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

CFR Citation: 21 CFR 314; 21 CFR 601

Legal Deadline: None

Abstract: The agency plans to publish a final rule that would amend its 
new drug and biological product regulations to identify the information 
needed to provide substantial evidence of the effectiveness 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. Efficacy studies in humans cannot be conducted

[[Page 33070]]

ethically if: 1) the studies would involve administering a potentially 
lethal or permanently disabling toxic substance or organism to healthy 
human volunteers; and 2) 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 recognizes the 
importance of improving medical responses to the use of lethal or 
permanently disabling chemical, biological, radiological, and nuclear 
substances in order to protect individuals exposed to these substances.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/05/99                    64 FR 53960
Final Action                    05/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Wayne H. Mitchell, Regulatory Counsel, Office of 
Regulatory Policy, 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
_______________________________________________________________________




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

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

Unfunded Mandates: Undetermined

Legal Authority: 21 USC 321; 21 USC 343; 21 USC 346; 21 USC 346a; 21 
USC 348; 21 USC 350a; 21 USC 350b; 21 USC 351 to 353; 21 USC 355; 21 
USC 360; 21 USC 360c to 360f; 21 USC 360h to 360j; 21 USC 371; 21 USC 
379e; 21 USC 381; 41 USC 216; 41 USC 241; 41 USC 262; 41 USC 263b to 
263n

CFR Citation: 21 CFR 50; 21 CFR 56

Legal Deadline: Other, Statutory, April 17, 2001, The Children's Health 
Act of 2000 requires that, within six months of the date of its 
enactment on 10/17/2000, FDA adopt existing HHS regulations providing 
additional protections for children involved as subjects in research. 
FDA published an interim rule in April 2001.

Abstract: The final rule will finalize the interim rule that published 
in April 2001 and provide additional protections for children involved 
as subjects in clinical investigations of FDA-regulated products, as 
required by the Children's Health Act of 2000.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Rule                    04/24/01                    66 FR 20589
Final Rule                      09/00/02

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0910-AC07
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

CFR Citation: 21 CFR 310.500

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/24/00                    65 FR 70538
Final Rule                      10/00/02

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Mary E. Catchings, Regulatory Counsel, Office of 
Regulatory Policy, 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
_______________________________________________________________________




769.  POSTMARKET SURVEILLANCE

Priority: Substantive, Nonsignificant

Legal Authority: 21 USC 331; 21 USC 352; 21 USC 360i; 21 USC 360l; 21 
USC 371; 21 USC 374; ...

CFR Citation: 21 CFR 822

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is implementing a 
final rule for the postmarket surveillance provisions of the Federal 
Food, Drug, and Cosmetic Act (the Act), as amended by the Food and Drug 
Administration Modernization Act of 1997 (FDAMA). The purpose of this 
rule is to provide for the collection of useful data about devices that 
can reveal unforeseen adverse events or other information necessary to 
protect the public health.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/29/00                    65 FR 52376
NPRM Comment Period End         11/27/00
Final Action                    06/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department 
of Health and Human Services, Food and Drug Administration, HFZ-215, 
Center for Devices and Radiological Health, 1350 Piccard Drive, 
Rockville, MD 20850
Phone: 301 827-2974
Fax: 301 594-4795
Email: [email protected]

RIN: 0910-AC31
_______________________________________________________________________




770.  REDACTING 510(K) SUBMISSIONS

Priority: Substantive, Nonsignificant

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

[[Page 33071]]

USC 360j; 21 USC 371; 21 USC 374; ...

CFR Citation: 21 CFR 807

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is issuing a final 
rule that amends the premarket notification provisions of our 
regulations at 21 CFR part 807 to require a 510(k) holder to submit a 
redacted version of a medical device premarket notification submission 
once we find the device to be substantially equivalent to another 
legally marketed device. The purpose of this requirement is to 
facilitate the release and dissemination of useful information to the 
health care community, the medical device industry, and the public, 
while providing the applicant a more timely opportunity to protect 
trade secret and confidential commercial information contained in the 
premarket notification. FDA will provide the redacted version to the 
public through the internet. The information to be released is 
information to which the public is entitled under the Federal Food, 
Drug, and Cosmetic Act, the Freedom of Information Act, and FDA's 
Public Information regulation. The regulation does not require 
submission of a redacted version of any premarket notification received 
by FDA prior to the effective date of the regulation.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Joseph M. Sheehan, Chief, Regulations Staff, Department 
of Health and Human Services, Food and Drug Administration, HFZ-215, 
Center for Devices and Radiological Health, 1350 Piccard Drive, 
Rockville, MD 20850
Phone: 301 827-2974
Fax: 301 594-4795
Email: [email protected]

RIN: 0910-AC33
_______________________________________________________________________




771.  SECTION 17 BEST PHARMACEUTICALS FOR CHILDREN ACT

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

Legal Authority: 21 USC 355a

CFR Citation: Not Yet Determined

Legal Deadline: Final, Statutory, January 4, 2003.

Abstract: To require drug product labeling to include a toll-free 
number for reports of adverse events regarding drug products, and a 
statement that the number is to be used for reporting purposes only and 
not to receive medical advice.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              12/00/02

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Ann L. Simoneau, Regulatory Counsel, Department of 
Health and Human Services, Food and Drug Administration, Suite 3037, 
HFD-7, 1451 Rockville Pike, Rockville, MD 20852
Phone: 301 594-2041
Fax: 301 827-5562

RIN: 0910-AC35
_______________________________________________________________________


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


Food and Drug Administration (FDA)



_______________________________________________________________________




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

Priority: Other Significant

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

CFR Citation: 21 CFR 106; 21 CFR 107

Legal Deadline: None

Abstract: The agency published a proposed rule on July 9, 1996 that 
would establish current good manufacturing practice regulations, 
quality control procedures, quality factors, notification requirements, 
and records and reports for the production of infant formula. This 
proposal was issued in response to the 1986 Amendments to the Infant 
Formula Act of 1980.

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 09/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Darla Danford, Supervisory Nutritionist, Department of 
Health and Human Services, Food and Drug Administration, (HFS-800), 
Center for Food Safety and Applied Nutrition, 5100 Paint Branch 
Parkway, College Park, MD 20740
Phone: 301 436-2373

RIN: 0910-AA04
_______________________________________________________________________




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

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

Unfunded Mandates: Undetermined

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

CFR Citation: 21 CFR 511; 21 CFR 512

Legal Deadline: None

Abstract: FDA is proposing to revise its regulations governing 
investigational use of new animal drugs by proposing to delete 21 CFR 
511 and establish in 21 CFR part 512 revised investigational use of new 
animal drug regulations.

[[Page 33072]]

The investigational use new animal drug regulations are expected to 
include regulations to implement provisions of the Animal Drug 
Availability Act of 1996, specifically presubmission conferences, and 
implement parts of the President's National Performance Report, 
``Reinventing the Regulation of Animal Drugs,'' May 1996. In the 
reinventing regulations report, FDA proposed to revise its regulations 
to reflect numerous new process changes and programs that will enable a 
more streamlined animal drug application review and approval process, 
and that would result in less regulatory burden upon industry and FDA 
while maintaining the safety and effectiveness of new animal drugs. In 
addition, FDA is initiating a review of this rule under section 610 of 
the Regulatory Flexibility Act. The purpose of the section 610 review 
is to determine if the rule should be amended to minimize adverse 
economic impacts on small entities. FDA will solicit and consider 
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
End Review                      12/00/03

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0910-AB02
_______________________________________________________________________




774. ELIGIBILITY DETERMINATION FOR DONORS OF HUMAN CELLS, TISSUES, AND 
CELLULAR AND TISSUE-BASED PRODUCTS (HCT/PS)

Priority: Other Significant

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

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

Legal Deadline: None

Abstract: The Food and Drug Administration is requiring certain 
manufacturers of human cells, tissues, and cellular and tissue-based 
products to take actions to screen 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 
cells, tissues, and cellular and tissue-based products regulated as 
drugs, medical devices, and/or biological products to incorporate the 
new donor suitability requirements into existing good manufacturing 
practice regulations for those products.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/30/99                    64 FR 52696
NPRM Comment Period End         12/29/99
NPRM Comment Period Reopened    04/18/00                    65 FR 20774
NPRM Comment Period Reopened End07/17/00
Final Action                     To Be                       Determined

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: Paula S. McKeever, Regulatory Policy Analyst, 
Department of Health and Human Services, Food and Drug Administration, 
Suite 200N (HFM-17), Center for Biologics Evaluation and Research, 1401 
Rockville Pike, Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 594-1944

RIN: 0910-AB27
_______________________________________________________________________




775. CURRENT GOOD TISSUE PRACTICE FOR MANUFACTURERS OF HUMAN CELLS, 
TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/PS)

Priority: Other Significant

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

CFR Citation: 21 CFR 1271

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is proposing to 
require certain manufacturers of human cells and tissue to follow 
current good tissue practice (GTP), which includes proper handling, 
processing, and storage of human cells and tissue, recordkeeping, the 
maintenance of a quality program, labeling, reporting, inspections, and 
enforcement.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/08/01                     66 FR 1508
NPRM Comment Period End         05/08/01
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

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

Agency Contact: Paula S. McKeever, Regulatory Policy Analyst, 
Department of Health and Human Services, Food and Drug Administration, 
Suite 200N (HFM-17), Center for Biologics Evaluation and Research, 1401 
Rockville Pike, Rockville, MD 20852-1448
Phone: 301 827-6210
Fax: 301 594-1944

RIN: 0910-AB28
_______________________________________________________________________




776. PREMARKET NOTICE CONCERNING BIOENGINEERED FOODS

Priority: Other Significant

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

CFR Citation: 21 CFR 192; 21 CFR 592

Legal Deadline: None

Abstract: The Food and Drug Administration (FDA) is requiring the

[[Page 33073]]

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0910-AC15
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Food and Drug Administration (FDA)



_______________________________________________________________________




777. EXPORTS; NOTIFICATION AND RECORDKEEPING REQUIREMENTS

Priority: Routine and Frequent

CFR Citation: 21 CFR 1.101

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    12/19/01                    66 FR 65429

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Philip L. Chao
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AB16
_______________________________________________________________________




778. FOREIGN ESTABLISHMENT REGISTRATION AND LISTING

Priority: Other Significant

CFR Citation: 21 CFR 207.3; 21 CFR 207.7; 21 CFR 207.10; 21 CFR 207.20; 
21 CFR 207.21; 21 CFR 207.25; 21 CFR 207.37; 21 CFR 207.40; 21 CFR 
607.3; 21 CFR 607.7; 21 CFR 607.20; 21 CFR 607.22; 21 CFR 607.25; 21 
CFR 607.26; 21 CFR 607.31; 21 CFR 607.35; 21 CFR 607.37; 21 CFR 607.40; 
21 CFR 607.65; 21 CFR 807.3; 21 CFR 807.20; 21 CFR 807.25; 21 CFR 
807.40

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/27/01                    66 FR 59138

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Philip L. Chao
Phone: 301 827-0587
Fax: 301 827-4774
Email: [email protected]

RIN: 0910-AB21
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    02/01/02                     67 FR 4904

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0910-AB39
_______________________________________________________________________




780. STATE CERTIFICATION OF MAMMOGRAPHY FACILITIES

Priority: Other Significant

CFR Citation: 21 CFR 900.2; 21 CFR 900.20 to 900.25

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      02/06/02                     67 FR 5446

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

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

Agency Contact: Ruth Fischer
Phone: 301 827-2960

RIN: 0910-AB98
_______________________________________________________________________




781. ADDITIONAL CRITERIA AND PROCEDURES FOR CLASSIFYING OVER-THE-COUNTER 
DRUGS AS GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED

Priority: Economically Significant

CFR Citation: 21 CFR 330

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    01/23/02                     67 FR 3060

Regulatory Flexibility Analysis Required: Yes

Government Levels Affected: None

Agency Contact: Gerald M. Rachanow
Phone: 301 827-2241
Fax: 301 827-2315
Email: [email protected]

RIN: 0910-AC22


[[Page 33074]]

_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 11131

CFR Citation: 45 CFR 60.7

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/24/98                    63 FR 71255
NPRM Comment Period End         02/22/99
Second NPRM                     10/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: John M. Heyob, Director, Division of Practitioner Data 
Banks, Department of Health and Human Services, Public Health Service, 
Suite 300, 7519 Standish Place, Rockville, MD 20957
Phone: 301 443-2300
Fax: 301 443-6725

RIN: 0906-AA41
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 5; 42 CFR 51c

Legal Deadline: None

Abstract: This rule would consolidate the process for designating areas 
of health professional shortage and medical underservice that apply in 
several department programs, and would improve the criteria for 
designating medically underserved populations (MUPs) and Primary Care 
Health Professional Shortage Areas (HPSAs). This NPRM will address 
issues raised by comments received in a previous NPRM, dated September 
1, 1998.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/01/98                    63 FR 46538
NPRM Comment Period End         01/04/99
Second NPRM                     11/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Jerilyn A. Thornburg RN., MPH., Chief, Shortage 
Designation Branch, Department of Health and Human Services, Health 
Resources and Services Administration, Room 91C4, National Center for 
Health Workforce Analysis, Bureau of Health Professions, 4350 East-West 
Highway, Bethesda, MD 20814
Phone: 301 594-0197
Email: [email protected]

RIN: 0906-AA44
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1396r-2

CFR Citation: 45 CFR 60

Legal Deadline: None

Abstract: Public Law 100-93 amended section 1921 of the Social Security 
Act to require that each State have in effect a system of reporting 
disciplinary licensure actions taken against all licensed health care 
practitioners and entities. It also requires States to report any 
negative action or finding which a peer review organization, private 
accreditation entity or a State has concluded against a health care 
practitioner or entity. Section 1921 directs the Secretary to provide 
for maximum appropriate coordination in the implementation of these 
reporting requirements with those of the Health Care Quality 
Improvement Act of 1986 (title IV of Pub. L. 99-660). Section 1921 
requirements will be incorporated into the National Practitioner Data 
Bank (NPDB).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: John M. Heyob, Director, Division of Practitioner Data 
Banks, Department of Health and Human Services, Public Health Service, 
Suite 300, 7519 Standish Place, Rockville, MD 20957
Phone: 301 443-2300
Fax: 301 443-6725

RIN: 0906-AA57

[[Page 33075]]

_______________________________________________________________________


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


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 100

Legal Deadline: None

Abstract: This NPRM proposes several changes to the Vaccine Injury 
Table (Table) (42 CFR 100.3), which will have an effect upon petitions 
for compensation under the National Childhood Vaccine Injury 
Compensation Program including the following: 1) amending the Table by 
adding the injury of intussusception to the Table for vaccines 
containing live, oral, rhesus-based rotavirus, a category of rotavirus 
vaccines; 2) removing residual seizure disorder and early onset Hib 
disease from the Table's Qualifications and Aids to Interpretation; 3) 
removing hemophilus influenzae type b polysaccharide vaccines from and 
adding pneumococcal conjugate vaccines to the Table; and 4) changing 
certain dates of coverage under the Table.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/05/01                    66 FR 36735
Final Rule                      06/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Geoffrey Evans, Medical Director, Division of Vaccine 
Injury Compensation, BHPR, Department of Health and Human Services, 
Health Resources and Services Administration, Room 8A-45, 5600 Fishers 
Lane, Rockville, MD 20857
Phone: 301 443-4998
Fax: 301 443-8196
Email: [email protected]

Related RIN: Duplicate of 0906-AA58
RIN: 0906-AA55
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Health Resources and Services Administration (HRSA)



_______________________________________________________________________




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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Duplicate of 0906-AA55          05/01/02

RIN: 0906-AA58
_______________________________________________________________________




787. ADOPTION OF THE INTERIM FINAL RULE AS A FINAL RULE WITH AMENDMENTS 
FOR RICKY RAY HEMOPHILIA

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 130

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      11/23/01                    66 FR 58667

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Thomas C. Croft
Phone: 301 443-2300

RIN: 0906-AA59

_______________________________________________________________________


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


Indian Health Service (IHS)



_______________________________________________________________________




788. TRIBAL SELF-GOVERNANCE AMENDMENTS

Priority: Other Significant

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

CFR Citation: None

Legal Deadline: NPRM, Statutory, August 18, 2001, Expiration of 
authority to promulgate final rule: May 18, 2002.

Abstract: Title V of the Tribal Self-Governance Amendments of 2000 
(Pub. L. 106-260) made permanent the demonstration program which 
allowed tribes full control over the operation and redesign of various 
activities historically managed by IHS. The proposal includes 
provisions that govern how IHS and Tribes will carry out their 
responsibilities under the Act.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/14/02                     67 FR 6998
NPRM Comment Period End         04/15/02
Final Rule                      05/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Federal, Tribal

Agency Contact: Paula K. Williams, Director of Tribal Self-Governance, 
Department of Health and Human Services, Indian Health Service, Suite 
240, Thompson Building, 801 Thompson Avenue, Rockville, MD 20852
Phone: 301 443-7821

RIN: 0917-AA05

[[Page 33076]]

_______________________________________________________________________


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


Indian Health Service (IHS)



_______________________________________________________________________




789. 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 to 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                    07/00/02

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, 12300 Twinbrook Parkway, Rockville, MD 20852
Phone: 301 443-1589

RIN: 0917-AA02

_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




790. UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING PROFESSIONS NEEDED BY 
THE NIH

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 68b

Legal Deadline: None

Abstract: Section 487D of the Public Health Service Act, as added by 
the National Institutes of Health Revitalization Act of 1993, creates a 
program offering scholarships, in an amount not to exceed $20,000 per 
year of academic study, to individuals from disadvantaged backgrounds 
who are enrolled as full-time students at accredited institutions 
pursuing academic programs appropriate for careers in professions 
needed by the NIH. For each year of scholarship support, the recipient 
agrees to service (employment) after graduation, at the NIH, for one 
year. Additionally, the individual agrees to at least 10 consecutive 
weeks of service (employment) at the NIH during which the individual is 
attending the educational institution and receiving the NIH 
scholarship. The proposed new regulations will cover this program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0925-AA10
_______________________________________________________________________




791. 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                            05/00/02

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
_______________________________________________________________________




792. NIH CENTER GRANTS

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 52a

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Governmental Jurisdictions

Government Levels Affected: None

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

RIN: 0925-AA24

[[Page 33077]]

_______________________________________________________________________




793. NIH TRAINING GRANTS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; PL 106-310

CFR Citation: 42 CFR 63a

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0925-AA28
_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

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

CFR Citation: 42 CFR 52h

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/21/00                    65 FR 57132
Final Action                    06/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0925-AA20
_______________________________________________________________________


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


National Institutes of Health (NIH)



_______________________________________________________________________




795. STANDARDS FOR A NATIONAL CHIMPANZEE SANCTUARY SYSTEM

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 287a-3a

CFR Citation: 42 CFR 8

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

Abstract: The National Institutes of Health proposes to establish 
standards for operating a national chimpanzee sanctuary system to 
provide for the permanent retirement of federally-owned or supported 
chimpanzees no longer needed for research.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0925-AA31
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


National Institutes of Health (NIH)



_______________________________________________________________________




796. NATIONAL INSTITUTES OF HEALTH AIDS RESEARCH LOAN REPAYMENT PROGRAM

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 68

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       04/30/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

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

RIN: 0925-AA02

[[Page 33078]]

_______________________________________________________________________




797. NATIONAL CANCER INSTITUTE CLINICAL CANCER EDUCATION PROGRAM

Priority: Info./Admin./Other

CFR Citation: 42 CFR 52d

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       03/20/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0925-AA17
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 68c

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      04/11/02                    67 FR 17650

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0925-AA19
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 68a

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       04/30/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0925-AA25
_______________________________________________________________________




800. NIH LOAN REPAYMENT PROGRAM FOR MINORITY HEALTH DISPARITIES RESEARCH

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 68f

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       04/30/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0925-AA26
_______________________________________________________________________




801. PEDIATRIC RESEARCH LOAN REPAYMENT PROGRAM

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 68f

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       04/30/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0925-AA27
_______________________________________________________________________




802. NATIONAL INSTITUTES OF HEALTH LOAN REPAYMENT PROGRAM FOR CLINICAL 
RESEARCHERS

Priority: Substantive, Nonsignificant

CFR Citation: 42 CFR 68f

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       04/30/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

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

RIN: 0925-AA30

_______________________________________________________________________


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


Office of Public Health and Science (OPHS)



_______________________________________________________________________




803. PUBLIC HEALTH SERVICES POLICIES ON RESEARCH MISCONDUCT

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 216; 42 USC 241; 42 USC 289b

CFR Citation: 42 CFR 93

Legal Deadline: None

Abstract: This notice of proposed rulemaking proposes substantial 
revisions to the existing regulations at 42 CFR part 50, subpart A, 
``Responsibilities of Awardee and Applicant Institutions for Dealing 
With and Reporting Possible Misconduct in Science,'' 54 FR 32449, 
August 8, 1989. The National Institutes of Health Revitalization Act of 
1993 (NIH Act), Public Law 103-43, contains provisions that affect the 
current rule. For example, section 161 of the NIH Act established the 
Office of Research Integrity (ORI) as an independent entity reporting 
to the Secretary, and recent organizational changes have also affected 
the ORI's operations. In addition, the Office of Science and Technology 
Policy (OSTP) published a governmentwide policy that applies to 
federally-funded research and proposals submitted to the Federal 
agencies for research funding, 65 FR 76260, December 6, 2000. The 
proposed revised regulation will implement this OSTP policy, which 
contains a definition of research misconduct and basic guidelines for 
the response of Federal agencies and research institutions to 
allegations of research misconduct. The current regulation, which 
implemented section 493(e) of the Public Health Service Act, would be 
deleted, and a new part 93, subparts A, B, C, D, and E would be added.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/02
NPRM Comment Period End         11/00/02

[[Page 33079]]

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

Related RIN: Related To 0940-AA01
RIN: 0940-AA04
_______________________________________________________________________


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


Office of Public Health and Science (OPHS)



_______________________________________________________________________




804. 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, Pub. L. 103-43), the Department is 
proposing to add a new part 94 to title 42 of the Code of Federal 
Regulations. Under this proposed regulation, covered institutions must 
follow certain requirements for preventing and responding to 
occurrences of retaliation against whistleblowers. The purpose of this 
part is to protect: (1) persons who make a good faith allegation that a 
covered institution or member thereof engaged in, or failed to respond 
adequately to, an allegation of research misconduct; and (2) persons 
who cooperate in good faith with an investigation of research 
misconduct.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/28/00                    65 FR 70830
NPRM Comment Period End         01/29/01
Final Action                    12/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

Related RIN: Related To 0940-AA04
RIN: 0940-AA01
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Office of Public Health and Science (OPHS)



_______________________________________________________________________




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

Priority: Other Significant

CFR Citation: 45 CFR 46

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       04/26/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Glen Drew
Phone: 301 402-4994
Fax: 301 402-2071
Email: [email protected]

RIN: 0940-AA03
_______________________________________________________________________




806. PROTECTION OF HUMAN RESEARCH SUBJECTS

Priority: Other Significant

CFR Citation: 45 CFR 46

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      11/13/01                    66 FR 56775

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Irene Stith-Coleman, Ph.D
Phone: 202 260-1587
Fax: 202 205-0493
Email: [email protected]

RIN: 0940-AA05

_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




807. REQUIREMENTS FOR ESTABLISHING AND MAINTAINING MEDICARE BILLING 
PRIVILEGES (CMS-6002-P)

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 424

Legal Deadline: None

Abstract: This regulation is needed as part of the Administration's 
anti-fraud and abuse efforts. It would give us the authority to enroll 
and re-enroll providers with time frames for re-enrollment.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

[[Page 33080]]

Additional Information: Formerly known as HCFA-1023-P

Agency Contact: Michael Collett, OFM, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6121

RIN: 0938-AH73
_______________________________________________________________________




808. NATIONAL STANDARD FOR IDENTIFIERS OF HEALTH PLANS (CMS-1212-P)

Priority: Other Significant. Major under 5 USC 801.

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

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

CFR Citation: 45 CFR 160; 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                            08/00/02

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: Helen Dietrick, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, S1-07-17, 7500 
Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-7448

RIN: 0938-AH87
_______________________________________________________________________




809. MEDICARE HOSPICE CARE AMENDMENTS (CMS-1022-P)

Priority: Substantive, Nonsignificant

Unfunded Mandates: Undetermined

Legal Authority: PL 105-33, sec 4441(a); PL 105-33, sec 4442 to 4444; 
PL 105-33, sec 4448 to 4449

CFR Citation: 42 CFR 418

Legal Deadline: None

Abstract: This proposed rule revises certain regulations governing 
coverage and payments for hospice care under the Medicare program as 
required by the BBA of 1997.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Carol Blackford, Center for Health Plans and Providers, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5909
Email: [email protected]

Related RIN: Previously reported as 0938-AH73
RIN: 0938-AJ36
_______________________________________________________________________




810. END-STAGE RENAL DISEASE BAD DEBT PAYMENT (CMS-1126-P)

Priority: Other Significant

Legal Authority: Sec 110 of the Social Security Act; sec 1812(d) of the 
Social Security Act; sec 1814(b) of the Social Security Act; sec 1815 
of the Social Security Act; sec 1833(a) of the Social Security Act; sec 
1833(i) of the Social Security Act; sec 1833(n) of the Social Security 
Act; sec 1861(v) of the Social Security Act; sec 1866 of the Social 
Security Act; sec 1871 of the Social Security Act; sec 1881 of the 
Social Security Act; sec 1883 of the Social Security Act; 42 USC 1302; 
42 USC 1395f(b); 42 USC 1395g; 42 USC 1395(a); 42 USC 1395(i); 42 USC 
1395(n); 42 USC 1395x(v); 42 USC 1395cc; 42 USC 1395hh; 42 USC 1395rr; 
42 USC 1395tt

CFR Citation: 42 CFR 413.178

Legal Deadline: None

Abstract: This proposed rule would implement a court settlement 
agreement and remove the cap on End-Stage Renal Disease (ESRD) bad debt 
reimbursement, which limits payment of allowable bad debts to the 
facility's unrecovered costs. The final rule following this proposed 
rule would be effective for cost reporting periods beginning on or 
after January 1, 2001.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Katie Walker, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, C5-03-03, 7500 Security 
Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-7278

RIN: 0938-AK02
_______________________________________________________________________




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

Priority: Other Significant

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 1302; 42 USC 1396d

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

Legal Deadline: None

Abstract: This proposed rule would revise the conditions of 
participation for ICFs/MR. We would set forth these new requirements 
that ICFs/MR must meet to adhere to current trends in the field of 
developmental disabilities. It would address recent developments in 
some facilities in the District of Columbia to further protect the 
health and safety of this vulnerable population.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/02

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, Centers for Medicare &

[[Page 33081]]

Medicaid Services, S3-05-27, 7500 Security Boulevard, Baltimore, MD 
21244-1850
Phone: 401 786-0596

RIN: 0938-AK23
_______________________________________________________________________




812. REVIEW OF NATIONAL COVERAGE DETERMINATIONS AND LOCAL COVERAGE 
DETERMINATIONS (CMS-3063-P)

Priority: Other Significant

Legal Authority: Sec 522 of the BIPA 2000

CFR Citation: 42 CFR 405

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

Abstract: This proposed rule would announce a new process for 
beneficiaries to appeal national and local coverage determinations 
(LCDs).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

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

RIN: 0938-AK60
_______________________________________________________________________




813. REVISED PROCESS FOR MAKING MEDICARE COVERAGE DETERMINATIONS (NCDS) 
(CMS-3062-N)

Priority: Other Significant

Legal Authority: Sec 522 of the BIPA

CFR Citation: None

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

Abstract: This notice will announce a revised process for making 
Medicare National Coverage Ddecisions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: Federal

Agency Contact: Vadim Lubarsky, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
C5-16-03, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0840

RIN: 0938-AK61
_______________________________________________________________________




814. HEALTH INSURANCE REFORM: CLAIMS ATTACHMENTS STANDARDS (CMS-0050-P)

Priority: Other Significant. Major under 5 USC 801.

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

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

CFR Citation: 45 CFR 162

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

Abstract: This proposed rule proposes an electronic standard for claims 
attachments. The standard is required by the Health Insurance 
Portability and Accountability Act. It would be used to transmit 
clinical data, beyond those data contained in the claims standard, to 
help establish medical necessity for coverage.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: State, Local, Federal, Tribal

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

Agency Contact: James Krall, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6999

RIN: 0938-AK62
_______________________________________________________________________




815. HEALTH INSURANCE REFORM: MODIFICATIONS TO STANDARDS FOR ELECTRONIC 
TRANSACTIONS (CMS-0003-P)

Priority: Other Significant

Unfunded Mandates: Undetermined

Legal Authority: Social Security Act, sec 1871

CFR Citation: 45 CFR 162

Legal Deadline: None

Abstract: This proposed rule would adopt a revised National Council for 
Prescription Drug Programs (NCPDP) standard for batched retail pharmacy 
transactions. This rule is not significant because the changes are 
technical with no policy or budget implications.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: Undetermined

Agency Contact: Gladys Wheeler, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, N2-14-17, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0273

RIN: 0938-AK64
_______________________________________________________________________




816. RATE OF REIMBURSEMENT OF PHOTOCOPY EXPENSES FOR PROSPECTIVE PAYMENT 
SYSTEM PROVIDERS (CMS-3055-P)

Priority: Economically Significant

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

CFR Citation: 42 CFR 476.78

Legal Deadline: None

Abstract: This proposed rule would increase the rate of reimbursement 
of photocopy expenses as required by the regulations governing 
Utilization and Quality Control Peer Review Organizations. Our current 
regulations identify the photocopying reimbursement methodology for 
prospective payment system hospitals.

[[Page 33082]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Valerie Mattison-Brown, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, Office of Clinical 
Standards, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5958

RIN: 0938-AK68
_______________________________________________________________________




817. MODIFICATIONS TO MEDICARE MANAGED CARE RULES (CMS-4041-P)

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

Legal Authority: BIPA, sec 605; BIPA, sec 606; BIPA, sec 612; BIPA, sec 
615 to 617; BIPA, sec 620; BIPA, sec 621; BIPA, sec 623

CFR Citation: 42 CFR 409; 42 CFR 417; 42 CFR 422

Legal Deadline: None

Abstract: This proposed rule would implement certain Medicare payment 
provisions of the Medicare, Medicaid, and SCHIP Benefits and 
Improvement Act of 2000. The policy changes include premium reductions 
for M+C enrollees, uniform coverage for M+C plans in multiple 
locations, eliminating health disparities, ESRD enrollees, and 
increased civil money penalties for M+C organizations that terminate 
contracts mid-year. Moreover, this proposed rule describes authority to 
waive or modify requirements that hinder the design of, the offering 
of, or the enrollment in the M+C plans offered to employers or labor 
unions.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal

Additional Information: CMS-4041-P was previously identified as CMS-
1180-P.

Agency Contact: Alfred G. D'Alberto, Office of Managed Care, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-1100

RIN: 0938-AK71
_______________________________________________________________________




818. REVISIONS TO TRANSACTION AND CODE SET STANDARDS FOR ELECTRONIC 
TRANSACTIONS (CMS-0005-P)

Priority: Other Significant

Legal Authority: Social Security Act, sec 1171 to 1179; PL 104-191

CFR Citation: 45 CFR 162

Legal Deadline: None

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/02

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: State, Local, Tribal, Federal

Agency Contact: Gladys Wheeler, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, N2-14-17, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0273

RIN: 0938-AK76
_______________________________________________________________________




819. ELIMINATION OF STATEMENT OF INTENT PROCEDURES FOR FILING MEDICARE 
CLAIMS (CMS-1185-P)

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

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 424

Legal Deadline: None

Abstract: This proposed rule would revise the requirements concerning 
the written statement of intent procedures for filing Medicare claims 
from the current Medicare regulation.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/02

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: State, Federal

Federalism:  Undetermined

Agency Contact: David Walczak, Center for Health Plans and Providers, 
Plan and Provider Purchasing Policy Group, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, C4-07-07, 
7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-4475

RIN: 0938-AK79
_______________________________________________________________________




820. CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND 
CALENDAR YEAR 2003 PAYMENT RATES (CMS-1206-P)

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

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

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This proposed rule would revise the Medicare hospital 
outpatient payment system beginning January 1, 2003.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM with Comment Period        06/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: Cindy Read, Division of Medical Services, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21207
Phone: 410 786-0378

RIN: 0938-AL19

[[Page 33083]]

_______________________________________________________________________




821. PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED 
NURSING FACILITIES--UPDATE FOR FY 2003 (CMS-1202-P)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: Social Security Act, sec 1888(e)

CFR Citation: None

Legal Deadline: NPRM, Statutory, April 12, 2002.
Final, Statutory, July 31, 2002.

Abstract: This annual proposed rule updates the payment rates used 
under the SNF PPS beginning October 1, 2002.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: William Ullman, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, C4-13-15, 7500 
Security Boulevard, Baltimore, MD 21244-1850
Phone: 401 786-5667

RIN: 0938-AL20
_______________________________________________________________________




822. REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE FOR 
CALENDAR YEAR 2003 (CMS-1204-P)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1395W-4

CFR Citation: 42 CFR 410; 42 CFR 414

Legal Deadline: None

Abstract: This rule would make several changes affecting Medicare part 
B payment.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: Latesha Walker, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-1101

RIN: 0938-AL21
_______________________________________________________________________




823. HOSPITAL INPATIENT REHABILITATION PROSPECTIVE PAYMENT SYSTEM FOR FY 
2003 (CMS-1205-N)

Priority: Economically Significant. Major under 5 USC 801.

Legal Authority: PL 105-33, sec 4421; 42 USC 1395ww(j), sec 1886(j) of 
the Social Security Act

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: A prospective payment system was implemented for inpatient 
rehabilitation services on 8/7/01, with an effective date of 1/1/02. 
Since 2002 is the first year of operation under the new system, there 
is not sufficient data for a proposed and final notice. This notice is 
limited to updating the marketbasket and wage rates for this category 
of facilities.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          08/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Laurence Wilson, Center for Medicare Management, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-4603

RIN: 0938-AL22
_______________________________________________________________________




824. HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEM FOR FY 2003 (CMS-
1203-P)

Priority: Economically Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

Legal Authority: Sec 1886(d) of the Social Security Act

CFR Citation: 42 CFR 405; 42 CFR 412; 42 CFR 413; 42 CFR 485; 42 CFR 
489

Legal Deadline: NPRM, Statutory, April 1, 2002.
Final, Statutory, August 1, 2002.

Abstract: We are proposing to revise the Medicare acute care hospital 
inpatient prospective payment systems for operating and capital costs 
to implement changes arising from our continuing experience with these 
systems. These changes would be applicable to discharges occurring on 
or after October 1, 2002. We also are setting forth proposed rate-of-
increase limits, as well as proposed policy changes for hospitals and 
hospital units excluded from the prospective payment systems.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

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

RIN: 0938-AL23
_______________________________________________________________________




825. PAYMENT FOR RESPIRATORY ASSIST DEVICES WITH BI-LEVEL CAPABILITY AND 
A BACK-UP RATE (CMS-1167-P)

Priority: Other Significant

Legal Authority: 42 CFR 1302; 42 CFR 1395hh; 42 CFR 1395rr(b)(1); PL 
103-66

CFR Citation: 42 CFR 414

Legal Deadline: None

Abstract: This rule removes respiratory assist devices with bi-level 
capability and a back-up rate from the category for items requiring 
frequent and substantial servicing, and places them in the category for 
other items, or capped rental items. This rule corrects an error that 
occurred in 1992, where these devices were inappropriately placed in 
the category for items requiring frequent and substantial servicing.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/02

[[Page 33084]]

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Joel Kaiser, Center for Medicare Management, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4499

RIN: 0938-AL27
_______________________________________________________________________




826.  SELF-DECLARATION OF CITIZENSHIP (CMS-2085-P)

Priority: Info./Admin./Other

Legal Authority: Public Law 104-193, Sec 431

CFR Citation: 42 CFR 435.410; 42 CFR 436.410

Legal Deadline: None

Abstract: This proposed rule would require States, on a post-
determination basis, to carry out a process for verifying citizenship 
in a sample of cases to ensure that program integrity is being 
maintained. This proposed rule would also clearly state that acceptance 
of the individual's self-declaration is an option.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Sarah DeLone, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S2-01-16, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7010

RIN: 0938-AL33
_______________________________________________________________________




827.  HOSPICE WAGE INDEX FOR FY 2003 (CMS-1211-N)

Priority: Routine and Frequent

Legal Authority: 42 USC 1395f(i)(1)

CFR Citation: None

Legal Deadline: None

Abstract: This notice will announce the annual update to the hospice 
wage index.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          08/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: None

Agency Contact: Lynn Riley, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
C5-02/23, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1286

RIN: 0938-AL41
_______________________________________________________________________




828.  ELECTRONIC SUBMISSION OF COST REPORTS (CMS-1199-P)

Priority: Substantive, Nonsignificant

Legal Authority: Social Security Act, sec 1815(a); Social Security Act, 
sec 1833(e)

CFR Citation: 42 CFR 413.24

Legal Deadline: None

Abstract: This proposed rule would establish the requirement for ESRD 
facilities, hospices, rural health clinics, and federally qualified 
health centers to file cost reports in a standardized electronic 
format. This rule would also provide a delay or waiver of this 
requirement where implementation would result in financial hardship. 
The provisions of this rule would allow for more accurate preparation 
and more efficient processing of each cost report.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Thomas Talbott, Center for Medicare Management, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, C5-01-01, 7500 Security Boulevard, Baltimore, MD 
21244-1850
Phone: 410 786-4592

RIN: 0938-AL51
_______________________________________________________________________




829.  HEALTH INSURANCE REFORM: NATIONAL STANDARD FOR IDENTIFIERS 
OF HEALTH PLANS (CMS-1212-F)

Priority: Other Significant. Major under 5 USC 801.

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

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

CFR Citation: 45 CFR 162

Legal Deadline: Final, Statutory, February 2, 1998.

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Local, Tribal

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

Agency Contact: Helen Dietrick, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, S1-07-17, 7500 
Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-7448

RIN: 0938-AL52
_______________________________________________________________________




830.  REVISED CIVIL MONEY PENALTIES, ASSESSMENTS, EXCLUSIONS, AND 
RELATED APPEALS PROCEDURES (CMS-6146-P)

Priority: Info./Admin./Other

Legal Authority: PL 97-35, sec 2105; PL 105-33, sec 4311(b); PL 105-33, 
sec 4317; PL 105-33, sec 4031(a)(2); PL 105-33, sec 4531(b)(2); PL 104-
191, sec 231c

CFR Citation: 42 CFR 402 subpart C

Legal Deadline: None

[[Page 33085]]

Abstract: This proposed rule revises CMS civil money penalty 
authorities. These proposed revisions are intended to add the specific 
exclusion sanction authorities as established in the procedures for 
imposing civil money penalties, assessments, and exclusions for certain 
violations of the Medicare program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Joel Cohen, Office of Financial Management, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
C3-04-06, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-3349

RIN: 0938-AL53
_______________________________________________________________________




831.  EFFECT OF CHANGE OF OWNERSHIP ON PROVIDER AND SUPPLIER 
PENALTIES (CMS-2215-P)

Priority: Substantive, Nonsignificant

Legal Authority: Social Security Act, sec 1866

CFR Citation: 42 CFR 405; 42 CFR 489

Legal Deadline: None

Abstract: This proposed rule would amend 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.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Mike Goldman, Division of Integrated Health Systems, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, S2-14-27, 7500 Security Boulevard, Baltimore, MD 
21244-1850
Phone: 410 786-6813

RIN: 0938-AL72
_______________________________________________________________________




832.  HEALTH COVERAGE PORTABILITY: TOLLING CERTAIN TIME PERIODS AND 
INTERACTIONS WITH FAMILY AND MEDICAL LEAVE ACT (CMS-2158-P)

Priority: Other Significant

Legal Authority: 42 USC 300 gg; PL 104-191

CFR Citation: 45 CFR 146.113; 45 CFR 146.115; 45 CFR 146.117; 45 CFR 
146.120; 45 CFR 146.145

Legal Deadline: None

Abstract: This proposed rule would clarify certain portability 
requirements for group health plans and issuers of health insurance 
coverage offered in connection with a group health plan. This rule 
would implement changes made to the Internal Revenue Code, the Employee 
Retirement Income Security Act, and the Public Health Service Act 
enacted as part of the Health Insurance Portability and Accountability 
Act of 1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: State, Local, Federal

Agency Contact: David Mlawsky, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S3-16-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6851

RIN: 0938-AL88
_______________________________________________________________________




833.  CHANGES TO THE HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT 
SYSTEM AND CALENDAR YEAR 2004 PAYMENT RATES (CMS-1471-P)

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

Unfunded Mandates: Undetermined

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

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This rule would revise the Medicare hospital outpatient 
department prospective payment system for the January 2, 2004 update.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: Cindy Read, Division of Medical Services, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21207
Phone: 410 786-0378

RIN: 0938-AL91
_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




834. SECURITY STANDARDS (CMS-0049-F)

Priority: Economically Significant. Major under 5 USC 801.

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

CFR Citation: 45 CFR 162

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

Abstract: This final rule is being jointly developed by CMS and the 
Department of Commerce. This final rule adopts standards for the 
security of certain electronic identifiable health information of 
health plans, health care clearinghouses, and certain health care 
providers. It implements administrative simplification initiatives that 
have a national scope beyond the Medicare and Medicaid programs.

[[Page 33086]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/12/98                    63 FR 43242
NPRM Comment Period End         10/13/98
Final Rule                      08/00/02

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, Centers for Medicare & 
Medicaid Services, N2-14-10, 7500 Security Boulevard, Baltimore, MD 
21244-1850
Phone: 410 786-3017

RIN: 0938-AI57
_______________________________________________________________________




835. NATIONAL STANDARD EMPLOYER IDENTIFIER (CMS-0047-F)

Priority: Economically Significant. Major under 5 USC 801.

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

CFR Citation: 45 CFR 162

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

Abstract: This rule is being jointly developed by CMS, Treasury, Labor, 
and Defense. The regulation adopts an employer's tax ID number as the 
standard for electronic transactions, implementing an administrative 
simplification initiative that has a national scope beyond the Medicare 
and Medicaid programs.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            06/16/98                    63 FR 32784
NPRM Comment Period End         08/17/98
Final Rule                      06/00/02

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: Patricia Peyton, Office of Information Services, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, N3-20-05, 7500 Security Boulevard, Baltimore, MD 
21224-1850
Phone: 410 786-1812

RIN: 0938-AI59
_______________________________________________________________________




836. EXTERNAL QUALITY REVIEW OF MEDICAID MANAGED CARE ORGANIZATIONS 
(CMS-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 final rule will require State agencies to contract with 
managed care organizations and to monitor and evaluate their 
performances through annual external, independent reviews conducted by 
accrediting organizations that are approved by CMS.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/01/99                    64 FR 67223
Final Rule                      07/00/02

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, Centers for 
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-1177

RIN: 0938-AJ06
_______________________________________________________________________




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

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 405; 42 CFR 491

Legal Deadline: None

Abstract: This rule amends the Medicare certification and payment 
requirements for rural health clinics (RHCs), as required by section 
4205 of the Balanced Budget Act of 1997.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            02/28/00                    65 FR 10450
Final Rule                      08/00/02

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, Centers for Medicare & Medicaid Services, C4-15-18, 7500 
Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-5919

RIN: 0938-AJ17
_______________________________________________________________________




838. HOSPITAL CONDITIONS OF PARTICIPATION: LABORATORY SERVICES (CMS-
3014-F)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 482.27

Legal Deadline: None

Abstract: This final rule revises requirements for hospitals that 
transfuse blood and blood products regarding written procedures, 
quarantine, testing, and counseling for hepatitis C virus (HCV) and 
records maintenance.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/16/00                    65 FR 69416
Final Rule                      12/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Mary Collins, OCSQ, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-3189

RIN: 0938-AJ29

[[Page 33087]]

_______________________________________________________________________




839. NON-FEDERAL GOVERNMENTAL PLANS EXEMPT FROM HEALTH INSURANCE 
PORTABILITY REQUIREMENTS (CMS-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 interim final rule revises certain procedural 
requirements associated with the filing of an election to exempt 
certain non-Federal governmental group health plans from various 
Federal requirements of HIPAA that are generally applicable to 
employment-related group health plans.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              07/00/02

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, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1564

RIN: 0938-AK00
_______________________________________________________________________




840. FIRE SAFETY REQUIREMENTS FOR RNHCI, ASC, HOSPICES, PACE, HOSPITALS, 
AND LONG-TERM CARE FACILITIES AND ICFS FOR THE MENTALLY RETARDED (CMS-
3047-P)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 1395hh

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

Legal Deadline: None

Abstract: This rule adopts the 2000 edition of the National Fire 
Protection Association's Life Safety Code as the fire standards for 
Religious Non-Medical Health Care Institutions, Ambulatory Surgery 
Centers, Hospices that provide in-patient services, Programs of All-
Inclusive Care for the Elderly, Hospitals, Long-Term Care Facilities, 
and Intermediate Care Facilities for the Mentally Retarded.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/26/01                    66 FR 54179
Final Rule                      09/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Tamara Syrek, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services
Phone: 410 786-3529

RIN: 0938-AK35
_______________________________________________________________________




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

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 482.21

Legal Deadline: None

Abstract: This final rule addresses provisions relating to the 
development and implementation of a QAPI program and its components. It 
imposes several requirements that are designed to increase patient 
safety and track the methodologies and/or programs or both used to 
increase patient safety.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/19/97                    62 FR 66725
NPRM Comment Period End         02/17/98
Final Rule                      08/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: State

Agency Contact: Stephanie Dyson, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, S3-02-01, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-9226

RIN: 0938-AK40
_______________________________________________________________________




842. SUPPLEMENTARY MEDICAL INSURANCE PREMIUM SURCHARGE AGREEMENTS (CMS-
4007-F)

Priority: Other Significant

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

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

Legal Deadline: None

Abstract: This proposed rule would provide a special payment 
arrangement with States and local government entities for the payment 
of part B premium late enrolment surcharges.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/26/01                    66 FR 54186
Final Rule                      08/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State, Local

Agency Contact: Marty Abeln, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Centers for Medicare 
Management, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-1032

Sandy Clarke, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, Center for Beneficiary Choices, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7451

RIN: 0938-AK42
_______________________________________________________________________




843. PAYMENT FOR UPGRADED DURABLE MEDICAL EQUIPMENT; WITHDRAWAL OF 
PROPOSED RULE (CMS-1084-WN)

Priority: Info./Admin./Other

Legal Authority: Not Yet Determined

CFR Citation: None

Legal Deadline: None

Abstract: This notice will withdraw the proposed rule that was 
published in the Federal Register on April 27, 2000.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            04/27/00                    65 FR 24666
Final Rule                      04/00/02

[[Page 33088]]

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: William J. Long, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, C5-08-27, Center 
for Medicare Management, 7500 Security Boulevard, Baltimore, MD 21228
Phone: 410 786-5655
Email: [email protected]

RIN: 0938-AK50
_______________________________________________________________________




844. PROSPECTIVE PAYMENT SYSTEM FOR LONG-TERM CARE HOSPITALS FOR FY 2003 
(CMS-1177-P)

Priority: Other Significant

Unfunded Mandates: Undetermined

Legal Authority: BBRA, sec 123; BIPA, sec 307; PL 105-33, sec 4422; PL 
106-113, sec 123; PL 106-544, sec 307(b)

CFR Citation: 42 CFR 412

Legal Deadline: NPRM, Statutory, October 1, 2002, Effective date.

Abstract: This rule would establish a PPS for long-term care facilities 
effective October 1, 2002.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/22/02                    67 FR 13416
NPRM Comment Period End         05/21/02
Final Rule                      08/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Local, Federal

Federalism:  Undetermined

Agency Contact: Judith H. Richter, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, C4-07-07, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-2590

RIN: 0938-AK69
_______________________________________________________________________




845. MEDICARE INPATIENT DISPROPORTIONATE SHARE HOSPITAL (DSH) ADJUSTMENT 
FORMULA (CMS-1171-IFC)

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 412106

Legal Deadline: None

Abstract: This interim final rule clarifies the Medicare DSH adjustment 
calculation in reference to the inclusion of Medicaid patient days. It 
describes the criteria to use in calculating the Medicare DSH 
adjustment for hospitals for purposes of payment under the hospital 
inpatient prospective payment system.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              09/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0938-AK77
_______________________________________________________________________




846. STATE ALLOTMENTS FOR PAYMENT OF MEDICARE PART B PREMIUMS FOR 
QUALIFIED INDIVIDUALS; FEDERAL FISCAL YEAR 2001 (CMS-2087-PN)

Priority: Other Significant

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

CFR Citation: None

Legal Deadline: None

Abstract: This notice announces the Federal fiscal year 2001 allotments 
that are available for State agencies to pay Medicare part B premiums 
for two specific eligibility groups of low-income Medicare 
beneficiaries, referred to as Qualified Individuals.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            01/25/02                     67 FR 3713
Final Action                    09/00/02

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: State

Federalism:  Undetermined

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

RIN: 0938-AK91
_______________________________________________________________________




847. MEDICAID MANAGED CARE; NEW PROVISIONS (CMS-2104-F)

Priority: Economically Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

Legal Authority: Balanced Budget Act of 1997, sec 4701 to 4710; Social 
Security Act, sec 1932

CFR Citation: 42 CFR 400; 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 final rule will revise recently published provisions for 
the Medicaid Managed Care Program. The provisions involve quality of 
care and services under Medicaid managed care arrangements. The 
provisions affect enrollee rights and responsibilities, as well as 
contracts between State Medicaid agencies and managed care 
organizations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/20/01                    66 FR 43613
NPRM Comment Period End         10/19/01
Final Rule                      05/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Agency Contact: Bruce Johnson, Center for Medicaid and State 
Operations, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD
Phone: 410 786-0615

Deirdre Duzor, Health Insurance Specialist, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, S3-13-15, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4626

RIN: 0938-AK96

[[Page 33089]]

_______________________________________________________________________




848. MODIFICATIONS TO THE STATE CHILDREN'S HEALTH INSURANCE PROGRAM 
(CMS-2006-F)

Priority: Substantive, Nonsignificant

Legal Authority: PL 105-33

CFR Citation: 42 CFR 435; 42 CFR 436; 42 CFR 457

Legal Deadline: None

Abstract: This final rule responds to public comments received and will 
revise certain provisions to the State Children's Health Insurance 
Program (SCHIP) final rule, published on January 11, 2002.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              06/25/01                    66 FR 33810
Interim Final Rule Comment 
Period End                      07/26/01
Interim Final Rule Effective    08/24/01
Final Rule                      09/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

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

Agency Contact: Regina Fletcher, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, S2-01-16, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-3293

RIN: 0938-AL00
_______________________________________________________________________




849. HOME HEALTH PROSPECTIVE PAYMENT SYSTEM RATE UPDATE FOR FY 2003 
(CMS-1198-NC)

Priority: Other Significant

Legal Authority: Balanced Budget Act, PL 105-33, sec 460.3(a); OCESAA, 
PL 105-277, sec 5101(c); OCESAA, PL 105-277, sec 5101(d); Balanced 
Budget Act Refinement Act of 1999, PL 100-113, sec 305; Balanced Budget 
Act Refinement Act of 1999, PL 100-113, sec 306; Medicare, Medicaid & 
SCHIP Benefits Improve.& Protection Act of 2000, PL 106-544; ...

CFR Citation: Not Yet Determined

Legal Deadline: Other, Statutory, October 1, 2002, Publish by 06/28/
2002.

Abstract: This notice with comment period sets forth an update to the 
60-day national episode rates and the national per-visit amounts under 
the Medicare prospective payment system for home health agencies for FY 
2003.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          06/00/02

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Susan Levy, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
C5-08-27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-9364

RIN: 0938-AL16
_______________________________________________________________________




850. MEDICARE PROGRAM; MEDICARE-ENDORSED PRESCRIPTION DRUG DISCOUNT CARD 
ASSISTANCE INITIATIVE (CMS-4027-P)

Priority: Economically Significant

Legal Authority: 42 USC 1395b-3; 42 USC 1302; 42 USC 1302b-10

CFR Citation: None

Legal Deadline: None

Abstract: This final rule would set forth a Department of Health and 
Human Services' initiative for a Medicare endorsement to entities 
currently offering prescription drug discounts to the general public to 
offer prescription drug discount cards to Medicare beneficiaries.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/06/02                    67 FR 10262
NPRM Comment Period End         05/06/02
Final Rule                      06/00/02

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Paula Stannard, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, Room 707F, 200 
Independence Avenue SW., Washington, DC 20201
Phone: 202 690-7741

Teresa Decaro, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, C5-17-14, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-6604
Email: [email protected]

RIN: 0938-AL28
_______________________________________________________________________




851.  PEER REVIEW ORGANIZATIONS: NAME AND OTHER CHANGES--TECHNICAL 
AMENDMENTS (CMS-3088-FC)

Priority: Other Significant

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

CFR Citation: 42 CFR 400

Legal Deadline: None

Abstract: This final rule with comment period changes the term ``peer 
review organization'' to ``quality improvement organization'' in the 
CFR.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule                      05/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Valerie Mattison-Brown, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, Office of Clinical 
Standards, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5958

RIN: 0938-AL38
_______________________________________________________________________




852.  END-STAGE RENAL DISEASE--RESCISSION OF WAIVER OF CONDITIONS 
FOR COVERAGE UNDER A STATE OF EMERGENCY IN HOUSTON, TEXAS AREA (CMS-3074-F2)

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 405

Legal Deadline: None

Abstract: This final rule removes an emergency waiver of the Medicare 
end-stage renal disease conditions for coverage granted to permit the 
transplant team of an approved renal transplant center to furnish 
kidney transplant services in three specific hospitals in the Houston, 
TX area during a state of emergency.

[[Page 33090]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule                      07/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Lori Davis, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0710

RIN: 0938-AL39
_______________________________________________________________________




853.  PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT REHABILITATION 
HOSPITAL; CORRECTING AMENDMENT (CMS-1069-F2)

Priority: Substantive, Nonsignificant

Legal Authority: Social Security Act, sec 1886(j); PL 105-33; PL 106-
554; PL 106-113

CFR Citation: 42 CFR 412; 42 CFR 413

Legal Deadline: None

Abstract: This notice corrects typographical and data errors identified 
in the August 7, 2001 rule.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule                      06/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Robert Kuhl, Technical Advisor, Bureau of Policy 
Development, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, C4-11-06, 7500 Security Boulevard, 
Baltimore, MD 21244-1850
Phone: 410 786-4597

RIN: 0938-AL40
_______________________________________________________________________




854.  PHYSICIAN FEE SCHEDULE FOR CY 2002: CORRECTION NOTICE 
(CMS-1169-CN)

Priority: Info./Admin./Other

Legal Authority: 42 USC 1395W-4

CFR Citation: 42 CFR 405; 42 CFR 410; 42 CFR 411; 42 CFR 414; 42 CFR 
415

Legal Deadline: None

Abstract: This notice corrects technical errors that occurred in the 
final rule with comment period published on November 1, 2001. The final 
rule sets forth the physician fee schedule for CY 2002.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          04/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Diane Milstead, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-3355

RIN: 0938-AL48
_______________________________________________________________________




855.  NOTICE OF MODIFICATION OF BENEFICIARY ASSESSMENT REQUIREMENTS 
FOR SKILLED NURSING FACILITIES (CMS-1209-N)

Priority: Info./Admin./Other

Legal Authority: None

CFR Citation: None

Legal Deadline: None

Abstract: This notice offers skilled nursing facilities the option of 
using a modified, shorter version of the minimum data set to satisfy 
Medicare payment and quality requirements.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          06/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Dana Burley, Policy Analyst, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, C5-06-27, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4547

RIN: 0938-AL55
_______________________________________________________________________




856.  INPATIENT HOSPITAL DEDUCTIBLE AND HOSPITAL AND EXTENDED CARE 
SERVICES COINSURANCE AMOUNTS FOR CALENDAR YEAR 2003 (CMS-8013-N)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 1395e-2(g)(2)

CFR Citation: None

Legal Deadline: None

Abstract: This notice announces the inpatient hospital deductible and 
the hospital and extended care services coinsurance amounts for 
services furnished in calendar year 2003 under the Medicare hospital 
insurance program (part A). The Medicare statute specifies the formula 
used to determine these amounts.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          09/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Clare McFarland, Deputy Directory, Medicare and 
Medicaid Cost Estimates Group, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, N3-26-24, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6390

RIN: 0938-AL56
_______________________________________________________________________




857.  REVISION OF THE PROCEDURES FOR REQUESTING EXCEPTIONS TO COST 
LIMITS FOR SKILLED NURSING FACILITIES AND ELIMINATION OF 
RECLASSIFICATIONS; CORRECTION (CMS-1883-F3)

Priority: Info./Admin./Other

Legal Authority: 42 USC 1302; 42 USC 1395d(d); 42 USC 1395F(b); 42 USC 
1395(g); 42 USC 13951(a); 42 USC 13951(n); 42 USC 1395hh; 42 USC 
1395rr; 42 USC 1395tt; 42 USC 1395ww

CFR Citation: 42 CFR 413.30(d)

Legal Deadline: None

Abstract: This technical correction corrects an error in 42 CFR 
413.30(d) found in the technical correction dated October 10, 2000.

[[Page 33091]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule                      08/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Julie Stankiuic, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, C5-06-27, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5725

RIN: 0938-AL61
_______________________________________________________________________




858.  MONTHLY ACTUARIAL RATES AND MONTHLY SUPPLEMENTARY MEDICAL 
INSURANCE PREMIUM RATE BEGINNING JANUARY 1, 2003 (CMS-8014-N)

Priority: Economically Significant

Legal Authority: 42 CFR 1395r; Social Security Act, sec 1839

CFR Citation: 42 CFR 407; 42 CFR 408

Legal Deadline: NPRM, Statutory, September 27, 2002.

Abstract: This notice announces the monthly actuarial rates for aged 
and disabled enrollees in the Medicare Supplementary Medical Insurance 
(SMI) program for 2003. It also announces the monthly SMI premium to be 
paid by all enrollees during 2003.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule                      09/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0938-AL63
_______________________________________________________________________




859.  REQUEST FOR INFORMATION ON BENEFIT-SPECIFIC WAITING PERIODS 
(CMS-2150-N)

Priority: Info./Admin./Other

Legal Authority: None

CFR Citation: None

Legal Deadline: None

Abstract: This notice requests information on the use of benefit-
specific waiting periods by group health plan and group health 
insurance issuers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          08/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: David Mlawsky, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S3-16-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6851

RIN: 0938-AL64
_______________________________________________________________________




860.  PART A PREMIUMS FOR 2003 FOR THE UNINSURED AGED AND FOR CERTAIN 
DISABLED INDIVIDUALS WHO HAVE EXHAUSTED OTHER ENTITLEMENT (CMS-8015-N)

Priority: Other Significant

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

CFR Citation: None

Legal Deadline: None

Abstract: This notice announces the hospital insurance premium for 
calendar year 2003 under Medicare's hospital insurance program (part A) 
for the uninsured aged and for certain disabled individuals who have 
exhausted other entitlement. (The statute requires that this notice be 
published September 30, 2002.)

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule                      09/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Clare McFarland, Deputy Directory, Medicare and 
Medicaid Cost Estimates Group, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, N3-26-24, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6390

RIN: 0938-AL69
_______________________________________________________________________




861.  MEDICAID MANAGED CARE: WITHDRAWAL (CMS-2001-F4)

Priority: Other Significant

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: None

Legal Deadline: None

Abstract: This final rule withdraws the January 2001 Medicaid Managed 
Care final rule and finalizes the IFC rule published on August 17, 
2001. It will be published at the same time as the new final Medicaid 
Managed Care Final Rule, CMS-2104-F.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule                      05/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Bruce Johnson, Center for Medicaid and State 
Operations, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD
Phone: 410 786-0615

RIN: 0938-AL83
_______________________________________________________________________




862.  FY 1999 SCHIP REALLOCATION NOTICE (CMS-2137-N)

Priority: Substantive, Nonsignificant

Legal Authority: PL 106-554, sec 801

CFR Citation: None

Legal Deadline: None

Abstract: This notice announces the application of statutory provisions 
concerning the redistribution and availability of unexpended funds 
appropriated for fiscal year 1999 for SCHIP. Title XXI of the Social 
Security Act authorizes payment of Federal matching funds to States, 
the District of Columbia, and U.S. Territories and Commonwealths to 
initiate and expand health insurance coverage to uninsured, low-income 
children under the State

[[Page 33092]]

Children's Health Insurance Program (SCHIP).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          04/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0938-AL86
_______________________________________________________________________


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


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1395gg; Social Security Act, sec 1870

CFR Citation: 42 CFR 401; 42 CFR 466.86; 42 CFR 466.94; 42 CFR 473.14; 
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 amends the Medicare regulations to clarify the 
interpretation of ``without fault'' as it applies to physicians, 
providers, suppliers and beneficiary liability for overpayments.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/25/98                    63 FR 14506
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Barbara Wright, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
C3-14-00, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4292

RIN: 0938-AD95
_______________________________________________________________________




864. REVISION OF MEDICARE/MEDICAID HOSPITAL CONDITIONS OF PARTICIPATION 
(CMS-3745-F)

Priority: Other Significant

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

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

Legal Deadline: None

Abstract: This rule will revise the requirements that hospitals must 
meet to participate in the Medicare and Medicaid programs. The revised 
requirements focus on patient care, and the outcomes of that care 
reflect a cross-functional view of patient treatment and unnecessary 
procedural requirements.

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, Centers for Medicare & 
Medicaid Services, S3-02-01, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-9226

RIN: 0938-AG79
_______________________________________________________________________




865. HOME HEALTH AGENCY (HHA) CONDITIONS OF PARTICIPATION (COPS) (CMS-
3819-FC)

Priority: Other Significant

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

CFR Citation: 42 CFR 484

Legal Deadline: None

Abstract: This final rule revises the existing CoPs that HHAs must meet 
to participate in the Medicare program. The requirements focus on the 
actual care delivered to patients by HHAs, reflect an interdisciplinary 
view of patient care, allow HHAs greater flexibility in meeting quality 
standards, and eliminate unnecessary procedural requirements. These 
changes are an integral part of the Administration's efforts to achieve 
broad-based improvements and measurements of the quality of care 
furnished through Federal programs, while at the same time reducing 
procedural burdens on providers.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/10/97                    62 FR 11005
NPRM Comment Period End         06/09/97
Final Rule                       To Be                       Determined

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, Centers for Medicare 
& Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4882


[[Page 33093]]


Rachael Weinstein, Health Insurance Specialist, Department of Health 
and Human Services, Centers for Medicare & Medicaid Services, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6775

RIN: 0938-AG81
_______________________________________________________________________




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

Priority: Other Significant

Legal Authority: 42 USC 1395rr

CFR Citation: 42 CFR 400; 42 CFR 405; 42 CFR 406; 42 CFR 409; 42 CFR 
410; 42 CFR 412 to 414; 42 CFR 489; 42 CFR 494

Legal Deadline: None

Abstract: This proposed rule would revise the requirements that end 
stage renal disease (ESRD) facilities must meet to be certified under 
the Medicare program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Governmental Jurisdictions, Businesses, 
Organizations

Government Levels Affected: None

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

Theresa Casey, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, S3-05-04, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-7215

RIN: 0938-AG82
_______________________________________________________________________




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

Priority: Other Significant

Legal Authority: 42 USC 1302; 42 USC 1395hh

CFR Citation: 42 CFR 482

Legal Deadline: None

Abstract: This proposed rule would establish conditions of 
participation for Medicare-covered transplants.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            07/00/03

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Marty Abeln, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, Centers for Medicare 
Management, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-1032

Kathy Linstromberg, Department of Health and Human Services, Centers 
for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, 
MD 21244
Phone: 410 786-8279

Eva Fung, Health Insurance Specialist, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, S3-06-6, 7500 
Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-7539

RIN: 0938-AH17
_______________________________________________________________________




868. HOSPICE CARE--CONDITIONS OF PARTICIPATION (CMS-3844-P)

Priority: Other Significant

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

CFR Citation: 42 CFR 418

Legal Deadline: None

Abstract: This proposed rule would revise existing conditions of 
participation that hospices must meet to participate in the Medicare 
program. The proposed requirements focus on the actual care delivered 
to patients and patients' families by hospices and the results of that 
care, reflect an interdisciplinary view of patient care, allow hospices 
greater flexibility in meeting quality standards, and eliminate 
unnecessary procedural requirements.

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, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6051

Rachael Weinstein, Health Insurance Specialist, Department of Health 
and Human Services, Centers for Medicare & Medicaid Services, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6775

RIN: 0938-AH27
_______________________________________________________________________




869. MEDICARE AND MEDICAID PROGRAMS; TERMS, DEFINITIONS, AND ADDRESSES: 
TECHNICAL AMENDMENTS (CMS-9877-F)

Priority: Substantive, Nonsignificant

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

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

________________________________________________________________________

NPRM                            01/25/02                     67 FR 3641
NPRM Comment Period End         03/26/02
Final Rule                       To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

[[Page 33094]]

Agency Contact: Margaret Teeters, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, C5-14-03, Division 
of Regulation and Issuances, 7500 Security Boulevard, Balitmore, MD 
21244
Phone: 410 786-4678

RIN: 0938-AH53
_______________________________________________________________________




870. HEALTH INSURANCE REFORM: STANDARD UNIQUE HEALTH CARE PROVIDER 
IDENTIFIER (CMS-0045-F)

Priority: Other Significant. Major under 5 USC 801.

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

CFR Citation: 42 CFR 160; 42 CFR 162

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

Abstract: This rule establishes a standard unique ID for all health 
care providers under HIPAA. The rule implements administrative 
simplification initiatives that have a national scope beyond Medicare 
and Medicaid.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            05/07/98                    63 FR 25320
NPRM Comment Period End         07/06/98
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal, State, Local, Tribal

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, Centers for Medicare & 
Medicaid Services, N3-20-05, 7500 Security Boulevard, Baltimore, MD 
21224-1850
Phone: 410 786-1812

RIN: 0938-AH99
_______________________________________________________________________




871. MEDICAL CHILD SUPPORT AND HEALTH INSURANCE COVERAGE OF DEPENDENT 
CHILDREN (CMS-2081-P)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302; 42 USC 1396(a)(25); 42 USC 1396(a)(45); 
42 USC 1396(a)(60); 42 USC 1396(o); 42 USC 1396g-1; 42 USC 1396(k)

CFR Citation: 42 CFR 433.135; 42 CFR 433.137; 42 CFR 433.170

Legal Deadline: None

Abstract: This rule would require States to provide assurances that 
laws relating to medical child support have satisfactorily been 
implemented in accordance with the Social Security 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. This requirement would 
implement section 13623, OBRA of 1993.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Rule                       To Be                       Determined

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, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0488

RIN: 0938-AI21
_______________________________________________________________________




872. APPEALS OF CARRIER DETERMINATION THAT A SUPPLIER FAILS TO MEET THE 
REQUIREMENTS FOR MEDICARE BILLING PRIVILEGES (CMS-6003-F)

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 extend appeal rights to all suppliers whose 
enrollment applications for Medicare billing privileges are disallowed 
by a carrier or whose Medicare billing privileges are revoked, except 
for those suppliers covered under other existing appeals provisions of 
our regulations.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/25/99                    64 FR 57431
Final Rule                       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, Centers for 
Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 
21244-1850
Phone: 410 786-6140

Yvonne West, Health Insurance Specialist, Department of Health and 
Human Services, Centers for Medicare & Medicaid Services, 7500 Security 
Blvd., Baltimore, MD 21244
Phone: 410 786-6479

RIN: 0938-AI49
_______________________________________________________________________




873. COVERAGE OF RELIGIOUS NON-MEDICAL HEALTH CARE INSTITUTIONS (CMS-
1909-F)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1395i-5; 42 USC 1395x(e); 42 USC 1395x(y); 42 
USC 1395x(ss); 42 USC 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 4454(d).

Abstract: This final rule follows an Interm Final with Comment that 
removed all references in the Medicare regulations to specific 
religious institutions to include all religious nonmedical 
institutions.

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,

[[Page 33095]]

Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3508

RIN: 0938-AI93
_______________________________________________________________________




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

Priority: Other Significant. Major under 5 USC 801.

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

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

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

Legal Deadline: None

Abstract: This final rule requires home health agencies to 
electronically report OASIS data as a condition of participation in the 
Medicare program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/25/99                     64 FR 3748
Final Rule                       To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: State, Local, Tribal

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

Agency Contact: Janice Stevenson, Office of Clinical Standards and 
Quality, Department of Health and Human Services, Centers for Medicare 
& Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4882

RIN: 0938-AJ10
_______________________________________________________________________




875. USE OF RESTRAINT AND SECLUSION IN RESIDENTIAL TREATMENT FACILITIES 
PROVIDING INPATIENT PSYCHIATRIC SERVICES TO INDIVIDUALS UNDER AGE 21 
(CMS-2065-F)

Priority: Economically Significant

Legal Authority: 42 USC 1302; 42 USC 1396d

CFR Citation: 42 CFR 441; 42 CFR 483

Legal Deadline: None

Abstract: This rule addresses standards of practices that residential 
treatment facilities providing inpatient psychiatric services for 
individuals under age 21 must meet with regard to the use of restraints 
and seclusion.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/22/01                     66 FR 7148
Interim Final Rule Comment 
Period End                      03/23/01
Interim Final Rule Effective    03/23/01
60-Day Delay of Effective Date 
To 05/22/2001                   03/21/01                    66 FR 15800
Interim Final Rule Amendment 
with Clarification              05/22/01                    66 FR 28110
Interim Final Rule Comment 
Period End                      07/23/01
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Larry Cutler, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-5903

RIN: 0938-AJ96
_______________________________________________________________________




876. APPLICATION OF INHERENT REASONABLENESS TO ALL MEDICARE PART B 
SERVICES (OTHER THAN PHYSICIAN SERVICES) (CMS-1908-F)

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

Legal Authority: PL 105-33, sec 4316

CFR Citation: 42 CFR 405

Legal Deadline: None

Abstract: This final rule sets forth the process for establishing 
realistic and equitable payment amounts for all Medicare part B items 
and services (other than physician services) when the existing payment 
amounts are inherently unreasonable because they are either grossly 
excessive or grossly deficient.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              01/07/98                      63 FR 687


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: William J. Long, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, C5-08-27, Center 
for Medicare Management, 7500 Security Boulevard, Baltimore, MD 21228
Phone: 410 786-5655
Email: [email protected]

RIN: 0938-AJ97
_______________________________________________________________________




877. SUPPLIER STANDARDS FOR HOME OXYGEN, THERAPEUTIC SHOES, HOME 
NUTRITION THERAPY, AND CONSIGNMENT CLOSETS (CMS-6010-P)

Priority: Substantive, Nonsignificant

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 424.57

Legal Deadline: None

Abstract: This rule would establish service standards for suppliers of 
home oxygen equipment, therapeutic shoes, home infusion therapy, and 
standards for consignment closets.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Frank Whelan, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
C3-02-16, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1302

RIN: 0938-AJ98
_______________________________________________________________________




878. CLINICAL LAB REQUIREMENTS--REVISIONS TO REGULATIONS IMPLEMENTING 
CLIA (CMS-2226-F)

Priority: Other Significant

Legal Authority: PL 100-578

CFR Citation: 42 CFR 493

Legal Deadline: None

[[Page 33096]]

Abstract: This final rule finalizes certain laboratory requirements 
under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

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, Centers for Medicare & Medicaid Services
Phone: 410 786-3347

RIN: 0938-AK24
_______________________________________________________________________




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

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

Unfunded Mandates: Undetermined

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

CFR Citation: 42 CFR 422; 42 CFR 489

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

Abstract: This final rule sets forth several improvements to the 
Medicare+Choice (M+C) appeal and grievance procedures. This rule 
addresses the termination date of provider services, independent review 
process, and discharge notices.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

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

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Organizations

Government Levels Affected: None

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

Agency Contact: Tony Culotta, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-4661

RIN: 0938-AK48
_______________________________________________________________________




880. PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY HAVE 
FINANCIAL RELATIONSHIPS--PHASE II (CMS-1810-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

Legal Deadline: None

Abstract: This final rule addresses the provisions of sections 1877 and 
1903(s) of the Social Security Act that preclude payment for services 
under the Medicare program if a physician makes a referral to a 
facility in which he/she has a financial interest. This rule with 
comment period will address comments from the January 9, 1998 proposed 
rule concerning the ownership and investment exceptions and the 
compensation exceptions. In addition, this rule will address comments 
from the January 4, 2001 Phase I final rule with comment period.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Local

Agency Contact: Joanne Sinsheimer, Technical Advisor, CMM, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-4620

RIN: 0938-AK67
_______________________________________________________________________




881. ORGAN PROCUREMENT ORGANIZATION CONDITION FOR COVERAGE (CMS-3064-
IFC)

Priority: Other Significant

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

CFR Citation: 42 CFR 486.301

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

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

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Jacqueline Morgan, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, S3-02-01, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-4282

RIN: 0938-AK81
_______________________________________________________________________




882. MODIFICATIONS TO MANAGED CARE RULES BASED ON PAYMENT PROVISIONS IN 
BIPA AND TECHNICAL CORRECTIONS (CMS-4040-F)

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

Legal Authority: BIPA, sec 601 to 605; BIPA, sec 601 to 603; BIPA, sec 
607; BIPA, sec 608; BIPA, sec 613; BIPA, sec 619; BIPA, sec 634; ...

CFR Citation: 42 CFR 417; 42 CFR 422

Legal Deadline: None

Abstract: This final rule will implement certain technical and minor 
changes of the provisions of sections 601 to 634 of the Medicare 
payment provisions of the Medicare, Medicaid & SCHIP Benefits 
Improvement and Protection Act of 2000. It is significant because 
although the changes mandated by BIPA are minor and technical in 
nature, they involve updates to payment rates.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

[[Page 33097]]

Agency Contact: Alfred G. D'Alberto, Office of Managed Care, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-1100

RIN: 0938-AK90
_______________________________________________________________________




883. EXTENDING MEDICARE ENTITLEMENT WHEN DISABILITY BENEFIT ENTITLEMENT 
ENDS BECAUSE OF SUBSTANTIAL GAINFUL ACTIVITY (CMS-4018-P)

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

Unfunded Mandates: Undetermined

Legal Authority: Sec. 202 of the TWWIIA of 1999; PL 106-170 of the 
TWWIIA of 1999

CFR Citation: 42 CFR 406.12

Legal Deadline: None

Abstract: This rule would provide working disabled individuals with 
continued Medicare entitlement for an additional 54 months beyond the 
current limit. It would implement the Ticket to Work and Work 
Incentives Improvement Act of 1999.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Denise Cox, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-3195

RIN: 0938-AK94
_______________________________________________________________________




884. MEDICARE LIMITS ON THE VALUATION OF A DEPRECIABLE ASSET RECOGNIZED 
AS AN ALLOWANCE FOR DEPRECIATION AND INTEREST ON CAPITAL INDEBTEDNESS 
AFTER A CHANGE OF OWNERSHIP (CMS-1004-F)

Priority: Other Significant

Unfunded Mandates: Undetermined

Legal Authority: Sec 1861(v)(1)(O) of the Social Security Act, as 
amended

CFR Citation: 42 CFR 413.134

Legal Deadline: None

Abstract: This final rule responds to public comments received and 
makes technical corrections to the Medicare provider reimbursement 
regulations that set forth requirements related to allowable costs.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Ann Pash, Center for Medicare Management, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4516
Email: [email protected]

RIN: 0938-AL12
_______________________________________________________________________




885. UPDATE INTEREST ASSESSMENT ON MEDICARE OVERPAYMENT AND UNDERPAYMENT 
(CMS-6014-P)

Priority: Other Significant

Legal Authority: Social Security Act, sec 1815(d); Social Security Act, 
sec 1833(j)

CFR Citation: 42 CFR 405.378

Legal Deadline: None

Abstract: This proposed rule would change the formula used to compute 
interest on provider, supplier overpayments and underpayments.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses, Organizations

Government Levels Affected: None

Agency Contact: Paul Thomas Reed, Financial Management Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, C3-15-07, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-4001
Email: [email protected]

RIN: 0938-AL14
_______________________________________________________________________




886. REQUIREMENTS FOR PAID FEEDING ASSISTANTS IN LONG-TERM CARE 
FACILITIES (CMS-2131-P)

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

Unfunded Mandates: Undetermined

Legal Authority: Sec 1819(a) to (f) of the Social Security Act; sec 
1919(a) to (g) of the Social Security Act; PL 100-203

CFR Citation: 42 CFR 483.73; 42 CFR 483.75(c)

Legal Deadline: None

Abstract: This final rule would allow long-term care facilities to use 
paid feeding assistants to supplement the services of certified nurse 
aides. If facilities choose this option, feeding assistants must 
complete a specified training program.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/29/02                    67 FR 15149
NPRM Comment Period End         05/28/02
Final Rule                       To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: State, Federal

Agency Contact: Nola Petrovich, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, S2-14-26, 7500 
Security Boulevard, Baltimore, MD 21244
Phone: 410 786-4671

RIN: 0938-AL18
_______________________________________________________________________




887. USE OF RESTRAINT AND SECLUSION IN MEDICARE AND MEDICAID 
PARTICIPATING FACILITIES THAT PROVIDE INPATIENT OR RESIDENTIAL CARE 
(CMS-2130-P)

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

Unfunded Mandates: Undetermined

Legal Authority: Children's Health Act of 2000

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This proposed rule would implement provisions of the 
Children's Health Act related to the use of restraints or seclusion for 
individuals receiving services in health care

[[Page 33098]]

facilities that receive Federal funding. The rule would establish 
common terminology and basic expectations for the use of restraints and 
seclusion for health care facilities that furnish inpatient or 
residential care and receive Medicare or Medicaid funding.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: Undetermined

Federalism:  Undetermined

Agency Contact: Frank Sokolik, Center for Medicaid and State 
Operations, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, S2-13-23, 7500 Security Boulevard, 
Baltimore, MD 21244-1850
Phone: 410 786-7089

RIN: 0938-AL26
_______________________________________________________________________




888.  MEDICARE-ENDORSED PRESCRIPTION DRUG DISCOUNT CARD ASSISTANCE 
INITIATIVE FOR STATE SPONSORS (CMS-4032-P)

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: None

Legal Deadline: None

Abstract: This proposed rule would outline steps that support State 
efforts to make affordable prescription drugs available to Medicare 
beneficiaries.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/06/02                    67 FR 10293
NPRM Comment Period End         05/06/02


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

Agency Contact: Teresa Decaro, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, C5-17-14, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6604
Email: [email protected]

RIN: 0938-AL30
_______________________________________________________________________




889.  STATE CHILDREN'S HEALTH INSURANCE PROGRAM; ELIGIBILITY FOR 
UNBORN CHILDREN (CMS-2127-F)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 2110

CFR Citation: 42 CFR 457

Legal Deadline: None

Abstract: This regulation would provide States with the option to 
consider an unborn child to be a targeted low-income child and 
therefore eligible for SCHIP if other applicable State eligibility 
requirements are met. This would mean that regardless of the age of the 
mother, eligibility for the unborn child may be established thereby 
making services including prenatal care and delivery available.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            03/05/02                     67 FR 9936
NPRM Comment Period End         05/06/02
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Kathleen Muriel Farrell, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, S2-03-18, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-3285

RIN: 0938-AL37
_______________________________________________________________________




890.  HEALTH COVERAGE PORTABILITY FOR GROUP HEALTH PLANS AND GROUP 
HEALTH INSURANCE ISSUERS (CMS-2151-F)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: 42 USC 300gg; PL 104-191

CFR Citation: 45 CFR 144.103; 45 CFR 146.101; 45 CFR 146.111; 45 CFR 
146.113; 45 CFR 146.115; 45 CFR 146.117; 45 CFR 146.119; 45 CFR 
146.145; ...

Legal Deadline: None

Abstract: This final rule addresses limitations on preexisting 
exclusions periods and requests for special enrollments.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              04/08/97                    62 FR 16894
Interim Final Rule Comment 
Period End                      07/07/97
Interim Final Rule Effective    07/07/97


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State, Local, Federal

Agency Contact: David Mlawsky, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S3-16-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-6851

RIN: 0938-AL43
_______________________________________________________________________




891.  INTERIM FINAL AMENDMENT FOR MENTAL HEALTH PARITY (CMS-2152-IFC)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 2705; PL 107-116; PL 104-191

CFR Citation: 45 CFR 146.136

Legal Deadline: None

Abstract: This interim final rule changes the sunset date of 
regulations under the Mental Health Parity Act of 1996.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              11/22/97                    62 FR 66932
Interim Final Rule Effective    01/01/98
Interim Final Rule Comment 
Period End                      03/23/98


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State, Local

Agency Contact: David Mlawsky, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S3-16-26, 7500 Security Boulevard, Baltimore, MD 21244

[[Page 33099]]

Phone: 410 786-6851

RIN: 0938-AL44
_______________________________________________________________________




892.  PERMITTING PREMIUM REDUCTIONS AS ADDITIONAL BENEFITS UNDER 
MEDICARE+CHOICE PLANS (CMS-1208-P)

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

Unfunded Mandates: Undetermined

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 408.ff

Legal Deadline: Final, Statutory, January 1, 2003.

Abstract: This proposed rule would implement section 606 of BIPA to 
allow M+C organizations to elect a reduction in capitation payments so 
that these organizations could offer Medicare part B premium reductions 
to enrollees.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State, Local, Federal

Agency Contact: Michele Sanders, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-0808

RIN: 0938-AL49
_______________________________________________________________________




893.  PROSPECTIVE PAYMENT SYSTEM FOR PSYCHIATRIC HOSPITALS 
(CMS-1213-P)

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

Unfunded Mandates: Undetermined

Legal Authority: PL 106-113, Sec 124

CFR Citation: Not Yet Determined

Legal Deadline: NPRM, Statutory, October 1, 2002, per section 124 of 
Public Law 106-113.

Abstract: This proposed rule would set forth a prospective payment 
system for psychiatric hospitals.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Government Levels Affected: State, Local, Federal

Federalism:  Undetermined

Agency Contact: Lana Price, Director, Division of End-Stage Renal 
Disease, Bureau of Policy Development, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, C5-05-27, 7500 
Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-4533

RIN: 0938-AL50
_______________________________________________________________________




894.  PROVIDER REIMBURSEMENT DETERMINATIONS AND APPEALS (CMS-1727-P)

Priority: Substantive, Nonsignificant

Legal Authority: Sec 1878 of the Social Security Act

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This proposed rule would redefine, clarify, and update the 
guidelines and procedures for provider reimbursement review board 
appeals.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Morton Marcus, Center for Health Plans and Providers, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, C4-26-22, 7500 Security Boulevard, Baltimore, MD 
21244-1850
Phone: 410 786-4477

RIN: 0938-AL54
_______________________________________________________________________




895.  DEFINITION OF SEVERE MEDICALLY DETERMINABLE IMPAIRMENT 
(CMS-2143-P)

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

Legal Authority: PL 106-170, sec 201(a)(2)(D)

CFR Citation: 42 CFR 430; 42 CFR 435; 42 CFR 436

Legal Deadline: None

Abstract: This proposed rule would define ``severe medically 
determinable impairment'' for purposes of eligibility to Medicaid buy-
in programs for employed individuals with a medically improved 
disability. States have the option, under the Ticket to Work and Work 
Incentives Improvement Act, of amending their State plans to include 
workers with a medically improved disability.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State, Local, Federal

Federalism:  Undetermined

Agency Contact: Carey M. O'Connor, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, S2-14-26, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-2117

RIN: 0938-AL57
_______________________________________________________________________




896.  PROGRAM FOR ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE): PROGRAM 
REVISIONS (CMS-1201-IFC)

Priority: Other Significant

Legal Authority: 42 USC 1395, as revised by sec 903 of BIPA; 42 USC 
1396, as revised by sec 903 of BIPA

CFR Citation: 42 CFR 460ff

Legal Deadline: None

Abstract: This rule revises the interim final rule with comment period 
that established requirements for Programs of All-Inclusive Care for 
the Elderly (PACE) under the Medicare and Medicaid programs. These are 
pre-paid, capitated programs for beneficiaries who meet special 
eligibility requirements and who elect to enroll. The revisions in this 
rule will implement section 903 of BIPA.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule               To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Organizations

[[Page 33100]]

Government Levels Affected: State, Tribal

Federalism:  Undetermined

Agency Contact: Janet Samen, Center for Medicare Management, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
C4-08-15, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-9161

RIN: 0938-AL59
_______________________________________________________________________




897.  SCHIP; PURCHASE OF FAMILY COVERAGE--BENEFIT FLEXIBILITY IN 
PARENT COVERAGE (CMS-2148-P)

Priority: Substantive, Nonsignificant

Unfunded Mandates: Undetermined

Legal Authority: 42 USC 2110

CFR Citation: 42 CFR 457

Legal Deadline: None

Abstract: This proposed rule would provide flexibility to States in 
defining their benefit package for adults covered under the State 
Children's Health Insurance Program (SCHIP) family coverage options.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Terese Klitenic, Center for Medicaid and State 
Operations, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, C4-25-02, 7500 Security Boulevard, 
Baltimore, MD 21244-1850
Phone: 410 786-5942

RIN: 0938-AL62
_______________________________________________________________________




898.  REVISIONS TO MEDICAID COST-SHARING REGULATIONS (CMS-2144-P)

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: 42 CFR 447

Legal Deadline: None

Abstract: This proposed rule would revise existing regulations related 
to cost-sharing in Medicaid.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State, Tribal

Federalism:  Undetermined

Agency Contact: Ginni Hain, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, S2-16-27, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-6036

RIN: 0938-AL66
_______________________________________________________________________




899.  REVISIONS TO THE MEDICARE APPEALS PROCESS (CMS-4004-P)

Priority: Other Significant

Legal Authority: Sec 521 of BIPA

CFR Citation: 42 CFR 426

Legal Deadline: NPRM, Statutory, October 1, 2002, Statutory effective 
date 10/01/2002.

Abstract: This rule will incorporate recommendations from an SSA/HHS 
workgroup to improve the Administrative Law Judge (ALJ) hearing 
process. ALJs within the SSA who conduct hearings for Medicare fee-for-
service and managed care cases are currently governed by the SSA 
disability regulations. These regulations apply to disability cases and 
not to Medicare. In an effort to improve the integrity of the appeals 
process, CMS has recognized the need to develop regulations that are 
specific to the adjudication of Medicare cases.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: No

Government Levels Affected: Undetermined

Agency Contact: Tony Culotta, Department of Health and Human Services, 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, MD 21244
Phone: 410 786-4661

RIN: 0938-AL67
_______________________________________________________________________




900.  NOTICE OF INTENT TO CONDUCT NEGOTIATED RULEMAKING FOR SPECIAL 
PAYMENT PROVISIONS AND STANDARDS FOR SUPPLIERS OF CUSTOM-FABRICATED 
ORTHOTICS AND PROSTHETICS (CMS-6012-N)

Priority: Substantive, Nonsignificant

Legal Authority: Section 1834(h)(i); 42 USC 1395m(h)(i)

CFR Citation: None

Legal Deadline: None

Abstract: This notice announces standards for suppliers allowed to bill 
for prosthetics and certain customized orthotics. The Congress requires 
this proposed rule to be developed by a negotiated rulemaking advisory 
committee.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                           To Be                       Determined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Kathryn S Cox, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
C3-02-16, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5954

RIN: 0938-AL68
_______________________________________________________________________




901.  DMERC SERVICE AREAS AND RELATED MATTERS (CMS-1219-P)

Priority: Substantive, Nonsignificant

Legal Authority: Social Security Act, sec 1842; Social Security Act, 
sec 1834(a)(12); Social Security Act, sec 1834(h)(3); Social Security 
Act, sec 1834(j)(1)(E)

CFR Citation: 42 CFR 421.210(c); 42 CFR 421.210(d); 42 CFR 421.210(e)

Legal Deadline: None

Abstract: This proposed rule would allow flexibility in regulatory 
changes to the DMERC contractor structure.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

[[Page 33101]]

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: James Holt, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
S1-14-27, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-1953
Email: [email protected]

RIN: 0938-AL76
_______________________________________________________________________




902.  STATE ALLOTMENTS FOR PAYMENT OF MEDICARE PART B PREMIUMS FOR 
QUALIFYING INDIVIDUALS; FEDERAL FISCAL YEAR 2002 (CMS-2136-PN)

Priority: Other Significant. Major under 5 USC 801.

Legal Authority: Social Security Act, sec 1902(a)(10); Social Security 
Act, sec 1933; 42 USC 139; PL 105-33

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: This proposed notice announces the Federal FY 2002 allotments 
that are available for State agencies to pay Medicare part B premiums 
for two distinct categories of low-income Medicare beneficiaries. The 
eligible groups are called qualified individuals.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                           To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0938-AL79
_______________________________________________________________________




903.  REVISIONS TO CONDITIONS FOR COVERAGE FOR AMBULATORY SURGICAL 
CENTERS (CMS-3887-P)

Priority: Other Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

Legal Authority: Social Security Act, sec 1102; Social Security Act, 
sec 1832; Social Security Act, sec 1871

CFR Citation: 42 CFR 410; 42 CFR 424; 42 CFR 416; 42 CFR 488; 42 CFR 
489

Legal Deadline: None

Abstract: This proposed rule would revise the ambulatory surgical 
center conditions for coverage to reflect current innovations in 
healthcare delivery, quality assessment, and performance improvement.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: State

Agency Contact: Joan Brooks, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-5526

RIN: 0938-AL80
_______________________________________________________________________




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

Priority: Substantive, Nonsignificant

Legal Authority: PL 105-33

CFR Citation: 42 CFR 435; 42 CFR 436; 42 CFR 457

Legal Deadline: None

Abstract: This final rule removes all references to the ``Boren 
Amendment'' and grants States greater flexibility in setting payment 
rates for inpatient hospital and long-term care services.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              06/25/01                    66 FR 33810
Interim Final Rule Comment 
Period End                      07/25/01
Interim Final Rule Effective    08/24/01
Final Action                     To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State

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

Agency Contact: Regina Fletcher, Health Insurance Specialist, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, S2-01-16, 7500 Security Boulevard, Baltimore, MD 
21244
Phone: 410 786-3293

RIN: 0938-AL81
_______________________________________________________________________




905.  CONTINUE TO ALLOW STATES AN OPTION UNDER THE MEDICAID SPOUSAL 
IMPOVERISHMENT PROVISIONS TO INCREASE THE COMMUNITY SPOUSE'S INCOME WHEN 
ADJUSTING THE PROTECTED RESOURCE ALLOWANCE (CMS-2128-F)

Priority: Substantive, Nonsignificant

Legal Authority: Sec 1924 of the Social Security Act

CFR Citation: 42 CFR 431

Legal Deadline: None

Abstract: This rule will continue CMS' policy of giving States an 
option to either require, or not require, that income be contributed to 
a community spouse before additional resources are made available in 
making certain calculations related to spousal impoverishment 
protection.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            09/07/01                    66 FR 46763


Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

Related RIN: Previously reported as 0938-AL06
RIN: 0938-AL84

[[Page 33102]]

_______________________________________________________________________




906.  MEDICAID COVERAGE RULES FOR INMATES OF PUBLIC INSTITUTIONS 
(CMS-2077-P)

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

Unfunded Mandates: Undetermined

Legal Authority: Social Security Act, sec 1905(a)(A)

CFR Citation: 42 CFR 435.1008; 42 CFR 435.1009; 42 CFR 435.1012; 42 CFR 
436.1004

Legal Deadline: None

Abstract: This rule would provide a new interpretation of the statute 
in order to eliminate confusion among the States and to ensure 
consistent application of the FFP exclusionary rules for services 
provided to inmates of a public institution.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: State, Local

Agency Contact: Tom Shenk, Center for Medicaid and State Operations, 
Department of Health and Human Services, Centers for Medicare & 
Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-3295

RIN: 0938-AL85
_______________________________________________________________________




907.  TARGETED CASE MANAGEMENT (CMS-2061-P)

Priority: Substantive, Nonsignificant

Legal Authority: Sec 1915(g) of the Social Security Act

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

Legal Deadline: None

Abstract: This proposed rule would amend the Medicaid regulations to 
provide for optional coverage of case management services furnished to 
specific groups, geographic areas, or political subdivisions within a 
State. This proposed rule rescinds the proposed rule that was published 
on 10/15/93.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Kathy Poisal, Health Insurance Specialist, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
S2-14-26, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-5940

RIN: 0938-AL87
_______________________________________________________________________




908.  CHANGES TO THE HOSPITAL INPATIENT PROSPECTIVE PAYMENT SYSTEM 
AND FY 2004 RATES (CMS-1470-P)

Priority: Other Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

Legal Authority: Sec 1886(d) of the Social Security Act

CFR Citation: 42 CFR 412 to 413; 42 CFR 485; 42 CFR 489

Legal Deadline: NPRM, Statutory, April 1, 2003.
Final, Statutory, August 1, 2003.

Abstract: We would revise the Medicare acute hospital inpatient 
prospective payment systems for operating and capital market costs to 
implement changes arising from our continuing experience with these 
systems. These changes apply to discharges occurring on or after 
October 1, 2003.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

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

RIN: 0938-AL89
_______________________________________________________________________




909.  PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED 
NURSING FACILITIES--UPDATE FOR FY 2004 (CMS-1469-P)

Priority: Other Significant. Major under 5 USC 801.

Unfunded Mandates: Undetermined

Legal Authority: Sec 1888(e) of the Social Security Act

CFR Citation: None

Legal Deadline: NPRM, Statutory, April 1, 2003.
Final, Statutory, July 31, 2003, final rule to be published before 
August 1, 2003.

Abstract: This annual proposed rule updates the payment rates used 
under the SNF PPS beginning October 1, 2003.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: William Ullman, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, C4-13-15, 7500 
Security Boulevard, Baltimore, MD 21244-1850
Phone: 401 786-5667

RIN: 0938-AL90
_______________________________________________________________________




910.  PROSPECTIVE PAYMENT SYSTEM FOR LONG-TERM CARE HOSPITALS: FY 
2004 (CMS-1472-P)

Priority: Substantive, Nonsignificant

Legal Authority: BBRA 1999, sec 123; BIPA 2000, sec 307(b)

CFR Citation: 42 CFR 412; 42 CFR 413

Legal Deadline: None

Abstract: This rule establishes a Prospective Payment System for 
Medicare payment of inpatient hospital services provided by long-term 
care hospitals to replace the reasonable cost-based payment system 
under which they are currently paid. It implements section 123 of the 
Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999 
and section 307(b) of the Medicare, Medicaid, and SCHIP Benefits 
Improvement and Protection Act of 2000.

[[Page 33103]]

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

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

RIN: 0938-AL92
_______________________________________________________________________




911.  PROSPECTIVE PAYMENT SYSTEM FOR PSYCHIATRIC HOSPITALS 
(CMS-1477-P)

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

Unfunded Mandates: Undetermined

Legal Authority: PL 106-113, sec 124

CFR Citation: Not Yet Determined

Legal Deadline: NPRM, Statutory, October 1, 2002.

Abstract: This proposed rule would implement a per diem inpatient 
psychiatric prospective payment system as required by section 124 of 
Public Law 106-113.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Undetermined

Small Entities Affected: Businesses, Governmental Jurisdictions, 
Organizations

Government Levels Affected: None

Federalism:  Undetermined

Agency Contact: Lana Price, Director, Division of End-Stage Renal 
Disease, Bureau of Policy Development, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, C5-05-27, 7500 
Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-4533

RIN: 0938-AL93
_______________________________________________________________________




912.  HOME HEALTH PROSPECTIVE PAYMENT SYSTEM RATE UPDATE FOR FY 2004 
(CMS-1473-NC)

Priority: Other Significant

Legal Authority: Not Yet Determined

CFR Citation: Not Yet Determined

Legal Deadline: Other, Statutory, June 28, 2003, notice must be 
published by 06/28/2003 deadline in order to meet statutory effective 
date of 10/01/2003.

Abstract: This notice with comment period sets forth an update to the 
60-day national episode rates and the national per-visit amounts under 
the Medicare prospective payment system for home health agencies for FY 
2004. (We must publish this notice by 06/28/04 to meet the statutory 
effective date of 10/01/04.)

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Susan Levy, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
C4-05-27, 7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-9364

RIN: 0938-AL94
_______________________________________________________________________




913.  PROSPECTIVE PAYMENT SYSTEM FOR INPATIENT REHABILITATION 
HOSPITALS (CMS-1474-P)

Priority: Substantive, Nonsignificant

Legal Authority: Social Security Act, sec 1886(j); PL 105-33; PL 106-
554; PL 106-113

CFR Citation: 42 CFR 412 to 413

Legal Deadline: None

Abstract: This rule will address comments on the published proposed 
rule and finalizes a new prospective payment system for inpatient 
rehabilitation facilities beginning on or after 1/1/2004.

Timetable: Next Action Undetermined

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Robert Kuhl, Technical Advisor, Bureau of Policy 
Development, Department of Health and Human Services, Centers for 
Medicare & Medicaid Services, C4-11-06, 7500 Security Boulevard, 
Baltimore, MD 21244-1850
Phone: 410 786-4597

RIN: 0938-AL95
_______________________________________________________________________




914.  REVISIONS TO PAYMENT POLICIES UNDER THE PHYSICIAN FEE SCHEDULE 
FOR CALENDAR YEAR 2004 (CMS-1476-P)

Priority: Other Significant

Legal Authority: 42 USC 1395W-4

CFR Citation: Not Yet Determined

Legal Deadline: None

Abstract: Revisions to payment policies under the physician fee 
schedule for calendar year 2004.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                             To Be                       Determined

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal

Agency Contact: Latesha Walker, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, 7500 Security 
Boulevard, Baltimore, MD 21244
Phone: 410 786-1101

RIN: 0938-AL96

[[Page 33104]]

_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Centers for Medicare & Medicaid Services (CMS)



_______________________________________________________________________




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

Priority: Other Significant. Major under 5 USC 801.

CFR Citation: 42 CFR ch 410

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Action                    11/25/01                    66 FR 50788

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Local, Tribal

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

Agency Contact: Jacqueline Sheridan
Phone: 410 786-4635

RIN: 0938-AI92
_______________________________________________________________________




916. FEE SCHEDULE FOR PAYMENT OF AMBULANCE SERVICES AND REVISIONS TO THE 
PHYSICIAN'S CERTIFICATION REQUIREMENTS FOR COVERAGE OF NONEMERGENCY 
AMBULANCE SERVICES (CMS-1002-FC)

Priority: Other Significant

CFR Citation: 42 CFR 410; 42 CFR 414

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Final Rule                      02/27/02                     67 FR 9100

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Glenn McGuirk
Phone: 410 786-5723

RIN: 0938-AK30
_______________________________________________________________________




917. MEDICARE PROGRAM; REPORTING AND REPAYMENT OF OVERPAYMENTS (CMS-
6011-P)

Priority: Other Significant

CFR Citation: 42 CFR 401.310

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Merged With 0938-AD95           03/06/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Barbara Wright
Phone: 410 786-4292

RIN: 0938-AK45
_______________________________________________________________________




918. PROSPECTIVE PAYMENT SYSTEM FOR HOSPITAL OUTPATIENT SERVICES: 
CRITERIA FOR ESTABLISHING NEW PASS-THROUGH CATEGORIES FOR MEDICAL 
DEVICES (CMS-1179-IFC)

Priority: Other Significant

CFR Citation: 42 CFR 419

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule with Comment 
Period                          11/02/01                    66 FR 55850

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Nancy Edwards
Phone: 410 786-0378
Email: [email protected]

RIN: 0938-AK59
_______________________________________________________________________




919. QUALIFICATION REQUIREMENTS FOR DIRECTORS OF LABORATORIES PERFORMING 
HIGH COMPLEXITY TESTING (CMS-2094-P)

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

CFR Citation: 42 CFR 493.1443

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/28/01                    66 FR 67163
Merged With 0938-AK24           03/21/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: Cecelia Hinkel
Phone: 410 786-3347

RIN: 0938-AK83
_______________________________________________________________________




920. MEDICAID UPPER PAYMENT LIMIT FOR NON-STATE GOVERNMENT-OWNED OR -
OPERATED HOSPITALS (CMS-2134-F)

Priority: Economically Significant. Major under 5 USC 801.

CFR Citation: 42 CFR 447.321

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

NPRM                            11/23/01                    66 FR 58694
Final Rule                      01/18/02                     67 FR 2602
Notice                          03/19/02                    67 FR 12479

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Larry Reed
Phone: 410 786-3325

RIN: 0938-AL05
_______________________________________________________________________




921.  PHYSICIANS' REFERRALS TO HEALTH CARE ENTITIES WITH WHICH THEY 
HAVE FINANCIAL RELATIONSHIPS; DELAY OF EFFECTIVE DATE OF THE ``SET IN 
ADVANCE'' PROVISION (CMS-1809-IFC)

Priority: Other Significant

Legal Authority: 42 USC 1395

CFR Citation: 42 CFR 411.354(d)(1)

Legal Deadline: None

Abstract: This final rule temporarily delays for a one-year period the 
effective date of the ``set in advance'' provision in section 
411.354(d)(1) contained in the rule entitled ``Medicare and Medicaid 
Programs; Physicians' Referrals to Health Care Entities With Which They 
Have Financial Relationships,'' published in the Federal Register on 
January 4, 2001 (66 FR 856).

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              12/03/01                    66 FR 60154
Interim Final Rule Comment 
Period End                      02/01/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Businesses

Government Levels Affected: None

Agency Contact: Joanne Sinsheimer, Technical Advisor, CMM, Department 
of Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244-1850
Phone: 410 786-4620

RIN: 0938-AL29
_______________________________________________________________________




922.  DEDUCTIBLE AMOUNT FOR MEDIGAP HIGH DEDUCTIBLE OPTIONS FOR 
CALENDAR YEAR 2002 (CMS-2135-N)

Priority: Other Significant

Legal Authority: None

CFR Citation: None

Legal Deadline: None

[[Page 33105]]

Abstract: This notice announces the annual deductible amount for the 
Medicare supplemental health insurance (Medigap) high deductible 
options for 2002. The deductible amount represents the annual out-of-
pocket expenses (excluding premiums) that a beneficiary who chooses one 
of these options must pay before the policy begins paying benefits.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          12/28/01                    66 FR 67266

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, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-7623

RIN: 0938-AL34
_______________________________________________________________________




923.  PROSPECTIVE PAYMENT SYSTEM FOR HOSPITAL OUTPATIENT SERVICES; 
DELAY IN EFFECTIVE DATE OF CALENDAR YEAR 2002 PAYMENT RATES AND THE PRO 
RATA REDUCTION ON TRANSITIONAL PASS-THROUGH PAYMENT (CMS-1159-F3)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1395L

CFR Citation: 42 CFR 419

Legal Deadline: None

Abstract: This final rule delays the effective date of the payment 
rates announced for Medicare hospital outpatient services paid under 
the prospective payment system for calendar year 2002. These rates were 
announced in a November 30, 2001 final rule (66 FR 59856). In addition, 
this final rule delays the effective date of the uniform reduction to 
be applied to each of the transitional pass-through payments for CY 
2002.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/24/01                    66 FR 44672
NPRM Comment Period End         10/03/01
Final Action                    12/31/01                    66 FR 67494
Final Action Effective          04/01/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: James Hart, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-2033

RIN: 0938-AL35
_______________________________________________________________________




924.  DISAPPROVAL OF ALCON LABORATORIES REQUEST FOR AN ADJUSTMENT IN 
PAYMENT AMOUNTS FOR NEW TECHNOLOGY INTRAOCULAR LENSES FURNISHED BY 
AMBULATORY SURGICAL CENTERS (CMS-3061-FN)

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1832(a)(2)(F)(i) of the Social Security Act; 42 
USC 1833(i)(2)(A) of the Social Security Act; 42 USC 1395K(a)(2)(F)(i); 
42 USC 13951(i)(2)(A)

CFR Citation: None

Legal Deadline: Other, Statutory, February 22, 2002, Notice.

Abstract: This final notice responds to comments received and announces 
which lenses will qualify as new technology intraocular lenses.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          02/22/02                     67 FR 8270

Regulatory Flexibility Analysis Required: No

Small Entities Affected: No

Government Levels Affected: None

Agency Contact: Lori Davis, Health Insurance Specialist, Department of 
Health and Human Services, Centers for Medicare & Medicaid Services, 
S3-02-01, 7500 Security Boulevard, Baltimore, MD 21244
Phone: 410 786-0710

RIN: 0938-AL36
_______________________________________________________________________




925.  CORRECTION OF CERTAIN CALENDAR YEAR 2003 PAYMENT RATES UNDER THE 
HOSPITAL OUTPATIENT PROSPECTIVE PAYMENT SYSTEM AND THE PRO RATA 
REDUCTION ON TRANSITIONAL PASS-THROUGH PAYMENT (CMS-1159-F4)

Priority: Other Significant

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

CFR Citation: 42 CFR 419

Legal Deadline: None

Abstract: This final rule corrects errors that affect the amount and 
factors used to determine the payment rates for services paid under the 
hospital prospective payment system as published in the November 30, 
2001 final rule. This final rule also corrects the amount of the 
uniform reduction to be applied to each of the transitional pass-
through payments CY 2002.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Final Action                    03/01/02                     67 FR 9556
Final Action Effective          04/01/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses

Government Levels Affected: Federal

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

RIN: 0938-AL42
_______________________________________________________________________




926.  PROSPECTIVE PAYMENT SYSTEM AND CONSOLIDATED BILLING FOR SKILLED 
NURSING FACILITIES--CORRECTION NOTICE (CMS-1163-CN)

Priority: Other Significant

Legal Authority: None

CFR Citation: None

Legal Deadline: None

Abstract: This correction notice will clarify special responsibilities 
of Medicare hospitals that offer services for treatment of emergency 
medical conditions, to promote consistent application of the Emergency 
Treatment and Labor Act to situations not discussed in current 
regulations.

[[Page 33106]]

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Notice                          03/27/02                    67 FR 13278

Regulatory Flexibility Analysis Required: No

Government Levels Affected: None

Agency Contact: William Ullman, Department of Health and Human 
Services, Centers for Medicare & Medicaid Services, C4-13-15, 7500 
Security Boulevard, Baltimore, MD 21244-1850
Phone: 401 786-5667

Related RIN: Previously reported as 0938-AK47
RIN: 0938-AL47

_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




927. PROGRAM PERFORMANCE STANDARDS FOR THE OPERATION OF HEAD START 
PROGRAMS

Priority: Other Significant

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                            12/00/02

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
_______________________________________________________________________




928. SAFEGUARDING CHILD SUPPORT AND EXPANDED FPLS INFORMATION

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 652 to 654A; 42 USC 663

CFR Citation: 45 CFR 303.3; 45 CFR 303.21; 45 CFR 303.70

Legal Deadline: None

Abstract: The Personal Responsibility and Work Opportunity 
Reconciliation Act of 1996 made far-reaching amendments to title IV-D 
of the Social Security Act, which governs the child support enforcement 
program. The Balanced Budget Act of 1997, the Adoption and Safe 
Families Act of 1997 and the Child Support Performance and Incentive 
Act of 1998 further amended title IV-D. A significant result of this 
legislation is an expansion in the scope of information available to 
State IV-D child support enforcement agencies. The legislation has 
rendered obsolete or inconsistent several regulations at 45 CFR chapter 
III, Office of Child Support Enforcement, including the regulations on 
the Federal Parent Locator Service, the State Parent Locator Services, 
offset of Federal payments for purposes of collecting child support, 
and safeguarding of information. This regulation would update various 
sections in 45 CFR chapter III to reflect the statutory changes.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State, Local, Tribal

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
_______________________________________________________________________




929. DEVELOPMENTAL DISABILITIES AND BILL OF RIGHTS ACT

Priority: Substantive, Nonsignificant

Legal Authority: PL 106-402; USC 15001 et seq

CFR Citation: 45 CFR 1385 to 1388

Legal Deadline: Final, Statutory, October 30, 2001, The final rule for 
the ``Indicator of Progress'' must be effective by October 1, 2001. All 
other changes to the regulation are required to be made by October 30, 
2001.

Abstract: A notice of proposed rulemaking will be published in the 
Federal Register to amend current regulations and to implement changes 
made by the Developmental Disabilities Assistance and Bill of Rights 
Act of 2000.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            12/00/02

Regulatory Flexibility Analysis Required: No

Small Entities Affected: Governmental Jurisdictions, Organizations

Government Levels Affected: State, Local, Tribal

Agency Contact: Elsbeth Wyatt, Program Specialist, Department of Health 
and Human Services, Administration for Children and Families, ADD HHH-
300F, 370 L'Enfant Promenade SW., Washington, DC 20447
Phone: 202 690-5841

RIN: 0970-AC07

[[Page 33107]]

_______________________________________________________________________


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


Administration for Children and Families (ACF)



_______________________________________________________________________




930. 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                    08/00/02

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
_______________________________________________________________________




931. CHILD SUPPORT ENFORCEMENT FOR INDIAN TRIBES

Priority: Other Significant

Legal Authority: 42 USC 655(f)

CFR Citation: 45 CFR 309

Legal Deadline: None

Abstract: This rule specifies how tribes can obtain direct payments 
from the Department of Health and Human Services for provision of child 
support enforcement services if they submit a plan meeting the 
objectives of title IV-D, including establishment of paternity, 
modification and enforcement of support orders, and location of absent 
parents.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            08/21/00                    65 FR 50800
Final Action                    12/00/02

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
_______________________________________________________________________




932. CHILD SUPPORT ENFORCEMENT PROGRAM OMNIBUS CONFORMING REGULATION

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 1302

CFR Citation: 45 CFR 301 to 305

Legal Deadline: None

Abstract: This rule eliminates child support enforcement program 
regulations rendered obsolete or inconsistent with the Personal 
Responsibility and Work Opportunity Reconciliation Act of 1996, and its 
technical amendments, the Balanced Budget Act of 1997, the Adoption and 
Safe Families Act of 1997, and the Child Support Performance and 
Incentive Act of 1998.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

Interim Final Rule              02/09/99                     64 FR 6237
Final Action                    11/00/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Eileen C. Brooks, Program Specialist, Department of 
Health and Human Services, Administration for Children and Families, 
4th Floor East, OCSE, DPP, 370 L'Enfant Promenade SW., Washington, DC 
20447
Phone: 202 401-5369
Email: [email protected]

RIN: 0970-AB81
_______________________________________________________________________




933. 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                    12/00/02

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
_______________________________________________________________________




934. 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 that 
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              12/00/02

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

[[Page 33108]]

Email: [email protected]

RIN: 0970-AC00
_______________________________________________________________________


Department of Health and Human Services (HHS)         Completed Actions


Administration for Children and Families (ACF)



_______________________________________________________________________




935. HIGH PERFORMANCE BONUS AWARDS UNDER THE TANF PROGRAM

Priority: Substantive, Nonsignificant

CFR Citation: 45 CFR 270

Completed:
________________________________________________________________________

Reason                            Date                      FR Cite

________________________________________________________________________

Withdrawn                       03/15/02

Regulatory Flexibility Analysis Required: No

Government Levels Affected: State

Agency Contact: Stephanie Fanjul
Phone: 202 690-6782
Email: [email protected]

RIN: 0970-AC06

_______________________________________________________________________


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


Administration on Aging (AOA)



_______________________________________________________________________




936. GRANTS FOR STATE AND COMMUNITY PROGRAMS ON AGING, TRAINING, 
RESEARCH, AND DISCRETIONARY PROGRAMS; VULNERABLE ELDER RIGHTS; AND 
GRANTS TO INDIANS AND NATIVE HAWAIIANS

Priority: Substantive, Nonsignificant

Legal Authority: 42 USC 3001 et seq

CFR Citation: 45 CFR 1321; 45 CFR 1326; 45 CFR 1328

Legal Deadline: None

Abstract: In response to the recent reauthorization of the Older 
Americans Act, Public Law 106-501, the Administration on Aging (AoA) 
proposes to issue a notice of proposed rulemaking by fall of 2002.

Timetable:
________________________________________________________________________

Action                            Date                      FR Cite

________________________________________________________________________

NPRM                            10/00/02

Regulatory Flexibility Analysis Required: Yes

Small Entities Affected: Businesses, Governmental Jurisdictions

Government Levels Affected: State, Tribal

Federalism:  Undetermined

Additional Information: Incorrectly reported as under Section 610 
Review in April 2001.

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. 02-11100 Filed 05-10-02; 8:45 am]
BILLING CODE 4150-24-S
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